Women's Health

Second-generation antipsychotics (SGAs) taken by pregnant women are linked to a low rate of adverse effects in their children, new research suggests.

monkeybusinessimages/Thinkstock

Data from a large registry study of almost 2,000 women showed that 2.5% of the live births in a group that had been exposed to antipsychotics had confirmed major malformations compared with 2% of the live births in a non-exposed group. This translated into an estimated odds ratio of 1.5 for major malformations.

“The 2.5% absolute risk for major malformations is consistent with the estimates of the Centers for Disease Control and Prevention’s national baseline rate of major malformations in the general population,” lead author Adele Viguera, MD, MPH, director of research for women’s mental health, Cleveland Clinic Neurological Institute, told this news organization.

“Our results are reassuring and suggest that second-generation antipsychotics, as a class, do not substantially increase the risk of major malformations,” Dr. Viguera said.

The findings were published online August 3 in the Journal of Clinical Psychiatry.
 

Safety data scarce

Despite the increasing use of SGAs to treat a “spectrum of psychiatric disorders,” relatively little data are available on the reproductive safety of these agents, Dr. Viguera said.

The National Pregnancy Registry for Atypical Antipsychotics (NPRAA) was established in 2008 to determine risk for major malformation among infants exposed to these medications during the first trimester, relative to a comparison group of unexposed infants of mothers with histories of psychiatric morbidity.

The NPRAA follows pregnant women (aged 18 to 45 years) with psychiatric illness who are exposed or unexposed to SGAs during pregnancy. Participants are recruited through nationwide provider referral, self-referral, and advertisement through the Massachusetts General Hospital Center for Women’s Mental Health website.

The women are interviewed by phone at three timepoints: Enrollment, 7 months, and 3 months postpartum. Specific data collected are shown in the following table.

Demographic differences

Of the 1,906 women who enrolled as of April 2020, 1,311 (mean age, 32.6 years; 81.3% White) completed the study and were eligible for inclusion in the analysis.

Although the groups had a virtually identical mean age, fewer women in the exposure group were married compared with those in the non-exposure group (77% vs. 90%, respectively) and fewer had a college education (71.2% vs. 87.8%). There was also a higher percentage of first-trimester cigarette smokers in the exposure group (18.4% vs. 5.1%).

On the other hand, more women in the non-exposure group used alcohol than in the exposure group (28.6% vs. 21.4%, respectively).

The most frequent psychiatric disorder in the exposure group was bipolar disorder (63.9%), followed by major depression (12.9%), anxiety (5.8%), and schizophrenia (4.5%). Only 11.4% of women in the non-exposure group were diagnosed with bipolar disorder, whereas 34.1% were diagnosed with major depression, 31.3% with anxiety, and none with schizophrenia.

Notably, a large percentage of women in both groups had a history of postpartum depression and/or psychosis (41.4% and 35.5%, respectively).

The most frequently used SGAs in the exposure group were quetiapine (Seroquel), aripiprazole (Abilify), and lurasidone (Latuda).

Participants in the exposure group had a higher age at initial onset of primary psychiatric diagnosis and a lower proportion of lifetime illness compared with those in the non-exposure group.
 

Major clinical implication?

Among 640 live births in the exposure group, which included 17 twin pregnancies and 1 triplet pregnancy, 2.5% reported major malformations. Among 704 live births in the control group, which included 14 twin pregnancies, 1.99% reported major malformations.

The estimated OR for major malformations comparing exposed and unexposed infants was 1.48 (95% confidence interval, 0.625-3.517).

The authors note that their findings were consistent with one of the largest studies to date, which included a nationwide sample of more than 1 million women. Its results showed that, among infants exposed to SGAs versus those who were not exposed, the estimated risk ratio after adjusting for psychiatric conditions was 1.05 (95% CI, 0.96-1.16).

Additionally, “a hallmark of a teratogen is that it tends to cause a specific type or pattern of malformations, and we found no preponderance of one single type of major malformation or specific pattern of malformations among the exposed and unexposed groups,” Dr. Viguera said

“A major clinical implication of these findings is that for women with major mood and/or psychotic disorders, treatment with an atypical antipsychotic during pregnancy may be the most prudent clinical decision, much as continued treatment is recommended for pregnant women with other serious and chronic medical conditions, such as epilepsy,” she added.
 

The concept of ‘satisficing’

Commenting on the study, Vivien Burt, MD, PhD, founder and director/consultant of the Women’s Life Center at the Resnick University of California, Los Angeles (UCLA) Neuropsychiatric Hospital, called the findings “reassuring.”

The results “support the conclusion that in pregnant women with serious psychiatric illnesses, the use of SGAs is often a better option than avoiding these medications and exposing both the women and their offspring to the adverse consequences of maternal mental illness,” she said.

An accompanying editorial co-authored by Dr. Burt and colleague Sonya Rasminsky, MD, introduced the concept of “satisficing” – a term coined by Herbert Simon, a behavioral economist and Nobel Laureate. “Satisficing” is a “decision-making strategy that aims for a satisfactory (‘good enough’) outcome rather than a perfect one.”

The concept applies to decision-making beyond the field of economics “and is critical to how physicians help patients make decisions when they are faced with multiple treatment options,” said Dr. Burt, a professor emeritus of psychiatry at UCLA.

“The goal of ‘satisficing’ is to plan for the most satisfactory outcome, knowing that there are always unknowns, so in an uncertain world, clinicians should carefully help their patients make decisions that will allow them to achieve an outcome they can best live with,” she noted.

The investigators note that their findings may not be generalizable to the larger population of women taking SGAs, given that their participants were “overwhelmingly White, married, and well-educated women.”

They add that enrollment into the NPRAA registry is ongoing and larger sample sizes will “further narrow the confidence interval around the risk estimates and allow for adjustment of likely sources of confounding.”

The NPRAA is supported by Alkermes, Johnson & Johnson/Janssen Pharmaceuticals, Otsuka America Pharmaceutical, Sunovion Pharmaceuticals, SAGE Therapeutics, Teva Pharmaceuticals, and Aurobindo Pharma. Past sponsors of the NPRAA are listed in the original paper. Dr. Viguera receives research support from the NPRAA, Alkermes Biopharmaceuticals, Aurobindo Pharma, Janssen Pharmaceuticals, Otsuka Pharmaceutical, Sunovion Pharmaceuticals, Teva Pharmaceuticals, and SAGE Therapeutics and receives adviser/consulting fees from Up-to-Date. Dr. Burt has been a consultant/speaker for Sage Therapeutics. Dr. Rasminsky has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Second-generation antipsychotics (SGAs) taken by pregnant women are linked to a low rate of adverse effects in their children, new research suggests.

monkeybusinessimages/Thinkstock

Data from a large registry study of almost 2,000 women showed that 2.5% of the live births in a group that had been exposed to antipsychotics had confirmed major malformations compared with 2% of the live births in a non-exposed group. This translated into an estimated odds ratio of 1.5 for major malformations.

“The 2.5% absolute risk for major malformations is consistent with the estimates of the Centers for Disease Control and Prevention’s national baseline rate of major malformations in the general population,” lead author Adele Viguera, MD, MPH, director of research for women’s mental health, Cleveland Clinic Neurological Institute, told this news organization.

“Our results are reassuring and suggest that second-generation antipsychotics, as a class, do not substantially increase the risk of major malformations,” Dr. Viguera said.

The findings were published online August 3 in the Journal of Clinical Psychiatry.
 

Safety data scarce

Despite the increasing use of SGAs to treat a “spectrum of psychiatric disorders,” relatively little data are available on the reproductive safety of these agents, Dr. Viguera said.

The National Pregnancy Registry for Atypical Antipsychotics (NPRAA) was established in 2008 to determine risk for major malformation among infants exposed to these medications during the first trimester, relative to a comparison group of unexposed infants of mothers with histories of psychiatric morbidity.

The NPRAA follows pregnant women (aged 18 to 45 years) with psychiatric illness who are exposed or unexposed to SGAs during pregnancy. Participants are recruited through nationwide provider referral, self-referral, and advertisement through the Massachusetts General Hospital Center for Women’s Mental Health website.

The women are interviewed by phone at three timepoints: Enrollment, 7 months, and 3 months postpartum. Specific data collected are shown in the following table.

Demographic differences

Of the 1,906 women who enrolled as of April 2020, 1,311 (mean age, 32.6 years; 81.3% White) completed the study and were eligible for inclusion in the analysis.

Although the groups had a virtually identical mean age, fewer women in the exposure group were married compared with those in the non-exposure group (77% vs. 90%, respectively) and fewer had a college education (71.2% vs. 87.8%). There was also a higher percentage of first-trimester cigarette smokers in the exposure group (18.4% vs. 5.1%).

On the other hand, more women in the non-exposure group used alcohol than in the exposure group (28.6% vs. 21.4%, respectively).

The most frequent psychiatric disorder in the exposure group was bipolar disorder (63.9%), followed by major depression (12.9%), anxiety (5.8%), and schizophrenia (4.5%). Only 11.4% of women in the non-exposure group were diagnosed with bipolar disorder, whereas 34.1% were diagnosed with major depression, 31.3% with anxiety, and none with schizophrenia.

Notably, a large percentage of women in both groups had a history of postpartum depression and/or psychosis (41.4% and 35.5%, respectively).

The most frequently used SGAs in the exposure group were quetiapine (Seroquel), aripiprazole (Abilify), and lurasidone (Latuda).

Participants in the exposure group had a higher age at initial onset of primary psychiatric diagnosis and a lower proportion of lifetime illness compared with those in the non-exposure group.
 

Major clinical implication?

Among 640 live births in the exposure group, which included 17 twin pregnancies and 1 triplet pregnancy, 2.5% reported major malformations. Among 704 live births in the control group, which included 14 twin pregnancies, 1.99% reported major malformations.

The estimated OR for major malformations comparing exposed and unexposed infants was 1.48 (95% confidence interval, 0.625-3.517).

The authors note that their findings were consistent with one of the largest studies to date, which included a nationwide sample of more than 1 million women. Its results showed that, among infants exposed to SGAs versus those who were not exposed, the estimated risk ratio after adjusting for psychiatric conditions was 1.05 (95% CI, 0.96-1.16).

Additionally, “a hallmark of a teratogen is that it tends to cause a specific type or pattern of malformations, and we found no preponderance of one single type of major malformation or specific pattern of malformations among the exposed and unexposed groups,” Dr. Viguera said

“A major clinical implication of these findings is that for women with major mood and/or psychotic disorders, treatment with an atypical antipsychotic during pregnancy may be the most prudent clinical decision, much as continued treatment is recommended for pregnant women with other serious and chronic medical conditions, such as epilepsy,” she added.
 

The concept of ‘satisficing’

Commenting on the study, Vivien Burt, MD, PhD, founder and director/consultant of the Women’s Life Center at the Resnick University of California, Los Angeles (UCLA) Neuropsychiatric Hospital, called the findings “reassuring.”

The results “support the conclusion that in pregnant women with serious psychiatric illnesses, the use of SGAs is often a better option than avoiding these medications and exposing both the women and their offspring to the adverse consequences of maternal mental illness,” she said.

An accompanying editorial co-authored by Dr. Burt and colleague Sonya Rasminsky, MD, introduced the concept of “satisficing” – a term coined by Herbert Simon, a behavioral economist and Nobel Laureate. “Satisficing” is a “decision-making strategy that aims for a satisfactory (‘good enough’) outcome rather than a perfect one.”

The concept applies to decision-making beyond the field of economics “and is critical to how physicians help patients make decisions when they are faced with multiple treatment options,” said Dr. Burt, a professor emeritus of psychiatry at UCLA.

“The goal of ‘satisficing’ is to plan for the most satisfactory outcome, knowing that there are always unknowns, so in an uncertain world, clinicians should carefully help their patients make decisions that will allow them to achieve an outcome they can best live with,” she noted.

The investigators note that their findings may not be generalizable to the larger population of women taking SGAs, given that their participants were “overwhelmingly White, married, and well-educated women.”

They add that enrollment into the NPRAA registry is ongoing and larger sample sizes will “further narrow the confidence interval around the risk estimates and allow for adjustment of likely sources of confounding.”

The NPRAA is supported by Alkermes, Johnson & Johnson/Janssen Pharmaceuticals, Otsuka America Pharmaceutical, Sunovion Pharmaceuticals, SAGE Therapeutics, Teva Pharmaceuticals, and Aurobindo Pharma. Past sponsors of the NPRAA are listed in the original paper. Dr. Viguera receives research support from the NPRAA, Alkermes Biopharmaceuticals, Aurobindo Pharma, Janssen Pharmaceuticals, Otsuka Pharmaceutical, Sunovion Pharmaceuticals, Teva Pharmaceuticals, and SAGE Therapeutics and receives adviser/consulting fees from Up-to-Date. Dr. Burt has been a consultant/speaker for Sage Therapeutics. Dr. Rasminsky has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Second-generation antipsychotics (SGAs) taken by pregnant women are linked to a low rate of adverse effects in their children, new research suggests.

monkeybusinessimages/Thinkstock

Data from a large registry study of almost 2,000 women showed that 2.5% of the live births in a group that had been exposed to antipsychotics had confirmed major malformations compared with 2% of the live births in a non-exposed group. This translated into an estimated odds ratio of 1.5 for major malformations.

“The 2.5% absolute risk for major malformations is consistent with the estimates of the Centers for Disease Control and Prevention’s national baseline rate of major malformations in the general population,” lead author Adele Viguera, MD, MPH, director of research for women’s mental health, Cleveland Clinic Neurological Institute, told this news organization.

“Our results are reassuring and suggest that second-generation antipsychotics, as a class, do not substantially increase the risk of major malformations,” Dr. Viguera said.

The findings were published online August 3 in the Journal of Clinical Psychiatry.
 

Safety data scarce

Despite the increasing use of SGAs to treat a “spectrum of psychiatric disorders,” relatively little data are available on the reproductive safety of these agents, Dr. Viguera said.

The National Pregnancy Registry for Atypical Antipsychotics (NPRAA) was established in 2008 to determine risk for major malformation among infants exposed to these medications during the first trimester, relative to a comparison group of unexposed infants of mothers with histories of psychiatric morbidity.

The NPRAA follows pregnant women (aged 18 to 45 years) with psychiatric illness who are exposed or unexposed to SGAs during pregnancy. Participants are recruited through nationwide provider referral, self-referral, and advertisement through the Massachusetts General Hospital Center for Women’s Mental Health website.

The women are interviewed by phone at three timepoints: Enrollment, 7 months, and 3 months postpartum. Specific data collected are shown in the following table.

Demographic differences

Of the 1,906 women who enrolled as of April 2020, 1,311 (mean age, 32.6 years; 81.3% White) completed the study and were eligible for inclusion in the analysis.

Although the groups had a virtually identical mean age, fewer women in the exposure group were married compared with those in the non-exposure group (77% vs. 90%, respectively) and fewer had a college education (71.2% vs. 87.8%). There was also a higher percentage of first-trimester cigarette smokers in the exposure group (18.4% vs. 5.1%).

On the other hand, more women in the non-exposure group used alcohol than in the exposure group (28.6% vs. 21.4%, respectively).

The most frequent psychiatric disorder in the exposure group was bipolar disorder (63.9%), followed by major depression (12.9%), anxiety (5.8%), and schizophrenia (4.5%). Only 11.4% of women in the non-exposure group were diagnosed with bipolar disorder, whereas 34.1% were diagnosed with major depression, 31.3% with anxiety, and none with schizophrenia.

Notably, a large percentage of women in both groups had a history of postpartum depression and/or psychosis (41.4% and 35.5%, respectively).

The most frequently used SGAs in the exposure group were quetiapine (Seroquel), aripiprazole (Abilify), and lurasidone (Latuda).

Participants in the exposure group had a higher age at initial onset of primary psychiatric diagnosis and a lower proportion of lifetime illness compared with those in the non-exposure group.
 

Major clinical implication?

Among 640 live births in the exposure group, which included 17 twin pregnancies and 1 triplet pregnancy, 2.5% reported major malformations. Among 704 live births in the control group, which included 14 twin pregnancies, 1.99% reported major malformations.

The estimated OR for major malformations comparing exposed and unexposed infants was 1.48 (95% confidence interval, 0.625-3.517).

The authors note that their findings were consistent with one of the largest studies to date, which included a nationwide sample of more than 1 million women. Its results showed that, among infants exposed to SGAs versus those who were not exposed, the estimated risk ratio after adjusting for psychiatric conditions was 1.05 (95% CI, 0.96-1.16).

Additionally, “a hallmark of a teratogen is that it tends to cause a specific type or pattern of malformations, and we found no preponderance of one single type of major malformation or specific pattern of malformations among the exposed and unexposed groups,” Dr. Viguera said

“A major clinical implication of these findings is that for women with major mood and/or psychotic disorders, treatment with an atypical antipsychotic during pregnancy may be the most prudent clinical decision, much as continued treatment is recommended for pregnant women with other serious and chronic medical conditions, such as epilepsy,” she added.
 

The concept of ‘satisficing’

Commenting on the study, Vivien Burt, MD, PhD, founder and director/consultant of the Women’s Life Center at the Resnick University of California, Los Angeles (UCLA) Neuropsychiatric Hospital, called the findings “reassuring.”

The results “support the conclusion that in pregnant women with serious psychiatric illnesses, the use of SGAs is often a better option than avoiding these medications and exposing both the women and their offspring to the adverse consequences of maternal mental illness,” she said.

An accompanying editorial co-authored by Dr. Burt and colleague Sonya Rasminsky, MD, introduced the concept of “satisficing” – a term coined by Herbert Simon, a behavioral economist and Nobel Laureate. “Satisficing” is a “decision-making strategy that aims for a satisfactory (‘good enough’) outcome rather than a perfect one.”

The concept applies to decision-making beyond the field of economics “and is critical to how physicians help patients make decisions when they are faced with multiple treatment options,” said Dr. Burt, a professor emeritus of psychiatry at UCLA.

“The goal of ‘satisficing’ is to plan for the most satisfactory outcome, knowing that there are always unknowns, so in an uncertain world, clinicians should carefully help their patients make decisions that will allow them to achieve an outcome they can best live with,” she noted.

The investigators note that their findings may not be generalizable to the larger population of women taking SGAs, given that their participants were “overwhelmingly White, married, and well-educated women.”

They add that enrollment into the NPRAA registry is ongoing and larger sample sizes will “further narrow the confidence interval around the risk estimates and allow for adjustment of likely sources of confounding.”

The NPRAA is supported by Alkermes, Johnson & Johnson/Janssen Pharmaceuticals, Otsuka America Pharmaceutical, Sunovion Pharmaceuticals, SAGE Therapeutics, Teva Pharmaceuticals, and Aurobindo Pharma. Past sponsors of the NPRAA are listed in the original paper. Dr. Viguera receives research support from the NPRAA, Alkermes Biopharmaceuticals, Aurobindo Pharma, Janssen Pharmaceuticals, Otsuka Pharmaceutical, Sunovion Pharmaceuticals, Teva Pharmaceuticals, and SAGE Therapeutics and receives adviser/consulting fees from Up-to-Date. Dr. Burt has been a consultant/speaker for Sage Therapeutics. Dr. Rasminsky has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

At a maternal–fetal medicine practice in New York, monochorionic pregnancies were not at increased risk for cesarean delivery, compared with dichorionic pregnancies, a retrospective study shows.

Between 2005 and 2021, mode of delivery of diamniotic twins at this practice did not significantly differ by chorionicity, researchers affiliated with Maternal Fetal Medicine Associates and the department of obstetrics, gynecology, and reproductive science at Icahn School of Medicine at Mount Sinai, New York reported in Obstetrics & Gynecology.

The study supports a recommendation from the American College of Obstetricians and Gynecologists that vaginal delivery “is a reasonable option in well selected diamniotic twin pregnancies, irrespective of chorionicity, and should be considered, provided that an experienced obstetrician is available,” said Iris Krishna, MD, assistant professor of maternal-fetal medicine at Emory University, Atlanta.

The experience at this practice, however, may not apply to many practices in the United States, said Dr. Krishna, who was not involved in the study.

Of 1,121 diamniotic twin pregnancies included in the analysis, 202 (18%) were monochorionic. The cesarean delivery rate was not significantly different between groups: 61% for monochorionic and 63% for dichorionic pregnancies.

Among women with planned vaginal delivery (101 monochorionic pregnancies and 422 dichorionic pregnancies), the cesarean delivery rate likewise did not significantly differ by chorionicity. Twenty-two percent of the monochorionic pregnancies and 21% of the dichorionic pregnancies in this subgroup had a cesarean delivery.

Among patients with a vaginal delivery of twin A, chorionicity was not associated with mode of delivery for twin B. Combined vaginal-cesarean deliveries occurred less than 1% of the time, and breech extraction of twin B occurred approximately 75% of the time, regardless of chorionicity.

The researchers also compared neonatal outcomes for monochorionic-diamniotic twin pregnancies at or after 34 weeks of gestation, based on the intended mode of delivery (95 women with planned vaginal delivery and 68 with planned cesarean delivery). Neonatal outcomes generally were similar, although the incidence of mechanical ventilation was less common in cases with planned vaginal delivery (7% vs. 21%).

“Our data affirm that an attempt at a vaginal birth for twin pregnancies, without contraindications to vaginal delivery and regardless of chorionicity, is reasonable and achievable,” wrote study author Henry N. Lesser, MD, with the department of obstetrics and gynecology at Sinai Hospital in Baltimore, and colleagues.

The patients with planned cesarean delivery had a contraindication to vaginal delivery or otherwise chose to have a cesarean delivery. The researchers excluded from their analysis pregnancies with intrauterine fetal demise of either twin before labor or planned cesarean delivery.

The study’s reliance on data from a single practice decreases its external validity, the researchers noted. Induction of labor at this center typically occurs at 37 weeks’ gestation for monochorionic twins and at 38 weeks for dichorionic twins, and “senior personnel experienced in intrauterine twin manipulation are always present at delivery,” the study authors said.

The study describes “the experience of a single site with skilled obstetricians following a standardized approach to management of diamniotic twin deliveries,” Dr. Krishna said. “Findings may not be generalizable to many U.S. practices as obstetrics and gynecology residents often lack training in breech extraction or internal podalic version of the second twin. This underscores the importance of a concerted effort by skilled senior physicians to train junior physicians in vaginal delivery of the second twin to improve overall outcomes amongst women with diamniotic twin gestations.”

Michael F. Greene, MD, professor emeritus of obstetrics, gynecology, and reproductive biology at Massachusetts General Hospital, Boston, agreed that the findings are not generalizable to the national population. Approximately 10% of the patients in the study had prepregnancy obesity, whereas doctors practicing in other areas likely encounter higher rates, Dr. Greene said in an interview.

He also wondered about other data points that could be of interest but were not reported, such as the racial or ethnic distribution of the patients, rates of birth defects, the use of instruments to aid delivery, and neonatal outcomes for the dichorionic twins.

Monochorionic pregnancies entail a risk of twin-twin transfusion syndrome and other complications, including an increased likelihood of birth defects.

Dr. Greene is an associate editor with the New England Journal of Medicine, which in 2013 published results from the Twin Birth Study, an international trial where women with dichorionic or monochorionic twins were randomly assigned to planned vaginal delivery or planned cesarean delivery. Outcomes did not significantly differ between groups. In the trial, the rate of cesarean delivery in the group with planned vaginal delivery was 43.8%, and Dr. Greene discussed the implications of the study in an accompanying editorial.

Since then, the obstetrics and gynecology community “has been focusing in recent years on trying to avoid the first cesarean section” when it is safe to do so, Dr. Greene said. “That has become almost a bumper sticker in modern obstetrics.”

And patients should know that it is an option, Dr. Krishna added.

“Women with monochorionic-diamniotic twins should be counseled that with an experienced obstetrician that an attempt at vaginal delivery is not associated with adverse neonatal outcomes when compared with planned cesarean delivery,” Dr. Krishna said.

A study coauthor disclosed serving on the speakers bureau for Natera and Hologic. Dr. Krishna is a member of the editorial advisory board for Ob.Gyn. News.
 

jremaly@mdedge.com

At a maternal–fetal medicine practice in New York, monochorionic pregnancies were not at increased risk for cesarean delivery, compared with dichorionic pregnancies, a retrospective study shows.

Between 2005 and 2021, mode of delivery of diamniotic twins at this practice did not significantly differ by chorionicity, researchers affiliated with Maternal Fetal Medicine Associates and the department of obstetrics, gynecology, and reproductive science at Icahn School of Medicine at Mount Sinai, New York reported in Obstetrics & Gynecology.

The study supports a recommendation from the American College of Obstetricians and Gynecologists that vaginal delivery “is a reasonable option in well selected diamniotic twin pregnancies, irrespective of chorionicity, and should be considered, provided that an experienced obstetrician is available,” said Iris Krishna, MD, assistant professor of maternal-fetal medicine at Emory University, Atlanta.

The experience at this practice, however, may not apply to many practices in the United States, said Dr. Krishna, who was not involved in the study.

Of 1,121 diamniotic twin pregnancies included in the analysis, 202 (18%) were monochorionic. The cesarean delivery rate was not significantly different between groups: 61% for monochorionic and 63% for dichorionic pregnancies.

Among women with planned vaginal delivery (101 monochorionic pregnancies and 422 dichorionic pregnancies), the cesarean delivery rate likewise did not significantly differ by chorionicity. Twenty-two percent of the monochorionic pregnancies and 21% of the dichorionic pregnancies in this subgroup had a cesarean delivery.

Among patients with a vaginal delivery of twin A, chorionicity was not associated with mode of delivery for twin B. Combined vaginal-cesarean deliveries occurred less than 1% of the time, and breech extraction of twin B occurred approximately 75% of the time, regardless of chorionicity.

The researchers also compared neonatal outcomes for monochorionic-diamniotic twin pregnancies at or after 34 weeks of gestation, based on the intended mode of delivery (95 women with planned vaginal delivery and 68 with planned cesarean delivery). Neonatal outcomes generally were similar, although the incidence of mechanical ventilation was less common in cases with planned vaginal delivery (7% vs. 21%).

“Our data affirm that an attempt at a vaginal birth for twin pregnancies, without contraindications to vaginal delivery and regardless of chorionicity, is reasonable and achievable,” wrote study author Henry N. Lesser, MD, with the department of obstetrics and gynecology at Sinai Hospital in Baltimore, and colleagues.

The patients with planned cesarean delivery had a contraindication to vaginal delivery or otherwise chose to have a cesarean delivery. The researchers excluded from their analysis pregnancies with intrauterine fetal demise of either twin before labor or planned cesarean delivery.

The study’s reliance on data from a single practice decreases its external validity, the researchers noted. Induction of labor at this center typically occurs at 37 weeks’ gestation for monochorionic twins and at 38 weeks for dichorionic twins, and “senior personnel experienced in intrauterine twin manipulation are always present at delivery,” the study authors said.

The study describes “the experience of a single site with skilled obstetricians following a standardized approach to management of diamniotic twin deliveries,” Dr. Krishna said. “Findings may not be generalizable to many U.S. practices as obstetrics and gynecology residents often lack training in breech extraction or internal podalic version of the second twin. This underscores the importance of a concerted effort by skilled senior physicians to train junior physicians in vaginal delivery of the second twin to improve overall outcomes amongst women with diamniotic twin gestations.”

Michael F. Greene, MD, professor emeritus of obstetrics, gynecology, and reproductive biology at Massachusetts General Hospital, Boston, agreed that the findings are not generalizable to the national population. Approximately 10% of the patients in the study had prepregnancy obesity, whereas doctors practicing in other areas likely encounter higher rates, Dr. Greene said in an interview.

He also wondered about other data points that could be of interest but were not reported, such as the racial or ethnic distribution of the patients, rates of birth defects, the use of instruments to aid delivery, and neonatal outcomes for the dichorionic twins.

Monochorionic pregnancies entail a risk of twin-twin transfusion syndrome and other complications, including an increased likelihood of birth defects.

Dr. Greene is an associate editor with the New England Journal of Medicine, which in 2013 published results from the Twin Birth Study, an international trial where women with dichorionic or monochorionic twins were randomly assigned to planned vaginal delivery or planned cesarean delivery. Outcomes did not significantly differ between groups. In the trial, the rate of cesarean delivery in the group with planned vaginal delivery was 43.8%, and Dr. Greene discussed the implications of the study in an accompanying editorial.

Since then, the obstetrics and gynecology community “has been focusing in recent years on trying to avoid the first cesarean section” when it is safe to do so, Dr. Greene said. “That has become almost a bumper sticker in modern obstetrics.”

And patients should know that it is an option, Dr. Krishna added.

“Women with monochorionic-diamniotic twins should be counseled that with an experienced obstetrician that an attempt at vaginal delivery is not associated with adverse neonatal outcomes when compared with planned cesarean delivery,” Dr. Krishna said.

A study coauthor disclosed serving on the speakers bureau for Natera and Hologic. Dr. Krishna is a member of the editorial advisory board for Ob.Gyn. News.
 

jremaly@mdedge.com

At a maternal–fetal medicine practice in New York, monochorionic pregnancies were not at increased risk for cesarean delivery, compared with dichorionic pregnancies, a retrospective study shows.

Between 2005 and 2021, mode of delivery of diamniotic twins at this practice did not significantly differ by chorionicity, researchers affiliated with Maternal Fetal Medicine Associates and the department of obstetrics, gynecology, and reproductive science at Icahn School of Medicine at Mount Sinai, New York reported in Obstetrics & Gynecology.

The study supports a recommendation from the American College of Obstetricians and Gynecologists that vaginal delivery “is a reasonable option in well selected diamniotic twin pregnancies, irrespective of chorionicity, and should be considered, provided that an experienced obstetrician is available,” said Iris Krishna, MD, assistant professor of maternal-fetal medicine at Emory University, Atlanta.

The experience at this practice, however, may not apply to many practices in the United States, said Dr. Krishna, who was not involved in the study.

Of 1,121 diamniotic twin pregnancies included in the analysis, 202 (18%) were monochorionic. The cesarean delivery rate was not significantly different between groups: 61% for monochorionic and 63% for dichorionic pregnancies.

Among women with planned vaginal delivery (101 monochorionic pregnancies and 422 dichorionic pregnancies), the cesarean delivery rate likewise did not significantly differ by chorionicity. Twenty-two percent of the monochorionic pregnancies and 21% of the dichorionic pregnancies in this subgroup had a cesarean delivery.

Among patients with a vaginal delivery of twin A, chorionicity was not associated with mode of delivery for twin B. Combined vaginal-cesarean deliveries occurred less than 1% of the time, and breech extraction of twin B occurred approximately 75% of the time, regardless of chorionicity.

The researchers also compared neonatal outcomes for monochorionic-diamniotic twin pregnancies at or after 34 weeks of gestation, based on the intended mode of delivery (95 women with planned vaginal delivery and 68 with planned cesarean delivery). Neonatal outcomes generally were similar, although the incidence of mechanical ventilation was less common in cases with planned vaginal delivery (7% vs. 21%).

“Our data affirm that an attempt at a vaginal birth for twin pregnancies, without contraindications to vaginal delivery and regardless of chorionicity, is reasonable and achievable,” wrote study author Henry N. Lesser, MD, with the department of obstetrics and gynecology at Sinai Hospital in Baltimore, and colleagues.

The patients with planned cesarean delivery had a contraindication to vaginal delivery or otherwise chose to have a cesarean delivery. The researchers excluded from their analysis pregnancies with intrauterine fetal demise of either twin before labor or planned cesarean delivery.

The study’s reliance on data from a single practice decreases its external validity, the researchers noted. Induction of labor at this center typically occurs at 37 weeks’ gestation for monochorionic twins and at 38 weeks for dichorionic twins, and “senior personnel experienced in intrauterine twin manipulation are always present at delivery,” the study authors said.

The study describes “the experience of a single site with skilled obstetricians following a standardized approach to management of diamniotic twin deliveries,” Dr. Krishna said. “Findings may not be generalizable to many U.S. practices as obstetrics and gynecology residents often lack training in breech extraction or internal podalic version of the second twin. This underscores the importance of a concerted effort by skilled senior physicians to train junior physicians in vaginal delivery of the second twin to improve overall outcomes amongst women with diamniotic twin gestations.”

Michael F. Greene, MD, professor emeritus of obstetrics, gynecology, and reproductive biology at Massachusetts General Hospital, Boston, agreed that the findings are not generalizable to the national population. Approximately 10% of the patients in the study had prepregnancy obesity, whereas doctors practicing in other areas likely encounter higher rates, Dr. Greene said in an interview.

He also wondered about other data points that could be of interest but were not reported, such as the racial or ethnic distribution of the patients, rates of birth defects, the use of instruments to aid delivery, and neonatal outcomes for the dichorionic twins.

Monochorionic pregnancies entail a risk of twin-twin transfusion syndrome and other complications, including an increased likelihood of birth defects.

Dr. Greene is an associate editor with the New England Journal of Medicine, which in 2013 published results from the Twin Birth Study, an international trial where women with dichorionic or monochorionic twins were randomly assigned to planned vaginal delivery or planned cesarean delivery. Outcomes did not significantly differ between groups. In the trial, the rate of cesarean delivery in the group with planned vaginal delivery was 43.8%, and Dr. Greene discussed the implications of the study in an accompanying editorial.

Since then, the obstetrics and gynecology community “has been focusing in recent years on trying to avoid the first cesarean section” when it is safe to do so, Dr. Greene said. “That has become almost a bumper sticker in modern obstetrics.”

And patients should know that it is an option, Dr. Krishna added.

“Women with monochorionic-diamniotic twins should be counseled that with an experienced obstetrician that an attempt at vaginal delivery is not associated with adverse neonatal outcomes when compared with planned cesarean delivery,” Dr. Krishna said.

A study coauthor disclosed serving on the speakers bureau for Natera and Hologic. Dr. Krishna is a member of the editorial advisory board for Ob.Gyn. News.
 

jremaly@mdedge.com

Asymptomatic pregnant women with no previous diagnosis of type 1 or 2 diabetes should be screened for gestational diabetes at 24 weeks’ gestation or later, according to an updated recommendation from the U.S. Preventive Services Task Force.

Pregnant individuals who develop gestational diabetes are at increased risk for complications including preeclampsia, fetal macrosomia, and neonatal hypoglycemia, as well as negative long-term outcomes for themselves and their children, wrote lead author Karina W. Davidson, PhD, of Feinstein Institute for Medical Research, Manhasset, N.Y., and colleagues. The statement was published online in JAMA.

The B recommendation and I statement reflect “moderate certainty” that current evidence supports the recommendation in terms of harms versus benefits, and is consistent with the 2014 USPSTF recommendation.

The statement calls for a one-time screening using a glucose tolerance test at or after 24 weeks’ gestation. Although most screening in the United States takes place prior to 28 weeks’ gestation, it can be performed later in patients who begin prenatal care after 28 weeks’ gestation, according to the statement. Data on the harms and benefits of gestational diabetes screening prior to 24 weeks’ gestation are limited, the authors noted. Gestational diabetes was defined as diabetes that develops during pregnancy that is not clearly overt diabetes.

To update the 2014 recommendation, the USPSTF commissioned a systematic review. In 45 prospective studies on the accuracy of gestational diabetes screening, several tests, included oral glucose challenge test, oral glucose tolerance test, and fasting plasma glucose using either a one- or two-step approach were accurate detectors of gestational diabetes; therefore, the USPSTF does not recommend a specific test.

In 13 trials on the impact of treating gestational diabetes on intermediate and health outcomes, treatment was associated with a reduced risk of outcomes, including primary cesarean delivery (but not total cesarean delivery) and preterm delivery, but not with a reduced risk of outcomes including preeclampsia, emergency cesarean delivery, induction of labor, or maternal birth trauma.

The task force also reviewed seven studies of harms associated with screening for gestational diabetes, including three on psychosocial harms, three on hospital experiences, and one of the odds of cesarean delivery after a diagnosis of gestational diabetes. No increase in anxiety or depression occurred following a positive diagnosis or false-positive test result, but data suggested that a gestational diabetes diagnosis may be associated with higher rates of cesarean delivery.

A total of 13 trials evaluated the harms associated with treatment of gestational diabetes, and found no association between treatment and increased risk of several outcomes including severe maternal hypoglycemia, low birth weight, and small for gestational age, and no effect was noted on the number of cesarean deliveries.

Evidence gaps that require additional research include randomized, controlled trials on the effects of gestational diabetes screening on health outcomes, as well as benefits versus harms of screening for pregnant individuals prior to 24 weeks, and studies on the effects of screening in subpopulations of race/ethnicity, age, and socioeconomic factors, according to the task force. Additional research also is needed in areas of maternal health outcomes, long-term outcomes, and the effect on outcomes of one-step versus two-step screening, the USPSTF said.

However, “screening for and detecting gestational diabetes provides a potential opportunity to control blood glucose levels (through lifestyle changes, pharmacological interventions, or both) and reduce the risk of macrosomia and LGA [large for gestational age] infants,” the task force wrote. “In turn, this can prevent associated complications such as primary cesarean delivery, shoulder dystocia, and [neonatal] ICU admissions.”
 

Support screening with counseling on risk reduction

The USPSTF recommendation is important at this time because “the prevalence of gestational diabetes is increasing secondary to rising rates of obesity,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview.

“In 2014, based on a systematic review of literature, the USPSTF recommended screening all asymptomatic pregnant women for gestational diabetes mellitus [GDM] starting at 24 weeks’ gestation. The recommended gestational age for screening coincides with increasing insulin resistance during pregnancy with advancing gestational age,” Dr. Krishna said.

“An updated systematic review by the USPSTF concluded that existing literature continues to affirm current recommendations of universal screening for GDM at 24 weeks gestation or later. There continues, however, to be no consensus on the optimal approach to screening,” she noted.

“Screening can be performed as a two-step or one-step approach,” said Dr. Krishna. “The two-step approach is commonly used in the United States, and all pregnant women are first screened with a 50-gram oral glucose solution followed by a diagnostic test if they have a positive initial screening.

“Women with risk factors for diabetes, such as prior GDM, obesity, strong family history of diabetes, or history of fetal macrosomia, should be screened early in pregnancy for GDM and have the GDM screen repeated at 24 weeks’ gestation or later if normal in early pregnancy,” Dr. Krishna said. “Pregnant women should be counseled on the importance of diet and exercise and appropriate weight gain in pregnancy to reduce the risk of GDM. Overall, timely diagnosis of gestational diabetes is crucial to improving maternal and fetal pregnancy outcomes.”

The full recommendation statement is also available on the USPSTF website. The research was supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose. Dr. Krishna had no disclosures, but serves on the editorial advisory board of Ob.Gyn News.

Asymptomatic pregnant women with no previous diagnosis of type 1 or 2 diabetes should be screened for gestational diabetes at 24 weeks’ gestation or later, according to an updated recommendation from the U.S. Preventive Services Task Force.

Pregnant individuals who develop gestational diabetes are at increased risk for complications including preeclampsia, fetal macrosomia, and neonatal hypoglycemia, as well as negative long-term outcomes for themselves and their children, wrote lead author Karina W. Davidson, PhD, of Feinstein Institute for Medical Research, Manhasset, N.Y., and colleagues. The statement was published online in JAMA.

The B recommendation and I statement reflect “moderate certainty” that current evidence supports the recommendation in terms of harms versus benefits, and is consistent with the 2014 USPSTF recommendation.

The statement calls for a one-time screening using a glucose tolerance test at or after 24 weeks’ gestation. Although most screening in the United States takes place prior to 28 weeks’ gestation, it can be performed later in patients who begin prenatal care after 28 weeks’ gestation, according to the statement. Data on the harms and benefits of gestational diabetes screening prior to 24 weeks’ gestation are limited, the authors noted. Gestational diabetes was defined as diabetes that develops during pregnancy that is not clearly overt diabetes.

To update the 2014 recommendation, the USPSTF commissioned a systematic review. In 45 prospective studies on the accuracy of gestational diabetes screening, several tests, included oral glucose challenge test, oral glucose tolerance test, and fasting plasma glucose using either a one- or two-step approach were accurate detectors of gestational diabetes; therefore, the USPSTF does not recommend a specific test.

In 13 trials on the impact of treating gestational diabetes on intermediate and health outcomes, treatment was associated with a reduced risk of outcomes, including primary cesarean delivery (but not total cesarean delivery) and preterm delivery, but not with a reduced risk of outcomes including preeclampsia, emergency cesarean delivery, induction of labor, or maternal birth trauma.

The task force also reviewed seven studies of harms associated with screening for gestational diabetes, including three on psychosocial harms, three on hospital experiences, and one of the odds of cesarean delivery after a diagnosis of gestational diabetes. No increase in anxiety or depression occurred following a positive diagnosis or false-positive test result, but data suggested that a gestational diabetes diagnosis may be associated with higher rates of cesarean delivery.

A total of 13 trials evaluated the harms associated with treatment of gestational diabetes, and found no association between treatment and increased risk of several outcomes including severe maternal hypoglycemia, low birth weight, and small for gestational age, and no effect was noted on the number of cesarean deliveries.

Evidence gaps that require additional research include randomized, controlled trials on the effects of gestational diabetes screening on health outcomes, as well as benefits versus harms of screening for pregnant individuals prior to 24 weeks, and studies on the effects of screening in subpopulations of race/ethnicity, age, and socioeconomic factors, according to the task force. Additional research also is needed in areas of maternal health outcomes, long-term outcomes, and the effect on outcomes of one-step versus two-step screening, the USPSTF said.

However, “screening for and detecting gestational diabetes provides a potential opportunity to control blood glucose levels (through lifestyle changes, pharmacological interventions, or both) and reduce the risk of macrosomia and LGA [large for gestational age] infants,” the task force wrote. “In turn, this can prevent associated complications such as primary cesarean delivery, shoulder dystocia, and [neonatal] ICU admissions.”
 

Support screening with counseling on risk reduction

The USPSTF recommendation is important at this time because “the prevalence of gestational diabetes is increasing secondary to rising rates of obesity,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview.

“In 2014, based on a systematic review of literature, the USPSTF recommended screening all asymptomatic pregnant women for gestational diabetes mellitus [GDM] starting at 24 weeks’ gestation. The recommended gestational age for screening coincides with increasing insulin resistance during pregnancy with advancing gestational age,” Dr. Krishna said.

“An updated systematic review by the USPSTF concluded that existing literature continues to affirm current recommendations of universal screening for GDM at 24 weeks gestation or later. There continues, however, to be no consensus on the optimal approach to screening,” she noted.

“Screening can be performed as a two-step or one-step approach,” said Dr. Krishna. “The two-step approach is commonly used in the United States, and all pregnant women are first screened with a 50-gram oral glucose solution followed by a diagnostic test if they have a positive initial screening.

“Women with risk factors for diabetes, such as prior GDM, obesity, strong family history of diabetes, or history of fetal macrosomia, should be screened early in pregnancy for GDM and have the GDM screen repeated at 24 weeks’ gestation or later if normal in early pregnancy,” Dr. Krishna said. “Pregnant women should be counseled on the importance of diet and exercise and appropriate weight gain in pregnancy to reduce the risk of GDM. Overall, timely diagnosis of gestational diabetes is crucial to improving maternal and fetal pregnancy outcomes.”

The full recommendation statement is also available on the USPSTF website. The research was supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose. Dr. Krishna had no disclosures, but serves on the editorial advisory board of Ob.Gyn News.

Asymptomatic pregnant women with no previous diagnosis of type 1 or 2 diabetes should be screened for gestational diabetes at 24 weeks’ gestation or later, according to an updated recommendation from the U.S. Preventive Services Task Force.

Pregnant individuals who develop gestational diabetes are at increased risk for complications including preeclampsia, fetal macrosomia, and neonatal hypoglycemia, as well as negative long-term outcomes for themselves and their children, wrote lead author Karina W. Davidson, PhD, of Feinstein Institute for Medical Research, Manhasset, N.Y., and colleagues. The statement was published online in JAMA.

The B recommendation and I statement reflect “moderate certainty” that current evidence supports the recommendation in terms of harms versus benefits, and is consistent with the 2014 USPSTF recommendation.

The statement calls for a one-time screening using a glucose tolerance test at or after 24 weeks’ gestation. Although most screening in the United States takes place prior to 28 weeks’ gestation, it can be performed later in patients who begin prenatal care after 28 weeks’ gestation, according to the statement. Data on the harms and benefits of gestational diabetes screening prior to 24 weeks’ gestation are limited, the authors noted. Gestational diabetes was defined as diabetes that develops during pregnancy that is not clearly overt diabetes.

To update the 2014 recommendation, the USPSTF commissioned a systematic review. In 45 prospective studies on the accuracy of gestational diabetes screening, several tests, included oral glucose challenge test, oral glucose tolerance test, and fasting plasma glucose using either a one- or two-step approach were accurate detectors of gestational diabetes; therefore, the USPSTF does not recommend a specific test.

In 13 trials on the impact of treating gestational diabetes on intermediate and health outcomes, treatment was associated with a reduced risk of outcomes, including primary cesarean delivery (but not total cesarean delivery) and preterm delivery, but not with a reduced risk of outcomes including preeclampsia, emergency cesarean delivery, induction of labor, or maternal birth trauma.

The task force also reviewed seven studies of harms associated with screening for gestational diabetes, including three on psychosocial harms, three on hospital experiences, and one of the odds of cesarean delivery after a diagnosis of gestational diabetes. No increase in anxiety or depression occurred following a positive diagnosis or false-positive test result, but data suggested that a gestational diabetes diagnosis may be associated with higher rates of cesarean delivery.

A total of 13 trials evaluated the harms associated with treatment of gestational diabetes, and found no association between treatment and increased risk of several outcomes including severe maternal hypoglycemia, low birth weight, and small for gestational age, and no effect was noted on the number of cesarean deliveries.

Evidence gaps that require additional research include randomized, controlled trials on the effects of gestational diabetes screening on health outcomes, as well as benefits versus harms of screening for pregnant individuals prior to 24 weeks, and studies on the effects of screening in subpopulations of race/ethnicity, age, and socioeconomic factors, according to the task force. Additional research also is needed in areas of maternal health outcomes, long-term outcomes, and the effect on outcomes of one-step versus two-step screening, the USPSTF said.

However, “screening for and detecting gestational diabetes provides a potential opportunity to control blood glucose levels (through lifestyle changes, pharmacological interventions, or both) and reduce the risk of macrosomia and LGA [large for gestational age] infants,” the task force wrote. “In turn, this can prevent associated complications such as primary cesarean delivery, shoulder dystocia, and [neonatal] ICU admissions.”
 

Support screening with counseling on risk reduction

The USPSTF recommendation is important at this time because “the prevalence of gestational diabetes is increasing secondary to rising rates of obesity,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview.

“In 2014, based on a systematic review of literature, the USPSTF recommended screening all asymptomatic pregnant women for gestational diabetes mellitus [GDM] starting at 24 weeks’ gestation. The recommended gestational age for screening coincides with increasing insulin resistance during pregnancy with advancing gestational age,” Dr. Krishna said.

“An updated systematic review by the USPSTF concluded that existing literature continues to affirm current recommendations of universal screening for GDM at 24 weeks gestation or later. There continues, however, to be no consensus on the optimal approach to screening,” she noted.

“Screening can be performed as a two-step or one-step approach,” said Dr. Krishna. “The two-step approach is commonly used in the United States, and all pregnant women are first screened with a 50-gram oral glucose solution followed by a diagnostic test if they have a positive initial screening.

“Women with risk factors for diabetes, such as prior GDM, obesity, strong family history of diabetes, or history of fetal macrosomia, should be screened early in pregnancy for GDM and have the GDM screen repeated at 24 weeks’ gestation or later if normal in early pregnancy,” Dr. Krishna said. “Pregnant women should be counseled on the importance of diet and exercise and appropriate weight gain in pregnancy to reduce the risk of GDM. Overall, timely diagnosis of gestational diabetes is crucial to improving maternal and fetal pregnancy outcomes.”

The full recommendation statement is also available on the USPSTF website. The research was supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose. Dr. Krishna had no disclosures, but serves on the editorial advisory board of Ob.Gyn News.

As working mothers with babies in tow when the COVID-19 crisis struck, countless uncertainties threatened our already precarious work-life balance. We suddenly had many questions:

“If my daycare closes, what will I do for childcare?”

“How do I navigate diaper changes, feedings, and naps with my hectic remote work schedule?”

“If I’m constantly interrupted during the day, should I skip sleep to catch up on work and not let my colleagues down?”

As professionals who work closely with medical trainees, we knew our parenting dilemmas were being experienced even more acutely by our frontline worker colleagues.

Medical training is an increasingly common time to start a family. In a recent study, 34% of trainees in Harvard-affiliated residency programs became parents during training, and another 52% planned to do so. Trainees have higher breastfeeding initiation rates but lower continuation rates than the general population. Early nursing cessation among trainees is well documented nationally and is most often attributed to work-related barriers. These barriers range from insufficient time and limited access to facilities to a lack of support and discrimination by supervisors and peers.

This trend does not discriminate by specialty. Even among training programs known to be “family friendly,” the average duration of nursing is just 4.5 months. Residents of color are disproportionately affected by inadequate support. Studies show that Black parents breastfeed at lower rates than White parents. This has been largely attributed to structural racism and implicit bias, such as Black parents receiving less assistance initiating nursing after delivery. Adequate lactation support and inclusivity are also lacking for transgender parents who choose to breastfeed or chestfeed.

The very nature of residency training, which includes shifts that can span more than 24 hours, conflicts with many health-promoting behaviors like sleeping and eating well. However, its interference with lactation is correlated with gender. Women are disproportionately affected by the negative outcomes of unmet lactation goals. These include work-life imbalance, career dissatisfaction, and negative emotions. In a study of pediatric residents, one in four did not achieve their breastfeeding goals. Respondents reported feeling “sad, devastated, defeated, disappointed, guilty, embarrassed, frustrated, angry, like a failure, and inadequate.” Among physician mothers more broadly, discrimination related to pregnancy, parental leave, and nursing is associated with higher self-reported burnout.

Navigating nursing during residency training has more than just emotional and psychological consequences – it also has professional ones. Pursuing personal lactation goals can delay residency program completion and board certification, influence specialty selection, negatively impact research productivity, impede career advancement, and lead to misgivings about career choice.

Trainees and their families are not the only ones harmed by inadequate support in residency programs. Patients and their families are affected, too. Research suggests that physicians’ personal breastfeeding practices affect the advice they give to patients. Those who receive lactation support are more likely to help patients meet their own goals. In the previously mentioned study of pediatric residents, more than 90% of the 400 respondents said their own or their partner’s nursing experience affected their interaction with lactating patients in their clinic or hospital.

Increased lactation support is a straightforward, low-cost, high-impact intervention. It benefits trainee well-being, satisfaction, workflow, and future patient care. The Accreditation Council for Graduate Medical Education mandated in July 2019 that all residency programs provide adequate lactation facilities – including refrigeration capabilities and proximity for safe patient care. However, to our knowledge, rates of compliance with this new policy and citation for noncompliance have yet to be seen. Regardless, facilities alone are not enough. Residency programs should develop and enforce formal lactation policies.

Several institutions have successfully piloted such policies in recent years. One in particular from the University of Michigan’s surgery residency program inspired the development of a lactation policy within the internal medicine residency at our institution. These policies designate appropriate spaces at each clinical rotation site, clarify that residents are encouraged to take pumping breaks as needed – in coordination with clinical teams so as not to compromise patient care – and communicate support from supervisors.

Our program also established an informal peer mentoring program. Residents with experience pumping at work pair up with newer trainees. The policy benefits residents who wish to chestfeed or breastfeed, normalizes lactation, and empowers trainees by diminishing the need to ask for individual accommodations. It also costs the program nothing.

As more women enter medicine and more trainees become parents during residency, the need for support in this area will only continue to grow. The widespread lack of such resources, and the fact that clean and private facilities are only now being mandated, is symbolic. If even this basic need is rarely acknowledged or met, what other resident needs are being neglected?

A version of this article first appeared on Medscape.com.

As working mothers with babies in tow when the COVID-19 crisis struck, countless uncertainties threatened our already precarious work-life balance. We suddenly had many questions:

“If my daycare closes, what will I do for childcare?”

“How do I navigate diaper changes, feedings, and naps with my hectic remote work schedule?”

“If I’m constantly interrupted during the day, should I skip sleep to catch up on work and not let my colleagues down?”

As professionals who work closely with medical trainees, we knew our parenting dilemmas were being experienced even more acutely by our frontline worker colleagues.

Medical training is an increasingly common time to start a family. In a recent study, 34% of trainees in Harvard-affiliated residency programs became parents during training, and another 52% planned to do so. Trainees have higher breastfeeding initiation rates but lower continuation rates than the general population. Early nursing cessation among trainees is well documented nationally and is most often attributed to work-related barriers. These barriers range from insufficient time and limited access to facilities to a lack of support and discrimination by supervisors and peers.

This trend does not discriminate by specialty. Even among training programs known to be “family friendly,” the average duration of nursing is just 4.5 months. Residents of color are disproportionately affected by inadequate support. Studies show that Black parents breastfeed at lower rates than White parents. This has been largely attributed to structural racism and implicit bias, such as Black parents receiving less assistance initiating nursing after delivery. Adequate lactation support and inclusivity are also lacking for transgender parents who choose to breastfeed or chestfeed.

The very nature of residency training, which includes shifts that can span more than 24 hours, conflicts with many health-promoting behaviors like sleeping and eating well. However, its interference with lactation is correlated with gender. Women are disproportionately affected by the negative outcomes of unmet lactation goals. These include work-life imbalance, career dissatisfaction, and negative emotions. In a study of pediatric residents, one in four did not achieve their breastfeeding goals. Respondents reported feeling “sad, devastated, defeated, disappointed, guilty, embarrassed, frustrated, angry, like a failure, and inadequate.” Among physician mothers more broadly, discrimination related to pregnancy, parental leave, and nursing is associated with higher self-reported burnout.

Navigating nursing during residency training has more than just emotional and psychological consequences – it also has professional ones. Pursuing personal lactation goals can delay residency program completion and board certification, influence specialty selection, negatively impact research productivity, impede career advancement, and lead to misgivings about career choice.

Trainees and their families are not the only ones harmed by inadequate support in residency programs. Patients and their families are affected, too. Research suggests that physicians’ personal breastfeeding practices affect the advice they give to patients. Those who receive lactation support are more likely to help patients meet their own goals. In the previously mentioned study of pediatric residents, more than 90% of the 400 respondents said their own or their partner’s nursing experience affected their interaction with lactating patients in their clinic or hospital.

Increased lactation support is a straightforward, low-cost, high-impact intervention. It benefits trainee well-being, satisfaction, workflow, and future patient care. The Accreditation Council for Graduate Medical Education mandated in July 2019 that all residency programs provide adequate lactation facilities – including refrigeration capabilities and proximity for safe patient care. However, to our knowledge, rates of compliance with this new policy and citation for noncompliance have yet to be seen. Regardless, facilities alone are not enough. Residency programs should develop and enforce formal lactation policies.

Several institutions have successfully piloted such policies in recent years. One in particular from the University of Michigan’s surgery residency program inspired the development of a lactation policy within the internal medicine residency at our institution. These policies designate appropriate spaces at each clinical rotation site, clarify that residents are encouraged to take pumping breaks as needed – in coordination with clinical teams so as not to compromise patient care – and communicate support from supervisors.

Our program also established an informal peer mentoring program. Residents with experience pumping at work pair up with newer trainees. The policy benefits residents who wish to chestfeed or breastfeed, normalizes lactation, and empowers trainees by diminishing the need to ask for individual accommodations. It also costs the program nothing.

As more women enter medicine and more trainees become parents during residency, the need for support in this area will only continue to grow. The widespread lack of such resources, and the fact that clean and private facilities are only now being mandated, is symbolic. If even this basic need is rarely acknowledged or met, what other resident needs are being neglected?

A version of this article first appeared on Medscape.com.

As working mothers with babies in tow when the COVID-19 crisis struck, countless uncertainties threatened our already precarious work-life balance. We suddenly had many questions:

“If my daycare closes, what will I do for childcare?”

“How do I navigate diaper changes, feedings, and naps with my hectic remote work schedule?”

“If I’m constantly interrupted during the day, should I skip sleep to catch up on work and not let my colleagues down?”

As professionals who work closely with medical trainees, we knew our parenting dilemmas were being experienced even more acutely by our frontline worker colleagues.

Medical training is an increasingly common time to start a family. In a recent study, 34% of trainees in Harvard-affiliated residency programs became parents during training, and another 52% planned to do so. Trainees have higher breastfeeding initiation rates but lower continuation rates than the general population. Early nursing cessation among trainees is well documented nationally and is most often attributed to work-related barriers. These barriers range from insufficient time and limited access to facilities to a lack of support and discrimination by supervisors and peers.

This trend does not discriminate by specialty. Even among training programs known to be “family friendly,” the average duration of nursing is just 4.5 months. Residents of color are disproportionately affected by inadequate support. Studies show that Black parents breastfeed at lower rates than White parents. This has been largely attributed to structural racism and implicit bias, such as Black parents receiving less assistance initiating nursing after delivery. Adequate lactation support and inclusivity are also lacking for transgender parents who choose to breastfeed or chestfeed.

The very nature of residency training, which includes shifts that can span more than 24 hours, conflicts with many health-promoting behaviors like sleeping and eating well. However, its interference with lactation is correlated with gender. Women are disproportionately affected by the negative outcomes of unmet lactation goals. These include work-life imbalance, career dissatisfaction, and negative emotions. In a study of pediatric residents, one in four did not achieve their breastfeeding goals. Respondents reported feeling “sad, devastated, defeated, disappointed, guilty, embarrassed, frustrated, angry, like a failure, and inadequate.” Among physician mothers more broadly, discrimination related to pregnancy, parental leave, and nursing is associated with higher self-reported burnout.

Navigating nursing during residency training has more than just emotional and psychological consequences – it also has professional ones. Pursuing personal lactation goals can delay residency program completion and board certification, influence specialty selection, negatively impact research productivity, impede career advancement, and lead to misgivings about career choice.

Trainees and their families are not the only ones harmed by inadequate support in residency programs. Patients and their families are affected, too. Research suggests that physicians’ personal breastfeeding practices affect the advice they give to patients. Those who receive lactation support are more likely to help patients meet their own goals. In the previously mentioned study of pediatric residents, more than 90% of the 400 respondents said their own or their partner’s nursing experience affected their interaction with lactating patients in their clinic or hospital.

Increased lactation support is a straightforward, low-cost, high-impact intervention. It benefits trainee well-being, satisfaction, workflow, and future patient care. The Accreditation Council for Graduate Medical Education mandated in July 2019 that all residency programs provide adequate lactation facilities – including refrigeration capabilities and proximity for safe patient care. However, to our knowledge, rates of compliance with this new policy and citation for noncompliance have yet to be seen. Regardless, facilities alone are not enough. Residency programs should develop and enforce formal lactation policies.

Several institutions have successfully piloted such policies in recent years. One in particular from the University of Michigan’s surgery residency program inspired the development of a lactation policy within the internal medicine residency at our institution. These policies designate appropriate spaces at each clinical rotation site, clarify that residents are encouraged to take pumping breaks as needed – in coordination with clinical teams so as not to compromise patient care – and communicate support from supervisors.

Our program also established an informal peer mentoring program. Residents with experience pumping at work pair up with newer trainees. The policy benefits residents who wish to chestfeed or breastfeed, normalizes lactation, and empowers trainees by diminishing the need to ask for individual accommodations. It also costs the program nothing.

As more women enter medicine and more trainees become parents during residency, the need for support in this area will only continue to grow. The widespread lack of such resources, and the fact that clean and private facilities are only now being mandated, is symbolic. If even this basic need is rarely acknowledged or met, what other resident needs are being neglected?

A version of this article first appeared on Medscape.com.

A new study documents a handful of cases of women with Munchausen syndrome by Internet who targeted doulas in the United Kingdom during the COVID-19 lockdown. The women pretended to have a variety of dramatic perinatal crises that garnered them significant attention from birth support professionals.

The five cases were investigated by Kathryn Newns, MSc, DClinPsy, a clinical psychologist in Cambridge, England, who said the cases were brought to her attention by a doula she herself had used for the birth of her own child a decade earlier.

Dr. Newns said she believes these are not isolated cases – either geographically or in terms of the specialty involved.

“I don’t think it is likely that this is only happening in the United Kingdom. And I’m sure it’s not just happening in the doula world,” Dr. Newns told this news organization.

Coinvestigator Marc Feldman, MD, a clinical professor of psychiatry at the University of Alabama, Tuscaloosa, coined the term “Munchausen by Internet” in a 2000 article. The expression refers to use of electronic media to perpetrate hoaxes that reward posers with sympathy, control, or emotional gratification. The hoaxers do not seek financial gain.

“The ease of carrying out Munchausen behaviors makes me think that it must be much more common than it ever was,” Dr. Feldman said in an interview.

He noted that the new DSM-5 will eliminate the terms “Munchausen” and “Munchausen by Internet” and will clarify that “factitious disorder” can be partly or wholly carried out online.

The study was published in the May issue of the Annals of Clinical Psychiatry.
 

A warning for others

In the past, those with factitious disorder had to go to medical libraries to study up on the ailment they wanted to feign. They would then present to an emergency department or a doctor’s office and act convincingly, Dr. Feldman said.

“Now all you have to do is go to Wikipedia and you can become an expert on a medical ailment within a few minutes,” he added.

In the five cases described in the study, the hoaxers created rich stories, especially in cases 1 and 2. In those cases, the perpetrator turned out to be the same person. Subterfuge “obviously made it much harder to know she wasn’t who she purported to be,” said Dr. Newns.

Dr. Feldman noted that in Munchausen by Internet, there may be some element of truth within the stories.

For health care professionals, “it takes a considerable leap to assume that somebody who’s talking about some dreaded ailment is in fact exaggerating or outright lying,” he said.

In the five cases described in the study, persons contacted doulas, then related traumatic stories and described dramatic, immediate needs. All of the doulas were working remotely because of the COVID-19 pandemic. This likely made it easier for the perpetrators to pull off the hoaxes. The health care professionals agreed to share their experiences in the hopes of warning others.
 

Elaborate scenarios

The first two cases were ultimately determined to involve one person who had created elaborate scenarios.

In case 1, the hoaxer, who called herself “Jessica,” texted the doula “Charlotte” when she was allegedly 39 weeks’ pregnant. She said she was unable to go to the hospital because of the COVID-19 risks to her husband, who had cystic fibrosis and had recently undergone a heart and lung transplant.

The husband “Jordan” took over communications, using the same WhatsApp number as Jessica, as Jessica went into labor.

Ostensibly, a midwife team had come to Jessica’s and Jordan’s house. When the doula was on the phone with Jordan, she heard Jessica crying, grunting, and screaming, and then, at 2:00 a.m., she heard the sound of a baby crying. A photo of the baby was texted to Charlotte.

Soon, there were many problems. Jessica allegedly had a postpartum hemorrhage, and mother and baby were taken to separate hospitals. The baby was then diagnosed with congenital heart disease.

Over the next week, “midwives” started texting back and forth with Charlotte. The doula began to have doubts and asked a midwife to share a visual communication.

After receiving no response, Charlotte used a video call, got Jessica on screen, and told her she thought there was no baby. Jessica said the baby was real and showed a “growth chart” as proof of the 5-day-old baby’s existence. The birth and baby noises were later determined to be recordings.
 

Child deaths

After sharing information among themselves on a private Facebook group, the doulas determined that the person in case 2, “Dakota,” was the same woman who was involved in case 1.

In case 2, a doula had spent 2 years supporting Dakota through the deaths of a parent and her baby, who had a congenital defect. A baby-loss charity had also worked with Dakota but could not confirm the baby’s existence.

Dakota had gone so far as to make a video for the doula that showed a hospital room. In a voice-over, Dakota thanks everyone for the support she received as the baby died.

In case 3, “Hannah” texted a doula seeking emotional but not birth support. The doula, Nikki Barrow, has recounted the case on her own blog.

Hannah became desperate when she went into labor. Ms. Barrow remained close via texts, phone, and video calls, even as the baby supposedly died after 3 days. The doula lit a candle for the baby and cried with Hannah.

Ms. Barrow was eventually able to break away from Hannah, saying she was not a bereavement specialist. However, days later, Hannah tracked her down and claimed she had an infection in her heart and did not have much time to live. At that point, Ms. Barrow stopped all contact.

She determined from other doulas that Hannah had been hoaxing doulas for 4 or 5 years. Some had offered to get her help, but she refused and ended all contact.
 

Multiple COVID crises?

In case 4, a woman sought support on a doula-centered Facebook page and said her partner “Jack” would be in touch. Jack sent the doula hundreds of emails, texts, and WhatsApp messages and then said he was hospitalized with COVID. The woman, “Hayley,” was also soon diagnosed with COVID.

Hayley refused video contact and did not share photos. Drama continued to unfold. She reported that her baby was breach, that she had a second uterus with a second pregnancy simultaneously, and that the baby had COVID.

Hayley also claimed that her partner had come to the hospital, had raped her, and had brandished a gun. When the doula called the police, they did not find Hayley at the hospital or elsewhere.

In case 5, a “grandmother” contacted “Lisa” to find a doula for her daughter-in-law, “Anna.” Hours later, Anna was giving birth, and the baby had to be taken to the hospital because of cardiac and breathing problems. The doula heard nothing more after a few weeks.

However, at least three other doulas said they had supported the same “family.”
 

Online training program

In all cases, the doulas were not paid for their time. Reports to the police prompted no action because no money had changed hands. Some doulas said they felt bereaved, angry, or “silly” that they had been hoodwinked. All noted how difficult it was to disengage from clients who seemed to be in peril.

Ms. Barrow decided to create an online training program in which doulas are advised on how to stay safe while working online.

DoulaMatch, which matches birth support specialists with women in the United States and Canada, offers tips to help protect doulas from hoaxes.

Kim James, BDT(DONA), ICCE, LCCE, CLE, the owner and operator of DoulaMatch, said the organization is aware of “scammers who waste everyone’s time and have found doulas to be the latest easy targets.”

However, she noted, “I’ve only very occasionally and anecdotally heard about people fabricating a pregnancy for emotional gratification.”

In his 2000 article, Dr. Feldman offers clues to help detect hoaxers. He advises clinicians to be wary of the following:

• Cases in which the length, frequency, and duration of posts are incongruous with the severity of the illness the person is claiming to have; for example, someone who claims to be in  submitting detailed posts.
• Near-fatal exacerbations of illness alternating with miraculous recoveries.
• Personal claims that are fantastic, are contradicted by later posts, or are disproved.
• Continual dramatic events occurring in the person’s life, especially when others in a group become the focus of attention.
• Others ostensibly posting on behalf of the individual who have identical patterns of writing, such as making grammatical errors, misspellings, and using stylistic idiosyncrasies.

A version of this article first appeared on Medscape.com.

A new study documents a handful of cases of women with Munchausen syndrome by Internet who targeted doulas in the United Kingdom during the COVID-19 lockdown. The women pretended to have a variety of dramatic perinatal crises that garnered them significant attention from birth support professionals.

The five cases were investigated by Kathryn Newns, MSc, DClinPsy, a clinical psychologist in Cambridge, England, who said the cases were brought to her attention by a doula she herself had used for the birth of her own child a decade earlier.

Dr. Newns said she believes these are not isolated cases – either geographically or in terms of the specialty involved.

“I don’t think it is likely that this is only happening in the United Kingdom. And I’m sure it’s not just happening in the doula world,” Dr. Newns told this news organization.

Coinvestigator Marc Feldman, MD, a clinical professor of psychiatry at the University of Alabama, Tuscaloosa, coined the term “Munchausen by Internet” in a 2000 article. The expression refers to use of electronic media to perpetrate hoaxes that reward posers with sympathy, control, or emotional gratification. The hoaxers do not seek financial gain.

“The ease of carrying out Munchausen behaviors makes me think that it must be much more common than it ever was,” Dr. Feldman said in an interview.

He noted that the new DSM-5 will eliminate the terms “Munchausen” and “Munchausen by Internet” and will clarify that “factitious disorder” can be partly or wholly carried out online.

The study was published in the May issue of the Annals of Clinical Psychiatry.
 

A warning for others

In the past, those with factitious disorder had to go to medical libraries to study up on the ailment they wanted to feign. They would then present to an emergency department or a doctor’s office and act convincingly, Dr. Feldman said.

“Now all you have to do is go to Wikipedia and you can become an expert on a medical ailment within a few minutes,” he added.

In the five cases described in the study, the hoaxers created rich stories, especially in cases 1 and 2. In those cases, the perpetrator turned out to be the same person. Subterfuge “obviously made it much harder to know she wasn’t who she purported to be,” said Dr. Newns.

Dr. Feldman noted that in Munchausen by Internet, there may be some element of truth within the stories.

For health care professionals, “it takes a considerable leap to assume that somebody who’s talking about some dreaded ailment is in fact exaggerating or outright lying,” he said.

In the five cases described in the study, persons contacted doulas, then related traumatic stories and described dramatic, immediate needs. All of the doulas were working remotely because of the COVID-19 pandemic. This likely made it easier for the perpetrators to pull off the hoaxes. The health care professionals agreed to share their experiences in the hopes of warning others.
 

Elaborate scenarios

The first two cases were ultimately determined to involve one person who had created elaborate scenarios.

In case 1, the hoaxer, who called herself “Jessica,” texted the doula “Charlotte” when she was allegedly 39 weeks’ pregnant. She said she was unable to go to the hospital because of the COVID-19 risks to her husband, who had cystic fibrosis and had recently undergone a heart and lung transplant.

The husband “Jordan” took over communications, using the same WhatsApp number as Jessica, as Jessica went into labor.

Ostensibly, a midwife team had come to Jessica’s and Jordan’s house. When the doula was on the phone with Jordan, she heard Jessica crying, grunting, and screaming, and then, at 2:00 a.m., she heard the sound of a baby crying. A photo of the baby was texted to Charlotte.

Soon, there were many problems. Jessica allegedly had a postpartum hemorrhage, and mother and baby were taken to separate hospitals. The baby was then diagnosed with congenital heart disease.

Over the next week, “midwives” started texting back and forth with Charlotte. The doula began to have doubts and asked a midwife to share a visual communication.

After receiving no response, Charlotte used a video call, got Jessica on screen, and told her she thought there was no baby. Jessica said the baby was real and showed a “growth chart” as proof of the 5-day-old baby’s existence. The birth and baby noises were later determined to be recordings.
 

Child deaths

After sharing information among themselves on a private Facebook group, the doulas determined that the person in case 2, “Dakota,” was the same woman who was involved in case 1.

In case 2, a doula had spent 2 years supporting Dakota through the deaths of a parent and her baby, who had a congenital defect. A baby-loss charity had also worked with Dakota but could not confirm the baby’s existence.

Dakota had gone so far as to make a video for the doula that showed a hospital room. In a voice-over, Dakota thanks everyone for the support she received as the baby died.

In case 3, “Hannah” texted a doula seeking emotional but not birth support. The doula, Nikki Barrow, has recounted the case on her own blog.

Hannah became desperate when she went into labor. Ms. Barrow remained close via texts, phone, and video calls, even as the baby supposedly died after 3 days. The doula lit a candle for the baby and cried with Hannah.

Ms. Barrow was eventually able to break away from Hannah, saying she was not a bereavement specialist. However, days later, Hannah tracked her down and claimed she had an infection in her heart and did not have much time to live. At that point, Ms. Barrow stopped all contact.

She determined from other doulas that Hannah had been hoaxing doulas for 4 or 5 years. Some had offered to get her help, but she refused and ended all contact.
 

Multiple COVID crises?

In case 4, a woman sought support on a doula-centered Facebook page and said her partner “Jack” would be in touch. Jack sent the doula hundreds of emails, texts, and WhatsApp messages and then said he was hospitalized with COVID. The woman, “Hayley,” was also soon diagnosed with COVID.

Hayley refused video contact and did not share photos. Drama continued to unfold. She reported that her baby was breach, that she had a second uterus with a second pregnancy simultaneously, and that the baby had COVID.

Hayley also claimed that her partner had come to the hospital, had raped her, and had brandished a gun. When the doula called the police, they did not find Hayley at the hospital or elsewhere.

In case 5, a “grandmother” contacted “Lisa” to find a doula for her daughter-in-law, “Anna.” Hours later, Anna was giving birth, and the baby had to be taken to the hospital because of cardiac and breathing problems. The doula heard nothing more after a few weeks.

However, at least three other doulas said they had supported the same “family.”
 

Online training program

In all cases, the doulas were not paid for their time. Reports to the police prompted no action because no money had changed hands. Some doulas said they felt bereaved, angry, or “silly” that they had been hoodwinked. All noted how difficult it was to disengage from clients who seemed to be in peril.

Ms. Barrow decided to create an online training program in which doulas are advised on how to stay safe while working online.

DoulaMatch, which matches birth support specialists with women in the United States and Canada, offers tips to help protect doulas from hoaxes.

Kim James, BDT(DONA), ICCE, LCCE, CLE, the owner and operator of DoulaMatch, said the organization is aware of “scammers who waste everyone’s time and have found doulas to be the latest easy targets.”

However, she noted, “I’ve only very occasionally and anecdotally heard about people fabricating a pregnancy for emotional gratification.”

In his 2000 article, Dr. Feldman offers clues to help detect hoaxers. He advises clinicians to be wary of the following:

• Cases in which the length, frequency, and duration of posts are incongruous with the severity of the illness the person is claiming to have; for example, someone who claims to be in  submitting detailed posts.
• Near-fatal exacerbations of illness alternating with miraculous recoveries.
• Personal claims that are fantastic, are contradicted by later posts, or are disproved.
• Continual dramatic events occurring in the person’s life, especially when others in a group become the focus of attention.
• Others ostensibly posting on behalf of the individual who have identical patterns of writing, such as making grammatical errors, misspellings, and using stylistic idiosyncrasies.

A version of this article first appeared on Medscape.com.

A new study documents a handful of cases of women with Munchausen syndrome by Internet who targeted doulas in the United Kingdom during the COVID-19 lockdown. The women pretended to have a variety of dramatic perinatal crises that garnered them significant attention from birth support professionals.

The five cases were investigated by Kathryn Newns, MSc, DClinPsy, a clinical psychologist in Cambridge, England, who said the cases were brought to her attention by a doula she herself had used for the birth of her own child a decade earlier.

Dr. Newns said she believes these are not isolated cases – either geographically or in terms of the specialty involved.

“I don’t think it is likely that this is only happening in the United Kingdom. And I’m sure it’s not just happening in the doula world,” Dr. Newns told this news organization.

Coinvestigator Marc Feldman, MD, a clinical professor of psychiatry at the University of Alabama, Tuscaloosa, coined the term “Munchausen by Internet” in a 2000 article. The expression refers to use of electronic media to perpetrate hoaxes that reward posers with sympathy, control, or emotional gratification. The hoaxers do not seek financial gain.

“The ease of carrying out Munchausen behaviors makes me think that it must be much more common than it ever was,” Dr. Feldman said in an interview.

He noted that the new DSM-5 will eliminate the terms “Munchausen” and “Munchausen by Internet” and will clarify that “factitious disorder” can be partly or wholly carried out online.

The study was published in the May issue of the Annals of Clinical Psychiatry.
 

A warning for others

In the past, those with factitious disorder had to go to medical libraries to study up on the ailment they wanted to feign. They would then present to an emergency department or a doctor’s office and act convincingly, Dr. Feldman said.

“Now all you have to do is go to Wikipedia and you can become an expert on a medical ailment within a few minutes,” he added.

In the five cases described in the study, the hoaxers created rich stories, especially in cases 1 and 2. In those cases, the perpetrator turned out to be the same person. Subterfuge “obviously made it much harder to know she wasn’t who she purported to be,” said Dr. Newns.

Dr. Feldman noted that in Munchausen by Internet, there may be some element of truth within the stories.

For health care professionals, “it takes a considerable leap to assume that somebody who’s talking about some dreaded ailment is in fact exaggerating or outright lying,” he said.

In the five cases described in the study, persons contacted doulas, then related traumatic stories and described dramatic, immediate needs. All of the doulas were working remotely because of the COVID-19 pandemic. This likely made it easier for the perpetrators to pull off the hoaxes. The health care professionals agreed to share their experiences in the hopes of warning others.
 

Elaborate scenarios

The first two cases were ultimately determined to involve one person who had created elaborate scenarios.

In case 1, the hoaxer, who called herself “Jessica,” texted the doula “Charlotte” when she was allegedly 39 weeks’ pregnant. She said she was unable to go to the hospital because of the COVID-19 risks to her husband, who had cystic fibrosis and had recently undergone a heart and lung transplant.

The husband “Jordan” took over communications, using the same WhatsApp number as Jessica, as Jessica went into labor.

Ostensibly, a midwife team had come to Jessica’s and Jordan’s house. When the doula was on the phone with Jordan, she heard Jessica crying, grunting, and screaming, and then, at 2:00 a.m., she heard the sound of a baby crying. A photo of the baby was texted to Charlotte.

Soon, there were many problems. Jessica allegedly had a postpartum hemorrhage, and mother and baby were taken to separate hospitals. The baby was then diagnosed with congenital heart disease.

Over the next week, “midwives” started texting back and forth with Charlotte. The doula began to have doubts and asked a midwife to share a visual communication.

After receiving no response, Charlotte used a video call, got Jessica on screen, and told her she thought there was no baby. Jessica said the baby was real and showed a “growth chart” as proof of the 5-day-old baby’s existence. The birth and baby noises were later determined to be recordings.
 

Child deaths

After sharing information among themselves on a private Facebook group, the doulas determined that the person in case 2, “Dakota,” was the same woman who was involved in case 1.

In case 2, a doula had spent 2 years supporting Dakota through the deaths of a parent and her baby, who had a congenital defect. A baby-loss charity had also worked with Dakota but could not confirm the baby’s existence.

Dakota had gone so far as to make a video for the doula that showed a hospital room. In a voice-over, Dakota thanks everyone for the support she received as the baby died.

In case 3, “Hannah” texted a doula seeking emotional but not birth support. The doula, Nikki Barrow, has recounted the case on her own blog.

Hannah became desperate when she went into labor. Ms. Barrow remained close via texts, phone, and video calls, even as the baby supposedly died after 3 days. The doula lit a candle for the baby and cried with Hannah.

Ms. Barrow was eventually able to break away from Hannah, saying she was not a bereavement specialist. However, days later, Hannah tracked her down and claimed she had an infection in her heart and did not have much time to live. At that point, Ms. Barrow stopped all contact.

She determined from other doulas that Hannah had been hoaxing doulas for 4 or 5 years. Some had offered to get her help, but she refused and ended all contact.
 

Multiple COVID crises?

In case 4, a woman sought support on a doula-centered Facebook page and said her partner “Jack” would be in touch. Jack sent the doula hundreds of emails, texts, and WhatsApp messages and then said he was hospitalized with COVID. The woman, “Hayley,” was also soon diagnosed with COVID.

Hayley refused video contact and did not share photos. Drama continued to unfold. She reported that her baby was breach, that she had a second uterus with a second pregnancy simultaneously, and that the baby had COVID.

Hayley also claimed that her partner had come to the hospital, had raped her, and had brandished a gun. When the doula called the police, they did not find Hayley at the hospital or elsewhere.

In case 5, a “grandmother” contacted “Lisa” to find a doula for her daughter-in-law, “Anna.” Hours later, Anna was giving birth, and the baby had to be taken to the hospital because of cardiac and breathing problems. The doula heard nothing more after a few weeks.

However, at least three other doulas said they had supported the same “family.”
 

Online training program

In all cases, the doulas were not paid for their time. Reports to the police prompted no action because no money had changed hands. Some doulas said they felt bereaved, angry, or “silly” that they had been hoodwinked. All noted how difficult it was to disengage from clients who seemed to be in peril.

Ms. Barrow decided to create an online training program in which doulas are advised on how to stay safe while working online.

DoulaMatch, which matches birth support specialists with women in the United States and Canada, offers tips to help protect doulas from hoaxes.

Kim James, BDT(DONA), ICCE, LCCE, CLE, the owner and operator of DoulaMatch, said the organization is aware of “scammers who waste everyone’s time and have found doulas to be the latest easy targets.”

However, she noted, “I’ve only very occasionally and anecdotally heard about people fabricating a pregnancy for emotional gratification.”

In his 2000 article, Dr. Feldman offers clues to help detect hoaxers. He advises clinicians to be wary of the following:

• Cases in which the length, frequency, and duration of posts are incongruous with the severity of the illness the person is claiming to have; for example, someone who claims to be in  submitting detailed posts.
• Near-fatal exacerbations of illness alternating with miraculous recoveries.
• Personal claims that are fantastic, are contradicted by later posts, or are disproved.
• Continual dramatic events occurring in the person’s life, especially when others in a group become the focus of attention.
• Others ostensibly posting on behalf of the individual who have identical patterns of writing, such as making grammatical errors, misspellings, and using stylistic idiosyncrasies.

A version of this article first appeared on Medscape.com.

Madison Cano knew she wanted to breastfeed her son, Theo. But breastfeeding was painful for her. The skin on her breasts was chafed and blistered last July when she returned home from the hospital. And Theo sometimes screamed during feedings.

Ms. Cano, 30, realized she needed help to get the short- and long-term health benefits of breastfeeding for moms and babies. New studies (Am J Obstet Gynecol. 2021 Mar 26. doi: 10.1016/j.ajog.2021.03.023) also have shown that COVID-vaccinated mothers pass protective antibodies on to their newborns. However, Ms. Cano lives in Montrose in western Colorado, 60 miles away from her lactation counselor, Ali Reynolds, in Grand Junction – and it was during the thick of the pandemic.

She messaged Ms. Reynolds on Facebook and took photos and recorded videos of herself breastfeeding so Reynolds could offer advice and encouragement from afar. It worked. She no longer had pain. Ms. Cano is still breastfeeding Theo, who just turned 1.

“I don’t think I would have understood what was happening and been able to work through it without that resource,” said Ms. Cano.

Support for breastfeeding was upended last year, when it no longer seemed safe to take a baby class at the hospital or invite a nurse into one’s home. Hospitals, lactation counselors, and support groups turned to virtual platforms like Zoom or phone calls. That made lactation support accessible to struggling families during the pandemic, said Danielle Harmon, executive director of the United States Lactation Consultant Association.

Today, although lactation specialists have more options to safely meet in person with families after their COVID-19 vaccinations, many are choosing to continue virtual classes, keeping alive the online communities they created and relying on the technology that worked for many families. Virtual options especially help those in remote areas or those with limited transportation access, breastfeeding experts say.

Right before the pandemic, for example, Sandrine Druon typically had one or two moms attend in-person meetings she held for La Leche League of Longmont at the First Evangelical Lutheran Church or at a Ziggi’s Coffee shop. But because they could no longer meet in person, last June she launched two monthly virtual meetings. Now, an online meeting will typically include 9 or 10 moms. She started an online Spanish-speaking meeting in May and parents joined from their homes in several states and even from other countries. She hopes eventually to have a mix of online and in-person meetings.

The virtual switch hasn’t worked for everyone. Ms. Harmon said the logistics of video support remain difficult, along with privacy concerns on platforms that could be hacked. Other lactation experts noted Black and Hispanic mothers are sometimes still left behind. So lactation specialists are trying to learn from the pandemic on what worked – and what didn’t – to reach all kinds of new parents.

Before the pandemic, 84% of U.S. mothers breastfed at least initially, according to 2019 data from the Centers for Disease Control and Prevention, while Colorado had a 93% rate.

The pandemic hasn’t seemed to change the picture, said Stacy Miller, Colorado’s breastfeeding coordinator for the Special Supplemental Nutrition Program for Women, Infants, and Children, shorthanded as WIC. Citing state birth certificate data, Ms. Miller said preliminary breastfeeding rates among families discharged from Colorado hospitals remained similar in the first quarter of 2021 to rates from 2020 or 2019.

Throughout the pandemic, lactation specialists have tried to offer convenient options for parents. St. Joseph Hospital in Denver launched virtual breastfeeding support groups that still occur today, in addition to breastfeeding help during families’ hospital stays, said Katie Halverstadt, the hospital’s clinical nurse manager of lactation and family education.

Last year in North Carolina, experts adapted an in-person prenatal breastfeeding program to an interactive video platform in English and Spanish. A separate effort on New York’s Long Island successfully converted in-person breastfeeding support to phone and video calls in 2020.

To help support parents in Grand Junction, Colo., Ms. Reynolds expanded her private practice, Valley Lactation, by offering virtual appointments while continuing to see some clients in their homes. That hybrid model continues today, although Ms. Reynolds said the demand for virtual or phone appointments has decreased lately as the country reopens.

Paying out-of-pocket for appointments is a hurdle her clients face, said Ms. Reynolds, but she encourages them to submit claims for telehealth or in-person visits to their health insurance companies for reimbursement. Early in the pandemic, telehealth rules were relaxed to encourage more telephone and virtual appointments – many of which have been covered by insurance.

But insurance coverage for lactation support will likely continue to be an issue independent of whether pandemic telehealth rules expire, Ms. Harmon said. While the Affordable Care Act mandates that insurance companies cover lactation support and supplies, such as breast pumps, Ms. Harmon said reimbursement is often spotty. Mirroring Medicaid, insurance providers often cover services only from licensed providers, she said, but just four states – Georgia, New Mexico, Oregon, and Rhode Island – license lactation consultants.

Experts such as Jennifer Schindler-Ruwisch, an assistant professor at Fairfield (Conn.) University, found the pandemic may have exacerbated breastfeeding barriers for those without access to online technology or translation services, among other things. She published one of the first studies in the United States to examine COVID’s effect on lactation services by collecting experiences from lactation support providers in Connecticut, including many working in WIC programs. For income-eligible WIC families, all breastfeeding classes, peer groups and one-on-one consultations are free.

Birdie Johnson, a doula who provides breastfeeding and other postpartum support to Black families as part of Sacred Seeds Black Doula Collective of Colorado, said virtual support groups during the pandemic also did not meet her clients’ needs for connection and interaction. Social media built communities online, particularly by normalizing breastfeeding struggles among Black parents, she said, but obstacles remained.

“COVID brought our community together and at the same time destroyed it,” Ms. Johnson said.

Black parents in the United States already had lower rates of breastfeeding than Asian or White parents, according to 2017 CDC data, and both Black and Hispanic parents have had lower rates of exclusively breastfeeding their babies at 6 months, which is what the American Academy of Pediatrics recommends. Socioeconomics and lack of workplace support have been found to contribute to the gap. Research also has found Black mothers are more likely than White moms to be introduced to infant formula at hospitals.

A scarcity of Black health care providers in lactation, women’s health and pediatrics is a continuing concern, Ms. Johnson said. In Colorado last year, the Colorado Breastfeeding Coalition, the Center for African American Health, Elephant Circle and Families Forward Resource Center held three training sessions for people of color to become lactation specialists, said Ms. Halverstadt, who chairs the coalition.

Jefferson County, which encompasses much of Denver’s western suburbs, is now training at least a dozen Spanish-speaking community members for lactation certification. In addition to classes, the trainees log clinical hours in breastfeeding support, sometimes during virtual meetings of a Spanish-speaking support group called Cuenta Conmigo Lactancia.

“You are more confident and more at ease with someone who knows your language, your culture and who is part of the community,” said Brenda Rodriguez, a dietitian and certified lactation consultant for Jefferson County Public Health, which reaches roughly 400 breastfeeding families each month through its WIC programs.

Angelica Pereda, a maternal and child health registered nurse, is part of that training program. Ms. Pereda, who is Hispanic and bilingual, gave birth to son Ahmias in April 2020 and struggled with breastfeeding because he could not latch on to her breasts. A lactation consultant could not come into her home during the pandemic, and she was skeptical of virtual consultations because of privacy concerns. So she pumped her breast milk and bottle-fed it to her son.

Her experience gave her newfound empathy for families, and she wants to help other Spanish-speaking parents find solutions – whether in person or virtually.

“There is just not enough breastfeeding support in general, but especially when that support is in a different language,” said Ms. Pereda.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Madison Cano knew she wanted to breastfeed her son, Theo. But breastfeeding was painful for her. The skin on her breasts was chafed and blistered last July when she returned home from the hospital. And Theo sometimes screamed during feedings.

Ms. Cano, 30, realized she needed help to get the short- and long-term health benefits of breastfeeding for moms and babies. New studies (Am J Obstet Gynecol. 2021 Mar 26. doi: 10.1016/j.ajog.2021.03.023) also have shown that COVID-vaccinated mothers pass protective antibodies on to their newborns. However, Ms. Cano lives in Montrose in western Colorado, 60 miles away from her lactation counselor, Ali Reynolds, in Grand Junction – and it was during the thick of the pandemic.

She messaged Ms. Reynolds on Facebook and took photos and recorded videos of herself breastfeeding so Reynolds could offer advice and encouragement from afar. It worked. She no longer had pain. Ms. Cano is still breastfeeding Theo, who just turned 1.

“I don’t think I would have understood what was happening and been able to work through it without that resource,” said Ms. Cano.

Support for breastfeeding was upended last year, when it no longer seemed safe to take a baby class at the hospital or invite a nurse into one’s home. Hospitals, lactation counselors, and support groups turned to virtual platforms like Zoom or phone calls. That made lactation support accessible to struggling families during the pandemic, said Danielle Harmon, executive director of the United States Lactation Consultant Association.

Today, although lactation specialists have more options to safely meet in person with families after their COVID-19 vaccinations, many are choosing to continue virtual classes, keeping alive the online communities they created and relying on the technology that worked for many families. Virtual options especially help those in remote areas or those with limited transportation access, breastfeeding experts say.

Right before the pandemic, for example, Sandrine Druon typically had one or two moms attend in-person meetings she held for La Leche League of Longmont at the First Evangelical Lutheran Church or at a Ziggi’s Coffee shop. But because they could no longer meet in person, last June she launched two monthly virtual meetings. Now, an online meeting will typically include 9 or 10 moms. She started an online Spanish-speaking meeting in May and parents joined from their homes in several states and even from other countries. She hopes eventually to have a mix of online and in-person meetings.

The virtual switch hasn’t worked for everyone. Ms. Harmon said the logistics of video support remain difficult, along with privacy concerns on platforms that could be hacked. Other lactation experts noted Black and Hispanic mothers are sometimes still left behind. So lactation specialists are trying to learn from the pandemic on what worked – and what didn’t – to reach all kinds of new parents.

Before the pandemic, 84% of U.S. mothers breastfed at least initially, according to 2019 data from the Centers for Disease Control and Prevention, while Colorado had a 93% rate.

The pandemic hasn’t seemed to change the picture, said Stacy Miller, Colorado’s breastfeeding coordinator for the Special Supplemental Nutrition Program for Women, Infants, and Children, shorthanded as WIC. Citing state birth certificate data, Ms. Miller said preliminary breastfeeding rates among families discharged from Colorado hospitals remained similar in the first quarter of 2021 to rates from 2020 or 2019.

Throughout the pandemic, lactation specialists have tried to offer convenient options for parents. St. Joseph Hospital in Denver launched virtual breastfeeding support groups that still occur today, in addition to breastfeeding help during families’ hospital stays, said Katie Halverstadt, the hospital’s clinical nurse manager of lactation and family education.

Last year in North Carolina, experts adapted an in-person prenatal breastfeeding program to an interactive video platform in English and Spanish. A separate effort on New York’s Long Island successfully converted in-person breastfeeding support to phone and video calls in 2020.

To help support parents in Grand Junction, Colo., Ms. Reynolds expanded her private practice, Valley Lactation, by offering virtual appointments while continuing to see some clients in their homes. That hybrid model continues today, although Ms. Reynolds said the demand for virtual or phone appointments has decreased lately as the country reopens.

Paying out-of-pocket for appointments is a hurdle her clients face, said Ms. Reynolds, but she encourages them to submit claims for telehealth or in-person visits to their health insurance companies for reimbursement. Early in the pandemic, telehealth rules were relaxed to encourage more telephone and virtual appointments – many of which have been covered by insurance.

But insurance coverage for lactation support will likely continue to be an issue independent of whether pandemic telehealth rules expire, Ms. Harmon said. While the Affordable Care Act mandates that insurance companies cover lactation support and supplies, such as breast pumps, Ms. Harmon said reimbursement is often spotty. Mirroring Medicaid, insurance providers often cover services only from licensed providers, she said, but just four states – Georgia, New Mexico, Oregon, and Rhode Island – license lactation consultants.

Experts such as Jennifer Schindler-Ruwisch, an assistant professor at Fairfield (Conn.) University, found the pandemic may have exacerbated breastfeeding barriers for those without access to online technology or translation services, among other things. She published one of the first studies in the United States to examine COVID’s effect on lactation services by collecting experiences from lactation support providers in Connecticut, including many working in WIC programs. For income-eligible WIC families, all breastfeeding classes, peer groups and one-on-one consultations are free.

Birdie Johnson, a doula who provides breastfeeding and other postpartum support to Black families as part of Sacred Seeds Black Doula Collective of Colorado, said virtual support groups during the pandemic also did not meet her clients’ needs for connection and interaction. Social media built communities online, particularly by normalizing breastfeeding struggles among Black parents, she said, but obstacles remained.

“COVID brought our community together and at the same time destroyed it,” Ms. Johnson said.

Black parents in the United States already had lower rates of breastfeeding than Asian or White parents, according to 2017 CDC data, and both Black and Hispanic parents have had lower rates of exclusively breastfeeding their babies at 6 months, which is what the American Academy of Pediatrics recommends. Socioeconomics and lack of workplace support have been found to contribute to the gap. Research also has found Black mothers are more likely than White moms to be introduced to infant formula at hospitals.

A scarcity of Black health care providers in lactation, women’s health and pediatrics is a continuing concern, Ms. Johnson said. In Colorado last year, the Colorado Breastfeeding Coalition, the Center for African American Health, Elephant Circle and Families Forward Resource Center held three training sessions for people of color to become lactation specialists, said Ms. Halverstadt, who chairs the coalition.

Jefferson County, which encompasses much of Denver’s western suburbs, is now training at least a dozen Spanish-speaking community members for lactation certification. In addition to classes, the trainees log clinical hours in breastfeeding support, sometimes during virtual meetings of a Spanish-speaking support group called Cuenta Conmigo Lactancia.

“You are more confident and more at ease with someone who knows your language, your culture and who is part of the community,” said Brenda Rodriguez, a dietitian and certified lactation consultant for Jefferson County Public Health, which reaches roughly 400 breastfeeding families each month through its WIC programs.

Angelica Pereda, a maternal and child health registered nurse, is part of that training program. Ms. Pereda, who is Hispanic and bilingual, gave birth to son Ahmias in April 2020 and struggled with breastfeeding because he could not latch on to her breasts. A lactation consultant could not come into her home during the pandemic, and she was skeptical of virtual consultations because of privacy concerns. So she pumped her breast milk and bottle-fed it to her son.

Her experience gave her newfound empathy for families, and she wants to help other Spanish-speaking parents find solutions – whether in person or virtually.

“There is just not enough breastfeeding support in general, but especially when that support is in a different language,” said Ms. Pereda.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Madison Cano knew she wanted to breastfeed her son, Theo. But breastfeeding was painful for her. The skin on her breasts was chafed and blistered last July when she returned home from the hospital. And Theo sometimes screamed during feedings.

Ms. Cano, 30, realized she needed help to get the short- and long-term health benefits of breastfeeding for moms and babies. New studies (Am J Obstet Gynecol. 2021 Mar 26. doi: 10.1016/j.ajog.2021.03.023) also have shown that COVID-vaccinated mothers pass protective antibodies on to their newborns. However, Ms. Cano lives in Montrose in western Colorado, 60 miles away from her lactation counselor, Ali Reynolds, in Grand Junction – and it was during the thick of the pandemic.

She messaged Ms. Reynolds on Facebook and took photos and recorded videos of herself breastfeeding so Reynolds could offer advice and encouragement from afar. It worked. She no longer had pain. Ms. Cano is still breastfeeding Theo, who just turned 1.

“I don’t think I would have understood what was happening and been able to work through it without that resource,” said Ms. Cano.

Support for breastfeeding was upended last year, when it no longer seemed safe to take a baby class at the hospital or invite a nurse into one’s home. Hospitals, lactation counselors, and support groups turned to virtual platforms like Zoom or phone calls. That made lactation support accessible to struggling families during the pandemic, said Danielle Harmon, executive director of the United States Lactation Consultant Association.

Today, although lactation specialists have more options to safely meet in person with families after their COVID-19 vaccinations, many are choosing to continue virtual classes, keeping alive the online communities they created and relying on the technology that worked for many families. Virtual options especially help those in remote areas or those with limited transportation access, breastfeeding experts say.

Right before the pandemic, for example, Sandrine Druon typically had one or two moms attend in-person meetings she held for La Leche League of Longmont at the First Evangelical Lutheran Church or at a Ziggi’s Coffee shop. But because they could no longer meet in person, last June she launched two monthly virtual meetings. Now, an online meeting will typically include 9 or 10 moms. She started an online Spanish-speaking meeting in May and parents joined from their homes in several states and even from other countries. She hopes eventually to have a mix of online and in-person meetings.

The virtual switch hasn’t worked for everyone. Ms. Harmon said the logistics of video support remain difficult, along with privacy concerns on platforms that could be hacked. Other lactation experts noted Black and Hispanic mothers are sometimes still left behind. So lactation specialists are trying to learn from the pandemic on what worked – and what didn’t – to reach all kinds of new parents.

Before the pandemic, 84% of U.S. mothers breastfed at least initially, according to 2019 data from the Centers for Disease Control and Prevention, while Colorado had a 93% rate.

The pandemic hasn’t seemed to change the picture, said Stacy Miller, Colorado’s breastfeeding coordinator for the Special Supplemental Nutrition Program for Women, Infants, and Children, shorthanded as WIC. Citing state birth certificate data, Ms. Miller said preliminary breastfeeding rates among families discharged from Colorado hospitals remained similar in the first quarter of 2021 to rates from 2020 or 2019.

Throughout the pandemic, lactation specialists have tried to offer convenient options for parents. St. Joseph Hospital in Denver launched virtual breastfeeding support groups that still occur today, in addition to breastfeeding help during families’ hospital stays, said Katie Halverstadt, the hospital’s clinical nurse manager of lactation and family education.

Last year in North Carolina, experts adapted an in-person prenatal breastfeeding program to an interactive video platform in English and Spanish. A separate effort on New York’s Long Island successfully converted in-person breastfeeding support to phone and video calls in 2020.

To help support parents in Grand Junction, Colo., Ms. Reynolds expanded her private practice, Valley Lactation, by offering virtual appointments while continuing to see some clients in their homes. That hybrid model continues today, although Ms. Reynolds said the demand for virtual or phone appointments has decreased lately as the country reopens.

Paying out-of-pocket for appointments is a hurdle her clients face, said Ms. Reynolds, but she encourages them to submit claims for telehealth or in-person visits to their health insurance companies for reimbursement. Early in the pandemic, telehealth rules were relaxed to encourage more telephone and virtual appointments – many of which have been covered by insurance.

But insurance coverage for lactation support will likely continue to be an issue independent of whether pandemic telehealth rules expire, Ms. Harmon said. While the Affordable Care Act mandates that insurance companies cover lactation support and supplies, such as breast pumps, Ms. Harmon said reimbursement is often spotty. Mirroring Medicaid, insurance providers often cover services only from licensed providers, she said, but just four states – Georgia, New Mexico, Oregon, and Rhode Island – license lactation consultants.

Experts such as Jennifer Schindler-Ruwisch, an assistant professor at Fairfield (Conn.) University, found the pandemic may have exacerbated breastfeeding barriers for those without access to online technology or translation services, among other things. She published one of the first studies in the United States to examine COVID’s effect on lactation services by collecting experiences from lactation support providers in Connecticut, including many working in WIC programs. For income-eligible WIC families, all breastfeeding classes, peer groups and one-on-one consultations are free.

Birdie Johnson, a doula who provides breastfeeding and other postpartum support to Black families as part of Sacred Seeds Black Doula Collective of Colorado, said virtual support groups during the pandemic also did not meet her clients’ needs for connection and interaction. Social media built communities online, particularly by normalizing breastfeeding struggles among Black parents, she said, but obstacles remained.

“COVID brought our community together and at the same time destroyed it,” Ms. Johnson said.

Black parents in the United States already had lower rates of breastfeeding than Asian or White parents, according to 2017 CDC data, and both Black and Hispanic parents have had lower rates of exclusively breastfeeding their babies at 6 months, which is what the American Academy of Pediatrics recommends. Socioeconomics and lack of workplace support have been found to contribute to the gap. Research also has found Black mothers are more likely than White moms to be introduced to infant formula at hospitals.

A scarcity of Black health care providers in lactation, women’s health and pediatrics is a continuing concern, Ms. Johnson said. In Colorado last year, the Colorado Breastfeeding Coalition, the Center for African American Health, Elephant Circle and Families Forward Resource Center held three training sessions for people of color to become lactation specialists, said Ms. Halverstadt, who chairs the coalition.

Jefferson County, which encompasses much of Denver’s western suburbs, is now training at least a dozen Spanish-speaking community members for lactation certification. In addition to classes, the trainees log clinical hours in breastfeeding support, sometimes during virtual meetings of a Spanish-speaking support group called Cuenta Conmigo Lactancia.

“You are more confident and more at ease with someone who knows your language, your culture and who is part of the community,” said Brenda Rodriguez, a dietitian and certified lactation consultant for Jefferson County Public Health, which reaches roughly 400 breastfeeding families each month through its WIC programs.

Angelica Pereda, a maternal and child health registered nurse, is part of that training program. Ms. Pereda, who is Hispanic and bilingual, gave birth to son Ahmias in April 2020 and struggled with breastfeeding because he could not latch on to her breasts. A lactation consultant could not come into her home during the pandemic, and she was skeptical of virtual consultations because of privacy concerns. So she pumped her breast milk and bottle-fed it to her son.

Her experience gave her newfound empathy for families, and she wants to help other Spanish-speaking parents find solutions – whether in person or virtually.

“There is just not enough breastfeeding support in general, but especially when that support is in a different language,” said Ms. Pereda.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) strongly recommend that all pregnant women be vaccinated against COVID-19.

Only about 16% of pregnant people have received one or more doses of a COVID-19 vaccine, according to the Centers for Disease Control and Prevention, despite evidence that COVID-19 infection puts pregnant people at an increased risk of severe complications and death.

That CDC report in June also found that vaccination during pregnancy was lowest among Hispanic (11.9%) and non-Hispanic Black women (6%) and women aged 18-24 years (5.5%) and highest among non-Hispanic Asian women (24.7%) and women aged 35-49 years (22.7%).

Linda Eckert, MD, professor of obstetrics and gynecology at University of Washington, Seattle, and a member of ACOG’s immunization expert work group, said in an interview that previously, ACOG has said that pregnant women should have the opportunity to be vaccinated, should they choose it.

Now the urgency has increased, she said: “This is a strong recommendation.”

The recommendation comes after mounting evidence demonstrating that COVID-19 vaccines are safe during pregnancy “from tens of thousands of reporting individuals over the last several months, as well as the current low vaccination rates and concerning increase in cases,” ACOG and SMFM said in the statement.

Both organizations said the timing of the advisory comes amid growing concern about the Delta variant.

CDC Director Rochelle Walensky, MD, has called the variant “one of the most infectious respiratory viruses we know of.”
 

No evidence of maternal/fetal harm

There is no evidence that COVID-19 vaccines could cause maternal or fetal harm, ACOG stated.

“ACOG encourages its members to enthusiastically recommend vaccination to their patients. This means emphasizing the known safety of the vaccines and the increased risk of severe complications associated with COVID-19 infection, including death, during pregnancy,” said J. Martin Tucker, MD, FACOG, president of ACOG. “It is clear that pregnant people need to feel confident in the decision to choose vaccination, and a strong recommendation from their obstetrician-gynecologist could make a meaningful difference for many pregnant people.”

Pregnant women are considered high risk because of concerns about the effect of COVID-19 during and after pregnancy, and on their offspring.

As this news organization has reported, research published in The BMJ found that pregnant women with COVID-19 may be at higher risk of admission to a hospital intensive care unit.

Preterm birth rates also were found to be higher among pregnant women with COVID-19 than among pregnant women without the disease.

Dr. Eckert said several of her patients have declined the vaccine. Among the reasons are that they don’t want to take any medications while pregnant or that they have heard that effects of the vaccines were not studied in pregnant women.

“Sometimes as I review with them the ongoing data coming in from pregnant individuals and newborns, [these patients] may change their minds and get the vaccine,” Dr. Eckert said.

In some cases, a pregnant patient’s family has pressured the patient not to get the vaccine.

The ACOG/SMFM advice notes that pregnant women who have decided to wait until after delivery to be vaccinated “may be inadvertently exposing themselves to an increased risk of severe illness or death.”

The recommendation extends to those who have already given birth.

“Those who have recently delivered and were not vaccinated during pregnancy are also strongly encouraged to get vaccinated as soon as possible,” the statement reads.

ACOG has developed talking points about the safety and efficacy of COVID-19 vaccines for pregnant patients.

Dr. Eckert disclosed no relevant financial relationships.

The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) strongly recommend that all pregnant women be vaccinated against COVID-19.

Only about 16% of pregnant people have received one or more doses of a COVID-19 vaccine, according to the Centers for Disease Control and Prevention, despite evidence that COVID-19 infection puts pregnant people at an increased risk of severe complications and death.

That CDC report in June also found that vaccination during pregnancy was lowest among Hispanic (11.9%) and non-Hispanic Black women (6%) and women aged 18-24 years (5.5%) and highest among non-Hispanic Asian women (24.7%) and women aged 35-49 years (22.7%).

Linda Eckert, MD, professor of obstetrics and gynecology at University of Washington, Seattle, and a member of ACOG’s immunization expert work group, said in an interview that previously, ACOG has said that pregnant women should have the opportunity to be vaccinated, should they choose it.

Now the urgency has increased, she said: “This is a strong recommendation.”

The recommendation comes after mounting evidence demonstrating that COVID-19 vaccines are safe during pregnancy “from tens of thousands of reporting individuals over the last several months, as well as the current low vaccination rates and concerning increase in cases,” ACOG and SMFM said in the statement.

Both organizations said the timing of the advisory comes amid growing concern about the Delta variant.

CDC Director Rochelle Walensky, MD, has called the variant “one of the most infectious respiratory viruses we know of.”
 

No evidence of maternal/fetal harm

There is no evidence that COVID-19 vaccines could cause maternal or fetal harm, ACOG stated.

“ACOG encourages its members to enthusiastically recommend vaccination to their patients. This means emphasizing the known safety of the vaccines and the increased risk of severe complications associated with COVID-19 infection, including death, during pregnancy,” said J. Martin Tucker, MD, FACOG, president of ACOG. “It is clear that pregnant people need to feel confident in the decision to choose vaccination, and a strong recommendation from their obstetrician-gynecologist could make a meaningful difference for many pregnant people.”

Pregnant women are considered high risk because of concerns about the effect of COVID-19 during and after pregnancy, and on their offspring.

As this news organization has reported, research published in The BMJ found that pregnant women with COVID-19 may be at higher risk of admission to a hospital intensive care unit.

Preterm birth rates also were found to be higher among pregnant women with COVID-19 than among pregnant women without the disease.

Dr. Eckert said several of her patients have declined the vaccine. Among the reasons are that they don’t want to take any medications while pregnant or that they have heard that effects of the vaccines were not studied in pregnant women.

“Sometimes as I review with them the ongoing data coming in from pregnant individuals and newborns, [these patients] may change their minds and get the vaccine,” Dr. Eckert said.

In some cases, a pregnant patient’s family has pressured the patient not to get the vaccine.

The ACOG/SMFM advice notes that pregnant women who have decided to wait until after delivery to be vaccinated “may be inadvertently exposing themselves to an increased risk of severe illness or death.”

The recommendation extends to those who have already given birth.

“Those who have recently delivered and were not vaccinated during pregnancy are also strongly encouraged to get vaccinated as soon as possible,” the statement reads.

ACOG has developed talking points about the safety and efficacy of COVID-19 vaccines for pregnant patients.

Dr. Eckert disclosed no relevant financial relationships.

The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) strongly recommend that all pregnant women be vaccinated against COVID-19.

Only about 16% of pregnant people have received one or more doses of a COVID-19 vaccine, according to the Centers for Disease Control and Prevention, despite evidence that COVID-19 infection puts pregnant people at an increased risk of severe complications and death.

That CDC report in June also found that vaccination during pregnancy was lowest among Hispanic (11.9%) and non-Hispanic Black women (6%) and women aged 18-24 years (5.5%) and highest among non-Hispanic Asian women (24.7%) and women aged 35-49 years (22.7%).

Linda Eckert, MD, professor of obstetrics and gynecology at University of Washington, Seattle, and a member of ACOG’s immunization expert work group, said in an interview that previously, ACOG has said that pregnant women should have the opportunity to be vaccinated, should they choose it.

Now the urgency has increased, she said: “This is a strong recommendation.”

The recommendation comes after mounting evidence demonstrating that COVID-19 vaccines are safe during pregnancy “from tens of thousands of reporting individuals over the last several months, as well as the current low vaccination rates and concerning increase in cases,” ACOG and SMFM said in the statement.

Both organizations said the timing of the advisory comes amid growing concern about the Delta variant.

CDC Director Rochelle Walensky, MD, has called the variant “one of the most infectious respiratory viruses we know of.”
 

No evidence of maternal/fetal harm

There is no evidence that COVID-19 vaccines could cause maternal or fetal harm, ACOG stated.

“ACOG encourages its members to enthusiastically recommend vaccination to their patients. This means emphasizing the known safety of the vaccines and the increased risk of severe complications associated with COVID-19 infection, including death, during pregnancy,” said J. Martin Tucker, MD, FACOG, president of ACOG. “It is clear that pregnant people need to feel confident in the decision to choose vaccination, and a strong recommendation from their obstetrician-gynecologist could make a meaningful difference for many pregnant people.”

Pregnant women are considered high risk because of concerns about the effect of COVID-19 during and after pregnancy, and on their offspring.

As this news organization has reported, research published in The BMJ found that pregnant women with COVID-19 may be at higher risk of admission to a hospital intensive care unit.

Preterm birth rates also were found to be higher among pregnant women with COVID-19 than among pregnant women without the disease.

Dr. Eckert said several of her patients have declined the vaccine. Among the reasons are that they don’t want to take any medications while pregnant or that they have heard that effects of the vaccines were not studied in pregnant women.

“Sometimes as I review with them the ongoing data coming in from pregnant individuals and newborns, [these patients] may change their minds and get the vaccine,” Dr. Eckert said.

In some cases, a pregnant patient’s family has pressured the patient not to get the vaccine.

The ACOG/SMFM advice notes that pregnant women who have decided to wait until after delivery to be vaccinated “may be inadvertently exposing themselves to an increased risk of severe illness or death.”

The recommendation extends to those who have already given birth.

“Those who have recently delivered and were not vaccinated during pregnancy are also strongly encouraged to get vaccinated as soon as possible,” the statement reads.

ACOG has developed talking points about the safety and efficacy of COVID-19 vaccines for pregnant patients.

Dr. Eckert disclosed no relevant financial relationships.

Nearly half of female surgeons (42%) who were recently surveyed have had a miscarriage or stillbirth – twice the rate of women aged 30-40 years in the general population – according to an article published online July 28 in JAMA Surgery.

The authors, led by Erika L. Rangel, MD, division of general and gastrointestinal surgery, department of surgery, Brigham and Women’s Hospital, Boston, found that after the losses, the women took little or no time off.

Of 692 surgeons surveyed, 347 female surgeons had experienced a pregnancy loss. Of those, 244 had had a miscarriage at less than 10 weeks’ gestation, 92 had had a miscarriage between 10 and 20 weeks’ gestation, and 11 had had a stillbirth (loss at 20 weeks or later).
 

Most took no time off after miscarriage

After a miscarriage, 225 of 336 women (75%) took no time off work, and after a stillbirth, 5 of 11 (45%) took off 1 week or less, the authors found.

The study addressed an issue that people have talked about anecdotally or on social media, Dr. Rangel told this news organization.

“This was finally an opportunity to do a study of enough magnitude to show that there is a very quantifiable difference in complication rate, use of IVF [in vitro fertilization], and the age at which we have children. These are not just anecdotal stories,” she said.

For the study, a self-administered questionnaire was distributed electronically. Answers were collected from November 2020 to January 2021 through multiple U.S. surgical societies and social media among attending and resident surgeons with children. The control group for the study comprised 158 male surgeons who answered questions regarding their partners’ pregnancies.

Female surgeons had fewer children compared with male surgeons and their female partners (mean [SD],1.8 [0.8], versus 2.3 [1.1]; P < .001) and were more likely to delay having children because of surgical training (450 of 692 [65.0%] versus 69 of 158 [43.7%]; P < .001).

In addition, Dr. Rangel and colleagues found that 57% of female surgeons worked more than 60 hours a week during pregnancy and that 37% took more than six overnight calls.

The data show that female surgeons who operated 12 or more hours per week during the last trimester of pregnancy were at higher risk compared with those who operated fewer hours (odds ratio, 1.57; 95% confidence interval, 1.08-2.26).

“Pregnant surgeons should not be operating more than 12 hours a week when they are in the third trimester,” Dr. Rangel said.

“That is a modifiable risk factor,” she told this news organization. “It’s a very brief period of support – a couple of months of support for a woman who may do 25-30 more years of serving the public with surgical skills.”

She said that training programs should be organized so as to have colleagues cover operating room (OR) shifts to reduce the operating hours for pregnant colleagues. In addition, advanced practice health care professionals should be paid to take up the paperwork and perform non-OR care to reduce the stigma associated with pregnant trainees overburdening other surgical trainees.
 

‘It’s too big an ask’

Obstetrician-gynecologist Maryam Siddiqui, MD, said in an interview that she was particularly struck by the number of female surgeons who experience involuntary childlessness.

“That’s a big ask for people who want childbearing to be a part of the fulfillment of their life. It’s too big,” said Dr. Siddiqui, a gynecologic surgeon at UChicago Medicine.

She said the amount of detail in the article and the large number of participants were persuasive factors that can support establishing a more humane system than one in which one person at a time has to ask for change.

Pointing to the finding that three-fourths of the women in the study who had had miscarriages didn’t take time off, she said, “That’s not really humane. But they’re afraid to ask or they don’t want to reveal they’re trying [to get pregnant]. Why should you be afraid of building your family?”

The authors also found other adverse outcomes. Female surgeons were more likely to have musculoskeletal disorders compared with female nonsurgeon partners (36.9% versus 18.4%; P < .001), and they were more likely to undergo nonelective cesarean delivery (25.5% versus 15.3%; P = .01) and to experience postpartum depression (11.1% versus 5.7%; P = .04).

Dr. Siddiqui said the conditions that surgeons encounter on their return to work after childbirth are “a perfect storm” for postpartum depression among women who are not accustomed to being reliant on others.

Women often feel coerced into returning to work before they are physically or emotionally ready, then toggle back and forth from night shift to day shift, losing sleep, she said. “We can do better.”

One of the solutions, she said, is to provide better work coverage for the surgeon while she is pregnant and when she returns to work. That includes properly compensating the person covering for the surgeon by giving that person extra pay or additional time off.

“You have to value both people,” she said. “If both people are valued, there’s still collegiality.”

She acknowledged that that kind of compensation may be more readily available at large academic centers.

At UChicago, she said, they are creative with scheduling in training. For women at the height of pregnancy, rotations are less intensive, and trauma rotations are avoided.

Dr. Siddiqui said one of the most important aspects of the article is the authors’ list of two dozen ways, both big and small, to improve conditions.

Adopting such changes will become increasingly important for hiring and retaining female surgeons. “You want to work someplace where you’re respected as a whole person,” she said.

Sarah Blair, MD, a surgical oncologist at University of California, San Diego, stated that the number of miscarriages in particular provides disturbing proof of a problem women in surgery frequently discuss.

For nearly a decade, she led a women-in-surgery committee at UCSD in which they discussed such issues regarding pregnancy and medicine.

She said she hopes these data can help push for change in flexibility in residency so that women can graduate on time and have the families they want.

“There’s a movement away from time-based training to competency-based training, so maybe that will help women,” she said.
 

‘We have to figure this out’

“We will have to figure this out, because more than half of the people in medical school are women, and there are a lot more women in surgery than when I trained more than 20 years ago. It’s not a problem that’s going away,” she said.

One sign of improvement happened recently, Dr. Rangel said.

As previously reported, according to the American Board of Medical Specialties, as of July 1, 2021, residents and fellows are allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation time or sick leave and without having to extend their training.

“That’s huge,” she said. “But we still have a long way to go, because the residency programs still don’t have to have policy that abides that. It merely says you can take 6 weeks off and take your boards. It doesn’t say that the residency program has to allow you to take 6 weeks off.”

The authors noted that the United States and Papua New Guinea are the only countries in the world without federally mandated paid parental leave.

“Most U.S. female surgeons rely on their employer for this benefit, but only half of top-ranked medical schools offer paid leave, and 33%-65% of U.S. surgical training programs lack clear maternity leave policies,” she said.

Funding for the study was provided by the department of surgery at Brigham and Women’s Hospital. The study authors, Dr. Blair, and Dr. Siddiqui have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Nearly half of female surgeons (42%) who were recently surveyed have had a miscarriage or stillbirth – twice the rate of women aged 30-40 years in the general population – according to an article published online July 28 in JAMA Surgery.

The authors, led by Erika L. Rangel, MD, division of general and gastrointestinal surgery, department of surgery, Brigham and Women’s Hospital, Boston, found that after the losses, the women took little or no time off.

Of 692 surgeons surveyed, 347 female surgeons had experienced a pregnancy loss. Of those, 244 had had a miscarriage at less than 10 weeks’ gestation, 92 had had a miscarriage between 10 and 20 weeks’ gestation, and 11 had had a stillbirth (loss at 20 weeks or later).
 

Most took no time off after miscarriage

After a miscarriage, 225 of 336 women (75%) took no time off work, and after a stillbirth, 5 of 11 (45%) took off 1 week or less, the authors found.

The study addressed an issue that people have talked about anecdotally or on social media, Dr. Rangel told this news organization.

“This was finally an opportunity to do a study of enough magnitude to show that there is a very quantifiable difference in complication rate, use of IVF [in vitro fertilization], and the age at which we have children. These are not just anecdotal stories,” she said.

For the study, a self-administered questionnaire was distributed electronically. Answers were collected from November 2020 to January 2021 through multiple U.S. surgical societies and social media among attending and resident surgeons with children. The control group for the study comprised 158 male surgeons who answered questions regarding their partners’ pregnancies.

Female surgeons had fewer children compared with male surgeons and their female partners (mean [SD],1.8 [0.8], versus 2.3 [1.1]; P < .001) and were more likely to delay having children because of surgical training (450 of 692 [65.0%] versus 69 of 158 [43.7%]; P < .001).

In addition, Dr. Rangel and colleagues found that 57% of female surgeons worked more than 60 hours a week during pregnancy and that 37% took more than six overnight calls.

The data show that female surgeons who operated 12 or more hours per week during the last trimester of pregnancy were at higher risk compared with those who operated fewer hours (odds ratio, 1.57; 95% confidence interval, 1.08-2.26).

“Pregnant surgeons should not be operating more than 12 hours a week when they are in the third trimester,” Dr. Rangel said.

“That is a modifiable risk factor,” she told this news organization. “It’s a very brief period of support – a couple of months of support for a woman who may do 25-30 more years of serving the public with surgical skills.”

She said that training programs should be organized so as to have colleagues cover operating room (OR) shifts to reduce the operating hours for pregnant colleagues. In addition, advanced practice health care professionals should be paid to take up the paperwork and perform non-OR care to reduce the stigma associated with pregnant trainees overburdening other surgical trainees.
 

‘It’s too big an ask’

Obstetrician-gynecologist Maryam Siddiqui, MD, said in an interview that she was particularly struck by the number of female surgeons who experience involuntary childlessness.

“That’s a big ask for people who want childbearing to be a part of the fulfillment of their life. It’s too big,” said Dr. Siddiqui, a gynecologic surgeon at UChicago Medicine.

She said the amount of detail in the article and the large number of participants were persuasive factors that can support establishing a more humane system than one in which one person at a time has to ask for change.

Pointing to the finding that three-fourths of the women in the study who had had miscarriages didn’t take time off, she said, “That’s not really humane. But they’re afraid to ask or they don’t want to reveal they’re trying [to get pregnant]. Why should you be afraid of building your family?”

The authors also found other adverse outcomes. Female surgeons were more likely to have musculoskeletal disorders compared with female nonsurgeon partners (36.9% versus 18.4%; P < .001), and they were more likely to undergo nonelective cesarean delivery (25.5% versus 15.3%; P = .01) and to experience postpartum depression (11.1% versus 5.7%; P = .04).

Dr. Siddiqui said the conditions that surgeons encounter on their return to work after childbirth are “a perfect storm” for postpartum depression among women who are not accustomed to being reliant on others.

Women often feel coerced into returning to work before they are physically or emotionally ready, then toggle back and forth from night shift to day shift, losing sleep, she said. “We can do better.”

One of the solutions, she said, is to provide better work coverage for the surgeon while she is pregnant and when she returns to work. That includes properly compensating the person covering for the surgeon by giving that person extra pay or additional time off.

“You have to value both people,” she said. “If both people are valued, there’s still collegiality.”

She acknowledged that that kind of compensation may be more readily available at large academic centers.

At UChicago, she said, they are creative with scheduling in training. For women at the height of pregnancy, rotations are less intensive, and trauma rotations are avoided.

Dr. Siddiqui said one of the most important aspects of the article is the authors’ list of two dozen ways, both big and small, to improve conditions.

Adopting such changes will become increasingly important for hiring and retaining female surgeons. “You want to work someplace where you’re respected as a whole person,” she said.

Sarah Blair, MD, a surgical oncologist at University of California, San Diego, stated that the number of miscarriages in particular provides disturbing proof of a problem women in surgery frequently discuss.

For nearly a decade, she led a women-in-surgery committee at UCSD in which they discussed such issues regarding pregnancy and medicine.

She said she hopes these data can help push for change in flexibility in residency so that women can graduate on time and have the families they want.

“There’s a movement away from time-based training to competency-based training, so maybe that will help women,” she said.
 

‘We have to figure this out’

“We will have to figure this out, because more than half of the people in medical school are women, and there are a lot more women in surgery than when I trained more than 20 years ago. It’s not a problem that’s going away,” she said.

One sign of improvement happened recently, Dr. Rangel said.

As previously reported, according to the American Board of Medical Specialties, as of July 1, 2021, residents and fellows are allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation time or sick leave and without having to extend their training.

“That’s huge,” she said. “But we still have a long way to go, because the residency programs still don’t have to have policy that abides that. It merely says you can take 6 weeks off and take your boards. It doesn’t say that the residency program has to allow you to take 6 weeks off.”

The authors noted that the United States and Papua New Guinea are the only countries in the world without federally mandated paid parental leave.

“Most U.S. female surgeons rely on their employer for this benefit, but only half of top-ranked medical schools offer paid leave, and 33%-65% of U.S. surgical training programs lack clear maternity leave policies,” she said.

Funding for the study was provided by the department of surgery at Brigham and Women’s Hospital. The study authors, Dr. Blair, and Dr. Siddiqui have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Nearly half of female surgeons (42%) who were recently surveyed have had a miscarriage or stillbirth – twice the rate of women aged 30-40 years in the general population – according to an article published online July 28 in JAMA Surgery.

The authors, led by Erika L. Rangel, MD, division of general and gastrointestinal surgery, department of surgery, Brigham and Women’s Hospital, Boston, found that after the losses, the women took little or no time off.

Of 692 surgeons surveyed, 347 female surgeons had experienced a pregnancy loss. Of those, 244 had had a miscarriage at less than 10 weeks’ gestation, 92 had had a miscarriage between 10 and 20 weeks’ gestation, and 11 had had a stillbirth (loss at 20 weeks or later).
 

Most took no time off after miscarriage

After a miscarriage, 225 of 336 women (75%) took no time off work, and after a stillbirth, 5 of 11 (45%) took off 1 week or less, the authors found.

The study addressed an issue that people have talked about anecdotally or on social media, Dr. Rangel told this news organization.

“This was finally an opportunity to do a study of enough magnitude to show that there is a very quantifiable difference in complication rate, use of IVF [in vitro fertilization], and the age at which we have children. These are not just anecdotal stories,” she said.

For the study, a self-administered questionnaire was distributed electronically. Answers were collected from November 2020 to January 2021 through multiple U.S. surgical societies and social media among attending and resident surgeons with children. The control group for the study comprised 158 male surgeons who answered questions regarding their partners’ pregnancies.

Female surgeons had fewer children compared with male surgeons and their female partners (mean [SD],1.8 [0.8], versus 2.3 [1.1]; P < .001) and were more likely to delay having children because of surgical training (450 of 692 [65.0%] versus 69 of 158 [43.7%]; P < .001).

In addition, Dr. Rangel and colleagues found that 57% of female surgeons worked more than 60 hours a week during pregnancy and that 37% took more than six overnight calls.

The data show that female surgeons who operated 12 or more hours per week during the last trimester of pregnancy were at higher risk compared with those who operated fewer hours (odds ratio, 1.57; 95% confidence interval, 1.08-2.26).

“Pregnant surgeons should not be operating more than 12 hours a week when they are in the third trimester,” Dr. Rangel said.

“That is a modifiable risk factor,” she told this news organization. “It’s a very brief period of support – a couple of months of support for a woman who may do 25-30 more years of serving the public with surgical skills.”

She said that training programs should be organized so as to have colleagues cover operating room (OR) shifts to reduce the operating hours for pregnant colleagues. In addition, advanced practice health care professionals should be paid to take up the paperwork and perform non-OR care to reduce the stigma associated with pregnant trainees overburdening other surgical trainees.
 

‘It’s too big an ask’

Obstetrician-gynecologist Maryam Siddiqui, MD, said in an interview that she was particularly struck by the number of female surgeons who experience involuntary childlessness.

“That’s a big ask for people who want childbearing to be a part of the fulfillment of their life. It’s too big,” said Dr. Siddiqui, a gynecologic surgeon at UChicago Medicine.

She said the amount of detail in the article and the large number of participants were persuasive factors that can support establishing a more humane system than one in which one person at a time has to ask for change.

Pointing to the finding that three-fourths of the women in the study who had had miscarriages didn’t take time off, she said, “That’s not really humane. But they’re afraid to ask or they don’t want to reveal they’re trying [to get pregnant]. Why should you be afraid of building your family?”

The authors also found other adverse outcomes. Female surgeons were more likely to have musculoskeletal disorders compared with female nonsurgeon partners (36.9% versus 18.4%; P < .001), and they were more likely to undergo nonelective cesarean delivery (25.5% versus 15.3%; P = .01) and to experience postpartum depression (11.1% versus 5.7%; P = .04).

Dr. Siddiqui said the conditions that surgeons encounter on their return to work after childbirth are “a perfect storm” for postpartum depression among women who are not accustomed to being reliant on others.

Women often feel coerced into returning to work before they are physically or emotionally ready, then toggle back and forth from night shift to day shift, losing sleep, she said. “We can do better.”

One of the solutions, she said, is to provide better work coverage for the surgeon while she is pregnant and when she returns to work. That includes properly compensating the person covering for the surgeon by giving that person extra pay or additional time off.

“You have to value both people,” she said. “If both people are valued, there’s still collegiality.”

She acknowledged that that kind of compensation may be more readily available at large academic centers.

At UChicago, she said, they are creative with scheduling in training. For women at the height of pregnancy, rotations are less intensive, and trauma rotations are avoided.

Dr. Siddiqui said one of the most important aspects of the article is the authors’ list of two dozen ways, both big and small, to improve conditions.

Adopting such changes will become increasingly important for hiring and retaining female surgeons. “You want to work someplace where you’re respected as a whole person,” she said.

Sarah Blair, MD, a surgical oncologist at University of California, San Diego, stated that the number of miscarriages in particular provides disturbing proof of a problem women in surgery frequently discuss.

For nearly a decade, she led a women-in-surgery committee at UCSD in which they discussed such issues regarding pregnancy and medicine.

She said she hopes these data can help push for change in flexibility in residency so that women can graduate on time and have the families they want.

“There’s a movement away from time-based training to competency-based training, so maybe that will help women,” she said.
 

‘We have to figure this out’

“We will have to figure this out, because more than half of the people in medical school are women, and there are a lot more women in surgery than when I trained more than 20 years ago. It’s not a problem that’s going away,” she said.

One sign of improvement happened recently, Dr. Rangel said.

As previously reported, according to the American Board of Medical Specialties, as of July 1, 2021, residents and fellows are allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation time or sick leave and without having to extend their training.

“That’s huge,” she said. “But we still have a long way to go, because the residency programs still don’t have to have policy that abides that. It merely says you can take 6 weeks off and take your boards. It doesn’t say that the residency program has to allow you to take 6 weeks off.”

The authors noted that the United States and Papua New Guinea are the only countries in the world without federally mandated paid parental leave.

“Most U.S. female surgeons rely on their employer for this benefit, but only half of top-ranked medical schools offer paid leave, and 33%-65% of U.S. surgical training programs lack clear maternity leave policies,” she said.

Funding for the study was provided by the department of surgery at Brigham and Women’s Hospital. The study authors, Dr. Blair, and Dr. Siddiqui have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Study Overview

Objective. To compare the risk of subsequent fractures after an initial traumatic or nontraumatic fracture in postmenopausal women.

Design. A prospective observational study utilizing data from the Women’s Health Initiative (WHI) Study, WHI Clinical Trials (WHI-CT), and WHI Bone Density Substudy to evaluate rates at which patients who suffered a traumatic fracture vs nontraumatic fracture develop a subsequent fracture.

Setting and participants. The WHI study, implemented at 40 United States clinical sites, enrolled 161 808 postmenopausal women aged 50 to 79 years at baseline between 1993 and 1998. The study cohort consisted of 75 335 patients who had self-reported fractures from September 1994 to December 1998 that were confirmed by the WHI Bone Density Substudy and WHI-CT. Of these participants, 253 (0.3%) were excluded because of a lack of follow-up information regarding incident fractures, and 8208 (10.9%) were excluded due to incomplete information on covariates, thus resulting in an analytic sample of 66 874 (88.8%) participants. Prospective fracture ascertainment with participants was conducted at least annually and the mechanism of fracture was assessed to differentiate traumatic vs nontraumatic incident fractures. Traumatic fractures were defined as fractures caused by motor vehicle collisions, falls from a height, falls downstairs, or sports injury. Nontraumatic fractures were defined as fractures caused by a trip and fall.

Main outcome measures. The primary outcome was an incident fracture at an anatomically distinct body part. Fractures were classified as upper extremity (carpal, elbow, lower or upper end of humerus, shaft of humerus, upper radius/ulna, or radius/ulna), lower extremity (ankle, hip, patella, pelvis, shaft of femur, tibia/fibula, or tibial plateau), or spine (lumbar and/or thoracic spine). Self-reported fractures were verified via medical chart review by WHI study physicians; hip fractures were confirmed by review of written reports of radiographic studies; and nonhip fractures were confirmed by review of radiography reports or clinical documentations.

Main results. In total, 66 874 women in the study (mean [SD] age) 63.1 (7.0) years without clinical fracture and 65.3 (7.2) years with clinical fracture at baseline were followed for 8.1 (1.6) years. Of these participants, 7142 (10.7%) experienced incident fracture during the study follow-up period (13.9 per 1000 person-years), and 721 (10.1%) of whom had a subsequent fracture. The adjusted hazard ratio (aHR) of subsequent fracture after an initial fracture was 1.49 (95% CI, 1.38-1.61, P < .001). Covariates adjusted were age, race, ethnicity, body mass index, treated diabetes, frequency of falls in the previous year, and physical function and activity. In women with initial traumatic fracture, the association between initial and subsequent fracture was increased (aHR, 1.25; 95% CI, 1.06-1.48, P = .01). Among women with initial nontraumatic fracture, the association between initial and subsequent fracture was also increased (aHR, 1.52; 95% CI, 1.37-1.68, P < .001). The confidence intervals for the 2 preceding associations for traumatic and nontraumatic initial fracture strata were overlapping.

Conclusion. Fractures, regardless of mechanism of injury, are similarly associated with an increased risk of subsequent fractures in postmenopausal women aged 50 years and older. Findings from this study provide evidence to support reevaluation of current clinical guidelines to include traumatic fracture as a trigger for osteoporosis screening.

Commentary

Osteoporosis is one of the most common age-associated disease that affects 1 in 4 women and 1 in 20 men over the age of 65.¹ It increases the risk of fracture, and its clinical sequelae include reduced mobility, health decline, and increased all-cause mortality. The high prevalence of osteoporosis poses a clinical challenge as the global population continues to age. Pharmacological treatments such as bisphosphonates are highly effective in preventing or slowing bone mineral density (BMD) loss and reducing risk of fragility fractures (eg, nontraumatic fractures of the vertebra, hip, and femur) and are commonly used to mitigate adverse effects of degenerative bone changes secondary to osteoporosis.¹

The high prevalence of osteoporosis and effectiveness of bisphosphonates raises the question of how to optimally identify adults at risk for osteoporosis so that pharmacologic therapy can be promptly initiated to prevent disease progression. Multiple osteoporosis screening guidelines, including those from the United States Preventive Services Task Force (USPSTF), American Association of Family Physicians, and National Osteoporosis Foundation, are widely used in the clinical setting to address this important clinical question. In general, the prevailing wisdom is to screen osteoporosis in postmenopausal women over the age of 65, women under the age of 65 who have a significant 10-year fracture risk, or women over the age of 50 who have experienced a fragility fracture.¹ In the study reported by Crandall et al, it was shown that the risks of having subsequent fractures were similar after an initial traumatic or nontraumatic (fragility) fracture in postmenopausal women aged 50 years and older.² This finding brings into question whether traumatic fractures should be viewed any differently than nontraumatic fractures in women over the age of 50 in light of evaluation for osteoporosis. Furthermore, these results suggest that most fractures in postmenopausal women may indicate decreased bone integrity, thus adding to the rationale that osteoporosis screening needs to be considered and expanded to include postmenopausal women under the age of 65 who endured a traumatic fracture.

Per current guidelines, a woman under the age of 65 is recommended for osteoporosis screening only if she has an increased 10-year fracture risk compared to women aged 65 years and older. This risk is calculated based on the World Health Organization fracture-risk algorithm (WHO FRAX) tool which uses multiple factors such as age, weight, and history of fragility fractures to predict whether an individual is at risk of developing a fracture in the next 10 years. The WHO FRAX tool does not include traumatic fractures in its risk calculation and current clinical guidelines do not account for traumatic fractures as a red flag to initiate osteoporosis screening. Therefore, postmenopausal women under the age of 65 are less likely to be screened for osteoporosis when they experience a traumatic fracture compared to a fragility fracture, despite being at a demonstrably higher risk for subsequent fracture. As an unintended consequence, this may lead to the under diagnosis of osteoporosis in postmenopausal women under the age of 65. Thus, Crandall et al conclude that a fracture due to any cause warrants follow up evaluation for osteoporosis including BMD testing in women older than 50 years of age.

Older men constitute another population who are commonly under screened for osteoporosis. The current USPSTF guidelines indicate that there is an insufficient body of evidence to screen men for osteoporosis given its lower prevalence.¹ However, it is important to note that men have significantly increased mortality after a hip fracture, are less likely to be on pharmacological treatment for osteoporosis, and are under diagnosed for osteoporosis.³ Consistent with findings from the current study, Leslie et al showed that high-trauma and low-trauma fractures have similarly elevated subsequent fracture risk in both men and women over the age of 40 in a Canadian study.⁴ Moreover, in the same study, BMD was decreased in both men and women who suffered a fracture regardless of the injury mechanism. This finding further underscores a need to consider traumatic fractures as a risk factor for osteoporosis. Taken together, given that men are under screened and treated for osteoporosis but have increased mortality post-fracture, considerations to initiate osteoporosis evaluation should be similarly given to men who endured a traumatic fracture.

The study conducted by Crandall et al has several strengths. It is noteworthy for the large size of the WHI cohort with participants from across the United States which enables the capture of a wider range of age groups as women under the age of 65 are not common participants of osteoporosis studies. Additionally, data ascertainment and outcome adjudication utilizing medical records and physician review assure data quality. A limitation of the study is that the study cohort consists exclusively of women and therefore the findings are not generalizable to men. However, findings from this study echo those from other studies that investigate the relationship between fracture mechanisms and subsequent fracture risk in men and women.^3,4 Collectively, these comparable findings highlight the need for additional research to validate traumatic fracture as a risk factor for osteoporosis and to incorporate it into clinical guidelines for osteoporosis screening.

Applications for Clinical Practice

The findings from the current study indicate that traumatic and fragility fractures may be more alike than previously recognized in regards to bone health and subsequent fracture prevention in postmenopausal women. If validated, these results may lead to changes in clinical practice whereby all fractures in postmenopausal women could trigger osteoporosis screening, assessment, and treatment if indicated for the secondary prevention of fractures.

Study Overview

Objective. To compare the risk of subsequent fractures after an initial traumatic or nontraumatic fracture in postmenopausal women.

Design. A prospective observational study utilizing data from the Women’s Health Initiative (WHI) Study, WHI Clinical Trials (WHI-CT), and WHI Bone Density Substudy to evaluate rates at which patients who suffered a traumatic fracture vs nontraumatic fracture develop a subsequent fracture.

Setting and participants. The WHI study, implemented at 40 United States clinical sites, enrolled 161 808 postmenopausal women aged 50 to 79 years at baseline between 1993 and 1998. The study cohort consisted of 75 335 patients who had self-reported fractures from September 1994 to December 1998 that were confirmed by the WHI Bone Density Substudy and WHI-CT. Of these participants, 253 (0.3%) were excluded because of a lack of follow-up information regarding incident fractures, and 8208 (10.9%) were excluded due to incomplete information on covariates, thus resulting in an analytic sample of 66 874 (88.8%) participants. Prospective fracture ascertainment with participants was conducted at least annually and the mechanism of fracture was assessed to differentiate traumatic vs nontraumatic incident fractures. Traumatic fractures were defined as fractures caused by motor vehicle collisions, falls from a height, falls downstairs, or sports injury. Nontraumatic fractures were defined as fractures caused by a trip and fall.

Main outcome measures. The primary outcome was an incident fracture at an anatomically distinct body part. Fractures were classified as upper extremity (carpal, elbow, lower or upper end of humerus, shaft of humerus, upper radius/ulna, or radius/ulna), lower extremity (ankle, hip, patella, pelvis, shaft of femur, tibia/fibula, or tibial plateau), or spine (lumbar and/or thoracic spine). Self-reported fractures were verified via medical chart review by WHI study physicians; hip fractures were confirmed by review of written reports of radiographic studies; and nonhip fractures were confirmed by review of radiography reports or clinical documentations.

Main results. In total, 66 874 women in the study (mean [SD] age) 63.1 (7.0) years without clinical fracture and 65.3 (7.2) years with clinical fracture at baseline were followed for 8.1 (1.6) years. Of these participants, 7142 (10.7%) experienced incident fracture during the study follow-up period (13.9 per 1000 person-years), and 721 (10.1%) of whom had a subsequent fracture. The adjusted hazard ratio (aHR) of subsequent fracture after an initial fracture was 1.49 (95% CI, 1.38-1.61, P < .001). Covariates adjusted were age, race, ethnicity, body mass index, treated diabetes, frequency of falls in the previous year, and physical function and activity. In women with initial traumatic fracture, the association between initial and subsequent fracture was increased (aHR, 1.25; 95% CI, 1.06-1.48, P = .01). Among women with initial nontraumatic fracture, the association between initial and subsequent fracture was also increased (aHR, 1.52; 95% CI, 1.37-1.68, P < .001). The confidence intervals for the 2 preceding associations for traumatic and nontraumatic initial fracture strata were overlapping.

Conclusion. Fractures, regardless of mechanism of injury, are similarly associated with an increased risk of subsequent fractures in postmenopausal women aged 50 years and older. Findings from this study provide evidence to support reevaluation of current clinical guidelines to include traumatic fracture as a trigger for osteoporosis screening.

Commentary

Osteoporosis is one of the most common age-associated disease that affects 1 in 4 women and 1 in 20 men over the age of 65.¹ It increases the risk of fracture, and its clinical sequelae include reduced mobility, health decline, and increased all-cause mortality. The high prevalence of osteoporosis poses a clinical challenge as the global population continues to age. Pharmacological treatments such as bisphosphonates are highly effective in preventing or slowing bone mineral density (BMD) loss and reducing risk of fragility fractures (eg, nontraumatic fractures of the vertebra, hip, and femur) and are commonly used to mitigate adverse effects of degenerative bone changes secondary to osteoporosis.¹

The high prevalence of osteoporosis and effectiveness of bisphosphonates raises the question of how to optimally identify adults at risk for osteoporosis so that pharmacologic therapy can be promptly initiated to prevent disease progression. Multiple osteoporosis screening guidelines, including those from the United States Preventive Services Task Force (USPSTF), American Association of Family Physicians, and National Osteoporosis Foundation, are widely used in the clinical setting to address this important clinical question. In general, the prevailing wisdom is to screen osteoporosis in postmenopausal women over the age of 65, women under the age of 65 who have a significant 10-year fracture risk, or women over the age of 50 who have experienced a fragility fracture.¹ In the study reported by Crandall et al, it was shown that the risks of having subsequent fractures were similar after an initial traumatic or nontraumatic (fragility) fracture in postmenopausal women aged 50 years and older.² This finding brings into question whether traumatic fractures should be viewed any differently than nontraumatic fractures in women over the age of 50 in light of evaluation for osteoporosis. Furthermore, these results suggest that most fractures in postmenopausal women may indicate decreased bone integrity, thus adding to the rationale that osteoporosis screening needs to be considered and expanded to include postmenopausal women under the age of 65 who endured a traumatic fracture.

Per current guidelines, a woman under the age of 65 is recommended for osteoporosis screening only if she has an increased 10-year fracture risk compared to women aged 65 years and older. This risk is calculated based on the World Health Organization fracture-risk algorithm (WHO FRAX) tool which uses multiple factors such as age, weight, and history of fragility fractures to predict whether an individual is at risk of developing a fracture in the next 10 years. The WHO FRAX tool does not include traumatic fractures in its risk calculation and current clinical guidelines do not account for traumatic fractures as a red flag to initiate osteoporosis screening. Therefore, postmenopausal women under the age of 65 are less likely to be screened for osteoporosis when they experience a traumatic fracture compared to a fragility fracture, despite being at a demonstrably higher risk for subsequent fracture. As an unintended consequence, this may lead to the under diagnosis of osteoporosis in postmenopausal women under the age of 65. Thus, Crandall et al conclude that a fracture due to any cause warrants follow up evaluation for osteoporosis including BMD testing in women older than 50 years of age.

Older men constitute another population who are commonly under screened for osteoporosis. The current USPSTF guidelines indicate that there is an insufficient body of evidence to screen men for osteoporosis given its lower prevalence.¹ However, it is important to note that men have significantly increased mortality after a hip fracture, are less likely to be on pharmacological treatment for osteoporosis, and are under diagnosed for osteoporosis.³ Consistent with findings from the current study, Leslie et al showed that high-trauma and low-trauma fractures have similarly elevated subsequent fracture risk in both men and women over the age of 40 in a Canadian study.⁴ Moreover, in the same study, BMD was decreased in both men and women who suffered a fracture regardless of the injury mechanism. This finding further underscores a need to consider traumatic fractures as a risk factor for osteoporosis. Taken together, given that men are under screened and treated for osteoporosis but have increased mortality post-fracture, considerations to initiate osteoporosis evaluation should be similarly given to men who endured a traumatic fracture.

The study conducted by Crandall et al has several strengths. It is noteworthy for the large size of the WHI cohort with participants from across the United States which enables the capture of a wider range of age groups as women under the age of 65 are not common participants of osteoporosis studies. Additionally, data ascertainment and outcome adjudication utilizing medical records and physician review assure data quality. A limitation of the study is that the study cohort consists exclusively of women and therefore the findings are not generalizable to men. However, findings from this study echo those from other studies that investigate the relationship between fracture mechanisms and subsequent fracture risk in men and women.^3,4 Collectively, these comparable findings highlight the need for additional research to validate traumatic fracture as a risk factor for osteoporosis and to incorporate it into clinical guidelines for osteoporosis screening.

Applications for Clinical Practice

The findings from the current study indicate that traumatic and fragility fractures may be more alike than previously recognized in regards to bone health and subsequent fracture prevention in postmenopausal women. If validated, these results may lead to changes in clinical practice whereby all fractures in postmenopausal women could trigger osteoporosis screening, assessment, and treatment if indicated for the secondary prevention of fractures.

Study Overview

Objective. To compare the risk of subsequent fractures after an initial traumatic or nontraumatic fracture in postmenopausal women.

Design. A prospective observational study utilizing data from the Women’s Health Initiative (WHI) Study, WHI Clinical Trials (WHI-CT), and WHI Bone Density Substudy to evaluate rates at which patients who suffered a traumatic fracture vs nontraumatic fracture develop a subsequent fracture.

Setting and participants. The WHI study, implemented at 40 United States clinical sites, enrolled 161 808 postmenopausal women aged 50 to 79 years at baseline between 1993 and 1998. The study cohort consisted of 75 335 patients who had self-reported fractures from September 1994 to December 1998 that were confirmed by the WHI Bone Density Substudy and WHI-CT. Of these participants, 253 (0.3%) were excluded because of a lack of follow-up information regarding incident fractures, and 8208 (10.9%) were excluded due to incomplete information on covariates, thus resulting in an analytic sample of 66 874 (88.8%) participants. Prospective fracture ascertainment with participants was conducted at least annually and the mechanism of fracture was assessed to differentiate traumatic vs nontraumatic incident fractures. Traumatic fractures were defined as fractures caused by motor vehicle collisions, falls from a height, falls downstairs, or sports injury. Nontraumatic fractures were defined as fractures caused by a trip and fall.

Main outcome measures. The primary outcome was an incident fracture at an anatomically distinct body part. Fractures were classified as upper extremity (carpal, elbow, lower or upper end of humerus, shaft of humerus, upper radius/ulna, or radius/ulna), lower extremity (ankle, hip, patella, pelvis, shaft of femur, tibia/fibula, or tibial plateau), or spine (lumbar and/or thoracic spine). Self-reported fractures were verified via medical chart review by WHI study physicians; hip fractures were confirmed by review of written reports of radiographic studies; and nonhip fractures were confirmed by review of radiography reports or clinical documentations.

Main results. In total, 66 874 women in the study (mean [SD] age) 63.1 (7.0) years without clinical fracture and 65.3 (7.2) years with clinical fracture at baseline were followed for 8.1 (1.6) years. Of these participants, 7142 (10.7%) experienced incident fracture during the study follow-up period (13.9 per 1000 person-years), and 721 (10.1%) of whom had a subsequent fracture. The adjusted hazard ratio (aHR) of subsequent fracture after an initial fracture was 1.49 (95% CI, 1.38-1.61, P < .001). Covariates adjusted were age, race, ethnicity, body mass index, treated diabetes, frequency of falls in the previous year, and physical function and activity. In women with initial traumatic fracture, the association between initial and subsequent fracture was increased (aHR, 1.25; 95% CI, 1.06-1.48, P = .01). Among women with initial nontraumatic fracture, the association between initial and subsequent fracture was also increased (aHR, 1.52; 95% CI, 1.37-1.68, P < .001). The confidence intervals for the 2 preceding associations for traumatic and nontraumatic initial fracture strata were overlapping.

Conclusion. Fractures, regardless of mechanism of injury, are similarly associated with an increased risk of subsequent fractures in postmenopausal women aged 50 years and older. Findings from this study provide evidence to support reevaluation of current clinical guidelines to include traumatic fracture as a trigger for osteoporosis screening.

Commentary

Osteoporosis is one of the most common age-associated disease that affects 1 in 4 women and 1 in 20 men over the age of 65.¹ It increases the risk of fracture, and its clinical sequelae include reduced mobility, health decline, and increased all-cause mortality. The high prevalence of osteoporosis poses a clinical challenge as the global population continues to age. Pharmacological treatments such as bisphosphonates are highly effective in preventing or slowing bone mineral density (BMD) loss and reducing risk of fragility fractures (eg, nontraumatic fractures of the vertebra, hip, and femur) and are commonly used to mitigate adverse effects of degenerative bone changes secondary to osteoporosis.¹

The high prevalence of osteoporosis and effectiveness of bisphosphonates raises the question of how to optimally identify adults at risk for osteoporosis so that pharmacologic therapy can be promptly initiated to prevent disease progression. Multiple osteoporosis screening guidelines, including those from the United States Preventive Services Task Force (USPSTF), American Association of Family Physicians, and National Osteoporosis Foundation, are widely used in the clinical setting to address this important clinical question. In general, the prevailing wisdom is to screen osteoporosis in postmenopausal women over the age of 65, women under the age of 65 who have a significant 10-year fracture risk, or women over the age of 50 who have experienced a fragility fracture.¹ In the study reported by Crandall et al, it was shown that the risks of having subsequent fractures were similar after an initial traumatic or nontraumatic (fragility) fracture in postmenopausal women aged 50 years and older.² This finding brings into question whether traumatic fractures should be viewed any differently than nontraumatic fractures in women over the age of 50 in light of evaluation for osteoporosis. Furthermore, these results suggest that most fractures in postmenopausal women may indicate decreased bone integrity, thus adding to the rationale that osteoporosis screening needs to be considered and expanded to include postmenopausal women under the age of 65 who endured a traumatic fracture.

Per current guidelines, a woman under the age of 65 is recommended for osteoporosis screening only if she has an increased 10-year fracture risk compared to women aged 65 years and older. This risk is calculated based on the World Health Organization fracture-risk algorithm (WHO FRAX) tool which uses multiple factors such as age, weight, and history of fragility fractures to predict whether an individual is at risk of developing a fracture in the next 10 years. The WHO FRAX tool does not include traumatic fractures in its risk calculation and current clinical guidelines do not account for traumatic fractures as a red flag to initiate osteoporosis screening. Therefore, postmenopausal women under the age of 65 are less likely to be screened for osteoporosis when they experience a traumatic fracture compared to a fragility fracture, despite being at a demonstrably higher risk for subsequent fracture. As an unintended consequence, this may lead to the under diagnosis of osteoporosis in postmenopausal women under the age of 65. Thus, Crandall et al conclude that a fracture due to any cause warrants follow up evaluation for osteoporosis including BMD testing in women older than 50 years of age.

Older men constitute another population who are commonly under screened for osteoporosis. The current USPSTF guidelines indicate that there is an insufficient body of evidence to screen men for osteoporosis given its lower prevalence.¹ However, it is important to note that men have significantly increased mortality after a hip fracture, are less likely to be on pharmacological treatment for osteoporosis, and are under diagnosed for osteoporosis.³ Consistent with findings from the current study, Leslie et al showed that high-trauma and low-trauma fractures have similarly elevated subsequent fracture risk in both men and women over the age of 40 in a Canadian study.⁴ Moreover, in the same study, BMD was decreased in both men and women who suffered a fracture regardless of the injury mechanism. This finding further underscores a need to consider traumatic fractures as a risk factor for osteoporosis. Taken together, given that men are under screened and treated for osteoporosis but have increased mortality post-fracture, considerations to initiate osteoporosis evaluation should be similarly given to men who endured a traumatic fracture.

The study conducted by Crandall et al has several strengths. It is noteworthy for the large size of the WHI cohort with participants from across the United States which enables the capture of a wider range of age groups as women under the age of 65 are not common participants of osteoporosis studies. Additionally, data ascertainment and outcome adjudication utilizing medical records and physician review assure data quality. A limitation of the study is that the study cohort consists exclusively of women and therefore the findings are not generalizable to men. However, findings from this study echo those from other studies that investigate the relationship between fracture mechanisms and subsequent fracture risk in men and women.^3,4 Collectively, these comparable findings highlight the need for additional research to validate traumatic fracture as a risk factor for osteoporosis and to incorporate it into clinical guidelines for osteoporosis screening.

Applications for Clinical Practice

The findings from the current study indicate that traumatic and fragility fractures may be more alike than previously recognized in regards to bone health and subsequent fracture prevention in postmenopausal women. If validated, these results may lead to changes in clinical practice whereby all fractures in postmenopausal women could trigger osteoporosis screening, assessment, and treatment if indicated for the secondary prevention of fractures.

Study Overview

Objective. To evaluate the efficacy and safety of the combination of nivolumab plus cabozantinib as compared with sunitinib monotherapy in the treatment of previously untreated advanced renal cell carcinoma (RCC).

Design. Multicenter, international, open-label, randomized, phase 3 trial.

Intervention. Patients were randomized in a 1:1 fashion to 1 of 2 treatment arms:

• Arm A: Nivolumab intravenously 240 mg every 2 weeks plus cabozantinib orally 40 mg once daily.
• Arm B: Sunitinib orally 50 mg daily for 4 weeks, followed by 2 weeks off therapy (6-week cycle).

Randomization was stratified by the International Metastatic RCC Database Consortium prognostic risk score (low-, intermediate-, and high-risk). Treatment was continued until disease progression or development of unacceptable toxic side effects with a maximum of 2-year duration of Nivolumab therapy.

Settings and participants. Adults with previously untreated advanced RCC with a clear cell component were eligible for enrollment. Subjects were excluded if they had active central nervous system metastases or active autoimmune disease.

Main outcome measures. The primary outcome of this study was progression-free survival (PFS) as assessed by an independent review committee. Secondary endpoints included overall survival, objective response rate, safety, and PFS as assessed by investigators. All subgroup analyses were prespecified. Efficacy was assessed in the intention-to-treat population, including all patients who underwent randomization.

Main results. A total of 651 patients underwent randomization: 323 to the nivolumab plus cabozantinib group, and 328 to the sunitinib group. Baseline demographics were balanced. The median follow-up period for overall survival (OS) was 18.1 months. The primary reason for treatment discontinuation in any group was disease progression. PFS as indicated by an independent review committee was significantly longer in the nivolumab plus cabozantinib group compared to the sunitinib group (median 16.6 months vs 8.2 months; hazard ratio [HR] 0.51, P < .001). The median OS was not reached for any group. Overall survival was longer in the nivolumab plus cabozantinib group compared to the sunitinib group (HR 0.60, 95% CI: 0.40-0.89; P = .001). The objective response rate was 55.7% with the nivolumab plus cabozantinib group versus 27.1% with sunitinib (P < .001). The complete response rate was 8% in the nivolumab plus cabozantinib group compared to 4.6% in the sunitinib group. The median time to response was 2.8 months with nivolumab plus cabozantinib and 4.2 months in the sunitinib group, while the median duration of response was 20.2 months and 11.5 months, respectively.

Nearly all patients (about 99% in each group) had an adverse event (AE). Hypertension was the most common side effect, with grade 3 or higher seen in 12.5% in the nivolumab plus cabzantinib group and 13.1% in the sunitinib group. Other grade 3 or higher side effects occurring in at least 10% of patients in any group were hyponatremia, diarrhea, palmar-plantar erythrodysesthesia, hypothyroidism, and fatigue. AEs of any cause leading to discontinuation of the therapy occurred in 19.7% in the nivolumab plus cabzantinib group vs 16.9% of the sunitinib group. One death was considered to be treatment-related (small intestinal perforation) in the nivolumab plus cabozantinib group vs 2 treatment-related deaths with sunitinib (pneumonia and respiratory distress). In the nivolumab plus cabozantinib group, 57% of the patients had a dose reduction of cabozantinib and 52% had a reduction in sunitinib dosage.

Using the Functional Assessment of Cancer Therapy-Kidney Symptoms Index, patients in the nivolumab plus cabozantinib group reported better health-related quality of life and less disease-related symptoms compared to the sunitinib group.

Commentary

The treatment landscape for frontline therapy for patients with advanced RCC has rapidly expanded over the last several years and has revolutionized cancer care. Ushered in by the results from the CheckMate 214 study highlighting the efficacy of dual checkpoint inhibition with nivolumab and ipilimumab in intermediate and poor risk patients, several subsequent trials have demonstrated improved outcomes with combination therapy with immune checkpoint inhibitors and tyrosine-kinase inhibitors (TKI). To date, data from Keynote-426 (pembrolizumab plus axitinib vs sunitinib), Javelin Renal 101 (avelumab plus axitinib vs sunitinib) and the CLEAR trial (lenvatinib plus pembrolizumab vs levatinib plus everolimus vs sunitinib) have demonstrated superiority of immune checkpoint inhibitor/TKI combinations over sunitinb in the first-line setting.^1-5

The current phase 3, CheckMate 9ER trial adds yet another dynamic option for patients with advanced clear cell RCC. While cross-trial comparisons are fraught with important caveats, the median PFS of almost 16.6 months and complete response rate of 8% the nivolumab plus cabozantinib group compares favorably with other combinations. Data from the CLEAR study with the combination of lenvatinib and pembrolizumab showed a complete response rate approaching 16%. Importantly, the current study highlights improved quality of life with the combination of cabozantinib and nivolumab compared to sunitinib alone adding to the efficacy and benefits of this combination treatment.

The selection of first line therapy for patients with advanced RCC should be always guided by individual patient characteristics, and any single immune checkpoint inhibitor/TKI combination is not “superior” to any other. Perhaps more importantly is developing an understanding of the overlapping toxicity profiles of checkpoint inhibitors and TKIs. Again, this trial results are consistent with prior studies in terms of the adverse event profile which were not trivial, and almost all patients (99%) experienced AEs. It is important for oncologists to understand the management of the toxicities with these combinations and dose reductions as appropriate. It is worth noting that 19% of patients with nivolumab plus cabozantinib received glucocorticoids for management of immune-related AEs.

While long-term follow-up data will be needed to further understand the durability of response to this combination, nivolumab-cabozantinib represents an exciting new option for patients with advanced clear cell RCC. As we continue to see improvement in outcomes in clear cell histology, further work must focus on optimization of therapy in non-clear cell RCC as this is a population that is not represented in these data sets. Furthermore, future efforts should begin to explore triplet combinations and biomarker driven patient selection for upfront therapy in ordercontinue to improve outcomes in patients with advanced RCC.

Applications for Clinical Practice

The combination of nivolumab plus cabozantinib adds to the growing list of highly active checkpoint inhibitor/TKI combinations for first-line treatment of advanced RCC. With significant higher response rates, improved outcomes, and improvement in the quality of life, this combination will add another standard treatment option for patients with previously untreated advanced RCC.

Study Overview

Objective. To evaluate the efficacy and safety of the combination of nivolumab plus cabozantinib as compared with sunitinib monotherapy in the treatment of previously untreated advanced renal cell carcinoma (RCC).

Design. Multicenter, international, open-label, randomized, phase 3 trial.

Intervention. Patients were randomized in a 1:1 fashion to 1 of 2 treatment arms:

• Arm A: Nivolumab intravenously 240 mg every 2 weeks plus cabozantinib orally 40 mg once daily.
• Arm B: Sunitinib orally 50 mg daily for 4 weeks, followed by 2 weeks off therapy (6-week cycle).

Randomization was stratified by the International Metastatic RCC Database Consortium prognostic risk score (low-, intermediate-, and high-risk). Treatment was continued until disease progression or development of unacceptable toxic side effects with a maximum of 2-year duration of Nivolumab therapy.

Settings and participants. Adults with previously untreated advanced RCC with a clear cell component were eligible for enrollment. Subjects were excluded if they had active central nervous system metastases or active autoimmune disease.

Main outcome measures. The primary outcome of this study was progression-free survival (PFS) as assessed by an independent review committee. Secondary endpoints included overall survival, objective response rate, safety, and PFS as assessed by investigators. All subgroup analyses were prespecified. Efficacy was assessed in the intention-to-treat population, including all patients who underwent randomization.

Main results. A total of 651 patients underwent randomization: 323 to the nivolumab plus cabozantinib group, and 328 to the sunitinib group. Baseline demographics were balanced. The median follow-up period for overall survival (OS) was 18.1 months. The primary reason for treatment discontinuation in any group was disease progression. PFS as indicated by an independent review committee was significantly longer in the nivolumab plus cabozantinib group compared to the sunitinib group (median 16.6 months vs 8.2 months; hazard ratio [HR] 0.51, P < .001). The median OS was not reached for any group. Overall survival was longer in the nivolumab plus cabozantinib group compared to the sunitinib group (HR 0.60, 95% CI: 0.40-0.89; P = .001). The objective response rate was 55.7% with the nivolumab plus cabozantinib group versus 27.1% with sunitinib (P < .001). The complete response rate was 8% in the nivolumab plus cabozantinib group compared to 4.6% in the sunitinib group. The median time to response was 2.8 months with nivolumab plus cabozantinib and 4.2 months in the sunitinib group, while the median duration of response was 20.2 months and 11.5 months, respectively.

Nearly all patients (about 99% in each group) had an adverse event (AE). Hypertension was the most common side effect, with grade 3 or higher seen in 12.5% in the nivolumab plus cabzantinib group and 13.1% in the sunitinib group. Other grade 3 or higher side effects occurring in at least 10% of patients in any group were hyponatremia, diarrhea, palmar-plantar erythrodysesthesia, hypothyroidism, and fatigue. AEs of any cause leading to discontinuation of the therapy occurred in 19.7% in the nivolumab plus cabzantinib group vs 16.9% of the sunitinib group. One death was considered to be treatment-related (small intestinal perforation) in the nivolumab plus cabozantinib group vs 2 treatment-related deaths with sunitinib (pneumonia and respiratory distress). In the nivolumab plus cabozantinib group, 57% of the patients had a dose reduction of cabozantinib and 52% had a reduction in sunitinib dosage.

Using the Functional Assessment of Cancer Therapy-Kidney Symptoms Index, patients in the nivolumab plus cabozantinib group reported better health-related quality of life and less disease-related symptoms compared to the sunitinib group.

Commentary

The treatment landscape for frontline therapy for patients with advanced RCC has rapidly expanded over the last several years and has revolutionized cancer care. Ushered in by the results from the CheckMate 214 study highlighting the efficacy of dual checkpoint inhibition with nivolumab and ipilimumab in intermediate and poor risk patients, several subsequent trials have demonstrated improved outcomes with combination therapy with immune checkpoint inhibitors and tyrosine-kinase inhibitors (TKI). To date, data from Keynote-426 (pembrolizumab plus axitinib vs sunitinib), Javelin Renal 101 (avelumab plus axitinib vs sunitinib) and the CLEAR trial (lenvatinib plus pembrolizumab vs levatinib plus everolimus vs sunitinib) have demonstrated superiority of immune checkpoint inhibitor/TKI combinations over sunitinb in the first-line setting.^1-5

The current phase 3, CheckMate 9ER trial adds yet another dynamic option for patients with advanced clear cell RCC. While cross-trial comparisons are fraught with important caveats, the median PFS of almost 16.6 months and complete response rate of 8% the nivolumab plus cabozantinib group compares favorably with other combinations. Data from the CLEAR study with the combination of lenvatinib and pembrolizumab showed a complete response rate approaching 16%. Importantly, the current study highlights improved quality of life with the combination of cabozantinib and nivolumab compared to sunitinib alone adding to the efficacy and benefits of this combination treatment.

The selection of first line therapy for patients with advanced RCC should be always guided by individual patient characteristics, and any single immune checkpoint inhibitor/TKI combination is not “superior” to any other. Perhaps more importantly is developing an understanding of the overlapping toxicity profiles of checkpoint inhibitors and TKIs. Again, this trial results are consistent with prior studies in terms of the adverse event profile which were not trivial, and almost all patients (99%) experienced AEs. It is important for oncologists to understand the management of the toxicities with these combinations and dose reductions as appropriate. It is worth noting that 19% of patients with nivolumab plus cabozantinib received glucocorticoids for management of immune-related AEs.

While long-term follow-up data will be needed to further understand the durability of response to this combination, nivolumab-cabozantinib represents an exciting new option for patients with advanced clear cell RCC. As we continue to see improvement in outcomes in clear cell histology, further work must focus on optimization of therapy in non-clear cell RCC as this is a population that is not represented in these data sets. Furthermore, future efforts should begin to explore triplet combinations and biomarker driven patient selection for upfront therapy in ordercontinue to improve outcomes in patients with advanced RCC.

Applications for Clinical Practice

The combination of nivolumab plus cabozantinib adds to the growing list of highly active checkpoint inhibitor/TKI combinations for first-line treatment of advanced RCC. With significant higher response rates, improved outcomes, and improvement in the quality of life, this combination will add another standard treatment option for patients with previously untreated advanced RCC.

Study Overview

Objective. To evaluate the efficacy and safety of the combination of nivolumab plus cabozantinib as compared with sunitinib monotherapy in the treatment of previously untreated advanced renal cell carcinoma (RCC).

Design. Multicenter, international, open-label, randomized, phase 3 trial.

Intervention. Patients were randomized in a 1:1 fashion to 1 of 2 treatment arms:

• Arm A: Nivolumab intravenously 240 mg every 2 weeks plus cabozantinib orally 40 mg once daily.
• Arm B: Sunitinib orally 50 mg daily for 4 weeks, followed by 2 weeks off therapy (6-week cycle).

Randomization was stratified by the International Metastatic RCC Database Consortium prognostic risk score (low-, intermediate-, and high-risk). Treatment was continued until disease progression or development of unacceptable toxic side effects with a maximum of 2-year duration of Nivolumab therapy.

Settings and participants. Adults with previously untreated advanced RCC with a clear cell component were eligible for enrollment. Subjects were excluded if they had active central nervous system metastases or active autoimmune disease.

Main outcome measures. The primary outcome of this study was progression-free survival (PFS) as assessed by an independent review committee. Secondary endpoints included overall survival, objective response rate, safety, and PFS as assessed by investigators. All subgroup analyses were prespecified. Efficacy was assessed in the intention-to-treat population, including all patients who underwent randomization.

Main results. A total of 651 patients underwent randomization: 323 to the nivolumab plus cabozantinib group, and 328 to the sunitinib group. Baseline demographics were balanced. The median follow-up period for overall survival (OS) was 18.1 months. The primary reason for treatment discontinuation in any group was disease progression. PFS as indicated by an independent review committee was significantly longer in the nivolumab plus cabozantinib group compared to the sunitinib group (median 16.6 months vs 8.2 months; hazard ratio [HR] 0.51, P < .001). The median OS was not reached for any group. Overall survival was longer in the nivolumab plus cabozantinib group compared to the sunitinib group (HR 0.60, 95% CI: 0.40-0.89; P = .001). The objective response rate was 55.7% with the nivolumab plus cabozantinib group versus 27.1% with sunitinib (P < .001). The complete response rate was 8% in the nivolumab plus cabozantinib group compared to 4.6% in the sunitinib group. The median time to response was 2.8 months with nivolumab plus cabozantinib and 4.2 months in the sunitinib group, while the median duration of response was 20.2 months and 11.5 months, respectively.

Nearly all patients (about 99% in each group) had an adverse event (AE). Hypertension was the most common side effect, with grade 3 or higher seen in 12.5% in the nivolumab plus cabzantinib group and 13.1% in the sunitinib group. Other grade 3 or higher side effects occurring in at least 10% of patients in any group were hyponatremia, diarrhea, palmar-plantar erythrodysesthesia, hypothyroidism, and fatigue. AEs of any cause leading to discontinuation of the therapy occurred in 19.7% in the nivolumab plus cabzantinib group vs 16.9% of the sunitinib group. One death was considered to be treatment-related (small intestinal perforation) in the nivolumab plus cabozantinib group vs 2 treatment-related deaths with sunitinib (pneumonia and respiratory distress). In the nivolumab plus cabozantinib group, 57% of the patients had a dose reduction of cabozantinib and 52% had a reduction in sunitinib dosage.

Using the Functional Assessment of Cancer Therapy-Kidney Symptoms Index, patients in the nivolumab plus cabozantinib group reported better health-related quality of life and less disease-related symptoms compared to the sunitinib group.

Commentary

The treatment landscape for frontline therapy for patients with advanced RCC has rapidly expanded over the last several years and has revolutionized cancer care. Ushered in by the results from the CheckMate 214 study highlighting the efficacy of dual checkpoint inhibition with nivolumab and ipilimumab in intermediate and poor risk patients, several subsequent trials have demonstrated improved outcomes with combination therapy with immune checkpoint inhibitors and tyrosine-kinase inhibitors (TKI). To date, data from Keynote-426 (pembrolizumab plus axitinib vs sunitinib), Javelin Renal 101 (avelumab plus axitinib vs sunitinib) and the CLEAR trial (lenvatinib plus pembrolizumab vs levatinib plus everolimus vs sunitinib) have demonstrated superiority of immune checkpoint inhibitor/TKI combinations over sunitinb in the first-line setting.^1-5

The current phase 3, CheckMate 9ER trial adds yet another dynamic option for patients with advanced clear cell RCC. While cross-trial comparisons are fraught with important caveats, the median PFS of almost 16.6 months and complete response rate of 8% the nivolumab plus cabozantinib group compares favorably with other combinations. Data from the CLEAR study with the combination of lenvatinib and pembrolizumab showed a complete response rate approaching 16%. Importantly, the current study highlights improved quality of life with the combination of cabozantinib and nivolumab compared to sunitinib alone adding to the efficacy and benefits of this combination treatment.

The selection of first line therapy for patients with advanced RCC should be always guided by individual patient characteristics, and any single immune checkpoint inhibitor/TKI combination is not “superior” to any other. Perhaps more importantly is developing an understanding of the overlapping toxicity profiles of checkpoint inhibitors and TKIs. Again, this trial results are consistent with prior studies in terms of the adverse event profile which were not trivial, and almost all patients (99%) experienced AEs. It is important for oncologists to understand the management of the toxicities with these combinations and dose reductions as appropriate. It is worth noting that 19% of patients with nivolumab plus cabozantinib received glucocorticoids for management of immune-related AEs.

While long-term follow-up data will be needed to further understand the durability of response to this combination, nivolumab-cabozantinib represents an exciting new option for patients with advanced clear cell RCC. As we continue to see improvement in outcomes in clear cell histology, further work must focus on optimization of therapy in non-clear cell RCC as this is a population that is not represented in these data sets. Furthermore, future efforts should begin to explore triplet combinations and biomarker driven patient selection for upfront therapy in ordercontinue to improve outcomes in patients with advanced RCC.

Applications for Clinical Practice

The combination of nivolumab plus cabozantinib adds to the growing list of highly active checkpoint inhibitor/TKI combinations for first-line treatment of advanced RCC. With significant higher response rates, improved outcomes, and improvement in the quality of life, this combination will add another standard treatment option for patients with previously untreated advanced RCC.