Women's Health

The more complaints of excessive force by police reported by neighborhood residents, the more likely it is that Black pregnant people living in that neighborhood will deliver preterm, according to findings from a new study presented Jan. 28 at the virtual Society for Maternal-Fetal Medicine 2021 Annual Pregnancy Meeting.

“We know there are significant racial disparities in preterm birth which aren’t fully explained by traditional risk factors, like being older, having health problems like high blood pressure, or limited income,” Alexa Freedman, PhD, a postdoctoral fellow at NorthShore University HealthSystem and Northwestern University Institute for Policy Research, Evanston, Ill., told this news organization. “This has left many wondering if there are stressors unique to Black individuals that may be involved,” which has led to past research on the association of preterm birth with neighborhood segregation and historical “redlining” practices.

Black individuals have a substantially higher rate of preterm birth, compared with all other racial and ethnic groups in the US: 13.8% of Black infants born between 2016 and 2018 were preterm, compared with 11.6% among Native Americans – the next highest group – and 9.1% among White women.

“Studies have shown that psychosocial stress contributes to preterm birth disparities, potentially through several physiologic pathways that impact pregnancy outcomes,” Dr. Freedman told attendees. “Pregnant Black individuals have been reported to experience greater psychosocial stress regardless of socioeconomic status, possibly secondary to experiences of racism and discrimination.”

Though past research has examined neighborhood disadvantage and violence as stressors potentially contributing to preterm birth, little data exist on police–community relationships or police violence and pregnancy outcomes, despite being a “particularly salient stressor for Black individuals,” Dr. Freedman said. “Among pregnant Black individuals, prenatal depression has been correlated with concern about negative interactions between youth in their community and police.” To cite one example of the prevalence of racial bias in policing, she noted that “Chicago police are almost 10 times more likely to use force when interacting with a Black individual as compared [with] a White individual.”

The researchers therefore sought to determine whether a relationship existed between preterm birth rates and complaints regarding use of excessive force by police in the same neighborhood. They compiled records on all singleton live births from one Chicago hospital between March 2008 and March 2018, excluding those who lived outside Chicago, had a missing address, listed their race as “other,” or lacked data for specific other confounders.
 

Assessing police complaints within census blocks

The researchers obtained data on police complaints in Chicago from the Invisible Institute’s Citizen Police Data Project. They focused only on complaints of excessive use of force, “such as unnecessary physical contact and unnecessary display of a weapon,” Dr. Freedman said. They considered a person exposed in the neighborhood if a complaint was reported in her census block in the year leading up to birth. During their study period, more than 6,000 complaints of excessive force were reported across an estimated 70% of the blocks.

The study population had an average age of 31 and included 59.5% White, 12% Black, 20% Hispanic, and 8.5% Asian people. Just over half the pregnancies (55%) were first-time pregnancies, and 3.3% of the population had a history of preterm birth (before 37 weeks). The researchers also gathered data to adjust for the study population’s:

• Age
• Parity (number of times the woman has given birth).
• Population size of census block.
• Exposure to a homicide on the block in the year leading up to birth.
• Socioeconomic status by block (based on a composite of median home value, median income, percentage of a high school diploma, and percentage employed).

“Those who lived in a block with an excessive force complaint were more likely to be Black, more likely to deliver preterm, and more likely to be exposed to homicide,” Dr. Freedman told attendees.

The proportion of pregnant women exposed to police complaints was 15.8%, and 10.2% lived in neighborhoods where a homicide occurred in the year leading up to birth. Within the group exposed to a homicide, 16.5% lived in a neighborhood with an excessive force complaint and 9.1% did not.

Overall, 8.1% of the population gave birth preterm. When stratified by whether or not they lived in a block with an excessive force complaint, the researchers found the proportion of preterm births was higher among those who did than those who did not (9.3% vs. 7.8%).

Both before and after adjusting for confounders, Black people were the only racial/ethnic group who had a significantly increased risk of preterm birth if they lived on a block with a complaint. They were nearly 30% more likely to deliver preterm if an excessive force complaint had been reported nearby (odds ratio, 1.29). The odds of preterm birth were slightly elevated for White people and slightly reduced for Hispanic and Asian people, but none of those associations reached significance.

In a sensitivity analysis comparing 189 Black individuals to themselves, the researchers compared those who had one preterm birth and one term birth. They found that the preterm birth was 32% more likely to occur in a year when an excessive force complaint was filed after adjusting for age and birth order (OR, 1.32; 95% confidence interval, 0.82-2.13).

“Police violence reflects just one component of structural racism,” Dr. Freedman said in an interview. “Our findings highlight the need to more thoroughly consider how these systemic and structural factors contribute to disparities in maternal and fetal health.”
 

Clinical and policy implications

The clinical implications of these findings focus on the need for obstetric clinical teams to understand patients’ stressors and to provide support and resources, according to Dr. Freedman’s mentor, Ann Borders, MD, MSc, MPH, a maternal-fetal medicine physician at NorthShore and Evanston Hospital and a clinical associate professor at the University of Chicago Pritzker School of Medicine.

“Potential strategies include training on improved listening and respectful patient-centered care, such as provided by the CDC Hear Her campaign, and consideration of universal social determinants of health screening during obstetric care,” Dr. Borders told this news organization..

Though the study included a large sample size and allowed the researchers to control for individual and neighborhood characteristics, Dr. Freedman acknowledged that census blocks may or may not correlate with the way individuals define their own neighborhoods. They also didn’t have the data to assess the quality of prenatal care or the type of preterm birth, but they are developing a qualitative study to determine the best ways of measuring exposure to police violence.

In addition, the researchers’ reliance only on formal police complaints could have underestimated prevalence of excessive force, and the study did not take into account people’s direct experience with police violence; police violence that occurs within a person’s social network; or police violence widely covered in the news. 

It wasn’t possible for the researchers to verify whether excessive force actually occurred or whether the force might have been justified, and it instead relied on the fact that someone lodged a complaint because he or she perceived the action as excessive.

Allison Bryant Mantha, MD, MPH, vice chair for Quality, Equity, and Safety at Massachusetts General Hospital in Boston and a board member of SMFM, said she was impressed with the adjustment of homicide exposure as a proxy for neighborhood crime.

“Many might assume that reports of police misconduct might be a marker for a ‘dangerous neighborhood,’ and it was thoughtful of the authors to adjust their analyses for exposure to crime to demonstrate that, even above and beyond crime, reports of police misconduct seem to be associated with adverse outcomes,” Dr. Bryant Mantha, who moderated the session, said in an interview.

Confronting this issue goes beyond what clinicians can do on their own, Dr. Bryant Mantha suggested.

“The greatest change will come with addressing the structural racism that underlies differential exposure to police misconduct in communities in the first place,” she said. “Concurrent with this, however, clinicians may consider adding in an assessment of neighborhood characteristics to include reports of police misconduct as they screen for other social determinants of health. While we do not have intervention studies to demonstrate efficacy, it is not a huge leap to imagine that recognition of this burden in individuals’ lives, plus offering ways to manage stress or seek redress, could be of benefit.”

The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute on Minority Health and Health Disparities, and the Northwestern Medicine Enterprise Data Warehouse Pilot Data Program. Dr. Freedman, Dr. Borders, and Dr. Bryant Mantha have disclosed no relevant financial relationships.

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

The more complaints of excessive force by police reported by neighborhood residents, the more likely it is that Black pregnant people living in that neighborhood will deliver preterm, according to findings from a new study presented Jan. 28 at the virtual Society for Maternal-Fetal Medicine 2021 Annual Pregnancy Meeting.

“We know there are significant racial disparities in preterm birth which aren’t fully explained by traditional risk factors, like being older, having health problems like high blood pressure, or limited income,” Alexa Freedman, PhD, a postdoctoral fellow at NorthShore University HealthSystem and Northwestern University Institute for Policy Research, Evanston, Ill., told this news organization. “This has left many wondering if there are stressors unique to Black individuals that may be involved,” which has led to past research on the association of preterm birth with neighborhood segregation and historical “redlining” practices.

Black individuals have a substantially higher rate of preterm birth, compared with all other racial and ethnic groups in the US: 13.8% of Black infants born between 2016 and 2018 were preterm, compared with 11.6% among Native Americans – the next highest group – and 9.1% among White women.

“Studies have shown that psychosocial stress contributes to preterm birth disparities, potentially through several physiologic pathways that impact pregnancy outcomes,” Dr. Freedman told attendees. “Pregnant Black individuals have been reported to experience greater psychosocial stress regardless of socioeconomic status, possibly secondary to experiences of racism and discrimination.”

Though past research has examined neighborhood disadvantage and violence as stressors potentially contributing to preterm birth, little data exist on police–community relationships or police violence and pregnancy outcomes, despite being a “particularly salient stressor for Black individuals,” Dr. Freedman said. “Among pregnant Black individuals, prenatal depression has been correlated with concern about negative interactions between youth in their community and police.” To cite one example of the prevalence of racial bias in policing, she noted that “Chicago police are almost 10 times more likely to use force when interacting with a Black individual as compared [with] a White individual.”

The researchers therefore sought to determine whether a relationship existed between preterm birth rates and complaints regarding use of excessive force by police in the same neighborhood. They compiled records on all singleton live births from one Chicago hospital between March 2008 and March 2018, excluding those who lived outside Chicago, had a missing address, listed their race as “other,” or lacked data for specific other confounders.
 

Assessing police complaints within census blocks

The researchers obtained data on police complaints in Chicago from the Invisible Institute’s Citizen Police Data Project. They focused only on complaints of excessive use of force, “such as unnecessary physical contact and unnecessary display of a weapon,” Dr. Freedman said. They considered a person exposed in the neighborhood if a complaint was reported in her census block in the year leading up to birth. During their study period, more than 6,000 complaints of excessive force were reported across an estimated 70% of the blocks.

The study population had an average age of 31 and included 59.5% White, 12% Black, 20% Hispanic, and 8.5% Asian people. Just over half the pregnancies (55%) were first-time pregnancies, and 3.3% of the population had a history of preterm birth (before 37 weeks). The researchers also gathered data to adjust for the study population’s:

• Age
• Parity (number of times the woman has given birth).
• Population size of census block.
• Exposure to a homicide on the block in the year leading up to birth.
• Socioeconomic status by block (based on a composite of median home value, median income, percentage of a high school diploma, and percentage employed).

“Those who lived in a block with an excessive force complaint were more likely to be Black, more likely to deliver preterm, and more likely to be exposed to homicide,” Dr. Freedman told attendees.

The proportion of pregnant women exposed to police complaints was 15.8%, and 10.2% lived in neighborhoods where a homicide occurred in the year leading up to birth. Within the group exposed to a homicide, 16.5% lived in a neighborhood with an excessive force complaint and 9.1% did not.

Overall, 8.1% of the population gave birth preterm. When stratified by whether or not they lived in a block with an excessive force complaint, the researchers found the proportion of preterm births was higher among those who did than those who did not (9.3% vs. 7.8%).

Both before and after adjusting for confounders, Black people were the only racial/ethnic group who had a significantly increased risk of preterm birth if they lived on a block with a complaint. They were nearly 30% more likely to deliver preterm if an excessive force complaint had been reported nearby (odds ratio, 1.29). The odds of preterm birth were slightly elevated for White people and slightly reduced for Hispanic and Asian people, but none of those associations reached significance.

In a sensitivity analysis comparing 189 Black individuals to themselves, the researchers compared those who had one preterm birth and one term birth. They found that the preterm birth was 32% more likely to occur in a year when an excessive force complaint was filed after adjusting for age and birth order (OR, 1.32; 95% confidence interval, 0.82-2.13).

“Police violence reflects just one component of structural racism,” Dr. Freedman said in an interview. “Our findings highlight the need to more thoroughly consider how these systemic and structural factors contribute to disparities in maternal and fetal health.”
 

Clinical and policy implications

The clinical implications of these findings focus on the need for obstetric clinical teams to understand patients’ stressors and to provide support and resources, according to Dr. Freedman’s mentor, Ann Borders, MD, MSc, MPH, a maternal-fetal medicine physician at NorthShore and Evanston Hospital and a clinical associate professor at the University of Chicago Pritzker School of Medicine.

“Potential strategies include training on improved listening and respectful patient-centered care, such as provided by the CDC Hear Her campaign, and consideration of universal social determinants of health screening during obstetric care,” Dr. Borders told this news organization..

Though the study included a large sample size and allowed the researchers to control for individual and neighborhood characteristics, Dr. Freedman acknowledged that census blocks may or may not correlate with the way individuals define their own neighborhoods. They also didn’t have the data to assess the quality of prenatal care or the type of preterm birth, but they are developing a qualitative study to determine the best ways of measuring exposure to police violence.

In addition, the researchers’ reliance only on formal police complaints could have underestimated prevalence of excessive force, and the study did not take into account people’s direct experience with police violence; police violence that occurs within a person’s social network; or police violence widely covered in the news. 

It wasn’t possible for the researchers to verify whether excessive force actually occurred or whether the force might have been justified, and it instead relied on the fact that someone lodged a complaint because he or she perceived the action as excessive.

Allison Bryant Mantha, MD, MPH, vice chair for Quality, Equity, and Safety at Massachusetts General Hospital in Boston and a board member of SMFM, said she was impressed with the adjustment of homicide exposure as a proxy for neighborhood crime.

“Many might assume that reports of police misconduct might be a marker for a ‘dangerous neighborhood,’ and it was thoughtful of the authors to adjust their analyses for exposure to crime to demonstrate that, even above and beyond crime, reports of police misconduct seem to be associated with adverse outcomes,” Dr. Bryant Mantha, who moderated the session, said in an interview.

Confronting this issue goes beyond what clinicians can do on their own, Dr. Bryant Mantha suggested.

“The greatest change will come with addressing the structural racism that underlies differential exposure to police misconduct in communities in the first place,” she said. “Concurrent with this, however, clinicians may consider adding in an assessment of neighborhood characteristics to include reports of police misconduct as they screen for other social determinants of health. While we do not have intervention studies to demonstrate efficacy, it is not a huge leap to imagine that recognition of this burden in individuals’ lives, plus offering ways to manage stress or seek redress, could be of benefit.”

The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute on Minority Health and Health Disparities, and the Northwestern Medicine Enterprise Data Warehouse Pilot Data Program. Dr. Freedman, Dr. Borders, and Dr. Bryant Mantha have disclosed no relevant financial relationships.

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

The more complaints of excessive force by police reported by neighborhood residents, the more likely it is that Black pregnant people living in that neighborhood will deliver preterm, according to findings from a new study presented Jan. 28 at the virtual Society for Maternal-Fetal Medicine 2021 Annual Pregnancy Meeting.

“We know there are significant racial disparities in preterm birth which aren’t fully explained by traditional risk factors, like being older, having health problems like high blood pressure, or limited income,” Alexa Freedman, PhD, a postdoctoral fellow at NorthShore University HealthSystem and Northwestern University Institute for Policy Research, Evanston, Ill., told this news organization. “This has left many wondering if there are stressors unique to Black individuals that may be involved,” which has led to past research on the association of preterm birth with neighborhood segregation and historical “redlining” practices.

Black individuals have a substantially higher rate of preterm birth, compared with all other racial and ethnic groups in the US: 13.8% of Black infants born between 2016 and 2018 were preterm, compared with 11.6% among Native Americans – the next highest group – and 9.1% among White women.

“Studies have shown that psychosocial stress contributes to preterm birth disparities, potentially through several physiologic pathways that impact pregnancy outcomes,” Dr. Freedman told attendees. “Pregnant Black individuals have been reported to experience greater psychosocial stress regardless of socioeconomic status, possibly secondary to experiences of racism and discrimination.”

Though past research has examined neighborhood disadvantage and violence as stressors potentially contributing to preterm birth, little data exist on police–community relationships or police violence and pregnancy outcomes, despite being a “particularly salient stressor for Black individuals,” Dr. Freedman said. “Among pregnant Black individuals, prenatal depression has been correlated with concern about negative interactions between youth in their community and police.” To cite one example of the prevalence of racial bias in policing, she noted that “Chicago police are almost 10 times more likely to use force when interacting with a Black individual as compared [with] a White individual.”

The researchers therefore sought to determine whether a relationship existed between preterm birth rates and complaints regarding use of excessive force by police in the same neighborhood. They compiled records on all singleton live births from one Chicago hospital between March 2008 and March 2018, excluding those who lived outside Chicago, had a missing address, listed their race as “other,” or lacked data for specific other confounders.
 

Assessing police complaints within census blocks

The researchers obtained data on police complaints in Chicago from the Invisible Institute’s Citizen Police Data Project. They focused only on complaints of excessive use of force, “such as unnecessary physical contact and unnecessary display of a weapon,” Dr. Freedman said. They considered a person exposed in the neighborhood if a complaint was reported in her census block in the year leading up to birth. During their study period, more than 6,000 complaints of excessive force were reported across an estimated 70% of the blocks.

The study population had an average age of 31 and included 59.5% White, 12% Black, 20% Hispanic, and 8.5% Asian people. Just over half the pregnancies (55%) were first-time pregnancies, and 3.3% of the population had a history of preterm birth (before 37 weeks). The researchers also gathered data to adjust for the study population’s:

• Age
• Parity (number of times the woman has given birth).
• Population size of census block.
• Exposure to a homicide on the block in the year leading up to birth.
• Socioeconomic status by block (based on a composite of median home value, median income, percentage of a high school diploma, and percentage employed).

“Those who lived in a block with an excessive force complaint were more likely to be Black, more likely to deliver preterm, and more likely to be exposed to homicide,” Dr. Freedman told attendees.

The proportion of pregnant women exposed to police complaints was 15.8%, and 10.2% lived in neighborhoods where a homicide occurred in the year leading up to birth. Within the group exposed to a homicide, 16.5% lived in a neighborhood with an excessive force complaint and 9.1% did not.

Overall, 8.1% of the population gave birth preterm. When stratified by whether or not they lived in a block with an excessive force complaint, the researchers found the proportion of preterm births was higher among those who did than those who did not (9.3% vs. 7.8%).

Both before and after adjusting for confounders, Black people were the only racial/ethnic group who had a significantly increased risk of preterm birth if they lived on a block with a complaint. They were nearly 30% more likely to deliver preterm if an excessive force complaint had been reported nearby (odds ratio, 1.29). The odds of preterm birth were slightly elevated for White people and slightly reduced for Hispanic and Asian people, but none of those associations reached significance.

In a sensitivity analysis comparing 189 Black individuals to themselves, the researchers compared those who had one preterm birth and one term birth. They found that the preterm birth was 32% more likely to occur in a year when an excessive force complaint was filed after adjusting for age and birth order (OR, 1.32; 95% confidence interval, 0.82-2.13).

“Police violence reflects just one component of structural racism,” Dr. Freedman said in an interview. “Our findings highlight the need to more thoroughly consider how these systemic and structural factors contribute to disparities in maternal and fetal health.”
 

Clinical and policy implications

The clinical implications of these findings focus on the need for obstetric clinical teams to understand patients’ stressors and to provide support and resources, according to Dr. Freedman’s mentor, Ann Borders, MD, MSc, MPH, a maternal-fetal medicine physician at NorthShore and Evanston Hospital and a clinical associate professor at the University of Chicago Pritzker School of Medicine.

“Potential strategies include training on improved listening and respectful patient-centered care, such as provided by the CDC Hear Her campaign, and consideration of universal social determinants of health screening during obstetric care,” Dr. Borders told this news organization..

Though the study included a large sample size and allowed the researchers to control for individual and neighborhood characteristics, Dr. Freedman acknowledged that census blocks may or may not correlate with the way individuals define their own neighborhoods. They also didn’t have the data to assess the quality of prenatal care or the type of preterm birth, but they are developing a qualitative study to determine the best ways of measuring exposure to police violence.

In addition, the researchers’ reliance only on formal police complaints could have underestimated prevalence of excessive force, and the study did not take into account people’s direct experience with police violence; police violence that occurs within a person’s social network; or police violence widely covered in the news. 

It wasn’t possible for the researchers to verify whether excessive force actually occurred or whether the force might have been justified, and it instead relied on the fact that someone lodged a complaint because he or she perceived the action as excessive.

Allison Bryant Mantha, MD, MPH, vice chair for Quality, Equity, and Safety at Massachusetts General Hospital in Boston and a board member of SMFM, said she was impressed with the adjustment of homicide exposure as a proxy for neighborhood crime.

“Many might assume that reports of police misconduct might be a marker for a ‘dangerous neighborhood,’ and it was thoughtful of the authors to adjust their analyses for exposure to crime to demonstrate that, even above and beyond crime, reports of police misconduct seem to be associated with adverse outcomes,” Dr. Bryant Mantha, who moderated the session, said in an interview.

Confronting this issue goes beyond what clinicians can do on their own, Dr. Bryant Mantha suggested.

“The greatest change will come with addressing the structural racism that underlies differential exposure to police misconduct in communities in the first place,” she said. “Concurrent with this, however, clinicians may consider adding in an assessment of neighborhood characteristics to include reports of police misconduct as they screen for other social determinants of health. While we do not have intervention studies to demonstrate efficacy, it is not a huge leap to imagine that recognition of this burden in individuals’ lives, plus offering ways to manage stress or seek redress, could be of benefit.”

The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute on Minority Health and Health Disparities, and the Northwestern Medicine Enterprise Data Warehouse Pilot Data Program. Dr. Freedman, Dr. Borders, and Dr. Bryant Mantha have disclosed no relevant financial relationships.

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

An analysis of data from the U.S. military suggests that the maternal morbidity disparities between Black and White women cannot be attributed solely to differences in access to care and socioeconomics.

Even in the U.S. military health care system, where all service members have universal access to the same facilities and providers, researchers found substantial racial disparities in cesarean deliveries, maternal ICU admission, and overall severe maternal morbidity and mortality between Black patients and White patients, according to findings from a new study presented Jan. 28, 2021, at a meeting sponsored by the Society for Maternal-Fetal Medicine.

“This was surprising given some of the driving theories behind maternal race disparities encountered in this country, such as access to care and socioeconomic status, are controlled for in this health care system,” Capt. Jameaka Hamilton, MD, who presented the research, said in an interview. “Our findings indicate that there are likely additional factors at play which impact the obstetrical outcomes of women based upon their race, including systems-based barriers to accessing the military health care system which contribute to health care disparities, or in systemic or implicit biases which occur within our health care delivery.”

Plenty of recent research has documented the rise in maternal morbidity and mortality in the United States and the considerable racial disparities within those statistics. Black women are twice as likely to suffer morbidity and three to four times more likely to die in childbirth, compared with White women, Dr. Hamilton, an ob.gyn. from the San Antonio Uniformed Services Health Education Consortium at Ft. Sam Houston in San Antonio, Texas, reminded attendees. So far, much of this disparity has been attributed to social determinants of health.

Military retirees, active-duty personnel, and dependents, however, have equal access to federal health insurance and care at military health care facilities, or at covered civilian facilities where needed. Hence the researchers’ hypothesis that the military medical system would not show the same disparities by race that are seen in civilian populations.

The researchers analyzed maternal morbidity data from the Neonatal Perinatal Information Center from April 2018 to March 2019. The retrospective study included data from 13 military treatment facilities that had more than 1,000 deliveries per year. In addition to statistics on cesarean delivery and adult ICU admission, the researchers compared numbers on overall severe maternal morbidity based on the indicators defined by the Centers for Disease Control and Prevention.

The 15,305 deliveries included 23% Black patients and 77% White patients from the Air Force, Army, and Navy branches.

The cesarean delivery rate ranged from 19.4% to 35.5%. ICU admissions totaled 38 women, 190 women had postpartum hemorrhage, and 282 women experienced severe maternal morbidity. All three measures revealed racial disparities:

• Overall severe maternal morbidity occurred in 2.66% of Black women and 1.66% of White women (P =.0001).
• ICU admission occurred in 0.49% of Black women and 0.18% of White women (P =.0026).
• 31.68% of Black women had a cesarean delivery, compared with 23.58% of White women (P <.0001).

After excluding cases with blood transfusions, Black women were twice as likely to have severe maternal morbidity (0.64% vs. 0.32%). There were no significant differences in postpartum hemorrhage rates between Black and White women, but this analysis was limited by the small overall numbers of postpartum hemorrhage.

Among the study’s limitations were the inability to stratify patients by retiree, active duty, or dependent status, and the lack of data on preeclampsia rates, maternal age, obesity, or other preexisting conditions. In addition, the initial dataset included 61% of patients who reported their race as “other” than Black or White, limiting the number of patients whose data could be analyzed. Since low-volume hospitals were excluded, the outcomes could be skewed if lower-volume facilities are more likely to care for more complex cases, Dr. Hamilton added.

Allison Bryant Mantha, MD, MPH, vice chair for quality, equity, and safety in the ob.gyn. department at Massachusetts General Hospital, Boston, praised Dr. Hamilton’s work for revealing that differential access – though still problematic – cannot fully explain inequities between Black women and other women.

“The findings are not shocking given that what underlies some of these inequities – namely structural and institutional racism, and differential treatment within the system – are not exclusive to civilian health care settings,” Dr. Bryant Mantha, who moderated the session, said in an interview. “That said, doing the work to demonstrate this is extremely valuable.”

Although the causes of these disparities are systemic, Dr. Hamilton said individual providers can play a role in addressing them.

“There can certainly be more done to address this dangerous trend at the provider, hospital/institution, and national level,” she said. I think we as providers should continue to self-reflect and address our own biases. Hospitals and institutions should continue to develop policies that draw attention health care disparities.”

Completely removing these inequalities, however, will require confronting the racism embedded in U.S. health care at all levels, Dr. Bryant Mantha suggested.

“Ultimately, moving to an antiracist health care system – and criminal justice system, educational system, political system, etc. – and dismantling the existing structural racism in policies and practices will be needed to drive this change,” Dr. Bryant Mantha said. “Individual clinicians can use their voices to advocate for these changes in their health systems, communities, and states. Awareness of these inequities is critical, as is a sense of collective efficacy that we can, indeed, change the status quo.”

Dr. Hamilton and Dr. Bryant Mantha reported no disclosures.

An analysis of data from the U.S. military suggests that the maternal morbidity disparities between Black and White women cannot be attributed solely to differences in access to care and socioeconomics.

Even in the U.S. military health care system, where all service members have universal access to the same facilities and providers, researchers found substantial racial disparities in cesarean deliveries, maternal ICU admission, and overall severe maternal morbidity and mortality between Black patients and White patients, according to findings from a new study presented Jan. 28, 2021, at a meeting sponsored by the Society for Maternal-Fetal Medicine.

“This was surprising given some of the driving theories behind maternal race disparities encountered in this country, such as access to care and socioeconomic status, are controlled for in this health care system,” Capt. Jameaka Hamilton, MD, who presented the research, said in an interview. “Our findings indicate that there are likely additional factors at play which impact the obstetrical outcomes of women based upon their race, including systems-based barriers to accessing the military health care system which contribute to health care disparities, or in systemic or implicit biases which occur within our health care delivery.”

Plenty of recent research has documented the rise in maternal morbidity and mortality in the United States and the considerable racial disparities within those statistics. Black women are twice as likely to suffer morbidity and three to four times more likely to die in childbirth, compared with White women, Dr. Hamilton, an ob.gyn. from the San Antonio Uniformed Services Health Education Consortium at Ft. Sam Houston in San Antonio, Texas, reminded attendees. So far, much of this disparity has been attributed to social determinants of health.

Military retirees, active-duty personnel, and dependents, however, have equal access to federal health insurance and care at military health care facilities, or at covered civilian facilities where needed. Hence the researchers’ hypothesis that the military medical system would not show the same disparities by race that are seen in civilian populations.

The researchers analyzed maternal morbidity data from the Neonatal Perinatal Information Center from April 2018 to March 2019. The retrospective study included data from 13 military treatment facilities that had more than 1,000 deliveries per year. In addition to statistics on cesarean delivery and adult ICU admission, the researchers compared numbers on overall severe maternal morbidity based on the indicators defined by the Centers for Disease Control and Prevention.

The 15,305 deliveries included 23% Black patients and 77% White patients from the Air Force, Army, and Navy branches.

The cesarean delivery rate ranged from 19.4% to 35.5%. ICU admissions totaled 38 women, 190 women had postpartum hemorrhage, and 282 women experienced severe maternal morbidity. All three measures revealed racial disparities:

• Overall severe maternal morbidity occurred in 2.66% of Black women and 1.66% of White women (P =.0001).
• ICU admission occurred in 0.49% of Black women and 0.18% of White women (P =.0026).
• 31.68% of Black women had a cesarean delivery, compared with 23.58% of White women (P <.0001).

After excluding cases with blood transfusions, Black women were twice as likely to have severe maternal morbidity (0.64% vs. 0.32%). There were no significant differences in postpartum hemorrhage rates between Black and White women, but this analysis was limited by the small overall numbers of postpartum hemorrhage.

Among the study’s limitations were the inability to stratify patients by retiree, active duty, or dependent status, and the lack of data on preeclampsia rates, maternal age, obesity, or other preexisting conditions. In addition, the initial dataset included 61% of patients who reported their race as “other” than Black or White, limiting the number of patients whose data could be analyzed. Since low-volume hospitals were excluded, the outcomes could be skewed if lower-volume facilities are more likely to care for more complex cases, Dr. Hamilton added.

Allison Bryant Mantha, MD, MPH, vice chair for quality, equity, and safety in the ob.gyn. department at Massachusetts General Hospital, Boston, praised Dr. Hamilton’s work for revealing that differential access – though still problematic – cannot fully explain inequities between Black women and other women.

“The findings are not shocking given that what underlies some of these inequities – namely structural and institutional racism, and differential treatment within the system – are not exclusive to civilian health care settings,” Dr. Bryant Mantha, who moderated the session, said in an interview. “That said, doing the work to demonstrate this is extremely valuable.”

Although the causes of these disparities are systemic, Dr. Hamilton said individual providers can play a role in addressing them.

“There can certainly be more done to address this dangerous trend at the provider, hospital/institution, and national level,” she said. I think we as providers should continue to self-reflect and address our own biases. Hospitals and institutions should continue to develop policies that draw attention health care disparities.”

Completely removing these inequalities, however, will require confronting the racism embedded in U.S. health care at all levels, Dr. Bryant Mantha suggested.

“Ultimately, moving to an antiracist health care system – and criminal justice system, educational system, political system, etc. – and dismantling the existing structural racism in policies and practices will be needed to drive this change,” Dr. Bryant Mantha said. “Individual clinicians can use their voices to advocate for these changes in their health systems, communities, and states. Awareness of these inequities is critical, as is a sense of collective efficacy that we can, indeed, change the status quo.”

Dr. Hamilton and Dr. Bryant Mantha reported no disclosures.

An analysis of data from the U.S. military suggests that the maternal morbidity disparities between Black and White women cannot be attributed solely to differences in access to care and socioeconomics.

Even in the U.S. military health care system, where all service members have universal access to the same facilities and providers, researchers found substantial racial disparities in cesarean deliveries, maternal ICU admission, and overall severe maternal morbidity and mortality between Black patients and White patients, according to findings from a new study presented Jan. 28, 2021, at a meeting sponsored by the Society for Maternal-Fetal Medicine.

“This was surprising given some of the driving theories behind maternal race disparities encountered in this country, such as access to care and socioeconomic status, are controlled for in this health care system,” Capt. Jameaka Hamilton, MD, who presented the research, said in an interview. “Our findings indicate that there are likely additional factors at play which impact the obstetrical outcomes of women based upon their race, including systems-based barriers to accessing the military health care system which contribute to health care disparities, or in systemic or implicit biases which occur within our health care delivery.”

Plenty of recent research has documented the rise in maternal morbidity and mortality in the United States and the considerable racial disparities within those statistics. Black women are twice as likely to suffer morbidity and three to four times more likely to die in childbirth, compared with White women, Dr. Hamilton, an ob.gyn. from the San Antonio Uniformed Services Health Education Consortium at Ft. Sam Houston in San Antonio, Texas, reminded attendees. So far, much of this disparity has been attributed to social determinants of health.

Military retirees, active-duty personnel, and dependents, however, have equal access to federal health insurance and care at military health care facilities, or at covered civilian facilities where needed. Hence the researchers’ hypothesis that the military medical system would not show the same disparities by race that are seen in civilian populations.

The researchers analyzed maternal morbidity data from the Neonatal Perinatal Information Center from April 2018 to March 2019. The retrospective study included data from 13 military treatment facilities that had more than 1,000 deliveries per year. In addition to statistics on cesarean delivery and adult ICU admission, the researchers compared numbers on overall severe maternal morbidity based on the indicators defined by the Centers for Disease Control and Prevention.

The 15,305 deliveries included 23% Black patients and 77% White patients from the Air Force, Army, and Navy branches.

The cesarean delivery rate ranged from 19.4% to 35.5%. ICU admissions totaled 38 women, 190 women had postpartum hemorrhage, and 282 women experienced severe maternal morbidity. All three measures revealed racial disparities:

• Overall severe maternal morbidity occurred in 2.66% of Black women and 1.66% of White women (P =.0001).
• ICU admission occurred in 0.49% of Black women and 0.18% of White women (P =.0026).
• 31.68% of Black women had a cesarean delivery, compared with 23.58% of White women (P <.0001).

After excluding cases with blood transfusions, Black women were twice as likely to have severe maternal morbidity (0.64% vs. 0.32%). There were no significant differences in postpartum hemorrhage rates between Black and White women, but this analysis was limited by the small overall numbers of postpartum hemorrhage.

Among the study’s limitations were the inability to stratify patients by retiree, active duty, or dependent status, and the lack of data on preeclampsia rates, maternal age, obesity, or other preexisting conditions. In addition, the initial dataset included 61% of patients who reported their race as “other” than Black or White, limiting the number of patients whose data could be analyzed. Since low-volume hospitals were excluded, the outcomes could be skewed if lower-volume facilities are more likely to care for more complex cases, Dr. Hamilton added.

Allison Bryant Mantha, MD, MPH, vice chair for quality, equity, and safety in the ob.gyn. department at Massachusetts General Hospital, Boston, praised Dr. Hamilton’s work for revealing that differential access – though still problematic – cannot fully explain inequities between Black women and other women.

“The findings are not shocking given that what underlies some of these inequities – namely structural and institutional racism, and differential treatment within the system – are not exclusive to civilian health care settings,” Dr. Bryant Mantha, who moderated the session, said in an interview. “That said, doing the work to demonstrate this is extremely valuable.”

Although the causes of these disparities are systemic, Dr. Hamilton said individual providers can play a role in addressing them.

“There can certainly be more done to address this dangerous trend at the provider, hospital/institution, and national level,” she said. I think we as providers should continue to self-reflect and address our own biases. Hospitals and institutions should continue to develop policies that draw attention health care disparities.”

Completely removing these inequalities, however, will require confronting the racism embedded in U.S. health care at all levels, Dr. Bryant Mantha suggested.

“Ultimately, moving to an antiracist health care system – and criminal justice system, educational system, political system, etc. – and dismantling the existing structural racism in policies and practices will be needed to drive this change,” Dr. Bryant Mantha said. “Individual clinicians can use their voices to advocate for these changes in their health systems, communities, and states. Awareness of these inequities is critical, as is a sense of collective efficacy that we can, indeed, change the status quo.”

Dr. Hamilton and Dr. Bryant Mantha reported no disclosures.

Women at risk of preterm birth who took daily low-dose aspirin did not have significantly lower rates of preterm birth than those who did not take aspirin, according to preliminary findings from a small randomized controlled trial. There was a trend toward lower rates, especially among those with the highest compliance, but the study was underpowered to detect a difference with statistical significance, said Anadeijda Landman, MD, of the Amsterdam University Medical Center. Dr. Landman presented the findings Jan. 28 at a meeting sponsored by the Society for Maternal-Fetal Medicine.

Preterm birth accounts for a third of all neonatal mortality, she told attendees. Among 15 million preterm births worldwide each year, 65% are spontaneous, indicating the need for effective preventive interventions. Dr. Landman reviewed several mechanisms by which aspirin may help reduce preterm birth via different pathways.

The researchers’ multicenter, placebo-controlled trial involved 8 tertiary care and 26 secondary care hospitals in the Netherlands between May 2016 and June 2019. Starting between 8 and 15 weeks’ gestation, women took either 80 mg of aspirin or a placebo daily until 36 weeks’ gestation or delivery. Women also received progesterone, cerclage, or pessary as indicated according to local protocols.

The study enrolled 406 women with singleton pregnancy and a history of preterm birth delivered between 22 and 37 weeks’ gestation. The final analysis, after exclusions for pregnancy termination, congenital anomalies, multiples pregnancy, or similar reasons, included 193 women in the intervention group and 194 in the placebo group. The women had similar baseline characteristics across both groups except a higher number of past mid-trimester fetal deaths in the aspirin group.

“It’s important to realize these women had multiple preterm births, as one of our inclusion criteria was previous spontaneous preterm birth later than 22 weeks’ gestation, so this particular group is very high risk for cervical insufficiency as a probable cause,” Dr. Landman told attendees.

Among women in the aspirin group, 21.2% delivered before 37 weeks, compared with 25.4% in the placebo group (P = .323). The rate of spontaneous birth was 20.1% in the aspirin group and 23.8% in the placebo group (P = .376). Though still not statistically significant, the difference between the groups was larger when the researchers limited their analysis to the 245 women with at least 80% compliance: 18.5% of women in the aspirin group had a preterm birth, compared with 24.8% of women in the placebo group (P = .238).

There were no significant differences between the groups in composite poor neonatal outcomes or in a range of prespecified newborn complications. The aspirin group did have two stillbirths, two mid-trimester fetal losses, and two extremely preterm newborns (at 24+2 weeks and 25+2 weeks). The placebo group had two mid-trimester fetal losses.

“These deaths are inherent to the study population, and it seems unlikely they are related to the use of aspirin,” Dr. Landman said. “Moreover other aspirin studies have not found an increased perinatal mortality rate, and some large studies indicated the neonatal mortality rate is even reduced.”

Although preterm birth only trended lower in the aspirin group, Dr. Landman said the researchers believe they cannot rule out an effect from aspirin.

“It’s also important to note that our study was underpowered as the recurrence risk of preterm birth in our study was lower than expected, so it’s possible a small treatment effect of aspirin could not be demonstrated in our study,” she said. “And, despite the proper randomization procedure, many more women in the aspirin group had a previous mid-trimester fetal loss. This indicates that the aspirin group might be more at risk for preterm birth than the placebo group, and this imbalance could also have diminished a small protective effect of aspirin.”

In response to an audience question, Dr. Landman acknowledged that more recent studies on aspirin have used 100- to 150-mg dosages, but that evidence was not as clear when their study began in 2015. She added that her research team does not advise changing clinical care currently and believes it is too soon to recommend aspirin to this population.

Tracy Manuck, MD, MS, an associate professor of ob.gyn. at the University of North Carolina in Chapel Hill, agreed that it is premature to begin prescribing aspirin for preterm birth prevention, but she noted that most of the patients she cares for clinically already meet criteria for aspirin based on their risk factors for preeclampsia.

“Additional research is needed in the form of a well-designed and large [randomized, controlled trial],” Dr Manuck, who moderated the session, said in an interview. “However, such a trial is becoming increasingly difficult to conduct because so many pregnant women qualify to receive aspirin for the prevention of preeclampsia due to their weight, medical comorbidities, or prior pregnancy history.”

She said she anticipates seeing patient-level data meta-analyses in the coming months as more data on aspirin for preterm birth prevention are published.

“Given that these data are supportive of the overall trends seen in prior publications, I do think that low-dose aspirin will eventually bear out as a helpful preventative measure to prevent recurrent preterm birth. Aspirin is low risk, readily available, and is inexpensive,” Dr. Manuck said. “I hope that meta-analysis data will provide additional information regarding the benefit of low-dose aspirin for prematurity prevention.”

The research was funded by the Dutch Organization for Health Care Research and the Dutch Consortium for Research in Women’s Health. Dr. Landman and Dr. Manuck had no disclosures.

Women at risk of preterm birth who took daily low-dose aspirin did not have significantly lower rates of preterm birth than those who did not take aspirin, according to preliminary findings from a small randomized controlled trial. There was a trend toward lower rates, especially among those with the highest compliance, but the study was underpowered to detect a difference with statistical significance, said Anadeijda Landman, MD, of the Amsterdam University Medical Center. Dr. Landman presented the findings Jan. 28 at a meeting sponsored by the Society for Maternal-Fetal Medicine.

Preterm birth accounts for a third of all neonatal mortality, she told attendees. Among 15 million preterm births worldwide each year, 65% are spontaneous, indicating the need for effective preventive interventions. Dr. Landman reviewed several mechanisms by which aspirin may help reduce preterm birth via different pathways.

The researchers’ multicenter, placebo-controlled trial involved 8 tertiary care and 26 secondary care hospitals in the Netherlands between May 2016 and June 2019. Starting between 8 and 15 weeks’ gestation, women took either 80 mg of aspirin or a placebo daily until 36 weeks’ gestation or delivery. Women also received progesterone, cerclage, or pessary as indicated according to local protocols.

The study enrolled 406 women with singleton pregnancy and a history of preterm birth delivered between 22 and 37 weeks’ gestation. The final analysis, after exclusions for pregnancy termination, congenital anomalies, multiples pregnancy, or similar reasons, included 193 women in the intervention group and 194 in the placebo group. The women had similar baseline characteristics across both groups except a higher number of past mid-trimester fetal deaths in the aspirin group.

“It’s important to realize these women had multiple preterm births, as one of our inclusion criteria was previous spontaneous preterm birth later than 22 weeks’ gestation, so this particular group is very high risk for cervical insufficiency as a probable cause,” Dr. Landman told attendees.

Among women in the aspirin group, 21.2% delivered before 37 weeks, compared with 25.4% in the placebo group (P = .323). The rate of spontaneous birth was 20.1% in the aspirin group and 23.8% in the placebo group (P = .376). Though still not statistically significant, the difference between the groups was larger when the researchers limited their analysis to the 245 women with at least 80% compliance: 18.5% of women in the aspirin group had a preterm birth, compared with 24.8% of women in the placebo group (P = .238).

There were no significant differences between the groups in composite poor neonatal outcomes or in a range of prespecified newborn complications. The aspirin group did have two stillbirths, two mid-trimester fetal losses, and two extremely preterm newborns (at 24+2 weeks and 25+2 weeks). The placebo group had two mid-trimester fetal losses.

“These deaths are inherent to the study population, and it seems unlikely they are related to the use of aspirin,” Dr. Landman said. “Moreover other aspirin studies have not found an increased perinatal mortality rate, and some large studies indicated the neonatal mortality rate is even reduced.”

Although preterm birth only trended lower in the aspirin group, Dr. Landman said the researchers believe they cannot rule out an effect from aspirin.

“It’s also important to note that our study was underpowered as the recurrence risk of preterm birth in our study was lower than expected, so it’s possible a small treatment effect of aspirin could not be demonstrated in our study,” she said. “And, despite the proper randomization procedure, many more women in the aspirin group had a previous mid-trimester fetal loss. This indicates that the aspirin group might be more at risk for preterm birth than the placebo group, and this imbalance could also have diminished a small protective effect of aspirin.”

In response to an audience question, Dr. Landman acknowledged that more recent studies on aspirin have used 100- to 150-mg dosages, but that evidence was not as clear when their study began in 2015. She added that her research team does not advise changing clinical care currently and believes it is too soon to recommend aspirin to this population.

Tracy Manuck, MD, MS, an associate professor of ob.gyn. at the University of North Carolina in Chapel Hill, agreed that it is premature to begin prescribing aspirin for preterm birth prevention, but she noted that most of the patients she cares for clinically already meet criteria for aspirin based on their risk factors for preeclampsia.

“Additional research is needed in the form of a well-designed and large [randomized, controlled trial],” Dr Manuck, who moderated the session, said in an interview. “However, such a trial is becoming increasingly difficult to conduct because so many pregnant women qualify to receive aspirin for the prevention of preeclampsia due to their weight, medical comorbidities, or prior pregnancy history.”

She said she anticipates seeing patient-level data meta-analyses in the coming months as more data on aspirin for preterm birth prevention are published.

“Given that these data are supportive of the overall trends seen in prior publications, I do think that low-dose aspirin will eventually bear out as a helpful preventative measure to prevent recurrent preterm birth. Aspirin is low risk, readily available, and is inexpensive,” Dr. Manuck said. “I hope that meta-analysis data will provide additional information regarding the benefit of low-dose aspirin for prematurity prevention.”

The research was funded by the Dutch Organization for Health Care Research and the Dutch Consortium for Research in Women’s Health. Dr. Landman and Dr. Manuck had no disclosures.

Women at risk of preterm birth who took daily low-dose aspirin did not have significantly lower rates of preterm birth than those who did not take aspirin, according to preliminary findings from a small randomized controlled trial. There was a trend toward lower rates, especially among those with the highest compliance, but the study was underpowered to detect a difference with statistical significance, said Anadeijda Landman, MD, of the Amsterdam University Medical Center. Dr. Landman presented the findings Jan. 28 at a meeting sponsored by the Society for Maternal-Fetal Medicine.

Preterm birth accounts for a third of all neonatal mortality, she told attendees. Among 15 million preterm births worldwide each year, 65% are spontaneous, indicating the need for effective preventive interventions. Dr. Landman reviewed several mechanisms by which aspirin may help reduce preterm birth via different pathways.

The researchers’ multicenter, placebo-controlled trial involved 8 tertiary care and 26 secondary care hospitals in the Netherlands between May 2016 and June 2019. Starting between 8 and 15 weeks’ gestation, women took either 80 mg of aspirin or a placebo daily until 36 weeks’ gestation or delivery. Women also received progesterone, cerclage, or pessary as indicated according to local protocols.

The study enrolled 406 women with singleton pregnancy and a history of preterm birth delivered between 22 and 37 weeks’ gestation. The final analysis, after exclusions for pregnancy termination, congenital anomalies, multiples pregnancy, or similar reasons, included 193 women in the intervention group and 194 in the placebo group. The women had similar baseline characteristics across both groups except a higher number of past mid-trimester fetal deaths in the aspirin group.

“It’s important to realize these women had multiple preterm births, as one of our inclusion criteria was previous spontaneous preterm birth later than 22 weeks’ gestation, so this particular group is very high risk for cervical insufficiency as a probable cause,” Dr. Landman told attendees.

Among women in the aspirin group, 21.2% delivered before 37 weeks, compared with 25.4% in the placebo group (P = .323). The rate of spontaneous birth was 20.1% in the aspirin group and 23.8% in the placebo group (P = .376). Though still not statistically significant, the difference between the groups was larger when the researchers limited their analysis to the 245 women with at least 80% compliance: 18.5% of women in the aspirin group had a preterm birth, compared with 24.8% of women in the placebo group (P = .238).

There were no significant differences between the groups in composite poor neonatal outcomes or in a range of prespecified newborn complications. The aspirin group did have two stillbirths, two mid-trimester fetal losses, and two extremely preterm newborns (at 24+2 weeks and 25+2 weeks). The placebo group had two mid-trimester fetal losses.

“These deaths are inherent to the study population, and it seems unlikely they are related to the use of aspirin,” Dr. Landman said. “Moreover other aspirin studies have not found an increased perinatal mortality rate, and some large studies indicated the neonatal mortality rate is even reduced.”

Although preterm birth only trended lower in the aspirin group, Dr. Landman said the researchers believe they cannot rule out an effect from aspirin.

“It’s also important to note that our study was underpowered as the recurrence risk of preterm birth in our study was lower than expected, so it’s possible a small treatment effect of aspirin could not be demonstrated in our study,” she said. “And, despite the proper randomization procedure, many more women in the aspirin group had a previous mid-trimester fetal loss. This indicates that the aspirin group might be more at risk for preterm birth than the placebo group, and this imbalance could also have diminished a small protective effect of aspirin.”

In response to an audience question, Dr. Landman acknowledged that more recent studies on aspirin have used 100- to 150-mg dosages, but that evidence was not as clear when their study began in 2015. She added that her research team does not advise changing clinical care currently and believes it is too soon to recommend aspirin to this population.

Tracy Manuck, MD, MS, an associate professor of ob.gyn. at the University of North Carolina in Chapel Hill, agreed that it is premature to begin prescribing aspirin for preterm birth prevention, but she noted that most of the patients she cares for clinically already meet criteria for aspirin based on their risk factors for preeclampsia.

“Additional research is needed in the form of a well-designed and large [randomized, controlled trial],” Dr Manuck, who moderated the session, said in an interview. “However, such a trial is becoming increasingly difficult to conduct because so many pregnant women qualify to receive aspirin for the prevention of preeclampsia due to their weight, medical comorbidities, or prior pregnancy history.”

She said she anticipates seeing patient-level data meta-analyses in the coming months as more data on aspirin for preterm birth prevention are published.

“Given that these data are supportive of the overall trends seen in prior publications, I do think that low-dose aspirin will eventually bear out as a helpful preventative measure to prevent recurrent preterm birth. Aspirin is low risk, readily available, and is inexpensive,” Dr. Manuck said. “I hope that meta-analysis data will provide additional information regarding the benefit of low-dose aspirin for prematurity prevention.”

The research was funded by the Dutch Organization for Health Care Research and the Dutch Consortium for Research in Women’s Health. Dr. Landman and Dr. Manuck had no disclosures.

When 42-year-old Danielle Simone Brand started having hormonal migraines, she first turned to cannabidiol (CBD) oil, eventually adding an occasional pull on a prefilled tetrahydrocannabinol (THC) vape for nighttime use. She was careful to avoid THC during work hours. A parenting and cannabis writer, Ms. Brand had more than a cursory background in cannabinoid medicine and had spent time at her local California dispensary discussing various cannabinoid components that might help alleviate her pain.

Anatoliy Sizov/Getty Images

A self-professed “do-it-yourselfer,” Ms. Brand continues to use cannabinoids for her monthly headaches, forgoing any other pain medication. “There are times for conventional medicine in partnership with your doctor, but when it comes to health and wellness, women should be empowered to make decisions and self-experiment,” she said in an interview.

Ms. Brand is not alone. Significant numbers of women are replacing or supplementing prescription medications with cannabinoids, often without consulting their primary care physician, ob.gyn., or other specialist. At times, women have tried to have these conversations, only to be met with silence or worse.

Take Linda Fuller, a 58-year-old yoga instructor from Long Island who says that she uses CBD and THC for chronic sacroiliac pain after a car accident and to alleviate stress-triggered eczema flares. “I’ve had doctors turn their backs on me; I’ve had nurse practitioners walk out on me in the middle of a sentence,” she said in an interview.

Ms. Fuller said her conversion to cannabinoid medicine is relatively new; she never used cannabis recreationally before her accident but now considers it a gift. She doesn’t keep aspirin in the house and refused pain medication immediately after she injured her back.

Diana Krach, a 34-year-old writer from Maryland, says she’s encountered roadblocks about her decision to use cannabinoids for endometriosis and for pain from Crohn’s disease. When she tried to discuss her CBD use with a gastroenterologist, he interrupted her: “Whatever pot you’re smoking isn’t going to work, you’re going on biologics.”

Ms. Krach had not been smoking anything but had turned to a CBD tincture for symptom relief after prescription pain medications failed to help.

Ms. Brand, Ms. Fuller, and Ms. Krach are the tip of the iceberg when it comes to women seeking symptom relief outside the medicine cabinet. A recent survey in the Journal of Women’s Health of almost 1,000 women show that 90% (most between the ages of 35 and 44) had used cannabis and would consider using it to treat gynecologic pain. Roughly 80% said they would consider using it for procedure-related pain or other conditions. Additionally, women have reported using cannabinoids for PTSD, sleep disturbances or insomnia, anxiety, and migraine headaches.

Observational survey data have likewise shown that 80% of women with advanced or recurrent gynecologic malignancies who were prescribed cannabis reported that it was equivalent or superior to other medications for relieving pain, neuropathy, nausea, insomnia, decreased appetite, and anxiety.

In another survey, almost half (45%) of women with gynecologic malignancies who used nonprescribed cannabis for the same symptoms reported that they had reduced their use of prescription narcotics after initiating use of cannabis.
 

The gray zone

There has been a surge in self-reported cannabis use among pregnant women in particular. The National Survey on Drug Use and Health findings for the periods 2002-2003 and 2016-2017 highlight increases in adjusted prevalence rates from 3.4% to 7% in past-month use among pregnant women overall and from 5.7% to 12.1% during the first trimester alone.

“The more that you talk to pregnant women, the more that you realize that a lot are using cannabinoids for something that is basically medicinal, for sleep, for anxiety, or for nausea,” Katrina Mark, MD, an ob.gyn. and associate professor of medicine at the University of Maryland, College Park, said in an interview. “I’m not saying it’s fine to use drugs in pregnancy, but it is a grayer conversation than a lot of colleagues want to believe. Telling women to quit seems foolish since the alternative is to be anxious, don’t sleep, don’t eat, or use a medication that also has risks to it.”

One observational study shows that pregnant women themselves are conflicted. Although the majority believe that cannabis is “natural” and “safe,” compared with prescription drugs, they aren’t entirely in the dark about potential risks. They often express frustration with practitioners’ responses when these topics are broached during office visits. An observational survey among women and practitioners published in 2020 highlights that only half of doctors openly discouraged perinatal cannabis use and that others opted out of the discussion entirely.

This is the experience of many of the women that this news organization spoke with. Ms. Krach pointed out that “there’s a big deficit in listening; the doctor is supposed to be working for our behalf, especially when it comes to reproductive health.”

Dr. Mark believed that a lot of the conversation has been clouded by the illegality of the substance but that cannabinoids deserve as much of a fair chance for discussion and consideration as other medicines, which also carry risks in pregnancy. “There’s literally no evidence that it will work in pregnancy [for these symptoms], but there’s no evidence that it doesn’t, either,” she said in an interview. “When I have this conversation with colleagues who do not share my views, I try to encourage them to look at the actual risks versus the benefits versus the alternatives.”

The ‘entourage effect’

Data supporting cannabinoids have been mostly laboratory based, case based, or observational. However, several well-designed (albeit small) trials have demonstrated efficacy for chronic pain conditions, including neuropathic and headache pain, as well as in Crohn’s disease. Most investigators have concluded that dosage is important and that there is a synergistic interaction between compounds (known as the “entourage effect”) that relates to cannabinoid efficacy or lack thereof, as well as possible adverse effects.

In addition to legality issues, the entourage effect is one of the most important factors related to the medical use of cannabinoids. “There are literally thousands of cultivars of cannabis, each with their own phytocannabinoid and terpenic profiles that may produce distinct therapeutic effects, [so] it is misguided to speak of cannabis in monolithic terms. It is like making broad claims about soup,” wrote coauthor Samoon Ahmad, MD, in Medical Marijuana: A Clinical Handbook.

Additionally, the role that reproductive hormones play is not entirely understood. Reproductive-aged women appear to be more susceptible to a “telescoping” (gender-related progression to dependence) effect in comparison with men. Ziva Cooper, PhD, director of the Cannabis Research Initiative at the University of California, Los Angeles, said in an interview. She explained that research has shown that factors such as the degree of exposure, frequency of use, and menses confound this susceptibility.
 

It’s the data

Frustration over cannabinoid therapeutics abound, especially when it comes to data, legal issues, and lack of training. “The feedback that I hear from providers is that there isn’t enough information; we just don’t know enough about it,” Dr. Mark said, “but there is information that we do have, and ignoring it is not beneficial.”

Dr. Cooper concurred. Although she readily acknowledges that data from randomized, placebo-controlled trials are mostly lacking, she says, “There are signals in the literature providing evidence for the utility of cannabis and cannabinoids for pain and some other effects.”

Other practitioners said in an interview that some patients admit to using cannabinoids but that they lack the ample information to guide these patients. By and large, many women equate “natural” with “safe,” and some will experiment on their own to see what works.

Those experiments are not without risk, which is why “it’s just as important for physicians to talk to their patients about cannabis use as it is for patients to be forthcoming about that use,” said Dr. Cooper. “It could have implications on their overall health as well as interactions with other drugs that they’re using.”

That balance from a clinical perspective on cannabis is crucial, wrote coauthor Kenneth Hill, MD, in Medical Marijuana: A Clinical Handbook. “Without it,” he wrote, “the window of opportunity for a patient to accept treatment that she needs may not be open very long.”

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

When 42-year-old Danielle Simone Brand started having hormonal migraines, she first turned to cannabidiol (CBD) oil, eventually adding an occasional pull on a prefilled tetrahydrocannabinol (THC) vape for nighttime use. She was careful to avoid THC during work hours. A parenting and cannabis writer, Ms. Brand had more than a cursory background in cannabinoid medicine and had spent time at her local California dispensary discussing various cannabinoid components that might help alleviate her pain.

Anatoliy Sizov/Getty Images

A self-professed “do-it-yourselfer,” Ms. Brand continues to use cannabinoids for her monthly headaches, forgoing any other pain medication. “There are times for conventional medicine in partnership with your doctor, but when it comes to health and wellness, women should be empowered to make decisions and self-experiment,” she said in an interview.

Ms. Brand is not alone. Significant numbers of women are replacing or supplementing prescription medications with cannabinoids, often without consulting their primary care physician, ob.gyn., or other specialist. At times, women have tried to have these conversations, only to be met with silence or worse.

Take Linda Fuller, a 58-year-old yoga instructor from Long Island who says that she uses CBD and THC for chronic sacroiliac pain after a car accident and to alleviate stress-triggered eczema flares. “I’ve had doctors turn their backs on me; I’ve had nurse practitioners walk out on me in the middle of a sentence,” she said in an interview.

Ms. Fuller said her conversion to cannabinoid medicine is relatively new; she never used cannabis recreationally before her accident but now considers it a gift. She doesn’t keep aspirin in the house and refused pain medication immediately after she injured her back.

Diana Krach, a 34-year-old writer from Maryland, says she’s encountered roadblocks about her decision to use cannabinoids for endometriosis and for pain from Crohn’s disease. When she tried to discuss her CBD use with a gastroenterologist, he interrupted her: “Whatever pot you’re smoking isn’t going to work, you’re going on biologics.”

Ms. Krach had not been smoking anything but had turned to a CBD tincture for symptom relief after prescription pain medications failed to help.

Ms. Brand, Ms. Fuller, and Ms. Krach are the tip of the iceberg when it comes to women seeking symptom relief outside the medicine cabinet. A recent survey in the Journal of Women’s Health of almost 1,000 women show that 90% (most between the ages of 35 and 44) had used cannabis and would consider using it to treat gynecologic pain. Roughly 80% said they would consider using it for procedure-related pain or other conditions. Additionally, women have reported using cannabinoids for PTSD, sleep disturbances or insomnia, anxiety, and migraine headaches.

Observational survey data have likewise shown that 80% of women with advanced or recurrent gynecologic malignancies who were prescribed cannabis reported that it was equivalent or superior to other medications for relieving pain, neuropathy, nausea, insomnia, decreased appetite, and anxiety.

In another survey, almost half (45%) of women with gynecologic malignancies who used nonprescribed cannabis for the same symptoms reported that they had reduced their use of prescription narcotics after initiating use of cannabis.
 

The gray zone

There has been a surge in self-reported cannabis use among pregnant women in particular. The National Survey on Drug Use and Health findings for the periods 2002-2003 and 2016-2017 highlight increases in adjusted prevalence rates from 3.4% to 7% in past-month use among pregnant women overall and from 5.7% to 12.1% during the first trimester alone.

“The more that you talk to pregnant women, the more that you realize that a lot are using cannabinoids for something that is basically medicinal, for sleep, for anxiety, or for nausea,” Katrina Mark, MD, an ob.gyn. and associate professor of medicine at the University of Maryland, College Park, said in an interview. “I’m not saying it’s fine to use drugs in pregnancy, but it is a grayer conversation than a lot of colleagues want to believe. Telling women to quit seems foolish since the alternative is to be anxious, don’t sleep, don’t eat, or use a medication that also has risks to it.”

One observational study shows that pregnant women themselves are conflicted. Although the majority believe that cannabis is “natural” and “safe,” compared with prescription drugs, they aren’t entirely in the dark about potential risks. They often express frustration with practitioners’ responses when these topics are broached during office visits. An observational survey among women and practitioners published in 2020 highlights that only half of doctors openly discouraged perinatal cannabis use and that others opted out of the discussion entirely.

This is the experience of many of the women that this news organization spoke with. Ms. Krach pointed out that “there’s a big deficit in listening; the doctor is supposed to be working for our behalf, especially when it comes to reproductive health.”

Dr. Mark believed that a lot of the conversation has been clouded by the illegality of the substance but that cannabinoids deserve as much of a fair chance for discussion and consideration as other medicines, which also carry risks in pregnancy. “There’s literally no evidence that it will work in pregnancy [for these symptoms], but there’s no evidence that it doesn’t, either,” she said in an interview. “When I have this conversation with colleagues who do not share my views, I try to encourage them to look at the actual risks versus the benefits versus the alternatives.”

The ‘entourage effect’

Data supporting cannabinoids have been mostly laboratory based, case based, or observational. However, several well-designed (albeit small) trials have demonstrated efficacy for chronic pain conditions, including neuropathic and headache pain, as well as in Crohn’s disease. Most investigators have concluded that dosage is important and that there is a synergistic interaction between compounds (known as the “entourage effect”) that relates to cannabinoid efficacy or lack thereof, as well as possible adverse effects.

In addition to legality issues, the entourage effect is one of the most important factors related to the medical use of cannabinoids. “There are literally thousands of cultivars of cannabis, each with their own phytocannabinoid and terpenic profiles that may produce distinct therapeutic effects, [so] it is misguided to speak of cannabis in monolithic terms. It is like making broad claims about soup,” wrote coauthor Samoon Ahmad, MD, in Medical Marijuana: A Clinical Handbook.

Additionally, the role that reproductive hormones play is not entirely understood. Reproductive-aged women appear to be more susceptible to a “telescoping” (gender-related progression to dependence) effect in comparison with men. Ziva Cooper, PhD, director of the Cannabis Research Initiative at the University of California, Los Angeles, said in an interview. She explained that research has shown that factors such as the degree of exposure, frequency of use, and menses confound this susceptibility.
 

It’s the data

Frustration over cannabinoid therapeutics abound, especially when it comes to data, legal issues, and lack of training. “The feedback that I hear from providers is that there isn’t enough information; we just don’t know enough about it,” Dr. Mark said, “but there is information that we do have, and ignoring it is not beneficial.”

Dr. Cooper concurred. Although she readily acknowledges that data from randomized, placebo-controlled trials are mostly lacking, she says, “There are signals in the literature providing evidence for the utility of cannabis and cannabinoids for pain and some other effects.”

Other practitioners said in an interview that some patients admit to using cannabinoids but that they lack the ample information to guide these patients. By and large, many women equate “natural” with “safe,” and some will experiment on their own to see what works.

Those experiments are not without risk, which is why “it’s just as important for physicians to talk to their patients about cannabis use as it is for patients to be forthcoming about that use,” said Dr. Cooper. “It could have implications on their overall health as well as interactions with other drugs that they’re using.”

That balance from a clinical perspective on cannabis is crucial, wrote coauthor Kenneth Hill, MD, in Medical Marijuana: A Clinical Handbook. “Without it,” he wrote, “the window of opportunity for a patient to accept treatment that she needs may not be open very long.”

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

When 42-year-old Danielle Simone Brand started having hormonal migraines, she first turned to cannabidiol (CBD) oil, eventually adding an occasional pull on a prefilled tetrahydrocannabinol (THC) vape for nighttime use. She was careful to avoid THC during work hours. A parenting and cannabis writer, Ms. Brand had more than a cursory background in cannabinoid medicine and had spent time at her local California dispensary discussing various cannabinoid components that might help alleviate her pain.

Anatoliy Sizov/Getty Images

A self-professed “do-it-yourselfer,” Ms. Brand continues to use cannabinoids for her monthly headaches, forgoing any other pain medication. “There are times for conventional medicine in partnership with your doctor, but when it comes to health and wellness, women should be empowered to make decisions and self-experiment,” she said in an interview.

Ms. Brand is not alone. Significant numbers of women are replacing or supplementing prescription medications with cannabinoids, often without consulting their primary care physician, ob.gyn., or other specialist. At times, women have tried to have these conversations, only to be met with silence or worse.

Take Linda Fuller, a 58-year-old yoga instructor from Long Island who says that she uses CBD and THC for chronic sacroiliac pain after a car accident and to alleviate stress-triggered eczema flares. “I’ve had doctors turn their backs on me; I’ve had nurse practitioners walk out on me in the middle of a sentence,” she said in an interview.

Ms. Fuller said her conversion to cannabinoid medicine is relatively new; she never used cannabis recreationally before her accident but now considers it a gift. She doesn’t keep aspirin in the house and refused pain medication immediately after she injured her back.

Diana Krach, a 34-year-old writer from Maryland, says she’s encountered roadblocks about her decision to use cannabinoids for endometriosis and for pain from Crohn’s disease. When she tried to discuss her CBD use with a gastroenterologist, he interrupted her: “Whatever pot you’re smoking isn’t going to work, you’re going on biologics.”

Ms. Krach had not been smoking anything but had turned to a CBD tincture for symptom relief after prescription pain medications failed to help.

Ms. Brand, Ms. Fuller, and Ms. Krach are the tip of the iceberg when it comes to women seeking symptom relief outside the medicine cabinet. A recent survey in the Journal of Women’s Health of almost 1,000 women show that 90% (most between the ages of 35 and 44) had used cannabis and would consider using it to treat gynecologic pain. Roughly 80% said they would consider using it for procedure-related pain or other conditions. Additionally, women have reported using cannabinoids for PTSD, sleep disturbances or insomnia, anxiety, and migraine headaches.

Observational survey data have likewise shown that 80% of women with advanced or recurrent gynecologic malignancies who were prescribed cannabis reported that it was equivalent or superior to other medications for relieving pain, neuropathy, nausea, insomnia, decreased appetite, and anxiety.

In another survey, almost half (45%) of women with gynecologic malignancies who used nonprescribed cannabis for the same symptoms reported that they had reduced their use of prescription narcotics after initiating use of cannabis.
 

The gray zone

There has been a surge in self-reported cannabis use among pregnant women in particular. The National Survey on Drug Use and Health findings for the periods 2002-2003 and 2016-2017 highlight increases in adjusted prevalence rates from 3.4% to 7% in past-month use among pregnant women overall and from 5.7% to 12.1% during the first trimester alone.

“The more that you talk to pregnant women, the more that you realize that a lot are using cannabinoids for something that is basically medicinal, for sleep, for anxiety, or for nausea,” Katrina Mark, MD, an ob.gyn. and associate professor of medicine at the University of Maryland, College Park, said in an interview. “I’m not saying it’s fine to use drugs in pregnancy, but it is a grayer conversation than a lot of colleagues want to believe. Telling women to quit seems foolish since the alternative is to be anxious, don’t sleep, don’t eat, or use a medication that also has risks to it.”

One observational study shows that pregnant women themselves are conflicted. Although the majority believe that cannabis is “natural” and “safe,” compared with prescription drugs, they aren’t entirely in the dark about potential risks. They often express frustration with practitioners’ responses when these topics are broached during office visits. An observational survey among women and practitioners published in 2020 highlights that only half of doctors openly discouraged perinatal cannabis use and that others opted out of the discussion entirely.

This is the experience of many of the women that this news organization spoke with. Ms. Krach pointed out that “there’s a big deficit in listening; the doctor is supposed to be working for our behalf, especially when it comes to reproductive health.”

Dr. Mark believed that a lot of the conversation has been clouded by the illegality of the substance but that cannabinoids deserve as much of a fair chance for discussion and consideration as other medicines, which also carry risks in pregnancy. “There’s literally no evidence that it will work in pregnancy [for these symptoms], but there’s no evidence that it doesn’t, either,” she said in an interview. “When I have this conversation with colleagues who do not share my views, I try to encourage them to look at the actual risks versus the benefits versus the alternatives.”

The ‘entourage effect’

Data supporting cannabinoids have been mostly laboratory based, case based, or observational. However, several well-designed (albeit small) trials have demonstrated efficacy for chronic pain conditions, including neuropathic and headache pain, as well as in Crohn’s disease. Most investigators have concluded that dosage is important and that there is a synergistic interaction between compounds (known as the “entourage effect”) that relates to cannabinoid efficacy or lack thereof, as well as possible adverse effects.

In addition to legality issues, the entourage effect is one of the most important factors related to the medical use of cannabinoids. “There are literally thousands of cultivars of cannabis, each with their own phytocannabinoid and terpenic profiles that may produce distinct therapeutic effects, [so] it is misguided to speak of cannabis in monolithic terms. It is like making broad claims about soup,” wrote coauthor Samoon Ahmad, MD, in Medical Marijuana: A Clinical Handbook.

Additionally, the role that reproductive hormones play is not entirely understood. Reproductive-aged women appear to be more susceptible to a “telescoping” (gender-related progression to dependence) effect in comparison with men. Ziva Cooper, PhD, director of the Cannabis Research Initiative at the University of California, Los Angeles, said in an interview. She explained that research has shown that factors such as the degree of exposure, frequency of use, and menses confound this susceptibility.
 

It’s the data

Frustration over cannabinoid therapeutics abound, especially when it comes to data, legal issues, and lack of training. “The feedback that I hear from providers is that there isn’t enough information; we just don’t know enough about it,” Dr. Mark said, “but there is information that we do have, and ignoring it is not beneficial.”

Dr. Cooper concurred. Although she readily acknowledges that data from randomized, placebo-controlled trials are mostly lacking, she says, “There are signals in the literature providing evidence for the utility of cannabis and cannabinoids for pain and some other effects.”

Other practitioners said in an interview that some patients admit to using cannabinoids but that they lack the ample information to guide these patients. By and large, many women equate “natural” with “safe,” and some will experiment on their own to see what works.

Those experiments are not without risk, which is why “it’s just as important for physicians to talk to their patients about cannabis use as it is for patients to be forthcoming about that use,” said Dr. Cooper. “It could have implications on their overall health as well as interactions with other drugs that they’re using.”

That balance from a clinical perspective on cannabis is crucial, wrote coauthor Kenneth Hill, MD, in Medical Marijuana: A Clinical Handbook. “Without it,” he wrote, “the window of opportunity for a patient to accept treatment that she needs may not be open very long.”

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

Researchers say women with type 2 diabetes treated with metformin had a reduced rate of the most common type of breast cancer, estrogen receptor (ER)–positive tumors, during a median follow-up of nearly 9 years in a prospective study of more than 44,000 individuals in the United States.

Conversely, the results also showed higher rates of ER-negative and triple-negative breast cancer among women with type 2 diabetes who received metformin, although case numbers were small.

“Our conclusion that having type 2 diabetes increases the risk of developing breast cancer but taking metformin may protect against developing ER-positive breast cancer – but not other types of breast cancer – is biologically plausible and supported by our results, even though some [endpoints] are not statistically significant,” senior author Dale P. Sandler, PhD, chief of the epidemiology branch, National Institute of Environmental Health Sciences, Research Triangle Park, N.C., said in an interview.

“Among our findings that are not statistically significant are several that helped us get a better picture of the relationships between type 2 diabetes, metformin treatment, and breast cancer risk,” Dr. Sandler added.

The results were published online Jan. 28 in Annals of Oncology by Yong-Moon Mark Park, MD, PhD, now an epidemiologist at the University of Arkansas for Medical Sciences in Little Rock, and colleagues.

Sara P. Cate, MD, a breast cancer surgeon at Mount Sinai Medical Center in New York, who was not involved with the study, said: “Certainly, metformin helps with weight loss, which is linked with estrogen-driven breast cancers, so this may explain why fewer patients on metformin got this type of breast cancer.”
 

A tangled web ... with no clear conclusions yet

But in an accompanying editorial, Ana E. Lohmann, MD, PhD, and Pamela J. Goodwin, MD, say that, while this is “a large, well-designed prospective cohort study,” it tells a complicated story.

“The report by Park adds to the growing evidence linking type 2 diabetes and its treatment to breast cancer risk, but definitive conclusions regarding these associations are not yet possible,” they observe.

The “largely negative” results of the new study perhaps in part occurred because the cohort included only 277 women with type 2 diabetes diagnosed with incident breast cancer, note Dr. Lohmann, of London Health Sciences Centre, University of Western Ontario, and Dr. Goodwin, of Mount Sinai Hospital, Toronto.

“Clearly, this is an important area, and additional research is needed to untangle the web of inter-related associations of type 2 diabetes, its treatment, and breast cancer risk,” they write.

Examination of the effects of metformin in studies such as the Canadian Cancer Trial Group MA.32, a phase 3 trial of over 3,500 women with hormone receptor–positive early-stage breast cancer who are being randomized to metformin or placebo for up to 5 years in addition to standard adjuvant therapy, will provide further insights, they observe. The trial is slated to be completed in February 2022.
 

Study followed women whose sisters had breast cancer 

The new data come from the Sister Study, which followed more than 50,000 women without a history of breast cancer who had sisters or half-sisters with a breast cancer diagnosis. The study, run by the NIEHS, enrolled women 35-74 years old from all 50 U.S. states and Puerto Rico in 2003-2009.

The current analysis excluded women with a history of any other type of cancer, missing data about diabetes, or an uncertain breast cancer diagnosis during the study, which left 44,541 available for study. At entry, 7% of the women had type 2 diabetes, and another 5% developed new-onset type 2 diabetes during follow-up.

Among those with diabetes, 61% received treatment with metformin either alone or with other antidiabetic drugs.

During a median follow-up of 8.6 years, 2,678 women received a diagnosis of primary breast cancer, either invasive or ductal carcinoma in situ.

In a series of multivariate analyses that adjusted for numerous potential confounders, the authors found that, overall, no association existed between diabetes and breast cancer incidence, with a hazard ratio of 0.99, compared with women without diabetes.

But, said Dr. Sandler, “there is a strong biological rationale to hypothesize that type 2 diabetes increases the risk for breast cancer, and results from earlier studies support this.”
 

Association of metformin and breast cancer

Women with type 2 diabetes who received metformin had a 14% lower rate of ER-positive breast cancer, compared with women with diabetes not taking metformin, a nonsignificant association.

Among women taking metformin for at least 10 years, the associated reduction in ER-positive breast cancer, compared with those who did not take it, was 38%, a difference that just missed significance, with a 95% confidence interval of 0.38-1.01.

In contrast, cases of ER-negative and triple-negative breast cancers increased in the women with diabetes taking metformin. The hazard ratio for ER-negative tumors showed a nonsignificant 25% relative increase in women taking metformin and a significant 74% increase in triple-negative cancers.

The editorialists note, however, that “the number of patients who were found to have triple-negative breast cancer was small [so] we cannot draw any practice-changing conclusions from it.”

In conclusion, Dr. Park and colleagues reiterate: “Our analysis is consistent with a potential protective effect of metformin and suggests that long-term use of metformin may reduce breast cancer risk associated with type 2 diabetes.”

The study received no commercial funding. Dr. Sandler, Dr. Park, Dr. Lohmann, Dr. Goodwin, and Dr. Cate have reported no relevant financial relationships.

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

Researchers say women with type 2 diabetes treated with metformin had a reduced rate of the most common type of breast cancer, estrogen receptor (ER)–positive tumors, during a median follow-up of nearly 9 years in a prospective study of more than 44,000 individuals in the United States.

Conversely, the results also showed higher rates of ER-negative and triple-negative breast cancer among women with type 2 diabetes who received metformin, although case numbers were small.

“Our conclusion that having type 2 diabetes increases the risk of developing breast cancer but taking metformin may protect against developing ER-positive breast cancer – but not other types of breast cancer – is biologically plausible and supported by our results, even though some [endpoints] are not statistically significant,” senior author Dale P. Sandler, PhD, chief of the epidemiology branch, National Institute of Environmental Health Sciences, Research Triangle Park, N.C., said in an interview.

“Among our findings that are not statistically significant are several that helped us get a better picture of the relationships between type 2 diabetes, metformin treatment, and breast cancer risk,” Dr. Sandler added.

The results were published online Jan. 28 in Annals of Oncology by Yong-Moon Mark Park, MD, PhD, now an epidemiologist at the University of Arkansas for Medical Sciences in Little Rock, and colleagues.

Sara P. Cate, MD, a breast cancer surgeon at Mount Sinai Medical Center in New York, who was not involved with the study, said: “Certainly, metformin helps with weight loss, which is linked with estrogen-driven breast cancers, so this may explain why fewer patients on metformin got this type of breast cancer.”
 

A tangled web ... with no clear conclusions yet

But in an accompanying editorial, Ana E. Lohmann, MD, PhD, and Pamela J. Goodwin, MD, say that, while this is “a large, well-designed prospective cohort study,” it tells a complicated story.

“The report by Park adds to the growing evidence linking type 2 diabetes and its treatment to breast cancer risk, but definitive conclusions regarding these associations are not yet possible,” they observe.

The “largely negative” results of the new study perhaps in part occurred because the cohort included only 277 women with type 2 diabetes diagnosed with incident breast cancer, note Dr. Lohmann, of London Health Sciences Centre, University of Western Ontario, and Dr. Goodwin, of Mount Sinai Hospital, Toronto.

“Clearly, this is an important area, and additional research is needed to untangle the web of inter-related associations of type 2 diabetes, its treatment, and breast cancer risk,” they write.

Examination of the effects of metformin in studies such as the Canadian Cancer Trial Group MA.32, a phase 3 trial of over 3,500 women with hormone receptor–positive early-stage breast cancer who are being randomized to metformin or placebo for up to 5 years in addition to standard adjuvant therapy, will provide further insights, they observe. The trial is slated to be completed in February 2022.
 

Study followed women whose sisters had breast cancer 

The new data come from the Sister Study, which followed more than 50,000 women without a history of breast cancer who had sisters or half-sisters with a breast cancer diagnosis. The study, run by the NIEHS, enrolled women 35-74 years old from all 50 U.S. states and Puerto Rico in 2003-2009.

The current analysis excluded women with a history of any other type of cancer, missing data about diabetes, or an uncertain breast cancer diagnosis during the study, which left 44,541 available for study. At entry, 7% of the women had type 2 diabetes, and another 5% developed new-onset type 2 diabetes during follow-up.

Among those with diabetes, 61% received treatment with metformin either alone or with other antidiabetic drugs.

During a median follow-up of 8.6 years, 2,678 women received a diagnosis of primary breast cancer, either invasive or ductal carcinoma in situ.

In a series of multivariate analyses that adjusted for numerous potential confounders, the authors found that, overall, no association existed between diabetes and breast cancer incidence, with a hazard ratio of 0.99, compared with women without diabetes.

But, said Dr. Sandler, “there is a strong biological rationale to hypothesize that type 2 diabetes increases the risk for breast cancer, and results from earlier studies support this.”
 

Association of metformin and breast cancer

Women with type 2 diabetes who received metformin had a 14% lower rate of ER-positive breast cancer, compared with women with diabetes not taking metformin, a nonsignificant association.

Among women taking metformin for at least 10 years, the associated reduction in ER-positive breast cancer, compared with those who did not take it, was 38%, a difference that just missed significance, with a 95% confidence interval of 0.38-1.01.

In contrast, cases of ER-negative and triple-negative breast cancers increased in the women with diabetes taking metformin. The hazard ratio for ER-negative tumors showed a nonsignificant 25% relative increase in women taking metformin and a significant 74% increase in triple-negative cancers.

The editorialists note, however, that “the number of patients who were found to have triple-negative breast cancer was small [so] we cannot draw any practice-changing conclusions from it.”

In conclusion, Dr. Park and colleagues reiterate: “Our analysis is consistent with a potential protective effect of metformin and suggests that long-term use of metformin may reduce breast cancer risk associated with type 2 diabetes.”

The study received no commercial funding. Dr. Sandler, Dr. Park, Dr. Lohmann, Dr. Goodwin, and Dr. Cate have reported no relevant financial relationships.

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

Researchers say women with type 2 diabetes treated with metformin had a reduced rate of the most common type of breast cancer, estrogen receptor (ER)–positive tumors, during a median follow-up of nearly 9 years in a prospective study of more than 44,000 individuals in the United States.

Conversely, the results also showed higher rates of ER-negative and triple-negative breast cancer among women with type 2 diabetes who received metformin, although case numbers were small.

“Our conclusion that having type 2 diabetes increases the risk of developing breast cancer but taking metformin may protect against developing ER-positive breast cancer – but not other types of breast cancer – is biologically plausible and supported by our results, even though some [endpoints] are not statistically significant,” senior author Dale P. Sandler, PhD, chief of the epidemiology branch, National Institute of Environmental Health Sciences, Research Triangle Park, N.C., said in an interview.

“Among our findings that are not statistically significant are several that helped us get a better picture of the relationships between type 2 diabetes, metformin treatment, and breast cancer risk,” Dr. Sandler added.

The results were published online Jan. 28 in Annals of Oncology by Yong-Moon Mark Park, MD, PhD, now an epidemiologist at the University of Arkansas for Medical Sciences in Little Rock, and colleagues.

Sara P. Cate, MD, a breast cancer surgeon at Mount Sinai Medical Center in New York, who was not involved with the study, said: “Certainly, metformin helps with weight loss, which is linked with estrogen-driven breast cancers, so this may explain why fewer patients on metformin got this type of breast cancer.”
 

A tangled web ... with no clear conclusions yet

But in an accompanying editorial, Ana E. Lohmann, MD, PhD, and Pamela J. Goodwin, MD, say that, while this is “a large, well-designed prospective cohort study,” it tells a complicated story.

“The report by Park adds to the growing evidence linking type 2 diabetes and its treatment to breast cancer risk, but definitive conclusions regarding these associations are not yet possible,” they observe.

The “largely negative” results of the new study perhaps in part occurred because the cohort included only 277 women with type 2 diabetes diagnosed with incident breast cancer, note Dr. Lohmann, of London Health Sciences Centre, University of Western Ontario, and Dr. Goodwin, of Mount Sinai Hospital, Toronto.

“Clearly, this is an important area, and additional research is needed to untangle the web of inter-related associations of type 2 diabetes, its treatment, and breast cancer risk,” they write.

Examination of the effects of metformin in studies such as the Canadian Cancer Trial Group MA.32, a phase 3 trial of over 3,500 women with hormone receptor–positive early-stage breast cancer who are being randomized to metformin or placebo for up to 5 years in addition to standard adjuvant therapy, will provide further insights, they observe. The trial is slated to be completed in February 2022.
 

Study followed women whose sisters had breast cancer 

The new data come from the Sister Study, which followed more than 50,000 women without a history of breast cancer who had sisters or half-sisters with a breast cancer diagnosis. The study, run by the NIEHS, enrolled women 35-74 years old from all 50 U.S. states and Puerto Rico in 2003-2009.

The current analysis excluded women with a history of any other type of cancer, missing data about diabetes, or an uncertain breast cancer diagnosis during the study, which left 44,541 available for study. At entry, 7% of the women had type 2 diabetes, and another 5% developed new-onset type 2 diabetes during follow-up.

Among those with diabetes, 61% received treatment with metformin either alone or with other antidiabetic drugs.

During a median follow-up of 8.6 years, 2,678 women received a diagnosis of primary breast cancer, either invasive or ductal carcinoma in situ.

In a series of multivariate analyses that adjusted for numerous potential confounders, the authors found that, overall, no association existed between diabetes and breast cancer incidence, with a hazard ratio of 0.99, compared with women without diabetes.

But, said Dr. Sandler, “there is a strong biological rationale to hypothesize that type 2 diabetes increases the risk for breast cancer, and results from earlier studies support this.”
 

Association of metformin and breast cancer

Women with type 2 diabetes who received metformin had a 14% lower rate of ER-positive breast cancer, compared with women with diabetes not taking metformin, a nonsignificant association.

Among women taking metformin for at least 10 years, the associated reduction in ER-positive breast cancer, compared with those who did not take it, was 38%, a difference that just missed significance, with a 95% confidence interval of 0.38-1.01.

In contrast, cases of ER-negative and triple-negative breast cancers increased in the women with diabetes taking metformin. The hazard ratio for ER-negative tumors showed a nonsignificant 25% relative increase in women taking metformin and a significant 74% increase in triple-negative cancers.

The editorialists note, however, that “the number of patients who were found to have triple-negative breast cancer was small [so] we cannot draw any practice-changing conclusions from it.”

In conclusion, Dr. Park and colleagues reiterate: “Our analysis is consistent with a potential protective effect of metformin and suggests that long-term use of metformin may reduce breast cancer risk associated with type 2 diabetes.”

The study received no commercial funding. Dr. Sandler, Dr. Park, Dr. Lohmann, Dr. Goodwin, and Dr. Cate have reported no relevant financial relationships.

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

A levonorgestrel 52-mg intrauterine device is noninferior to a copper IUD for emergency contraception, according to randomized trial results published online in the New England Journal of Medicine.

Although the trial didn’t directly compare emergency oral contraception to the hormonal IUD, the authors speculated, on the basis of prior findings, that the levonorgestrel IUD is more effective than oral emergency contraceptive pills. In addition, there is no delay in providing ongoing contraception as there is when ulipristal acetate is used for emergency contraception.

Prior research has found that copper IUDs are a highly effective method of emergency contraception, but studies of the use of other IUDs as emergency contraception have been lacking.

To examine whether the levonorgestrel IUD is noninferior to the copper IUD as emergency contraception after unprotected sexual intercourse during the previous 5 days, David K. Turok, MD, MPH, associate professor of obstetrics and gynecology at the University of Utah Health, Salt Lake City, and colleagues conducted a trial at six Planned Parenthood health centers in Utah.

Researchers enrolled patients between August 2016 and December 2019. Trial sites purchased levonorgestrel 52-mg IUDs (Liletta) and copper T380A IUDs (ParaGard) for the study. The companies that distribute the IUDs were not involved in the trial.

Pregnancy rates were 1 of 317 participants (0.3%) among those who received the levonorgestrel IUD, and 0 of 321 (0%) among those who received the copper IUD. The difference between the two arms was well within the prespecified noninferiority margin of 2.5%.

Adverse event rates were generally similar between the two groups, with 5.2% of participants in the levonorgestrel IUD group seeking medical care in the month after IUD placement, compared with 4.9% in the copper IUD group.
 

A welcome option

The study “benefits women by allowing us to introduce a new option into the method mix of emergency contraception,” commented Wing Kay Fok, MD, a clinical assistant professor of obstetrics and gynecology at Weill Cornell Medicine, New York.

Specialists in family planning had followed preliminary data from this study and were anticipating the final results. Clinicians who are comfortable placing a copper IUD for emergency contraception are likely to be comfortable placing a levonorgestrel 52-mg IUD, given these data, Dr. Fok said.

“This is definitely – from what we can tell – a more effective method than the pill,” she said.

Gabriela Aguilar, MD, MPH, fellow and clinical instructor in the department of obstetrics, gynecology, and reproductive sciences at Yale University, New Haven, Conn., said she is reassured by the data and is prepared to offer the 52-mg levonorgestrel IUD as emergency contraception.

The trial is “an important clinical study that has the ability to significantly change clinical practice,” Dr. Aguilar said. She credited the University of Utah and Planned Parenthood for their roles in it.

“Anytime that there are more options, ideally, that means that access is also increased,” Dr. Aguilar said.

Many patients will still prefer oral emergency contraceptive pills, she said. “But for those who are interested in an IUD ... for the immediate and ongoing birth control after that, now they have the two options instead of just the one IUD option.”
 

One pregnancy

The trial included women aged 18-35 years who requested emergency contraception after unprotected sexual intercourse within the previous 5 days. Other inclusion criteria were that participants had a desire to initiate use of an IUD; a desire to prevent pregnancy for at least 1 year; a negative result on urine pregnancy testing; a history of regular menstrual cycles; and a known date of the last menstrual period. The investigators did not exclude individuals who had unprotected sexual intercourse more than 5 days before IUD placement.

Participants were unaware of their assigned intervention. The nurse practitioners and certified nurse midwives who performed the IUD insertions were aware of the IUD type.

The primary outcome was pregnancy, as determined by a positive result on urine pregnancy testing 1 month after IUD insertion or by a review of survey and health record data.

One pregnancy “occurred in a participant who reported a single episode of unprotected sexual intercourse 48 hours before IUD placement,” the study authors wrote. “Pregnancy dating by an ultrasound examination at 10 weeks was consistent with conception occurring as a result of an emergency contraception failure. The pregnancy ended in a spontaneous abortion at 10 weeks with the IUD still in place.”

“We hope that providers can begin to deliver this method to everyone who wants and needs it and that people considering both emergency contraception and an ongoing method of birth control know that they now have the option of a hormonal IUD in addition to the nonhormonal, copper IUD,” Dr. Turok said in a news release from Planned Parenthood.

The study used a hormonal IUD manufactured by Liletta; Mirena also manufactures a levonorgestrel 52-mg IUD. The results of the study would apply to Mirena’s product too, according to Planned Parenthood.

“There are various IUDs on the market that are at lower doses, and so those IUDs may not demonstrate similar results,” Dr. Aguilar said.

The research was supported by the National Institutes of Health and the University of Utah. Dr. Turok is the director of surgical services for Planned Parenthood Association of Utah; the trial was conducted at PPAU centers, but Dr. Turok does not work at the sites where the study was conducted. Dr. Turok has consulted for Sebela Pharmaceuticals as the principal investigator for two phase 3 studies that assessed novel IUDs. Dr. Turok and one coauthor received grant support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Fok and Dr. Aguilar disclosed no relevant financial relationships.

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

A levonorgestrel 52-mg intrauterine device is noninferior to a copper IUD for emergency contraception, according to randomized trial results published online in the New England Journal of Medicine.

Although the trial didn’t directly compare emergency oral contraception to the hormonal IUD, the authors speculated, on the basis of prior findings, that the levonorgestrel IUD is more effective than oral emergency contraceptive pills. In addition, there is no delay in providing ongoing contraception as there is when ulipristal acetate is used for emergency contraception.

Prior research has found that copper IUDs are a highly effective method of emergency contraception, but studies of the use of other IUDs as emergency contraception have been lacking.

To examine whether the levonorgestrel IUD is noninferior to the copper IUD as emergency contraception after unprotected sexual intercourse during the previous 5 days, David K. Turok, MD, MPH, associate professor of obstetrics and gynecology at the University of Utah Health, Salt Lake City, and colleagues conducted a trial at six Planned Parenthood health centers in Utah.

Researchers enrolled patients between August 2016 and December 2019. Trial sites purchased levonorgestrel 52-mg IUDs (Liletta) and copper T380A IUDs (ParaGard) for the study. The companies that distribute the IUDs were not involved in the trial.

Pregnancy rates were 1 of 317 participants (0.3%) among those who received the levonorgestrel IUD, and 0 of 321 (0%) among those who received the copper IUD. The difference between the two arms was well within the prespecified noninferiority margin of 2.5%.

Adverse event rates were generally similar between the two groups, with 5.2% of participants in the levonorgestrel IUD group seeking medical care in the month after IUD placement, compared with 4.9% in the copper IUD group.
 

A welcome option

The study “benefits women by allowing us to introduce a new option into the method mix of emergency contraception,” commented Wing Kay Fok, MD, a clinical assistant professor of obstetrics and gynecology at Weill Cornell Medicine, New York.

Specialists in family planning had followed preliminary data from this study and were anticipating the final results. Clinicians who are comfortable placing a copper IUD for emergency contraception are likely to be comfortable placing a levonorgestrel 52-mg IUD, given these data, Dr. Fok said.

“This is definitely – from what we can tell – a more effective method than the pill,” she said.

Gabriela Aguilar, MD, MPH, fellow and clinical instructor in the department of obstetrics, gynecology, and reproductive sciences at Yale University, New Haven, Conn., said she is reassured by the data and is prepared to offer the 52-mg levonorgestrel IUD as emergency contraception.

The trial is “an important clinical study that has the ability to significantly change clinical practice,” Dr. Aguilar said. She credited the University of Utah and Planned Parenthood for their roles in it.

“Anytime that there are more options, ideally, that means that access is also increased,” Dr. Aguilar said.

Many patients will still prefer oral emergency contraceptive pills, she said. “But for those who are interested in an IUD ... for the immediate and ongoing birth control after that, now they have the two options instead of just the one IUD option.”
 

One pregnancy

The trial included women aged 18-35 years who requested emergency contraception after unprotected sexual intercourse within the previous 5 days. Other inclusion criteria were that participants had a desire to initiate use of an IUD; a desire to prevent pregnancy for at least 1 year; a negative result on urine pregnancy testing; a history of regular menstrual cycles; and a known date of the last menstrual period. The investigators did not exclude individuals who had unprotected sexual intercourse more than 5 days before IUD placement.

Participants were unaware of their assigned intervention. The nurse practitioners and certified nurse midwives who performed the IUD insertions were aware of the IUD type.

The primary outcome was pregnancy, as determined by a positive result on urine pregnancy testing 1 month after IUD insertion or by a review of survey and health record data.

One pregnancy “occurred in a participant who reported a single episode of unprotected sexual intercourse 48 hours before IUD placement,” the study authors wrote. “Pregnancy dating by an ultrasound examination at 10 weeks was consistent with conception occurring as a result of an emergency contraception failure. The pregnancy ended in a spontaneous abortion at 10 weeks with the IUD still in place.”

“We hope that providers can begin to deliver this method to everyone who wants and needs it and that people considering both emergency contraception and an ongoing method of birth control know that they now have the option of a hormonal IUD in addition to the nonhormonal, copper IUD,” Dr. Turok said in a news release from Planned Parenthood.

The study used a hormonal IUD manufactured by Liletta; Mirena also manufactures a levonorgestrel 52-mg IUD. The results of the study would apply to Mirena’s product too, according to Planned Parenthood.

“There are various IUDs on the market that are at lower doses, and so those IUDs may not demonstrate similar results,” Dr. Aguilar said.

The research was supported by the National Institutes of Health and the University of Utah. Dr. Turok is the director of surgical services for Planned Parenthood Association of Utah; the trial was conducted at PPAU centers, but Dr. Turok does not work at the sites where the study was conducted. Dr. Turok has consulted for Sebela Pharmaceuticals as the principal investigator for two phase 3 studies that assessed novel IUDs. Dr. Turok and one coauthor received grant support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Fok and Dr. Aguilar disclosed no relevant financial relationships.

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

A levonorgestrel 52-mg intrauterine device is noninferior to a copper IUD for emergency contraception, according to randomized trial results published online in the New England Journal of Medicine.

Although the trial didn’t directly compare emergency oral contraception to the hormonal IUD, the authors speculated, on the basis of prior findings, that the levonorgestrel IUD is more effective than oral emergency contraceptive pills. In addition, there is no delay in providing ongoing contraception as there is when ulipristal acetate is used for emergency contraception.

Prior research has found that copper IUDs are a highly effective method of emergency contraception, but studies of the use of other IUDs as emergency contraception have been lacking.

To examine whether the levonorgestrel IUD is noninferior to the copper IUD as emergency contraception after unprotected sexual intercourse during the previous 5 days, David K. Turok, MD, MPH, associate professor of obstetrics and gynecology at the University of Utah Health, Salt Lake City, and colleagues conducted a trial at six Planned Parenthood health centers in Utah.

Researchers enrolled patients between August 2016 and December 2019. Trial sites purchased levonorgestrel 52-mg IUDs (Liletta) and copper T380A IUDs (ParaGard) for the study. The companies that distribute the IUDs were not involved in the trial.

Pregnancy rates were 1 of 317 participants (0.3%) among those who received the levonorgestrel IUD, and 0 of 321 (0%) among those who received the copper IUD. The difference between the two arms was well within the prespecified noninferiority margin of 2.5%.

Adverse event rates were generally similar between the two groups, with 5.2% of participants in the levonorgestrel IUD group seeking medical care in the month after IUD placement, compared with 4.9% in the copper IUD group.
 

A welcome option

The study “benefits women by allowing us to introduce a new option into the method mix of emergency contraception,” commented Wing Kay Fok, MD, a clinical assistant professor of obstetrics and gynecology at Weill Cornell Medicine, New York.

Specialists in family planning had followed preliminary data from this study and were anticipating the final results. Clinicians who are comfortable placing a copper IUD for emergency contraception are likely to be comfortable placing a levonorgestrel 52-mg IUD, given these data, Dr. Fok said.

“This is definitely – from what we can tell – a more effective method than the pill,” she said.

Gabriela Aguilar, MD, MPH, fellow and clinical instructor in the department of obstetrics, gynecology, and reproductive sciences at Yale University, New Haven, Conn., said she is reassured by the data and is prepared to offer the 52-mg levonorgestrel IUD as emergency contraception.

The trial is “an important clinical study that has the ability to significantly change clinical practice,” Dr. Aguilar said. She credited the University of Utah and Planned Parenthood for their roles in it.

“Anytime that there are more options, ideally, that means that access is also increased,” Dr. Aguilar said.

Many patients will still prefer oral emergency contraceptive pills, she said. “But for those who are interested in an IUD ... for the immediate and ongoing birth control after that, now they have the two options instead of just the one IUD option.”
 

One pregnancy

The trial included women aged 18-35 years who requested emergency contraception after unprotected sexual intercourse within the previous 5 days. Other inclusion criteria were that participants had a desire to initiate use of an IUD; a desire to prevent pregnancy for at least 1 year; a negative result on urine pregnancy testing; a history of regular menstrual cycles; and a known date of the last menstrual period. The investigators did not exclude individuals who had unprotected sexual intercourse more than 5 days before IUD placement.

Participants were unaware of their assigned intervention. The nurse practitioners and certified nurse midwives who performed the IUD insertions were aware of the IUD type.

The primary outcome was pregnancy, as determined by a positive result on urine pregnancy testing 1 month after IUD insertion or by a review of survey and health record data.

One pregnancy “occurred in a participant who reported a single episode of unprotected sexual intercourse 48 hours before IUD placement,” the study authors wrote. “Pregnancy dating by an ultrasound examination at 10 weeks was consistent with conception occurring as a result of an emergency contraception failure. The pregnancy ended in a spontaneous abortion at 10 weeks with the IUD still in place.”

“We hope that providers can begin to deliver this method to everyone who wants and needs it and that people considering both emergency contraception and an ongoing method of birth control know that they now have the option of a hormonal IUD in addition to the nonhormonal, copper IUD,” Dr. Turok said in a news release from Planned Parenthood.

The study used a hormonal IUD manufactured by Liletta; Mirena also manufactures a levonorgestrel 52-mg IUD. The results of the study would apply to Mirena’s product too, according to Planned Parenthood.

“There are various IUDs on the market that are at lower doses, and so those IUDs may not demonstrate similar results,” Dr. Aguilar said.

The research was supported by the National Institutes of Health and the University of Utah. Dr. Turok is the director of surgical services for Planned Parenthood Association of Utah; the trial was conducted at PPAU centers, but Dr. Turok does not work at the sites where the study was conducted. Dr. Turok has consulted for Sebela Pharmaceuticals as the principal investigator for two phase 3 studies that assessed novel IUDs. Dr. Turok and one coauthor received grant support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Fok and Dr. Aguilar disclosed no relevant financial relationships.

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

Many women with hidradenitis suppurativa have pregnancy-related concerns that go unaddressed by their doctors, according to a study that surveyed 59 women with HS.

Previous studies have shown the potential for adverse pregnancy outcomes associated with inflammatory conditions such as systemic vasculitis and lupus, but such data on HS and pregnancy are limited, which makes patient counseling a challenge, Ademide A. Adelekun, MD, of the University of Pennsylvania, Philadelphia, and colleagues wrote.

In a research letter published in JAMA Dermatology, they reported their findings from an email survey of female patients at two academic dermatology departments. A total of 59 women responded to the survey; their average age was 32 years, the majority (76%) had Hurley stage II disease, and 29 (49%) reported having ever been pregnant.

Two of the 29 women (7%) were pregnant at the time of the study survey; 20 of the other 27 pregnant women (74%) said they had full-term births, 4 (15%) reported miscarriages, and 3 (11%) had undergone an abortion.

A total of five patients (9%) reported difficulty getting pregnant after 1 year, and seven (12%) reported undergoing fertility treatments.

Nearly three-quarters of the women (73%) reported that HS had a negative impact on their sexual health, and 54% said they wished their doctors provided more counseling on HS and pregnancy.

A total of 14 patients (24%) said they believed HS affected their ability to become pregnant because of either decreased sexual activity or decreased fertility caused by HS medications, and nearly half (49%) said they believed that discontinuing all HS medications during pregnancy was necessary for safety reasons.

Patients also expressed concern about the possible heritability of HS: 80% said that physicians had not counseled them about HS heritability and 68% expressed concern that their child would have HS.

In addition, 83% said they had not received information about the potential impact of HS on pregnancy, and 22%, or 13 women, were concerned that childbirth would be more difficult; 11 of these 13 women (85%) had HS that affected the vulva and groin, and 4 of the 8 women who reported concerns about difficulty breastfeeding had HS that involved the breast.

Of the 59 patients surveyed, 12 (20%) said they believed HS poses risks to the child, including through transmission of HS in 8 (67%) or through an infection during a vaginal delivery in 7 women (58%).

The prevalence of HS patients’ concerns about pregnancy “may have unfavorable implications for family planning and mental health and may play a role in the inadequate treatment of HS in patients who are pregnant or planning to become pregnant,” the authors noted. “Family planning and prenatal counseling are particularly critical for those with HS given that clinicians weigh the risks of medication use against the benefits of disease control, which is associated with improved pregnancy outcomes for those with inflammatory conditions.”

The study findings were limited by several factors including “recall bias, low response rate, use of a nonvalidated survey, and generalizability to nonacademic settings,” the researchers noted. However, the results emphasize the often-underrecognized concerns of women with HS and the need for improvements in pregnancy-related counseling and systematic evaluation of outcomes.

The researchers had no financial conflicts to disclose. This study was funded by a FOCUS Medical Student Fellowship in Women’s Health grant.

Many women with hidradenitis suppurativa have pregnancy-related concerns that go unaddressed by their doctors, according to a study that surveyed 59 women with HS.

Previous studies have shown the potential for adverse pregnancy outcomes associated with inflammatory conditions such as systemic vasculitis and lupus, but such data on HS and pregnancy are limited, which makes patient counseling a challenge, Ademide A. Adelekun, MD, of the University of Pennsylvania, Philadelphia, and colleagues wrote.

In a research letter published in JAMA Dermatology, they reported their findings from an email survey of female patients at two academic dermatology departments. A total of 59 women responded to the survey; their average age was 32 years, the majority (76%) had Hurley stage II disease, and 29 (49%) reported having ever been pregnant.

Two of the 29 women (7%) were pregnant at the time of the study survey; 20 of the other 27 pregnant women (74%) said they had full-term births, 4 (15%) reported miscarriages, and 3 (11%) had undergone an abortion.

A total of five patients (9%) reported difficulty getting pregnant after 1 year, and seven (12%) reported undergoing fertility treatments.

Nearly three-quarters of the women (73%) reported that HS had a negative impact on their sexual health, and 54% said they wished their doctors provided more counseling on HS and pregnancy.

A total of 14 patients (24%) said they believed HS affected their ability to become pregnant because of either decreased sexual activity or decreased fertility caused by HS medications, and nearly half (49%) said they believed that discontinuing all HS medications during pregnancy was necessary for safety reasons.

Patients also expressed concern about the possible heritability of HS: 80% said that physicians had not counseled them about HS heritability and 68% expressed concern that their child would have HS.

In addition, 83% said they had not received information about the potential impact of HS on pregnancy, and 22%, or 13 women, were concerned that childbirth would be more difficult; 11 of these 13 women (85%) had HS that affected the vulva and groin, and 4 of the 8 women who reported concerns about difficulty breastfeeding had HS that involved the breast.

Of the 59 patients surveyed, 12 (20%) said they believed HS poses risks to the child, including through transmission of HS in 8 (67%) or through an infection during a vaginal delivery in 7 women (58%).

The prevalence of HS patients’ concerns about pregnancy “may have unfavorable implications for family planning and mental health and may play a role in the inadequate treatment of HS in patients who are pregnant or planning to become pregnant,” the authors noted. “Family planning and prenatal counseling are particularly critical for those with HS given that clinicians weigh the risks of medication use against the benefits of disease control, which is associated with improved pregnancy outcomes for those with inflammatory conditions.”

The study findings were limited by several factors including “recall bias, low response rate, use of a nonvalidated survey, and generalizability to nonacademic settings,” the researchers noted. However, the results emphasize the often-underrecognized concerns of women with HS and the need for improvements in pregnancy-related counseling and systematic evaluation of outcomes.

The researchers had no financial conflicts to disclose. This study was funded by a FOCUS Medical Student Fellowship in Women’s Health grant.

Many women with hidradenitis suppurativa have pregnancy-related concerns that go unaddressed by their doctors, according to a study that surveyed 59 women with HS.

Previous studies have shown the potential for adverse pregnancy outcomes associated with inflammatory conditions such as systemic vasculitis and lupus, but such data on HS and pregnancy are limited, which makes patient counseling a challenge, Ademide A. Adelekun, MD, of the University of Pennsylvania, Philadelphia, and colleagues wrote.

In a research letter published in JAMA Dermatology, they reported their findings from an email survey of female patients at two academic dermatology departments. A total of 59 women responded to the survey; their average age was 32 years, the majority (76%) had Hurley stage II disease, and 29 (49%) reported having ever been pregnant.

Two of the 29 women (7%) were pregnant at the time of the study survey; 20 of the other 27 pregnant women (74%) said they had full-term births, 4 (15%) reported miscarriages, and 3 (11%) had undergone an abortion.

A total of five patients (9%) reported difficulty getting pregnant after 1 year, and seven (12%) reported undergoing fertility treatments.

Nearly three-quarters of the women (73%) reported that HS had a negative impact on their sexual health, and 54% said they wished their doctors provided more counseling on HS and pregnancy.

A total of 14 patients (24%) said they believed HS affected their ability to become pregnant because of either decreased sexual activity or decreased fertility caused by HS medications, and nearly half (49%) said they believed that discontinuing all HS medications during pregnancy was necessary for safety reasons.

Patients also expressed concern about the possible heritability of HS: 80% said that physicians had not counseled them about HS heritability and 68% expressed concern that their child would have HS.

In addition, 83% said they had not received information about the potential impact of HS on pregnancy, and 22%, or 13 women, were concerned that childbirth would be more difficult; 11 of these 13 women (85%) had HS that affected the vulva and groin, and 4 of the 8 women who reported concerns about difficulty breastfeeding had HS that involved the breast.

Of the 59 patients surveyed, 12 (20%) said they believed HS poses risks to the child, including through transmission of HS in 8 (67%) or through an infection during a vaginal delivery in 7 women (58%).

The prevalence of HS patients’ concerns about pregnancy “may have unfavorable implications for family planning and mental health and may play a role in the inadequate treatment of HS in patients who are pregnant or planning to become pregnant,” the authors noted. “Family planning and prenatal counseling are particularly critical for those with HS given that clinicians weigh the risks of medication use against the benefits of disease control, which is associated with improved pregnancy outcomes for those with inflammatory conditions.”

The study findings were limited by several factors including “recall bias, low response rate, use of a nonvalidated survey, and generalizability to nonacademic settings,” the researchers noted. However, the results emphasize the often-underrecognized concerns of women with HS and the need for improvements in pregnancy-related counseling and systematic evaluation of outcomes.

The researchers had no financial conflicts to disclose. This study was funded by a FOCUS Medical Student Fellowship in Women’s Health grant.

Higher fiber intake may be associated with decreased risk of depression in premenopausal women, new research suggests.

Nic_Ol/Thinkstock

Investigators analyzed data from close to 6,000 pre- and postmenopausal women. They found that, in premenopausal women, dietary fiber intake was higher among those without depression versus their counterparts with the disorder in a dose-dependent manner. However, there appeared to be no relationship between higher fiber intake and depression risk in postmenopausal women.

“We think the most important finding of our study is that dietary fiber intake was inversely associated with depression in premenopausal but not postmenopausal women,” lead author Yunsun Kim, MD, resident, department of family medicine, Chung-Ang University Hospital, Seoul, South Korea, said in an interview.

“We hope that the findings of this study could form the basis of future investigations to determine the causal relationship between dietary fiber intake and depression,” she added.

The study was published online Dec. 21, 2020, in Menopause.
 

Gut-brain interaction

The prevalence of depression is twice as high in women, compared with men, which may be attributable to a number of factors, including hormonal status – especially during menstruation and menopause, the authors wrote.

Previous research suggests a potential association between dietary fiber and depression in premenopausal women and between estrogen and gut microbiota. Fiber intake has an impact on gut microbiota, Dr. Kim said.

“We are motivated by the fact that depression provokes disease burden internationally and we would like to find modifiable factors that could prevent depression, especially in women, who are more vulnerable to depression,” she noted.

To investigate, the researchers drew on data from the Korea National Health and Nutrition Examination Survey for 2014, 2016, and 2018. Of the total number of women who met inclusion criteria (n = 5807; mean age, 47.11), roughly half were premenopausal and half were postmenopausal (n = 2,949 [mean age, 36.23 years] and n = 2,868 [mean age, 62.73], respectively).

Dietary fiber intake was assessed using the 24-hour dietary recall method, while depression was assessed using the Patient Health Questionnaire-9. The researchers used the Dietary Reference Intakes for Koreans to define a sufficient intake of dietary fiber (i.e., 12 g/1,000 kcal).

Covariates included chronic diseases, body mass index, medications, smoking status, alcohol use, physical activity, and sociodemographic factors.

When the researchers looked at all participants, they found that the estimated mean dietary fiber intake was significantly higher in women without depression, compared with those with depression (14.07 g/1,000 kcal/d; 95% confidence interval, 13.85-14.29 vs. 12.67 g/1,000 kcal/d; 95% CI, 11.79-13.55; P = .003).

Although the relationship remained significant in premenopausal women, it lost significance in postmenopausal women.

A 5% decrease in the prevalence of depression in premenopausal (but not postmenopausal) women was found in those with an increased intake of dietary fiber – i..e, there was a 1-g increase for every 1,000 kcal of daily energy intake, after adjusting for potential confounders in premenopausal women (OR, 0.949; 95% CI, 0.906-0.993]).

“The inverse relationship between dietary fiber intake and depression could be explained by the gut-brain interactions,” said Dr. Kim.

“Changes in the gut microbiota composition may affect neurotransmission and various neuropsychiatric phenomena in the brain,” she said, noting that previous studies have suggested that dietary fiber intake “may modulate the richness and diversity of the gut microbiota, and this change may promote brain health by affecting neurotransmission.”

Because postmenopausal women experience estrogen depletion, “the decreased interaction between estrogen and the gut microbiota may be related to the insignificant association between dietary fiber intake and depression in postmenopausal women,” she said.

Despite the lack of a significant association between postmenopausal depression and fiber intake, Dr. Kim said she “advises middle-aged women to have dietary fiber–rich diets, regardless of their menopausal status.”
 

Link between food and mood

In a comment, Stephanie S. Faubion, MD, MBA, a professor and chair of the department of medicine and the Penny and Bill George director of the Mayo Clinic’s Center for Women’s Health in Rochester, Minn., noted the study was cross-sectional and therefore the direction of the association could not be determined and “causality cannot be assumed.”

It is possible that “depressed women are less likely to eat fiber than women without depression. For example, a depressed woman may be more likely to sit on the couch eating Cheetos than shopping for and preparing a healthy meal,” said Dr. Faubion, who is also the medical director of the North American Menopause Society and was not involved with the study.

She noted that other potential confounders, including access to fresh fruits and vegetables or geographic locations could also “impact the findings and it is important that we do not somehow imply that eating a high-fiber diet can in any way treat a major depression.”

Nevertheless, the study does “add to the body of evidence suggesting a link between diet and overall health, including brain health,” Dr. Faubion said.

One take-home message for practicing clinicians is that a healthy diet that includes fiber may benefit women (and men) for a number of reasons and “appears to be linked to mood.”

More research is needed “to determine the pathophysiologic mechanisms (such as potential brain-gut connection that involves the microbiome) that may explain this association,” Dr. Faubion added.

No source of funding listed. Dr. Kim and coauthors, as well as Dr. Faubion, disclosed no relevant financial relationships.

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

Higher fiber intake may be associated with decreased risk of depression in premenopausal women, new research suggests.

Nic_Ol/Thinkstock

Investigators analyzed data from close to 6,000 pre- and postmenopausal women. They found that, in premenopausal women, dietary fiber intake was higher among those without depression versus their counterparts with the disorder in a dose-dependent manner. However, there appeared to be no relationship between higher fiber intake and depression risk in postmenopausal women.

“We think the most important finding of our study is that dietary fiber intake was inversely associated with depression in premenopausal but not postmenopausal women,” lead author Yunsun Kim, MD, resident, department of family medicine, Chung-Ang University Hospital, Seoul, South Korea, said in an interview.

“We hope that the findings of this study could form the basis of future investigations to determine the causal relationship between dietary fiber intake and depression,” she added.

The study was published online Dec. 21, 2020, in Menopause.
 

Gut-brain interaction

The prevalence of depression is twice as high in women, compared with men, which may be attributable to a number of factors, including hormonal status – especially during menstruation and menopause, the authors wrote.

Previous research suggests a potential association between dietary fiber and depression in premenopausal women and between estrogen and gut microbiota. Fiber intake has an impact on gut microbiota, Dr. Kim said.

“We are motivated by the fact that depression provokes disease burden internationally and we would like to find modifiable factors that could prevent depression, especially in women, who are more vulnerable to depression,” she noted.

To investigate, the researchers drew on data from the Korea National Health and Nutrition Examination Survey for 2014, 2016, and 2018. Of the total number of women who met inclusion criteria (n = 5807; mean age, 47.11), roughly half were premenopausal and half were postmenopausal (n = 2,949 [mean age, 36.23 years] and n = 2,868 [mean age, 62.73], respectively).

Dietary fiber intake was assessed using the 24-hour dietary recall method, while depression was assessed using the Patient Health Questionnaire-9. The researchers used the Dietary Reference Intakes for Koreans to define a sufficient intake of dietary fiber (i.e., 12 g/1,000 kcal).

Covariates included chronic diseases, body mass index, medications, smoking status, alcohol use, physical activity, and sociodemographic factors.

When the researchers looked at all participants, they found that the estimated mean dietary fiber intake was significantly higher in women without depression, compared with those with depression (14.07 g/1,000 kcal/d; 95% confidence interval, 13.85-14.29 vs. 12.67 g/1,000 kcal/d; 95% CI, 11.79-13.55; P = .003).

Although the relationship remained significant in premenopausal women, it lost significance in postmenopausal women.

A 5% decrease in the prevalence of depression in premenopausal (but not postmenopausal) women was found in those with an increased intake of dietary fiber – i..e, there was a 1-g increase for every 1,000 kcal of daily energy intake, after adjusting for potential confounders in premenopausal women (OR, 0.949; 95% CI, 0.906-0.993]).

“The inverse relationship between dietary fiber intake and depression could be explained by the gut-brain interactions,” said Dr. Kim.

“Changes in the gut microbiota composition may affect neurotransmission and various neuropsychiatric phenomena in the brain,” she said, noting that previous studies have suggested that dietary fiber intake “may modulate the richness and diversity of the gut microbiota, and this change may promote brain health by affecting neurotransmission.”

Because postmenopausal women experience estrogen depletion, “the decreased interaction between estrogen and the gut microbiota may be related to the insignificant association between dietary fiber intake and depression in postmenopausal women,” she said.

Despite the lack of a significant association between postmenopausal depression and fiber intake, Dr. Kim said she “advises middle-aged women to have dietary fiber–rich diets, regardless of their menopausal status.”
 

Link between food and mood

In a comment, Stephanie S. Faubion, MD, MBA, a professor and chair of the department of medicine and the Penny and Bill George director of the Mayo Clinic’s Center for Women’s Health in Rochester, Minn., noted the study was cross-sectional and therefore the direction of the association could not be determined and “causality cannot be assumed.”

It is possible that “depressed women are less likely to eat fiber than women without depression. For example, a depressed woman may be more likely to sit on the couch eating Cheetos than shopping for and preparing a healthy meal,” said Dr. Faubion, who is also the medical director of the North American Menopause Society and was not involved with the study.

She noted that other potential confounders, including access to fresh fruits and vegetables or geographic locations could also “impact the findings and it is important that we do not somehow imply that eating a high-fiber diet can in any way treat a major depression.”

Nevertheless, the study does “add to the body of evidence suggesting a link between diet and overall health, including brain health,” Dr. Faubion said.

One take-home message for practicing clinicians is that a healthy diet that includes fiber may benefit women (and men) for a number of reasons and “appears to be linked to mood.”

More research is needed “to determine the pathophysiologic mechanisms (such as potential brain-gut connection that involves the microbiome) that may explain this association,” Dr. Faubion added.

No source of funding listed. Dr. Kim and coauthors, as well as Dr. Faubion, disclosed no relevant financial relationships.

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

Higher fiber intake may be associated with decreased risk of depression in premenopausal women, new research suggests.

Nic_Ol/Thinkstock

Investigators analyzed data from close to 6,000 pre- and postmenopausal women. They found that, in premenopausal women, dietary fiber intake was higher among those without depression versus their counterparts with the disorder in a dose-dependent manner. However, there appeared to be no relationship between higher fiber intake and depression risk in postmenopausal women.

“We think the most important finding of our study is that dietary fiber intake was inversely associated with depression in premenopausal but not postmenopausal women,” lead author Yunsun Kim, MD, resident, department of family medicine, Chung-Ang University Hospital, Seoul, South Korea, said in an interview.

“We hope that the findings of this study could form the basis of future investigations to determine the causal relationship between dietary fiber intake and depression,” she added.

The study was published online Dec. 21, 2020, in Menopause.
 

Gut-brain interaction

The prevalence of depression is twice as high in women, compared with men, which may be attributable to a number of factors, including hormonal status – especially during menstruation and menopause, the authors wrote.

Previous research suggests a potential association between dietary fiber and depression in premenopausal women and between estrogen and gut microbiota. Fiber intake has an impact on gut microbiota, Dr. Kim said.

“We are motivated by the fact that depression provokes disease burden internationally and we would like to find modifiable factors that could prevent depression, especially in women, who are more vulnerable to depression,” she noted.

To investigate, the researchers drew on data from the Korea National Health and Nutrition Examination Survey for 2014, 2016, and 2018. Of the total number of women who met inclusion criteria (n = 5807; mean age, 47.11), roughly half were premenopausal and half were postmenopausal (n = 2,949 [mean age, 36.23 years] and n = 2,868 [mean age, 62.73], respectively).

Dietary fiber intake was assessed using the 24-hour dietary recall method, while depression was assessed using the Patient Health Questionnaire-9. The researchers used the Dietary Reference Intakes for Koreans to define a sufficient intake of dietary fiber (i.e., 12 g/1,000 kcal).

Covariates included chronic diseases, body mass index, medications, smoking status, alcohol use, physical activity, and sociodemographic factors.

When the researchers looked at all participants, they found that the estimated mean dietary fiber intake was significantly higher in women without depression, compared with those with depression (14.07 g/1,000 kcal/d; 95% confidence interval, 13.85-14.29 vs. 12.67 g/1,000 kcal/d; 95% CI, 11.79-13.55; P = .003).

Although the relationship remained significant in premenopausal women, it lost significance in postmenopausal women.

A 5% decrease in the prevalence of depression in premenopausal (but not postmenopausal) women was found in those with an increased intake of dietary fiber – i..e, there was a 1-g increase for every 1,000 kcal of daily energy intake, after adjusting for potential confounders in premenopausal women (OR, 0.949; 95% CI, 0.906-0.993]).

“The inverse relationship between dietary fiber intake and depression could be explained by the gut-brain interactions,” said Dr. Kim.

“Changes in the gut microbiota composition may affect neurotransmission and various neuropsychiatric phenomena in the brain,” she said, noting that previous studies have suggested that dietary fiber intake “may modulate the richness and diversity of the gut microbiota, and this change may promote brain health by affecting neurotransmission.”

Because postmenopausal women experience estrogen depletion, “the decreased interaction between estrogen and the gut microbiota may be related to the insignificant association between dietary fiber intake and depression in postmenopausal women,” she said.

Despite the lack of a significant association between postmenopausal depression and fiber intake, Dr. Kim said she “advises middle-aged women to have dietary fiber–rich diets, regardless of their menopausal status.”
 

Link between food and mood

In a comment, Stephanie S. Faubion, MD, MBA, a professor and chair of the department of medicine and the Penny and Bill George director of the Mayo Clinic’s Center for Women’s Health in Rochester, Minn., noted the study was cross-sectional and therefore the direction of the association could not be determined and “causality cannot be assumed.”

It is possible that “depressed women are less likely to eat fiber than women without depression. For example, a depressed woman may be more likely to sit on the couch eating Cheetos than shopping for and preparing a healthy meal,” said Dr. Faubion, who is also the medical director of the North American Menopause Society and was not involved with the study.

She noted that other potential confounders, including access to fresh fruits and vegetables or geographic locations could also “impact the findings and it is important that we do not somehow imply that eating a high-fiber diet can in any way treat a major depression.”

Nevertheless, the study does “add to the body of evidence suggesting a link between diet and overall health, including brain health,” Dr. Faubion said.

One take-home message for practicing clinicians is that a healthy diet that includes fiber may benefit women (and men) for a number of reasons and “appears to be linked to mood.”

More research is needed “to determine the pathophysiologic mechanisms (such as potential brain-gut connection that involves the microbiome) that may explain this association,” Dr. Faubion added.

No source of funding listed. Dr. Kim and coauthors, as well as Dr. Faubion, disclosed no relevant financial relationships.

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

Metformin extended gestation by nearly a week in women with preterm preeclampsia and was also linked to a shorter neonatal hospital stay, according to findings from a study presented Jan. 28 at the virtual Society for Maternal-Fetal Medicine 2021 Annual Pregnancy Meeting.

The causes of preeclampsia have continued to elude researchers, but most agree the placenta plays a key role, explained Cathy Cluver, PhD, director of the preeclampsia research unit and an associate professor at Stellenbosch University, Cape Town. Past trials have tested sildenafil, antithrombin, pravastatin, and esomeprazole, but the drugs either did not show promise, had unacceptable side effects, or need further study.

“This trial provides proof of concept that preterm preeclampsia can be treated and that we can slow the progression of preterm preeclampsia,” Dr. Cluver said.

In this trial, the researchers enrolled 180 women with preterm preeclampsia between 26 and 31 weeks of gestation. All the women were taking hypertensives. They were randomly assigned to receive 3 g oral metformin XR or placebo daily. The intention-to-treat analysis included 87 women who received metformin and 84 who received placebo, with baseline characteristics similar in both groups.

Women in the metformin group gave birth a median 16.2 days after randomization, which was 6.7 days longer than the 9.5 days postrandomization delivery of women in the placebo group. The differences, however, narrowly missed statistical significance (P =.056).

But when the researchers took compliance and dose into account, the effect of the metformin increased, showing a dose-dependent effect, and did reach statistical significance. Among the 147 women who continued treatment until delivery, those in the metformin group delivered a median 8.4 days later than those in the placebo group (16.2 vs. 7.4 days; P =.026). Further, when the analysis was further restricted to just the 100 women who continued taking the full dose until delivery, the difference was even greater (16.2 vs. 4.8 days; P =.008). In accordance with the safety profile of metformin, women taking the drug had more diarrhea and a trend toward more nausea than those taking the placebo.

There were no differences between the groups in composite maternal or neonatal outcomes, but the infants were an average 136 g (4.8 ounces) heavier in the metformin group, albeit the difference did not reach statistical significance. The 6-day–shorter neonatal stay at the study site facility for infants of the metformin group also did not reach statistical significance, but there was a significant difference between the groups on overall stay, including transfers to other facilities. Infants in the metformin group averaged 26 days vs. 34 days for infants in the placebo group (P =.007).

“We have shown that metformin XR may be a treatment for preterm preeclampsia. We now plan to do a larger study to hopefully confirm these findings, which will be powered to both prolongation of pregnancy and neonatal outcomes,” Dr. Cluver told this news organization. “We have also shown that one can prolong pregnancy in preterm preeclampsia, and we hope that this will encourage others in our field to continue researching therapeutics for preterm preeclampsia.”

In response to questions from attendees, Dr. Cluver reported that her team did not collect histological data from placentas in this study, and lack of funding is limiting their ability to evaluate longer-term outcomes.

The findings of prolonged gestation were certainly exciting, but they warrant caution before any changes in clinical practice, Michelle Y. Owens, MD, professor and chief of maternal-fetal medicine at the University of Mississippi Medical Center, Jackson, said in an interview.

“While the findings of this study are promising, the sample size was small, the dosing exceeds what we typically use in the U.S., and this was undertaken in Cape Town, South Africa, all of which may render this study less generalizable to our population and others across the globe,” said Dr. Owens, who moderated the oral abstract session.

She also pointed out a possible conflicting effect on birth weight brought on by using metformin to extend gestation.

“If larger studies are undertaken, I believe it is quite possible that, with extended gestation, there will be bigger babies,” she said. “However, metformin also helps control blood glucose and in so doing, may contribute to lower birth weights over time, compared with women not exposed to the drug.”

Dr. Cluver and Dr. Owens have disclosed no relevant financial relationships.

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

*This story was updated on 2/9/2021. 

Metformin extended gestation by nearly a week in women with preterm preeclampsia and was also linked to a shorter neonatal hospital stay, according to findings from a study presented Jan. 28 at the virtual Society for Maternal-Fetal Medicine 2021 Annual Pregnancy Meeting.

The causes of preeclampsia have continued to elude researchers, but most agree the placenta plays a key role, explained Cathy Cluver, PhD, director of the preeclampsia research unit and an associate professor at Stellenbosch University, Cape Town. Past trials have tested sildenafil, antithrombin, pravastatin, and esomeprazole, but the drugs either did not show promise, had unacceptable side effects, or need further study.

“This trial provides proof of concept that preterm preeclampsia can be treated and that we can slow the progression of preterm preeclampsia,” Dr. Cluver said.

In this trial, the researchers enrolled 180 women with preterm preeclampsia between 26 and 31 weeks of gestation. All the women were taking hypertensives. They were randomly assigned to receive 3 g oral metformin XR or placebo daily. The intention-to-treat analysis included 87 women who received metformin and 84 who received placebo, with baseline characteristics similar in both groups.

Women in the metformin group gave birth a median 16.2 days after randomization, which was 6.7 days longer than the 9.5 days postrandomization delivery of women in the placebo group. The differences, however, narrowly missed statistical significance (P =.056).

But when the researchers took compliance and dose into account, the effect of the metformin increased, showing a dose-dependent effect, and did reach statistical significance. Among the 147 women who continued treatment until delivery, those in the metformin group delivered a median 8.4 days later than those in the placebo group (16.2 vs. 7.4 days; P =.026). Further, when the analysis was further restricted to just the 100 women who continued taking the full dose until delivery, the difference was even greater (16.2 vs. 4.8 days; P =.008). In accordance with the safety profile of metformin, women taking the drug had more diarrhea and a trend toward more nausea than those taking the placebo.

There were no differences between the groups in composite maternal or neonatal outcomes, but the infants were an average 136 g (4.8 ounces) heavier in the metformin group, albeit the difference did not reach statistical significance. The 6-day–shorter neonatal stay at the study site facility for infants of the metformin group also did not reach statistical significance, but there was a significant difference between the groups on overall stay, including transfers to other facilities. Infants in the metformin group averaged 26 days vs. 34 days for infants in the placebo group (P =.007).

“We have shown that metformin XR may be a treatment for preterm preeclampsia. We now plan to do a larger study to hopefully confirm these findings, which will be powered to both prolongation of pregnancy and neonatal outcomes,” Dr. Cluver told this news organization. “We have also shown that one can prolong pregnancy in preterm preeclampsia, and we hope that this will encourage others in our field to continue researching therapeutics for preterm preeclampsia.”

In response to questions from attendees, Dr. Cluver reported that her team did not collect histological data from placentas in this study, and lack of funding is limiting their ability to evaluate longer-term outcomes.

The findings of prolonged gestation were certainly exciting, but they warrant caution before any changes in clinical practice, Michelle Y. Owens, MD, professor and chief of maternal-fetal medicine at the University of Mississippi Medical Center, Jackson, said in an interview.

“While the findings of this study are promising, the sample size was small, the dosing exceeds what we typically use in the U.S., and this was undertaken in Cape Town, South Africa, all of which may render this study less generalizable to our population and others across the globe,” said Dr. Owens, who moderated the oral abstract session.

She also pointed out a possible conflicting effect on birth weight brought on by using metformin to extend gestation.

“If larger studies are undertaken, I believe it is quite possible that, with extended gestation, there will be bigger babies,” she said. “However, metformin also helps control blood glucose and in so doing, may contribute to lower birth weights over time, compared with women not exposed to the drug.”

Dr. Cluver and Dr. Owens have disclosed no relevant financial relationships.

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

*This story was updated on 2/9/2021. 

Metformin extended gestation by nearly a week in women with preterm preeclampsia and was also linked to a shorter neonatal hospital stay, according to findings from a study presented Jan. 28 at the virtual Society for Maternal-Fetal Medicine 2021 Annual Pregnancy Meeting.

The causes of preeclampsia have continued to elude researchers, but most agree the placenta plays a key role, explained Cathy Cluver, PhD, director of the preeclampsia research unit and an associate professor at Stellenbosch University, Cape Town. Past trials have tested sildenafil, antithrombin, pravastatin, and esomeprazole, but the drugs either did not show promise, had unacceptable side effects, or need further study.

“This trial provides proof of concept that preterm preeclampsia can be treated and that we can slow the progression of preterm preeclampsia,” Dr. Cluver said.

In this trial, the researchers enrolled 180 women with preterm preeclampsia between 26 and 31 weeks of gestation. All the women were taking hypertensives. They were randomly assigned to receive 3 g oral metformin XR or placebo daily. The intention-to-treat analysis included 87 women who received metformin and 84 who received placebo, with baseline characteristics similar in both groups.

Women in the metformin group gave birth a median 16.2 days after randomization, which was 6.7 days longer than the 9.5 days postrandomization delivery of women in the placebo group. The differences, however, narrowly missed statistical significance (P =.056).

But when the researchers took compliance and dose into account, the effect of the metformin increased, showing a dose-dependent effect, and did reach statistical significance. Among the 147 women who continued treatment until delivery, those in the metformin group delivered a median 8.4 days later than those in the placebo group (16.2 vs. 7.4 days; P =.026). Further, when the analysis was further restricted to just the 100 women who continued taking the full dose until delivery, the difference was even greater (16.2 vs. 4.8 days; P =.008). In accordance with the safety profile of metformin, women taking the drug had more diarrhea and a trend toward more nausea than those taking the placebo.

There were no differences between the groups in composite maternal or neonatal outcomes, but the infants were an average 136 g (4.8 ounces) heavier in the metformin group, albeit the difference did not reach statistical significance. The 6-day–shorter neonatal stay at the study site facility for infants of the metformin group also did not reach statistical significance, but there was a significant difference between the groups on overall stay, including transfers to other facilities. Infants in the metformin group averaged 26 days vs. 34 days for infants in the placebo group (P =.007).

“We have shown that metformin XR may be a treatment for preterm preeclampsia. We now plan to do a larger study to hopefully confirm these findings, which will be powered to both prolongation of pregnancy and neonatal outcomes,” Dr. Cluver told this news organization. “We have also shown that one can prolong pregnancy in preterm preeclampsia, and we hope that this will encourage others in our field to continue researching therapeutics for preterm preeclampsia.”

In response to questions from attendees, Dr. Cluver reported that her team did not collect histological data from placentas in this study, and lack of funding is limiting their ability to evaluate longer-term outcomes.

The findings of prolonged gestation were certainly exciting, but they warrant caution before any changes in clinical practice, Michelle Y. Owens, MD, professor and chief of maternal-fetal medicine at the University of Mississippi Medical Center, Jackson, said in an interview.

“While the findings of this study are promising, the sample size was small, the dosing exceeds what we typically use in the U.S., and this was undertaken in Cape Town, South Africa, all of which may render this study less generalizable to our population and others across the globe,” said Dr. Owens, who moderated the oral abstract session.

She also pointed out a possible conflicting effect on birth weight brought on by using metformin to extend gestation.

“If larger studies are undertaken, I believe it is quite possible that, with extended gestation, there will be bigger babies,” she said. “However, metformin also helps control blood glucose and in so doing, may contribute to lower birth weights over time, compared with women not exposed to the drug.”

Dr. Cluver and Dr. Owens have disclosed no relevant financial relationships.

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

*This story was updated on 2/9/2021. 

Having COVID-19 during pregnancy is linked to a significantly increased risk for gestational hypertension and preeclampsia compared with not having COVID-19 while pregnant, according to findings from a retrospective study presented Jan. 28 at the Society for Maternal-Fetal Medicine 2021 Annual Pregnancy Meeting.

“This was not entirely surprising given that inflammation has been implicated in the pathogenesis of both hypertensive disorders of pregnancy and COVID-19 infection and thus may serve to exacerbate each other,” Nigel Madden, MD, a resident physician in the ob.gyn. department at Columbia University, New York. , told this news organization after she presented the results.

Hypertensive disorders of pregnancy occur in 10%-15% of all pregnancies and are the leading cause of maternal and perinatal morbidity and mortality worldwide, Dr. Madden told attendees of the meeting. Although it’s not clear what causes hypertensive diseases in pregnancy generally, “it is possible that the acute inflammatory state of the COVID infection may incite or exacerbate hypertensive disease of pregnancy,” Dr. Madden said.

The researchers conducted a retrospective chart review of 1,715 patients who had a singleton pregnancy and who underwent routine nasal polymerase chain reaction testing at admission to one institution’s labor and delivery department between March and June 2020. The researchers excluded patients who had a history of chronic hypertension.

Overall, 10% of the patients tested positive for COVID-19 (n = 167), and 90% tested negative (n = 1,548). There were several differences at baseline between the groups. Those who tested positive tended to be younger, with an average age of 28, compared with an average age of 31 years for the group that tested negative. The group that tested negative also had a higher proportion of mothers aged 35 and older (P < .01). There were also significant differences in the racial makeup of the groups. Half of those in the COVID-positive group reported “other” for their race. The biggest baseline disparity between the groups was with regard to insurance type: 73% of those who tested positive for COVID-19 used Medicaid; only 36% of patients in the COVID-negative group used Medicaid. Those with private insurance were more likely to test negative (43%) than positive (25%) (P < .01).

The researchers defined gestational hypertension as having a systolic blood pressure greater than or equal to 140 mm Hg or a diastolic blood pressure greater than or equal to 90 mm Hg on two occasions at least 4 hours apart. A preeclampsia diagnosis required elevated blood pressure (using the same definition as for hypertension) as well as proteinuria, characterized by a protein/creatine ratio greater than or equal to 0.3 mg/dL or greater than or equal to 300 mg of protein on a 24-hour urine collection. Preeclampsia with severe features required prespecified laboratory abnormalities, pulmonary edema, or symptoms of headache, vision changes, chest pain, shortness of breath, or right upper quadrant pain.

More than twice as many patients with COVID had a hypertensive disorder of pregnancy (18%) as those who tested negative (8%). The patients who were COVID positive were significantly more likely than those who tested negative to have gestational hypertension and preeclampsia without severe features. Rates of preeclampsia with severe features were not significantly different between the groups.

The severity of hypertensive disease did not differ between the groups. Limitations of the study included its retrospective design, the small number of COVID-positive patients, and the fact that it was conducted at a single institution in New York. However, the study population was diverse, and it was conducted during the height of infections at the epicenter of the COVID-19 pandemic.

“This was a study of great clinical significance,” said Kim Boggess, MD, of the University of North Carolina at Chapel Hill, while moderating the session. “I would argue that you guys in New York are the best poised to answer some of the questions that need to be answered as it relates to the effect of coronavirus infection in pregnancy.”

Dr. Boggess asked whether the study examined associations related to the severity of COVID-19. Only 10 of the patients were symptomatic, Dr. Madden said, and only one of those patients developed preeclampsia with severe features.

Michelle Y. Owens, MD, professor and chief of maternal fetal medicine at the University of Mississippi Medical Center, Jackson, who also moderated the session, said in an interview that the findings call for physicians to remain vigilant about evaluating patients who test positive for COVID-19 for hypertensive disease and disorders.

“Additionally, these women should be educated about hypertensive disorders and the common symptoms to facilitate early diagnosis and treatment when indicated,” Dr. Owens said. “I believe this is of particular interest in those women who are not severely affected by COVID, as these changes may occur while they are undergoing quarantine or being monitored remotely. This amplifies the need for remote assessment or home monitoring of maternal blood pressures.”

Dr. Madden, Dr. Boggess, and Dr. Owens have disclosed no relevant financial relationships.

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

Having COVID-19 during pregnancy is linked to a significantly increased risk for gestational hypertension and preeclampsia compared with not having COVID-19 while pregnant, according to findings from a retrospective study presented Jan. 28 at the Society for Maternal-Fetal Medicine 2021 Annual Pregnancy Meeting.

“This was not entirely surprising given that inflammation has been implicated in the pathogenesis of both hypertensive disorders of pregnancy and COVID-19 infection and thus may serve to exacerbate each other,” Nigel Madden, MD, a resident physician in the ob.gyn. department at Columbia University, New York. , told this news organization after she presented the results.

Hypertensive disorders of pregnancy occur in 10%-15% of all pregnancies and are the leading cause of maternal and perinatal morbidity and mortality worldwide, Dr. Madden told attendees of the meeting. Although it’s not clear what causes hypertensive diseases in pregnancy generally, “it is possible that the acute inflammatory state of the COVID infection may incite or exacerbate hypertensive disease of pregnancy,” Dr. Madden said.

The researchers conducted a retrospective chart review of 1,715 patients who had a singleton pregnancy and who underwent routine nasal polymerase chain reaction testing at admission to one institution’s labor and delivery department between March and June 2020. The researchers excluded patients who had a history of chronic hypertension.

Overall, 10% of the patients tested positive for COVID-19 (n = 167), and 90% tested negative (n = 1,548). There were several differences at baseline between the groups. Those who tested positive tended to be younger, with an average age of 28, compared with an average age of 31 years for the group that tested negative. The group that tested negative also had a higher proportion of mothers aged 35 and older (P < .01). There were also significant differences in the racial makeup of the groups. Half of those in the COVID-positive group reported “other” for their race. The biggest baseline disparity between the groups was with regard to insurance type: 73% of those who tested positive for COVID-19 used Medicaid; only 36% of patients in the COVID-negative group used Medicaid. Those with private insurance were more likely to test negative (43%) than positive (25%) (P < .01).

The researchers defined gestational hypertension as having a systolic blood pressure greater than or equal to 140 mm Hg or a diastolic blood pressure greater than or equal to 90 mm Hg on two occasions at least 4 hours apart. A preeclampsia diagnosis required elevated blood pressure (using the same definition as for hypertension) as well as proteinuria, characterized by a protein/creatine ratio greater than or equal to 0.3 mg/dL or greater than or equal to 300 mg of protein on a 24-hour urine collection. Preeclampsia with severe features required prespecified laboratory abnormalities, pulmonary edema, or symptoms of headache, vision changes, chest pain, shortness of breath, or right upper quadrant pain.

More than twice as many patients with COVID had a hypertensive disorder of pregnancy (18%) as those who tested negative (8%). The patients who were COVID positive were significantly more likely than those who tested negative to have gestational hypertension and preeclampsia without severe features. Rates of preeclampsia with severe features were not significantly different between the groups.

The severity of hypertensive disease did not differ between the groups. Limitations of the study included its retrospective design, the small number of COVID-positive patients, and the fact that it was conducted at a single institution in New York. However, the study population was diverse, and it was conducted during the height of infections at the epicenter of the COVID-19 pandemic.

“This was a study of great clinical significance,” said Kim Boggess, MD, of the University of North Carolina at Chapel Hill, while moderating the session. “I would argue that you guys in New York are the best poised to answer some of the questions that need to be answered as it relates to the effect of coronavirus infection in pregnancy.”

Dr. Boggess asked whether the study examined associations related to the severity of COVID-19. Only 10 of the patients were symptomatic, Dr. Madden said, and only one of those patients developed preeclampsia with severe features.

Michelle Y. Owens, MD, professor and chief of maternal fetal medicine at the University of Mississippi Medical Center, Jackson, who also moderated the session, said in an interview that the findings call for physicians to remain vigilant about evaluating patients who test positive for COVID-19 for hypertensive disease and disorders.

“Additionally, these women should be educated about hypertensive disorders and the common symptoms to facilitate early diagnosis and treatment when indicated,” Dr. Owens said. “I believe this is of particular interest in those women who are not severely affected by COVID, as these changes may occur while they are undergoing quarantine or being monitored remotely. This amplifies the need for remote assessment or home monitoring of maternal blood pressures.”

Dr. Madden, Dr. Boggess, and Dr. Owens have disclosed no relevant financial relationships.

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

Having COVID-19 during pregnancy is linked to a significantly increased risk for gestational hypertension and preeclampsia compared with not having COVID-19 while pregnant, according to findings from a retrospective study presented Jan. 28 at the Society for Maternal-Fetal Medicine 2021 Annual Pregnancy Meeting.

“This was not entirely surprising given that inflammation has been implicated in the pathogenesis of both hypertensive disorders of pregnancy and COVID-19 infection and thus may serve to exacerbate each other,” Nigel Madden, MD, a resident physician in the ob.gyn. department at Columbia University, New York. , told this news organization after she presented the results.

Hypertensive disorders of pregnancy occur in 10%-15% of all pregnancies and are the leading cause of maternal and perinatal morbidity and mortality worldwide, Dr. Madden told attendees of the meeting. Although it’s not clear what causes hypertensive diseases in pregnancy generally, “it is possible that the acute inflammatory state of the COVID infection may incite or exacerbate hypertensive disease of pregnancy,” Dr. Madden said.

The researchers conducted a retrospective chart review of 1,715 patients who had a singleton pregnancy and who underwent routine nasal polymerase chain reaction testing at admission to one institution’s labor and delivery department between March and June 2020. The researchers excluded patients who had a history of chronic hypertension.

Overall, 10% of the patients tested positive for COVID-19 (n = 167), and 90% tested negative (n = 1,548). There were several differences at baseline between the groups. Those who tested positive tended to be younger, with an average age of 28, compared with an average age of 31 years for the group that tested negative. The group that tested negative also had a higher proportion of mothers aged 35 and older (P < .01). There were also significant differences in the racial makeup of the groups. Half of those in the COVID-positive group reported “other” for their race. The biggest baseline disparity between the groups was with regard to insurance type: 73% of those who tested positive for COVID-19 used Medicaid; only 36% of patients in the COVID-negative group used Medicaid. Those with private insurance were more likely to test negative (43%) than positive (25%) (P < .01).

The researchers defined gestational hypertension as having a systolic blood pressure greater than or equal to 140 mm Hg or a diastolic blood pressure greater than or equal to 90 mm Hg on two occasions at least 4 hours apart. A preeclampsia diagnosis required elevated blood pressure (using the same definition as for hypertension) as well as proteinuria, characterized by a protein/creatine ratio greater than or equal to 0.3 mg/dL or greater than or equal to 300 mg of protein on a 24-hour urine collection. Preeclampsia with severe features required prespecified laboratory abnormalities, pulmonary edema, or symptoms of headache, vision changes, chest pain, shortness of breath, or right upper quadrant pain.

More than twice as many patients with COVID had a hypertensive disorder of pregnancy (18%) as those who tested negative (8%). The patients who were COVID positive were significantly more likely than those who tested negative to have gestational hypertension and preeclampsia without severe features. Rates of preeclampsia with severe features were not significantly different between the groups.

The severity of hypertensive disease did not differ between the groups. Limitations of the study included its retrospective design, the small number of COVID-positive patients, and the fact that it was conducted at a single institution in New York. However, the study population was diverse, and it was conducted during the height of infections at the epicenter of the COVID-19 pandemic.

“This was a study of great clinical significance,” said Kim Boggess, MD, of the University of North Carolina at Chapel Hill, while moderating the session. “I would argue that you guys in New York are the best poised to answer some of the questions that need to be answered as it relates to the effect of coronavirus infection in pregnancy.”

Dr. Boggess asked whether the study examined associations related to the severity of COVID-19. Only 10 of the patients were symptomatic, Dr. Madden said, and only one of those patients developed preeclampsia with severe features.

Michelle Y. Owens, MD, professor and chief of maternal fetal medicine at the University of Mississippi Medical Center, Jackson, who also moderated the session, said in an interview that the findings call for physicians to remain vigilant about evaluating patients who test positive for COVID-19 for hypertensive disease and disorders.

“Additionally, these women should be educated about hypertensive disorders and the common symptoms to facilitate early diagnosis and treatment when indicated,” Dr. Owens said. “I believe this is of particular interest in those women who are not severely affected by COVID, as these changes may occur while they are undergoing quarantine or being monitored remotely. This amplifies the need for remote assessment or home monitoring of maternal blood pressures.”

Dr. Madden, Dr. Boggess, and Dr. Owens have disclosed no relevant financial relationships.

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