Obstetrics

Women with moderate to severe psoriasis had a lower fertility rate, compared with age-matched peers without psoriasis, and overall, those with psoriasis had a slightly higher risk of pregnancy loss, compared with those who did not have the disease, in a U.K. cohort study.

Those are key findings from what is believed to be one of the largest studies to investigate fertility and obstetric outcomes in patients with psoriasis.

“Studies that have examined fertility and pregnancy outcomes in women with psoriasis have reported conflicting findings,” lead author Teng-Chou Chen, PhD, of the Centre for Pharmacoepidemiology and Drug Safety at the University of Manchester (England), and colleagues from the Global Psoriasis Atlas wrote in the study, published in JAMA Dermatology. Most of the studies were small, with under 100 women, “and are thus likely underpowered to detect a difference in pregnancy outcomes. The majority of those studies used disease registry data or lacked a matched comparison group and hence were unable to estimate the association of fertility and adverse pregnancy outcomes in women with psoriasis when compared with the general population.”

To determine fertility rates and birth outcomes in female patients with psoriasis, compared with age- and practice-matched patients without psoriasis, the researchers evaluated EHR data from a large U.K. primary care database, the Clinical Practice Research Datalink GOLD, from 1998 to 2019. They limited the analysis to patients aged 15-44 years and used relevant codes from clinical consultations to identify those with psoriasis. Then, for each patient with psoriasis, the researchers selected five comparators without psoriasis from the same primary care practice and matched for year of birth.

Both sets of patients were followed from the index date to age 45 years, death, transfer out of practice, last date of data collection, or end of the study period (Dec. 31, 2019), whichever came first. Pregnancy records were extracted for both sets of patients, and birth outcomes were categorized as pregnancy loss, live birth, stillbirth, and preterm birth. Adverse pregnancy outcomes were also collected. Finally, Dr. Chen and colleagues used a negative binomial model to examine the association between psoriasis and the fertility rate, and they applied logistic regression to compare the association between psoriasis and obstetric outcomes.

The analysis included 63,681 patients with psoriasis and 318,405 comparators whose median age on the index date was 30 years and who were followed for a median of 4.1 years. Among patients with psoriasis, 5.1% met criteria for moderate to severe disease in the follow-up period. The researchers observed that, compared with their age- and practice-matched counterparts, patients with psoriasis were more likely to be current smokers, alcohol drinkers, or overweight on the index date. They were also more often diagnosed with diabetes, hypertension, inflammatory bowel disease, thyroid disorders, and respiratory diseases such as asthma and chronic obstructive pulmonary disease.

Fertility, birth outcomes

When they looked at fertility outcomes, the researchers found that, compared with their matched peers without psoriasis, those with psoriasis had higher rates of fertility (risk ratio, 1.30; 95% confidence interval, 1.27-1.33; P < .001). But after the researchers stratified patients based on psoriasis severity, those with moderate to severe disease had significantly lower rates of fertility (RR, 0.75; 95% CI, 0.69-0.83; P < .001), compared those who did not have psoriasis.

As for adverse birth outcomes, compared with their matched comparators, pregnancies in patients with psoriasis were less likely to end in a live birth (odds ratio, 0.91; 95% CI, 0.88-0.93; P < .001). They also had a higher risk of pregnancy loss (OR, 1.06; 95% CI, 1.03-1.10; P < .001), most during the first trimester, at a gestation period of under 91 days.

In addition to psoriasis, patients younger than age 20 (OR, 2.04; 95% CI, 1.94-2.15; P < .011) and those aged between 20 and 24 years (OR, 1.35; 95% CI, 1.31-1.40; P < .001) had a higher risk of pregnancy loss, compared with those aged between 25 and 34 years.

However, no increases in the risks of antenatal hemorrhage, preeclampsia, or gestational diabetes were observed in patients with psoriasis, and no statistically significant differences in the odds of stillbirth and preterm birth were found between patients with psoriasis and matched comparators who did not have psoriasis.

“The mechanism to link the higher risk of pregnancy loss in patients with psoriasis is not clear, but there might be potential explanations,” the researchers wrote. “Psoriasis is characterized by the increased activity of [interleukin]-17, IL-23, and tumor necrosis factor–alpha. Those proinflammatory cytokines may negatively affect the placenta and cause impaired fetal growth.”

They recommended that further studies “evaluate the effects of better management of psoriasis and close monitoring during pregnancy on pregnancy loss.” In particular, “patients with psoriasis were more likely to have comorbidities that may be related to poor pregnancy outcomes, and hence increased emphasis of managing comorbidities as part of the routine management plan is also warranted.”

Asked to comment on the study, Alexa B. Kimball, MD, MPH, who has been involved with research on this topic, said that she and other investigators had observed some years ago that fertility rates for women with moderate to severe psoriasis might be lower than expected.

This trend was observed in some psoriasis registries, some pregnancy registries, and in clinical practice, Dr. Kimball, professor of dermatology at Harvard Medical School, Boston, said in an interview. “This study clearly demonstrates that lower fertility rates in the moderate to severe psoriasis population occurs and compels further exploration of the reason why.” The reasons could be biologic, she continued, including difficulty conceiving or an increased risk of miscarriage, sociobehavioral issues, or a combination.

“Behavioral examples could include that some women with moderate to severe psoriasis can flare during pregnancy, which might affect their choice” to become pregnant, Dr. Kimball said. “Stigma may also play a role in how women with moderate to severe psoriasis form relationships. Now that there are much better treatments for moderate to severe psoriasis and better knowledge about managing psoriasis during pregnancy, it will also be important to explore whether these trends change over time.”

The study was funded by the International League of Dermatological Societies on behalf of the Global Psoriasis Atlas. Two of the study authors reported receiving consulting fees and grant support from many pharmaceutical companies. Dr. Kimball disclosed that she serves or has served on several Organization of Teratology Information Specialists advisory board pregnancy registries, is a consultant and investigator for Abbvie, Janssen, Lilly, Bristol-Myers Squibb, Moonlake, UCB, and Amgen; has fellowship funding from Janssen; and serves on the board of Almirall.

Women with moderate to severe psoriasis had a lower fertility rate, compared with age-matched peers without psoriasis, and overall, those with psoriasis had a slightly higher risk of pregnancy loss, compared with those who did not have the disease, in a U.K. cohort study.

Those are key findings from what is believed to be one of the largest studies to investigate fertility and obstetric outcomes in patients with psoriasis.

“Studies that have examined fertility and pregnancy outcomes in women with psoriasis have reported conflicting findings,” lead author Teng-Chou Chen, PhD, of the Centre for Pharmacoepidemiology and Drug Safety at the University of Manchester (England), and colleagues from the Global Psoriasis Atlas wrote in the study, published in JAMA Dermatology. Most of the studies were small, with under 100 women, “and are thus likely underpowered to detect a difference in pregnancy outcomes. The majority of those studies used disease registry data or lacked a matched comparison group and hence were unable to estimate the association of fertility and adverse pregnancy outcomes in women with psoriasis when compared with the general population.”

To determine fertility rates and birth outcomes in female patients with psoriasis, compared with age- and practice-matched patients without psoriasis, the researchers evaluated EHR data from a large U.K. primary care database, the Clinical Practice Research Datalink GOLD, from 1998 to 2019. They limited the analysis to patients aged 15-44 years and used relevant codes from clinical consultations to identify those with psoriasis. Then, for each patient with psoriasis, the researchers selected five comparators without psoriasis from the same primary care practice and matched for year of birth.

Both sets of patients were followed from the index date to age 45 years, death, transfer out of practice, last date of data collection, or end of the study period (Dec. 31, 2019), whichever came first. Pregnancy records were extracted for both sets of patients, and birth outcomes were categorized as pregnancy loss, live birth, stillbirth, and preterm birth. Adverse pregnancy outcomes were also collected. Finally, Dr. Chen and colleagues used a negative binomial model to examine the association between psoriasis and the fertility rate, and they applied logistic regression to compare the association between psoriasis and obstetric outcomes.

The analysis included 63,681 patients with psoriasis and 318,405 comparators whose median age on the index date was 30 years and who were followed for a median of 4.1 years. Among patients with psoriasis, 5.1% met criteria for moderate to severe disease in the follow-up period. The researchers observed that, compared with their age- and practice-matched counterparts, patients with psoriasis were more likely to be current smokers, alcohol drinkers, or overweight on the index date. They were also more often diagnosed with diabetes, hypertension, inflammatory bowel disease, thyroid disorders, and respiratory diseases such as asthma and chronic obstructive pulmonary disease.

Fertility, birth outcomes

When they looked at fertility outcomes, the researchers found that, compared with their matched peers without psoriasis, those with psoriasis had higher rates of fertility (risk ratio, 1.30; 95% confidence interval, 1.27-1.33; P < .001). But after the researchers stratified patients based on psoriasis severity, those with moderate to severe disease had significantly lower rates of fertility (RR, 0.75; 95% CI, 0.69-0.83; P < .001), compared those who did not have psoriasis.

As for adverse birth outcomes, compared with their matched comparators, pregnancies in patients with psoriasis were less likely to end in a live birth (odds ratio, 0.91; 95% CI, 0.88-0.93; P < .001). They also had a higher risk of pregnancy loss (OR, 1.06; 95% CI, 1.03-1.10; P < .001), most during the first trimester, at a gestation period of under 91 days.

In addition to psoriasis, patients younger than age 20 (OR, 2.04; 95% CI, 1.94-2.15; P < .011) and those aged between 20 and 24 years (OR, 1.35; 95% CI, 1.31-1.40; P < .001) had a higher risk of pregnancy loss, compared with those aged between 25 and 34 years.

However, no increases in the risks of antenatal hemorrhage, preeclampsia, or gestational diabetes were observed in patients with psoriasis, and no statistically significant differences in the odds of stillbirth and preterm birth were found between patients with psoriasis and matched comparators who did not have psoriasis.

“The mechanism to link the higher risk of pregnancy loss in patients with psoriasis is not clear, but there might be potential explanations,” the researchers wrote. “Psoriasis is characterized by the increased activity of [interleukin]-17, IL-23, and tumor necrosis factor–alpha. Those proinflammatory cytokines may negatively affect the placenta and cause impaired fetal growth.”

They recommended that further studies “evaluate the effects of better management of psoriasis and close monitoring during pregnancy on pregnancy loss.” In particular, “patients with psoriasis were more likely to have comorbidities that may be related to poor pregnancy outcomes, and hence increased emphasis of managing comorbidities as part of the routine management plan is also warranted.”

Asked to comment on the study, Alexa B. Kimball, MD, MPH, who has been involved with research on this topic, said that she and other investigators had observed some years ago that fertility rates for women with moderate to severe psoriasis might be lower than expected.

This trend was observed in some psoriasis registries, some pregnancy registries, and in clinical practice, Dr. Kimball, professor of dermatology at Harvard Medical School, Boston, said in an interview. “This study clearly demonstrates that lower fertility rates in the moderate to severe psoriasis population occurs and compels further exploration of the reason why.” The reasons could be biologic, she continued, including difficulty conceiving or an increased risk of miscarriage, sociobehavioral issues, or a combination.

“Behavioral examples could include that some women with moderate to severe psoriasis can flare during pregnancy, which might affect their choice” to become pregnant, Dr. Kimball said. “Stigma may also play a role in how women with moderate to severe psoriasis form relationships. Now that there are much better treatments for moderate to severe psoriasis and better knowledge about managing psoriasis during pregnancy, it will also be important to explore whether these trends change over time.”

The study was funded by the International League of Dermatological Societies on behalf of the Global Psoriasis Atlas. Two of the study authors reported receiving consulting fees and grant support from many pharmaceutical companies. Dr. Kimball disclosed that she serves or has served on several Organization of Teratology Information Specialists advisory board pregnancy registries, is a consultant and investigator for Abbvie, Janssen, Lilly, Bristol-Myers Squibb, Moonlake, UCB, and Amgen; has fellowship funding from Janssen; and serves on the board of Almirall.

Women with moderate to severe psoriasis had a lower fertility rate, compared with age-matched peers without psoriasis, and overall, those with psoriasis had a slightly higher risk of pregnancy loss, compared with those who did not have the disease, in a U.K. cohort study.

Those are key findings from what is believed to be one of the largest studies to investigate fertility and obstetric outcomes in patients with psoriasis.

“Studies that have examined fertility and pregnancy outcomes in women with psoriasis have reported conflicting findings,” lead author Teng-Chou Chen, PhD, of the Centre for Pharmacoepidemiology and Drug Safety at the University of Manchester (England), and colleagues from the Global Psoriasis Atlas wrote in the study, published in JAMA Dermatology. Most of the studies were small, with under 100 women, “and are thus likely underpowered to detect a difference in pregnancy outcomes. The majority of those studies used disease registry data or lacked a matched comparison group and hence were unable to estimate the association of fertility and adverse pregnancy outcomes in women with psoriasis when compared with the general population.”

To determine fertility rates and birth outcomes in female patients with psoriasis, compared with age- and practice-matched patients without psoriasis, the researchers evaluated EHR data from a large U.K. primary care database, the Clinical Practice Research Datalink GOLD, from 1998 to 2019. They limited the analysis to patients aged 15-44 years and used relevant codes from clinical consultations to identify those with psoriasis. Then, for each patient with psoriasis, the researchers selected five comparators without psoriasis from the same primary care practice and matched for year of birth.

Both sets of patients were followed from the index date to age 45 years, death, transfer out of practice, last date of data collection, or end of the study period (Dec. 31, 2019), whichever came first. Pregnancy records were extracted for both sets of patients, and birth outcomes were categorized as pregnancy loss, live birth, stillbirth, and preterm birth. Adverse pregnancy outcomes were also collected. Finally, Dr. Chen and colleagues used a negative binomial model to examine the association between psoriasis and the fertility rate, and they applied logistic regression to compare the association between psoriasis and obstetric outcomes.

The analysis included 63,681 patients with psoriasis and 318,405 comparators whose median age on the index date was 30 years and who were followed for a median of 4.1 years. Among patients with psoriasis, 5.1% met criteria for moderate to severe disease in the follow-up period. The researchers observed that, compared with their age- and practice-matched counterparts, patients with psoriasis were more likely to be current smokers, alcohol drinkers, or overweight on the index date. They were also more often diagnosed with diabetes, hypertension, inflammatory bowel disease, thyroid disorders, and respiratory diseases such as asthma and chronic obstructive pulmonary disease.

Fertility, birth outcomes

When they looked at fertility outcomes, the researchers found that, compared with their matched peers without psoriasis, those with psoriasis had higher rates of fertility (risk ratio, 1.30; 95% confidence interval, 1.27-1.33; P < .001). But after the researchers stratified patients based on psoriasis severity, those with moderate to severe disease had significantly lower rates of fertility (RR, 0.75; 95% CI, 0.69-0.83; P < .001), compared those who did not have psoriasis.

As for adverse birth outcomes, compared with their matched comparators, pregnancies in patients with psoriasis were less likely to end in a live birth (odds ratio, 0.91; 95% CI, 0.88-0.93; P < .001). They also had a higher risk of pregnancy loss (OR, 1.06; 95% CI, 1.03-1.10; P < .001), most during the first trimester, at a gestation period of under 91 days.

In addition to psoriasis, patients younger than age 20 (OR, 2.04; 95% CI, 1.94-2.15; P < .011) and those aged between 20 and 24 years (OR, 1.35; 95% CI, 1.31-1.40; P < .001) had a higher risk of pregnancy loss, compared with those aged between 25 and 34 years.

However, no increases in the risks of antenatal hemorrhage, preeclampsia, or gestational diabetes were observed in patients with psoriasis, and no statistically significant differences in the odds of stillbirth and preterm birth were found between patients with psoriasis and matched comparators who did not have psoriasis.

“The mechanism to link the higher risk of pregnancy loss in patients with psoriasis is not clear, but there might be potential explanations,” the researchers wrote. “Psoriasis is characterized by the increased activity of [interleukin]-17, IL-23, and tumor necrosis factor–alpha. Those proinflammatory cytokines may negatively affect the placenta and cause impaired fetal growth.”

They recommended that further studies “evaluate the effects of better management of psoriasis and close monitoring during pregnancy on pregnancy loss.” In particular, “patients with psoriasis were more likely to have comorbidities that may be related to poor pregnancy outcomes, and hence increased emphasis of managing comorbidities as part of the routine management plan is also warranted.”

Asked to comment on the study, Alexa B. Kimball, MD, MPH, who has been involved with research on this topic, said that she and other investigators had observed some years ago that fertility rates for women with moderate to severe psoriasis might be lower than expected.

This trend was observed in some psoriasis registries, some pregnancy registries, and in clinical practice, Dr. Kimball, professor of dermatology at Harvard Medical School, Boston, said in an interview. “This study clearly demonstrates that lower fertility rates in the moderate to severe psoriasis population occurs and compels further exploration of the reason why.” The reasons could be biologic, she continued, including difficulty conceiving or an increased risk of miscarriage, sociobehavioral issues, or a combination.

“Behavioral examples could include that some women with moderate to severe psoriasis can flare during pregnancy, which might affect their choice” to become pregnant, Dr. Kimball said. “Stigma may also play a role in how women with moderate to severe psoriasis form relationships. Now that there are much better treatments for moderate to severe psoriasis and better knowledge about managing psoriasis during pregnancy, it will also be important to explore whether these trends change over time.”

The study was funded by the International League of Dermatological Societies on behalf of the Global Psoriasis Atlas. Two of the study authors reported receiving consulting fees and grant support from many pharmaceutical companies. Dr. Kimball disclosed that she serves or has served on several Organization of Teratology Information Specialists advisory board pregnancy registries, is a consultant and investigator for Abbvie, Janssen, Lilly, Bristol-Myers Squibb, Moonlake, UCB, and Amgen; has fellowship funding from Janssen; and serves on the board of Almirall.

A new guide offers recommendations for the nonsurgical management of major hemorrhage, which is a challenging clinical problem.

Major hemorrhage is a significant cause of death and can occur in a myriad of clinical settings.

“In Ontario, we’ve been collecting quality metrics on major hemorrhages to try and make sure that a higher percentage of patients gets the best possible care when they are experiencing significant bleeding,” author Jeannie Callum, MD, professor and director of transfusion medicine at Kingston (Ont.) Health Sciences Centre and Queen’s University, also in Kingston, said in an interview. “There were some gaps, so this is our effort to get open, clear information out to the emergency doctors, intensive care unit doctors, the surgeons, and everyone else involved in managing major hemorrhage, to help close these gaps.”

The guide was published in the Canadian Medical Association Journal.
 

Fast care essential

The guide aims to provide answers, based on the latest research, to questions such as when to activate a massive hemorrhage protocol (MHP), which patients should receive tranexamic acid (TXA), which blood products should be transfused before laboratory results are available, how to monitor the effects of blood transfusion, and when fibrinogen concentrate or prothrombin complex concentrate should be given.

Not all recommendations will be followed, Dr. Callum said, especially in rural hospitals with limited resources. But the guide is adaptable, and rural hospitals can create protocols that are customized to their unique circumstances.

Care must be “perfect and fast” in the first hour of major injury, said Dr. Callum. “You need to get a proclotting drug in that first hour if you have a traumatic or postpartum bleed. You have to make sure your clotting factors never fail you throughout your resuscitation. You have to be fast with the transfusion. You have to monitor for the complications of the transfusion, electrolyte disturbances, and the patient’s temperature dropping. It’s a complicated situation that needs a multidisciplinary team.”

Bleeding affects everybody in medicine, from family doctors in smaller institutions who work in emergency departments to obstetricians and surgeons, she added.

“For people under the age of 45, trauma is the most common cause of death. When people die of trauma, they die of bleeding. So many people experience these extreme bleeds. We believe that some of them might be preventable with faster, more standardized, more aggressive care. That’s why we wrote this review,” said Dr. Callum.
 

Administer TXA quickly  

The first recommendation is to ensure that every hospital has a massive hemorrhage protocol. Such a protocol is vital for the emergency department, operating room, and obstetric unit. “Making sure you’ve got a protocol that is updated every 3 years and adjusted to the local hospital context is essential,” said Dr. Callum.

Smaller hospitals will have to adjust their protocols according to the capabilities of their sites. “Some smaller hospitals do not have platelets in stock and get their platelets from another hospital, so you need to adjust your protocol to what you are able to do. Not every hospital can control bleeding in a trauma patient, so your protocol would be to stabilize and call a helicopter. Make sure all of this is detailed so that implementing it becomes automatic,” said Dr. Callum.

An MHP should be activated for patients with uncontrolled hemorrhage who meet the clinical criteria of the local hospital and are expected to need blood product support and red blood cells.

“Lots of people bleed, but not everybody is bleeding enough that they need a code transfusion,” said Dr. Callum. Most patients with gastrointestinal bleeds caused by NSAID use can be managed with uncrossed matched blood from the local blood bank. “But in patients who need the full code transfusion because they are going to need plasma, clotting factor replacement, and many other drugs, that is when the MHP should be activated. Don’t activate it when you don’t need it, because doing so activates the whole hospital and diverts care away from other patients.”

TXA should be administered as soon as possible after onset of hemorrhage in most patients, with the exception of gastrointestinal hemorrhage, where a benefit has not been shown.

TXA has been a major advance in treating massive bleeding, Dr. Callum said. “TXA was invented by a Japanese husband-and-wife research team. We know that it reduces the death rate in trauma and in postpartum hemorrhage, and it reduces the chance of major bleeding with major surgical procedures. We give it routinely in surgical procedures. If a patient gets TXA within 60 minutes of injury, it dramatically reduces the death rate. And it costs $10 per patient. It’s cheap, it’s easy, it has no side effects. It’s just amazing.”

Future research must address several unanswered questions, said Dr. Callum. These questions include whether prehospital transfusion improves patient outcomes, whether whole blood has a role in the early management of major hemorrhage, and what role factor concentrates play in patients with major bleeding.
 

‘Optimal recommendations’

Commenting on the document, Bourke Tillmann, MD, PhD, trauma team leader at Sunnybrook Health Sciences Centre and the Ross Tilley Burn Center in Toronto, said: “Overall, I think it is a good overview of MHPs as an approach to major hemorrhage.”

The review also is timely, since Ontario released its MHP guidelines in 2021, he added. “I would have liked to see more about the treatment aspects than just an overview of an MHP. But if you are the person overseeing the emergency department or running the blood bank, these protocols are incredibly useful and incredibly important.”

“This report is a nice and thoughtful overview of best practices in many areas, especially trauma, and makes recommendations that are optimal, although they are not necessarily practical in all centers,” Eric L. Legome, MD, professor and chair of emergency medicine at Mount Sinai West and Mount Sinai Morningside, New York, said in an interview.

“If you’re in a small rural hospital with one lab technician, trying to do all of these things, it will not be possible. These are optimal recommendations that people can use to the best of their ability, but they are not standard of care, because some places will not be able to provide this level of care,” he added. “This paper provides practical, reasonable advice that should be looked at as you are trying to implement transfusion policies and processes, with the understanding that it is not necessarily applicable or practical for very small hospitals in very rural centers that might not have access to these types of products and tools, but it’s a reasonable and nicely written paper.”

No outside funding for the guideline was reported. Dr. Callum has received research funding from Canadian Blood Services and Octapharma. She sits on the nominating committee with the Association for the Advancement of Blood & Biotherapies and on the data safety monitoring boards for the Tranexamic Acid for Subdural Hematoma trial and the Fibrinogen Replacement in Trauma trial. Dr. Tillmann and Dr. Legome reported no relevant financial relationships.

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

A new guide offers recommendations for the nonsurgical management of major hemorrhage, which is a challenging clinical problem.

Major hemorrhage is a significant cause of death and can occur in a myriad of clinical settings.

“In Ontario, we’ve been collecting quality metrics on major hemorrhages to try and make sure that a higher percentage of patients gets the best possible care when they are experiencing significant bleeding,” author Jeannie Callum, MD, professor and director of transfusion medicine at Kingston (Ont.) Health Sciences Centre and Queen’s University, also in Kingston, said in an interview. “There were some gaps, so this is our effort to get open, clear information out to the emergency doctors, intensive care unit doctors, the surgeons, and everyone else involved in managing major hemorrhage, to help close these gaps.”

The guide was published in the Canadian Medical Association Journal.
 

Fast care essential

The guide aims to provide answers, based on the latest research, to questions such as when to activate a massive hemorrhage protocol (MHP), which patients should receive tranexamic acid (TXA), which blood products should be transfused before laboratory results are available, how to monitor the effects of blood transfusion, and when fibrinogen concentrate or prothrombin complex concentrate should be given.

Not all recommendations will be followed, Dr. Callum said, especially in rural hospitals with limited resources. But the guide is adaptable, and rural hospitals can create protocols that are customized to their unique circumstances.

Care must be “perfect and fast” in the first hour of major injury, said Dr. Callum. “You need to get a proclotting drug in that first hour if you have a traumatic or postpartum bleed. You have to make sure your clotting factors never fail you throughout your resuscitation. You have to be fast with the transfusion. You have to monitor for the complications of the transfusion, electrolyte disturbances, and the patient’s temperature dropping. It’s a complicated situation that needs a multidisciplinary team.”

Bleeding affects everybody in medicine, from family doctors in smaller institutions who work in emergency departments to obstetricians and surgeons, she added.

“For people under the age of 45, trauma is the most common cause of death. When people die of trauma, they die of bleeding. So many people experience these extreme bleeds. We believe that some of them might be preventable with faster, more standardized, more aggressive care. That’s why we wrote this review,” said Dr. Callum.
 

Administer TXA quickly  

The first recommendation is to ensure that every hospital has a massive hemorrhage protocol. Such a protocol is vital for the emergency department, operating room, and obstetric unit. “Making sure you’ve got a protocol that is updated every 3 years and adjusted to the local hospital context is essential,” said Dr. Callum.

Smaller hospitals will have to adjust their protocols according to the capabilities of their sites. “Some smaller hospitals do not have platelets in stock and get their platelets from another hospital, so you need to adjust your protocol to what you are able to do. Not every hospital can control bleeding in a trauma patient, so your protocol would be to stabilize and call a helicopter. Make sure all of this is detailed so that implementing it becomes automatic,” said Dr. Callum.

An MHP should be activated for patients with uncontrolled hemorrhage who meet the clinical criteria of the local hospital and are expected to need blood product support and red blood cells.

“Lots of people bleed, but not everybody is bleeding enough that they need a code transfusion,” said Dr. Callum. Most patients with gastrointestinal bleeds caused by NSAID use can be managed with uncrossed matched blood from the local blood bank. “But in patients who need the full code transfusion because they are going to need plasma, clotting factor replacement, and many other drugs, that is when the MHP should be activated. Don’t activate it when you don’t need it, because doing so activates the whole hospital and diverts care away from other patients.”

TXA should be administered as soon as possible after onset of hemorrhage in most patients, with the exception of gastrointestinal hemorrhage, where a benefit has not been shown.

TXA has been a major advance in treating massive bleeding, Dr. Callum said. “TXA was invented by a Japanese husband-and-wife research team. We know that it reduces the death rate in trauma and in postpartum hemorrhage, and it reduces the chance of major bleeding with major surgical procedures. We give it routinely in surgical procedures. If a patient gets TXA within 60 minutes of injury, it dramatically reduces the death rate. And it costs $10 per patient. It’s cheap, it’s easy, it has no side effects. It’s just amazing.”

Future research must address several unanswered questions, said Dr. Callum. These questions include whether prehospital transfusion improves patient outcomes, whether whole blood has a role in the early management of major hemorrhage, and what role factor concentrates play in patients with major bleeding.
 

‘Optimal recommendations’

Commenting on the document, Bourke Tillmann, MD, PhD, trauma team leader at Sunnybrook Health Sciences Centre and the Ross Tilley Burn Center in Toronto, said: “Overall, I think it is a good overview of MHPs as an approach to major hemorrhage.”

The review also is timely, since Ontario released its MHP guidelines in 2021, he added. “I would have liked to see more about the treatment aspects than just an overview of an MHP. But if you are the person overseeing the emergency department or running the blood bank, these protocols are incredibly useful and incredibly important.”

“This report is a nice and thoughtful overview of best practices in many areas, especially trauma, and makes recommendations that are optimal, although they are not necessarily practical in all centers,” Eric L. Legome, MD, professor and chair of emergency medicine at Mount Sinai West and Mount Sinai Morningside, New York, said in an interview.

“If you’re in a small rural hospital with one lab technician, trying to do all of these things, it will not be possible. These are optimal recommendations that people can use to the best of their ability, but they are not standard of care, because some places will not be able to provide this level of care,” he added. “This paper provides practical, reasonable advice that should be looked at as you are trying to implement transfusion policies and processes, with the understanding that it is not necessarily applicable or practical for very small hospitals in very rural centers that might not have access to these types of products and tools, but it’s a reasonable and nicely written paper.”

No outside funding for the guideline was reported. Dr. Callum has received research funding from Canadian Blood Services and Octapharma. She sits on the nominating committee with the Association for the Advancement of Blood & Biotherapies and on the data safety monitoring boards for the Tranexamic Acid for Subdural Hematoma trial and the Fibrinogen Replacement in Trauma trial. Dr. Tillmann and Dr. Legome reported no relevant financial relationships.

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

A new guide offers recommendations for the nonsurgical management of major hemorrhage, which is a challenging clinical problem.

Major hemorrhage is a significant cause of death and can occur in a myriad of clinical settings.

“In Ontario, we’ve been collecting quality metrics on major hemorrhages to try and make sure that a higher percentage of patients gets the best possible care when they are experiencing significant bleeding,” author Jeannie Callum, MD, professor and director of transfusion medicine at Kingston (Ont.) Health Sciences Centre and Queen’s University, also in Kingston, said in an interview. “There were some gaps, so this is our effort to get open, clear information out to the emergency doctors, intensive care unit doctors, the surgeons, and everyone else involved in managing major hemorrhage, to help close these gaps.”

The guide was published in the Canadian Medical Association Journal.
 

Fast care essential

The guide aims to provide answers, based on the latest research, to questions such as when to activate a massive hemorrhage protocol (MHP), which patients should receive tranexamic acid (TXA), which blood products should be transfused before laboratory results are available, how to monitor the effects of blood transfusion, and when fibrinogen concentrate or prothrombin complex concentrate should be given.

Not all recommendations will be followed, Dr. Callum said, especially in rural hospitals with limited resources. But the guide is adaptable, and rural hospitals can create protocols that are customized to their unique circumstances.

Care must be “perfect and fast” in the first hour of major injury, said Dr. Callum. “You need to get a proclotting drug in that first hour if you have a traumatic or postpartum bleed. You have to make sure your clotting factors never fail you throughout your resuscitation. You have to be fast with the transfusion. You have to monitor for the complications of the transfusion, electrolyte disturbances, and the patient’s temperature dropping. It’s a complicated situation that needs a multidisciplinary team.”

Bleeding affects everybody in medicine, from family doctors in smaller institutions who work in emergency departments to obstetricians and surgeons, she added.

“For people under the age of 45, trauma is the most common cause of death. When people die of trauma, they die of bleeding. So many people experience these extreme bleeds. We believe that some of them might be preventable with faster, more standardized, more aggressive care. That’s why we wrote this review,” said Dr. Callum.
 

Administer TXA quickly  

The first recommendation is to ensure that every hospital has a massive hemorrhage protocol. Such a protocol is vital for the emergency department, operating room, and obstetric unit. “Making sure you’ve got a protocol that is updated every 3 years and adjusted to the local hospital context is essential,” said Dr. Callum.

Smaller hospitals will have to adjust their protocols according to the capabilities of their sites. “Some smaller hospitals do not have platelets in stock and get their platelets from another hospital, so you need to adjust your protocol to what you are able to do. Not every hospital can control bleeding in a trauma patient, so your protocol would be to stabilize and call a helicopter. Make sure all of this is detailed so that implementing it becomes automatic,” said Dr. Callum.

An MHP should be activated for patients with uncontrolled hemorrhage who meet the clinical criteria of the local hospital and are expected to need blood product support and red blood cells.

“Lots of people bleed, but not everybody is bleeding enough that they need a code transfusion,” said Dr. Callum. Most patients with gastrointestinal bleeds caused by NSAID use can be managed with uncrossed matched blood from the local blood bank. “But in patients who need the full code transfusion because they are going to need plasma, clotting factor replacement, and many other drugs, that is when the MHP should be activated. Don’t activate it when you don’t need it, because doing so activates the whole hospital and diverts care away from other patients.”

TXA should be administered as soon as possible after onset of hemorrhage in most patients, with the exception of gastrointestinal hemorrhage, where a benefit has not been shown.

TXA has been a major advance in treating massive bleeding, Dr. Callum said. “TXA was invented by a Japanese husband-and-wife research team. We know that it reduces the death rate in trauma and in postpartum hemorrhage, and it reduces the chance of major bleeding with major surgical procedures. We give it routinely in surgical procedures. If a patient gets TXA within 60 minutes of injury, it dramatically reduces the death rate. And it costs $10 per patient. It’s cheap, it’s easy, it has no side effects. It’s just amazing.”

Future research must address several unanswered questions, said Dr. Callum. These questions include whether prehospital transfusion improves patient outcomes, whether whole blood has a role in the early management of major hemorrhage, and what role factor concentrates play in patients with major bleeding.
 

‘Optimal recommendations’

Commenting on the document, Bourke Tillmann, MD, PhD, trauma team leader at Sunnybrook Health Sciences Centre and the Ross Tilley Burn Center in Toronto, said: “Overall, I think it is a good overview of MHPs as an approach to major hemorrhage.”

The review also is timely, since Ontario released its MHP guidelines in 2021, he added. “I would have liked to see more about the treatment aspects than just an overview of an MHP. But if you are the person overseeing the emergency department or running the blood bank, these protocols are incredibly useful and incredibly important.”

“This report is a nice and thoughtful overview of best practices in many areas, especially trauma, and makes recommendations that are optimal, although they are not necessarily practical in all centers,” Eric L. Legome, MD, professor and chair of emergency medicine at Mount Sinai West and Mount Sinai Morningside, New York, said in an interview.

“If you’re in a small rural hospital with one lab technician, trying to do all of these things, it will not be possible. These are optimal recommendations that people can use to the best of their ability, but they are not standard of care, because some places will not be able to provide this level of care,” he added. “This paper provides practical, reasonable advice that should be looked at as you are trying to implement transfusion policies and processes, with the understanding that it is not necessarily applicable or practical for very small hospitals in very rural centers that might not have access to these types of products and tools, but it’s a reasonable and nicely written paper.”

No outside funding for the guideline was reported. Dr. Callum has received research funding from Canadian Blood Services and Octapharma. She sits on the nominating committee with the Association for the Advancement of Blood & Biotherapies and on the data safety monitoring boards for the Tranexamic Acid for Subdural Hematoma trial and the Fibrinogen Replacement in Trauma trial. Dr. Tillmann and Dr. Legome reported no relevant financial relationships.

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

Therapeutic hypothermia (TH) for moderate and severe neonatal encephalopathy has been shown to reduce the risk of newborn death, major neurodevelopmental disability, developmental delay, and cerebral palsy.¹ It is estimated that 8 newborns with moderate or severe neonatal encephalopathy need to be treated with TH to prevent 1 case of cerebral palsy.¹ The key elements of TH include:

• initiate hypothermia within 6 hoursof birth
• cool the newborn to a core temperature of 33.5˚ C to 34.5˚ C (92.3˚ F to 94.1˚ F) for 72 hours
• obtain brain ultrasonography to assess for intracranial hemorrhage
• obtain sequential MRI studies to assess brain structure and function
• initiate EEG monitoring for seizure activity.

During hypothermia the newborn is sedated, and oral feedings are reduced. During TH, important physiological goals are to maintain normal oxygenation, blood pressure, fluid balance, and glucose levels.^1,2

TH: The basics

Most of the major published randomized clinical trials used the following inclusion criteria to initiate TH²:

• gestational age at birth of ≥ 35 weeks
• neonate is within 6 hours of birth
• an Apgar score ≤ 5 at 10 minutes of life or prolonged resuscitation at birth or umbilical artery cord pH < 7.1 or neonatal blood gas within 60 minutes of life < 7.1
• moderate to severe encephalopathy or the presence of seizures
• absence of recognizable congenital abnormalities at birth.

However, in some institutions, expert neonatologists have developed more liberal criteria for the initiation of TH, to be considered on a case-by-case basis. These more inclusive criteria, which will result in more newborns being treated with TH, include^3:

• gestational age at birth of ≥ 34 weeks
• neonate is within 12 hours of birth
• a sentinel event at birth or Apgar score ≤ 5 at 10 minutes of life or prolonged resuscitation or umbilical artery cord pH < 7.1 or neonatal blood gas within 60 minutes of life < 7.1 or postnatal cardiopulmonary failure
• moderate to severe encephalopathy or concern for the presence of seizures.

Birth at a gestational age ≤ 34 weeks is a contraindication to TH. Relative contraindications to initiation of TH include: birth weight < 1,750 g, severe congenital anomaly, major genetic disorders, known severe metabolic disorders, major intracranial hemorrhage, severe septicemia, and uncorrectable coagulopathy.³ Adverse outcomes of TH include thrombocytopenia, cardiac arrythmia, and fat necrosis.⁴

Diagnosing neonatal encephalopathy

Neonatal encephalopathy is a clinical diagnosis, defined as abnormal neurologic function in the first few days of life in an infant born at ≥ 35 weeks’ gestation. It is divided into 3 categories: mild (Stage 1), moderate (Stage 2), and severe (Stage 3).^5,6 Institutions vary in the criteria used to differentiate mild from moderate neonatal encephalopathy, the two most frequent forms of encephalopathy. Newborns with mild encephalopathy are not routinely treated with TH because TH has not been shown to be helpful in this setting. Institutions with liberal criteria for diagnosing moderate encephalopathy will initiate TH in more cases. Involvement of a pediatric neurologist in the diagnosis of moderate encephalopathy may help confirm the diagnosis made by the primary neonatologist and provide an independent, second opinion about whether the newborn should be diagnosed with mild or moderate encephalopathy, a clinically important distinction. Physical examination and EEG findings associated with cases of mild, moderate, and severe encephalopathy are presented in TABLE 1.⁷

Continue: Obstetric factors that may be associated with neonatal encephalopathy...

Obstetric factors that may be associated with neonatal encephalopathy

In a retrospective case-control study that included 405 newborns at ≥ 35 weeks’ gestational age with neonatal encephalopathy thought to be due to hypoxia, 8 obstetric factors were identified as being associated with an increased risk of neonatal encephalopathy, including (TABLE 2)⁸:

1. an obstetric sentinel event (uterine rupture, placental abruption, umbilical cord prolapse, maternal collapse, or severe fetal bleeding)

2. shoulder dystocia

3. abnormal cardiotocogram (persistent late or variable decelerations, fetal bradycardia, and/or absent or minimal fetal heart variability)

4. failed vacuum delivery

5. prolonged rupture of the membranes (> 24 hours)

6. tight nuchal cord

7. gestational age at birth > 41 weeks

8. thick meconium. 

Genetic causes of neonatal seizures and neonatal encephalopathy

Many neonatologists practice with the belief that for a newborn with encephalopathy in the setting of a sentinel labor event, a low Apgar score at 5 minutes, an umbilical cord artery pH < 7.00, and/or an elevated lactate level, the diagnosis of hypoxic ischemic encephalopathy is warranted. However, there are many causes of neonatal encephalopathy not related to intrapartum events. For example, neonatal encephalopathy and seizures may be caused by infectious, vascular, metabolic, medications, or congenital problems.¹⁰

There are genetic disorders that can be associated with both neonatal seizures and encephalopathy, suggesting that in some cases the primary cause of the encephalopathy is a genetic problem, not management of labor. Mutations in the potassium channel and sodium channel genes are well recognized causes of neonatal seizures.^11,12 Cerebral palsy, a childhood outcome that may follow neonatal encephalopathy, also has numerous etiologies, including genetic causes. Among 1,345 children with cerebral palsy referred for exome sequencing, investigators reported that a genetic abnormality was identified in 33% of the cases.¹³ Mutations in 86 genes were identified in multiple children. Similar results have been reported in other cohorts.^14-16 Maintaining an open mind about the causes of a case of neonatal encephalopathy and not jumping to a conclusion before completing an evaluation is an optimal approach.

Parent’s evolving emotional and intellectual reaction to the initiation of TH

Initiation of TH for a newborn with encephalopathy catalyzes parents to wonder, “How did my baby develop an encephalopathy?”, “Did my obstetrician’s management of labor and delivery contribute to the outcome?” and “What is the prognosis for my baby?” These are difficult questions with high emotional valence for both patients and clinicians. Obstetricians and neonatologists should collaborate to provide consistent responses to these questions.

The presence of a low umbilical cord artery pH and high lactate in combination with a low Apgar score at 5 minutes may lead the neonatologist to diagnose hypoxic-ischemic encephalopathy in the medical record. The diagnosis of brain hypoxia and ischemia in a newborn may be interpreted by parents as meaning that labor events caused or contributed to the encephalopathy. During the 72 hours of TH, the newborn is sedated and separated from the parents, causing additional emotional stress and uncertainty. When a baby is transferred from a community hospital to a neonatal intensive care unit (NICU) at a tertiary center, the parents may be geographically separated from their baby during a critical period of time, adding to their anxiety. At some point during the care process most newborns treated with TH will have an EEG, brain ultrasound, and brain magnetic resonance imaging (MRI). These data will be discussed with the parent(s) and may cause confusion and additional stress.

The optimal approach to communicating with parents whose newborn is treated with TH continues to evolve. Best practices may include^17-20:

• in-person, regular multidisciplinary family meetings with the parents, including neonatologists, obstetricians, social service specialists and mental health experts when possible
• providing emotional support to parents, recognizing the psychological trauma of the clinical events
• encouraging parents to have physical contact with the newborn during TH
• elevating the role of the parents in the care process by having them participate in care events such as diapering the newborn
• ensuring that clinicians do not blame other clinicians for the clinical outcome
• communicating the results and interpretation of advanced physiological monitoring and imaging studies, with an emphasis on clarity, recognizing the limitations of the studies
• providing educational materials for parents about TH, early intervention programs, and support resources.

Coordinated and consistent communication with the parents is often difficult to facilitate due to many factors, including the unique perspectives and vocabularies of clinicians from different specialties and the difficulty of coordinating communications with all those involved over multiple shifts and sites of care. In terms of vocabulary, neonatologists are comfortable with making a diagnosis of hypoxic-ischemic encephalopathy in a newborn, but obstetricians would prefer that neonatologists use the more generic diagnosis of encephalopathy, holding judgment on the cause until additional data are available. In terms of coordinating communication over multiple shifts and sites of care, interactions between an obstetrician and their patient typically occurs in the postpartum unit, while interactions between neonatologists and parents occur in the NICU.

Parents of a baby with neonatal encephalopathy undergoing TH may have numerous traumatic experiences during the care process. For weeks or months after birth, they may recall or dream about the absence of sounds from their newborn at birth, the resuscitation events including chest compressions and intubation, the shivering of the baby during TH, and the jarring pivot from the expectation of holding and bonding with a healthy newborn to the reality of a sick newborn requiring intensive care. Obstetricians are also traumatized by these events and support from peers and mental health experts may help them recognize, explore, and adapt to the trauma. Neonatologists believe that TH can help improve the childhood outcomes of newborns with encephalopathy, a goal endorsed by all clinicians and family members. ●

Therapeutic hypothermia (TH) for moderate and severe neonatal encephalopathy has been shown to reduce the risk of newborn death, major neurodevelopmental disability, developmental delay, and cerebral palsy.¹ It is estimated that 8 newborns with moderate or severe neonatal encephalopathy need to be treated with TH to prevent 1 case of cerebral palsy.¹ The key elements of TH include:

• initiate hypothermia within 6 hoursof birth
• cool the newborn to a core temperature of 33.5˚ C to 34.5˚ C (92.3˚ F to 94.1˚ F) for 72 hours
• obtain brain ultrasonography to assess for intracranial hemorrhage
• obtain sequential MRI studies to assess brain structure and function
• initiate EEG monitoring for seizure activity.

During hypothermia the newborn is sedated, and oral feedings are reduced. During TH, important physiological goals are to maintain normal oxygenation, blood pressure, fluid balance, and glucose levels.^1,2

TH: The basics

Most of the major published randomized clinical trials used the following inclusion criteria to initiate TH²:

• gestational age at birth of ≥ 35 weeks
• neonate is within 6 hours of birth
• an Apgar score ≤ 5 at 10 minutes of life or prolonged resuscitation at birth or umbilical artery cord pH < 7.1 or neonatal blood gas within 60 minutes of life < 7.1
• moderate to severe encephalopathy or the presence of seizures
• absence of recognizable congenital abnormalities at birth.

However, in some institutions, expert neonatologists have developed more liberal criteria for the initiation of TH, to be considered on a case-by-case basis. These more inclusive criteria, which will result in more newborns being treated with TH, include^3:

• gestational age at birth of ≥ 34 weeks
• neonate is within 12 hours of birth
• a sentinel event at birth or Apgar score ≤ 5 at 10 minutes of life or prolonged resuscitation or umbilical artery cord pH < 7.1 or neonatal blood gas within 60 minutes of life < 7.1 or postnatal cardiopulmonary failure
• moderate to severe encephalopathy or concern for the presence of seizures.

Birth at a gestational age ≤ 34 weeks is a contraindication to TH. Relative contraindications to initiation of TH include: birth weight < 1,750 g, severe congenital anomaly, major genetic disorders, known severe metabolic disorders, major intracranial hemorrhage, severe septicemia, and uncorrectable coagulopathy.³ Adverse outcomes of TH include thrombocytopenia, cardiac arrythmia, and fat necrosis.⁴

Diagnosing neonatal encephalopathy

Neonatal encephalopathy is a clinical diagnosis, defined as abnormal neurologic function in the first few days of life in an infant born at ≥ 35 weeks’ gestation. It is divided into 3 categories: mild (Stage 1), moderate (Stage 2), and severe (Stage 3).^5,6 Institutions vary in the criteria used to differentiate mild from moderate neonatal encephalopathy, the two most frequent forms of encephalopathy. Newborns with mild encephalopathy are not routinely treated with TH because TH has not been shown to be helpful in this setting. Institutions with liberal criteria for diagnosing moderate encephalopathy will initiate TH in more cases. Involvement of a pediatric neurologist in the diagnosis of moderate encephalopathy may help confirm the diagnosis made by the primary neonatologist and provide an independent, second opinion about whether the newborn should be diagnosed with mild or moderate encephalopathy, a clinically important distinction. Physical examination and EEG findings associated with cases of mild, moderate, and severe encephalopathy are presented in TABLE 1.⁷

Continue: Obstetric factors that may be associated with neonatal encephalopathy...

Obstetric factors that may be associated with neonatal encephalopathy

In a retrospective case-control study that included 405 newborns at ≥ 35 weeks’ gestational age with neonatal encephalopathy thought to be due to hypoxia, 8 obstetric factors were identified as being associated with an increased risk of neonatal encephalopathy, including (TABLE 2)⁸:

1. an obstetric sentinel event (uterine rupture, placental abruption, umbilical cord prolapse, maternal collapse, or severe fetal bleeding)

2. shoulder dystocia

3. abnormal cardiotocogram (persistent late or variable decelerations, fetal bradycardia, and/or absent or minimal fetal heart variability)

4. failed vacuum delivery

5. prolonged rupture of the membranes (> 24 hours)

6. tight nuchal cord

7. gestational age at birth > 41 weeks

8. thick meconium. 

Genetic causes of neonatal seizures and neonatal encephalopathy

Many neonatologists practice with the belief that for a newborn with encephalopathy in the setting of a sentinel labor event, a low Apgar score at 5 minutes, an umbilical cord artery pH < 7.00, and/or an elevated lactate level, the diagnosis of hypoxic ischemic encephalopathy is warranted. However, there are many causes of neonatal encephalopathy not related to intrapartum events. For example, neonatal encephalopathy and seizures may be caused by infectious, vascular, metabolic, medications, or congenital problems.¹⁰

There are genetic disorders that can be associated with both neonatal seizures and encephalopathy, suggesting that in some cases the primary cause of the encephalopathy is a genetic problem, not management of labor. Mutations in the potassium channel and sodium channel genes are well recognized causes of neonatal seizures.^11,12 Cerebral palsy, a childhood outcome that may follow neonatal encephalopathy, also has numerous etiologies, including genetic causes. Among 1,345 children with cerebral palsy referred for exome sequencing, investigators reported that a genetic abnormality was identified in 33% of the cases.¹³ Mutations in 86 genes were identified in multiple children. Similar results have been reported in other cohorts.^14-16 Maintaining an open mind about the causes of a case of neonatal encephalopathy and not jumping to a conclusion before completing an evaluation is an optimal approach.

Parent’s evolving emotional and intellectual reaction to the initiation of TH

Initiation of TH for a newborn with encephalopathy catalyzes parents to wonder, “How did my baby develop an encephalopathy?”, “Did my obstetrician’s management of labor and delivery contribute to the outcome?” and “What is the prognosis for my baby?” These are difficult questions with high emotional valence for both patients and clinicians. Obstetricians and neonatologists should collaborate to provide consistent responses to these questions.

The presence of a low umbilical cord artery pH and high lactate in combination with a low Apgar score at 5 minutes may lead the neonatologist to diagnose hypoxic-ischemic encephalopathy in the medical record. The diagnosis of brain hypoxia and ischemia in a newborn may be interpreted by parents as meaning that labor events caused or contributed to the encephalopathy. During the 72 hours of TH, the newborn is sedated and separated from the parents, causing additional emotional stress and uncertainty. When a baby is transferred from a community hospital to a neonatal intensive care unit (NICU) at a tertiary center, the parents may be geographically separated from their baby during a critical period of time, adding to their anxiety. At some point during the care process most newborns treated with TH will have an EEG, brain ultrasound, and brain magnetic resonance imaging (MRI). These data will be discussed with the parent(s) and may cause confusion and additional stress.

The optimal approach to communicating with parents whose newborn is treated with TH continues to evolve. Best practices may include^17-20:

• in-person, regular multidisciplinary family meetings with the parents, including neonatologists, obstetricians, social service specialists and mental health experts when possible
• providing emotional support to parents, recognizing the psychological trauma of the clinical events
• encouraging parents to have physical contact with the newborn during TH
• elevating the role of the parents in the care process by having them participate in care events such as diapering the newborn
• ensuring that clinicians do not blame other clinicians for the clinical outcome
• communicating the results and interpretation of advanced physiological monitoring and imaging studies, with an emphasis on clarity, recognizing the limitations of the studies
• providing educational materials for parents about TH, early intervention programs, and support resources.

Coordinated and consistent communication with the parents is often difficult to facilitate due to many factors, including the unique perspectives and vocabularies of clinicians from different specialties and the difficulty of coordinating communications with all those involved over multiple shifts and sites of care. In terms of vocabulary, neonatologists are comfortable with making a diagnosis of hypoxic-ischemic encephalopathy in a newborn, but obstetricians would prefer that neonatologists use the more generic diagnosis of encephalopathy, holding judgment on the cause until additional data are available. In terms of coordinating communication over multiple shifts and sites of care, interactions between an obstetrician and their patient typically occurs in the postpartum unit, while interactions between neonatologists and parents occur in the NICU.

Parents of a baby with neonatal encephalopathy undergoing TH may have numerous traumatic experiences during the care process. For weeks or months after birth, they may recall or dream about the absence of sounds from their newborn at birth, the resuscitation events including chest compressions and intubation, the shivering of the baby during TH, and the jarring pivot from the expectation of holding and bonding with a healthy newborn to the reality of a sick newborn requiring intensive care. Obstetricians are also traumatized by these events and support from peers and mental health experts may help them recognize, explore, and adapt to the trauma. Neonatologists believe that TH can help improve the childhood outcomes of newborns with encephalopathy, a goal endorsed by all clinicians and family members. ●

Therapeutic hypothermia (TH) for moderate and severe neonatal encephalopathy has been shown to reduce the risk of newborn death, major neurodevelopmental disability, developmental delay, and cerebral palsy.¹ It is estimated that 8 newborns with moderate or severe neonatal encephalopathy need to be treated with TH to prevent 1 case of cerebral palsy.¹ The key elements of TH include:

• initiate hypothermia within 6 hoursof birth
• cool the newborn to a core temperature of 33.5˚ C to 34.5˚ C (92.3˚ F to 94.1˚ F) for 72 hours
• obtain brain ultrasonography to assess for intracranial hemorrhage
• obtain sequential MRI studies to assess brain structure and function
• initiate EEG monitoring for seizure activity.

During hypothermia the newborn is sedated, and oral feedings are reduced. During TH, important physiological goals are to maintain normal oxygenation, blood pressure, fluid balance, and glucose levels.^1,2

TH: The basics

Most of the major published randomized clinical trials used the following inclusion criteria to initiate TH²:

• gestational age at birth of ≥ 35 weeks
• neonate is within 6 hours of birth
• an Apgar score ≤ 5 at 10 minutes of life or prolonged resuscitation at birth or umbilical artery cord pH < 7.1 or neonatal blood gas within 60 minutes of life < 7.1
• moderate to severe encephalopathy or the presence of seizures
• absence of recognizable congenital abnormalities at birth.

However, in some institutions, expert neonatologists have developed more liberal criteria for the initiation of TH, to be considered on a case-by-case basis. These more inclusive criteria, which will result in more newborns being treated with TH, include^3:

• gestational age at birth of ≥ 34 weeks
• neonate is within 12 hours of birth
• a sentinel event at birth or Apgar score ≤ 5 at 10 minutes of life or prolonged resuscitation or umbilical artery cord pH < 7.1 or neonatal blood gas within 60 minutes of life < 7.1 or postnatal cardiopulmonary failure
• moderate to severe encephalopathy or concern for the presence of seizures.

Birth at a gestational age ≤ 34 weeks is a contraindication to TH. Relative contraindications to initiation of TH include: birth weight < 1,750 g, severe congenital anomaly, major genetic disorders, known severe metabolic disorders, major intracranial hemorrhage, severe septicemia, and uncorrectable coagulopathy.³ Adverse outcomes of TH include thrombocytopenia, cardiac arrythmia, and fat necrosis.⁴

Diagnosing neonatal encephalopathy

Neonatal encephalopathy is a clinical diagnosis, defined as abnormal neurologic function in the first few days of life in an infant born at ≥ 35 weeks’ gestation. It is divided into 3 categories: mild (Stage 1), moderate (Stage 2), and severe (Stage 3).^5,6 Institutions vary in the criteria used to differentiate mild from moderate neonatal encephalopathy, the two most frequent forms of encephalopathy. Newborns with mild encephalopathy are not routinely treated with TH because TH has not been shown to be helpful in this setting. Institutions with liberal criteria for diagnosing moderate encephalopathy will initiate TH in more cases. Involvement of a pediatric neurologist in the diagnosis of moderate encephalopathy may help confirm the diagnosis made by the primary neonatologist and provide an independent, second opinion about whether the newborn should be diagnosed with mild or moderate encephalopathy, a clinically important distinction. Physical examination and EEG findings associated with cases of mild, moderate, and severe encephalopathy are presented in TABLE 1.⁷

Continue: Obstetric factors that may be associated with neonatal encephalopathy...

Obstetric factors that may be associated with neonatal encephalopathy

In a retrospective case-control study that included 405 newborns at ≥ 35 weeks’ gestational age with neonatal encephalopathy thought to be due to hypoxia, 8 obstetric factors were identified as being associated with an increased risk of neonatal encephalopathy, including (TABLE 2)⁸:

1. an obstetric sentinel event (uterine rupture, placental abruption, umbilical cord prolapse, maternal collapse, or severe fetal bleeding)

2. shoulder dystocia

3. abnormal cardiotocogram (persistent late or variable decelerations, fetal bradycardia, and/or absent or minimal fetal heart variability)

4. failed vacuum delivery

5. prolonged rupture of the membranes (> 24 hours)

6. tight nuchal cord

7. gestational age at birth > 41 weeks

8. thick meconium. 

Genetic causes of neonatal seizures and neonatal encephalopathy

Many neonatologists practice with the belief that for a newborn with encephalopathy in the setting of a sentinel labor event, a low Apgar score at 5 minutes, an umbilical cord artery pH < 7.00, and/or an elevated lactate level, the diagnosis of hypoxic ischemic encephalopathy is warranted. However, there are many causes of neonatal encephalopathy not related to intrapartum events. For example, neonatal encephalopathy and seizures may be caused by infectious, vascular, metabolic, medications, or congenital problems.¹⁰

There are genetic disorders that can be associated with both neonatal seizures and encephalopathy, suggesting that in some cases the primary cause of the encephalopathy is a genetic problem, not management of labor. Mutations in the potassium channel and sodium channel genes are well recognized causes of neonatal seizures.^11,12 Cerebral palsy, a childhood outcome that may follow neonatal encephalopathy, also has numerous etiologies, including genetic causes. Among 1,345 children with cerebral palsy referred for exome sequencing, investigators reported that a genetic abnormality was identified in 33% of the cases.¹³ Mutations in 86 genes were identified in multiple children. Similar results have been reported in other cohorts.^14-16 Maintaining an open mind about the causes of a case of neonatal encephalopathy and not jumping to a conclusion before completing an evaluation is an optimal approach.

Parent’s evolving emotional and intellectual reaction to the initiation of TH

Initiation of TH for a newborn with encephalopathy catalyzes parents to wonder, “How did my baby develop an encephalopathy?”, “Did my obstetrician’s management of labor and delivery contribute to the outcome?” and “What is the prognosis for my baby?” These are difficult questions with high emotional valence for both patients and clinicians. Obstetricians and neonatologists should collaborate to provide consistent responses to these questions.

The presence of a low umbilical cord artery pH and high lactate in combination with a low Apgar score at 5 minutes may lead the neonatologist to diagnose hypoxic-ischemic encephalopathy in the medical record. The diagnosis of brain hypoxia and ischemia in a newborn may be interpreted by parents as meaning that labor events caused or contributed to the encephalopathy. During the 72 hours of TH, the newborn is sedated and separated from the parents, causing additional emotional stress and uncertainty. When a baby is transferred from a community hospital to a neonatal intensive care unit (NICU) at a tertiary center, the parents may be geographically separated from their baby during a critical period of time, adding to their anxiety. At some point during the care process most newborns treated with TH will have an EEG, brain ultrasound, and brain magnetic resonance imaging (MRI). These data will be discussed with the parent(s) and may cause confusion and additional stress.

The optimal approach to communicating with parents whose newborn is treated with TH continues to evolve. Best practices may include^17-20:

• in-person, regular multidisciplinary family meetings with the parents, including neonatologists, obstetricians, social service specialists and mental health experts when possible
• providing emotional support to parents, recognizing the psychological trauma of the clinical events
• encouraging parents to have physical contact with the newborn during TH
• elevating the role of the parents in the care process by having them participate in care events such as diapering the newborn
• ensuring that clinicians do not blame other clinicians for the clinical outcome
• communicating the results and interpretation of advanced physiological monitoring and imaging studies, with an emphasis on clarity, recognizing the limitations of the studies
• providing educational materials for parents about TH, early intervention programs, and support resources.

Coordinated and consistent communication with the parents is often difficult to facilitate due to many factors, including the unique perspectives and vocabularies of clinicians from different specialties and the difficulty of coordinating communications with all those involved over multiple shifts and sites of care. In terms of vocabulary, neonatologists are comfortable with making a diagnosis of hypoxic-ischemic encephalopathy in a newborn, but obstetricians would prefer that neonatologists use the more generic diagnosis of encephalopathy, holding judgment on the cause until additional data are available. In terms of coordinating communication over multiple shifts and sites of care, interactions between an obstetrician and their patient typically occurs in the postpartum unit, while interactions between neonatologists and parents occur in the NICU.

Parents of a baby with neonatal encephalopathy undergoing TH may have numerous traumatic experiences during the care process. For weeks or months after birth, they may recall or dream about the absence of sounds from their newborn at birth, the resuscitation events including chest compressions and intubation, the shivering of the baby during TH, and the jarring pivot from the expectation of holding and bonding with a healthy newborn to the reality of a sick newborn requiring intensive care. Obstetricians are also traumatized by these events and support from peers and mental health experts may help them recognize, explore, and adapt to the trauma. Neonatologists believe that TH can help improve the childhood outcomes of newborns with encephalopathy, a goal endorsed by all clinicians and family members. ●

Hartwig TJ, Ambye L, Gruhn JR, et al. Cell-free fetal DNA for genetic evaluation in Copenhagen Pregnancy Loss Study (COPL): a prospective cohort study. Lancet. 2023;401:762-771. https://doi.org/10.1016/S0140-6736(22)02610-1.

Expert Commentary

A devastating outcome for women, pregnancy loss is directly proportional to maternal age, estimated to occur in approximately 15% of clinically recognized pregnancies and 30% of preclinical pregnancies.¹ Approximately 80% of pregnancy losses occur in the first trimester.² The frequency of clinically recognized early pregnancy loss for women aged 20–30 years is 9% to 17%, and these rates increase sharply, from 20% at age 35 years to 40% at age 40 years, and 80% at age 45 years. Recurrent pregnancy loss (RPL), defined as the spontaneous loss of 2 or more clinically recognized pregnancies, affects less than 5% of women.³ Genetic testing using chromosomal microarray analysis (CMA) has identified aneuploidy in about 55% of cases of miscarriage.⁴

Following ASRM guidelines for the evaluation of RPL, which consists of analyzing parental chromosomal abnormalities, congenital and acquired uterine anomalies, endocrine imbalances, and autoimmune factors (including antiphospholipid syndrome), no explainable cause is determined in 50% of cases.³ Recently, it has been shown that more than 90% of patients with RPL will have a probable or definitive cause identified when CMA testing on miscarriage tissue with the ASRM evaluation guidelines.⁵

Details of the study

In this prospective cohort study from Denmark, the authors analyzed maternal serum for cell-free fetal DNA (cffDNA) to determine the ploidy status of the pregnancy loss. One thousand women older than age 18 were included (those who demonstrated an ultrasound-confirmed intrauterine pregnancy loss prior to 22 weeks’ gestation). Maternal blood was obtained while pregnancy tissue was in situ or within 24 hours of passage of products of conception (POC), then analyzed by genome-wide sequencing of cffDNA.

For the first 333 recruited women (validation phase), direct sequencing of the POC was performed for sensitivity and specificity. Following the elimination of inconclusive samples, 302 of the 333 cases demonstrated a sensitivity of 85% and specificity of 93%. In the subsequent evaluation of 667 women, researchers analyzed maternal serum from the gestational age of fetuses ranging from 35 days to 149 days.

Results. In total, nearly 90% of cases yielded conclusive results, with 50% euploid, 46% aneuploid, and 4% multiple aneuploidies. Earlier gestational ages (less than 7 weeks) had a no-call rate (ie, inconclusive) of approximately 50% (only based on 16 patients), with results typically obtained in maternal serum following passage of POC; in pregnancies at gestational ages past 7 weeks, the no-call rate was about 10%. In general, the longer the time after the pregnancy tissue passed, the higher likelihood of a no-call result.

Applying the technology of single-nucleotide polymorphism (SNP)-based CMA can improve identification of fetal and/or maternal sources as causes of pregnancy loss with accuracy, but it does require collection of POC. Of note, samples were deficient in this study, the authors cite, in one-third of the cases. Given this limitation of collection, the authors argue for use of the noninvasive method of cffDNA, obtained from maternal serum.

Study strengths and weaknesses

Several weaknesses of this study are highlighted. Of the validation cohort, one-third of pregnancy tissue could not be analyzed due to insufficient collection. Only 73% of cases allowed for DNA isolation from fetal tissue or chorionic villi; in 27% of cases samples were labeled “unknown tissue.” In those cases classified as unknown, 70% were further determined to be maternal. When all female and monosomy cases were excluded in an effort to assuredly reduce the risk of contamination with maternal DNA, sensitivity of the cffDNA testing process declined to 78%. Another limitation was the required short window for maternal blood sampling (within 24 hours) and its impact on the no-call rate.

The authors note an association with later-life morbidity in patients with a history of pregnancy loss and RPL (including cardiovascular disease, type 2 diabetes, and mental health disorders), thereby arguing for cffDNA-based testing versus no causal testing; however, no treatment has been proven to be effective at reducing pregnancy loss. ●

Hartwig TJ, Ambye L, Gruhn JR, et al. Cell-free fetal DNA for genetic evaluation in Copenhagen Pregnancy Loss Study (COPL): a prospective cohort study. Lancet. 2023;401:762-771. https://doi.org/10.1016/S0140-6736(22)02610-1.

Expert Commentary

A devastating outcome for women, pregnancy loss is directly proportional to maternal age, estimated to occur in approximately 15% of clinically recognized pregnancies and 30% of preclinical pregnancies.¹ Approximately 80% of pregnancy losses occur in the first trimester.² The frequency of clinically recognized early pregnancy loss for women aged 20–30 years is 9% to 17%, and these rates increase sharply, from 20% at age 35 years to 40% at age 40 years, and 80% at age 45 years. Recurrent pregnancy loss (RPL), defined as the spontaneous loss of 2 or more clinically recognized pregnancies, affects less than 5% of women.³ Genetic testing using chromosomal microarray analysis (CMA) has identified aneuploidy in about 55% of cases of miscarriage.⁴

Following ASRM guidelines for the evaluation of RPL, which consists of analyzing parental chromosomal abnormalities, congenital and acquired uterine anomalies, endocrine imbalances, and autoimmune factors (including antiphospholipid syndrome), no explainable cause is determined in 50% of cases.³ Recently, it has been shown that more than 90% of patients with RPL will have a probable or definitive cause identified when CMA testing on miscarriage tissue with the ASRM evaluation guidelines.⁵

Details of the study

In this prospective cohort study from Denmark, the authors analyzed maternal serum for cell-free fetal DNA (cffDNA) to determine the ploidy status of the pregnancy loss. One thousand women older than age 18 were included (those who demonstrated an ultrasound-confirmed intrauterine pregnancy loss prior to 22 weeks’ gestation). Maternal blood was obtained while pregnancy tissue was in situ or within 24 hours of passage of products of conception (POC), then analyzed by genome-wide sequencing of cffDNA.

For the first 333 recruited women (validation phase), direct sequencing of the POC was performed for sensitivity and specificity. Following the elimination of inconclusive samples, 302 of the 333 cases demonstrated a sensitivity of 85% and specificity of 93%. In the subsequent evaluation of 667 women, researchers analyzed maternal serum from the gestational age of fetuses ranging from 35 days to 149 days.

Results. In total, nearly 90% of cases yielded conclusive results, with 50% euploid, 46% aneuploid, and 4% multiple aneuploidies. Earlier gestational ages (less than 7 weeks) had a no-call rate (ie, inconclusive) of approximately 50% (only based on 16 patients), with results typically obtained in maternal serum following passage of POC; in pregnancies at gestational ages past 7 weeks, the no-call rate was about 10%. In general, the longer the time after the pregnancy tissue passed, the higher likelihood of a no-call result.

Applying the technology of single-nucleotide polymorphism (SNP)-based CMA can improve identification of fetal and/or maternal sources as causes of pregnancy loss with accuracy, but it does require collection of POC. Of note, samples were deficient in this study, the authors cite, in one-third of the cases. Given this limitation of collection, the authors argue for use of the noninvasive method of cffDNA, obtained from maternal serum.

Study strengths and weaknesses

Several weaknesses of this study are highlighted. Of the validation cohort, one-third of pregnancy tissue could not be analyzed due to insufficient collection. Only 73% of cases allowed for DNA isolation from fetal tissue or chorionic villi; in 27% of cases samples were labeled “unknown tissue.” In those cases classified as unknown, 70% were further determined to be maternal. When all female and monosomy cases were excluded in an effort to assuredly reduce the risk of contamination with maternal DNA, sensitivity of the cffDNA testing process declined to 78%. Another limitation was the required short window for maternal blood sampling (within 24 hours) and its impact on the no-call rate.

The authors note an association with later-life morbidity in patients with a history of pregnancy loss and RPL (including cardiovascular disease, type 2 diabetes, and mental health disorders), thereby arguing for cffDNA-based testing versus no causal testing; however, no treatment has been proven to be effective at reducing pregnancy loss. ●

Hartwig TJ, Ambye L, Gruhn JR, et al. Cell-free fetal DNA for genetic evaluation in Copenhagen Pregnancy Loss Study (COPL): a prospective cohort study. Lancet. 2023;401:762-771. https://doi.org/10.1016/S0140-6736(22)02610-1.

Expert Commentary

A devastating outcome for women, pregnancy loss is directly proportional to maternal age, estimated to occur in approximately 15% of clinically recognized pregnancies and 30% of preclinical pregnancies.¹ Approximately 80% of pregnancy losses occur in the first trimester.² The frequency of clinically recognized early pregnancy loss for women aged 20–30 years is 9% to 17%, and these rates increase sharply, from 20% at age 35 years to 40% at age 40 years, and 80% at age 45 years. Recurrent pregnancy loss (RPL), defined as the spontaneous loss of 2 or more clinically recognized pregnancies, affects less than 5% of women.³ Genetic testing using chromosomal microarray analysis (CMA) has identified aneuploidy in about 55% of cases of miscarriage.⁴

Following ASRM guidelines for the evaluation of RPL, which consists of analyzing parental chromosomal abnormalities, congenital and acquired uterine anomalies, endocrine imbalances, and autoimmune factors (including antiphospholipid syndrome), no explainable cause is determined in 50% of cases.³ Recently, it has been shown that more than 90% of patients with RPL will have a probable or definitive cause identified when CMA testing on miscarriage tissue with the ASRM evaluation guidelines.⁵

Details of the study

In this prospective cohort study from Denmark, the authors analyzed maternal serum for cell-free fetal DNA (cffDNA) to determine the ploidy status of the pregnancy loss. One thousand women older than age 18 were included (those who demonstrated an ultrasound-confirmed intrauterine pregnancy loss prior to 22 weeks’ gestation). Maternal blood was obtained while pregnancy tissue was in situ or within 24 hours of passage of products of conception (POC), then analyzed by genome-wide sequencing of cffDNA.

For the first 333 recruited women (validation phase), direct sequencing of the POC was performed for sensitivity and specificity. Following the elimination of inconclusive samples, 302 of the 333 cases demonstrated a sensitivity of 85% and specificity of 93%. In the subsequent evaluation of 667 women, researchers analyzed maternal serum from the gestational age of fetuses ranging from 35 days to 149 days.

Results. In total, nearly 90% of cases yielded conclusive results, with 50% euploid, 46% aneuploid, and 4% multiple aneuploidies. Earlier gestational ages (less than 7 weeks) had a no-call rate (ie, inconclusive) of approximately 50% (only based on 16 patients), with results typically obtained in maternal serum following passage of POC; in pregnancies at gestational ages past 7 weeks, the no-call rate was about 10%. In general, the longer the time after the pregnancy tissue passed, the higher likelihood of a no-call result.

Applying the technology of single-nucleotide polymorphism (SNP)-based CMA can improve identification of fetal and/or maternal sources as causes of pregnancy loss with accuracy, but it does require collection of POC. Of note, samples were deficient in this study, the authors cite, in one-third of the cases. Given this limitation of collection, the authors argue for use of the noninvasive method of cffDNA, obtained from maternal serum.

Study strengths and weaknesses

Several weaknesses of this study are highlighted. Of the validation cohort, one-third of pregnancy tissue could not be analyzed due to insufficient collection. Only 73% of cases allowed for DNA isolation from fetal tissue or chorionic villi; in 27% of cases samples were labeled “unknown tissue.” In those cases classified as unknown, 70% were further determined to be maternal. When all female and monosomy cases were excluded in an effort to assuredly reduce the risk of contamination with maternal DNA, sensitivity of the cffDNA testing process declined to 78%. Another limitation was the required short window for maternal blood sampling (within 24 hours) and its impact on the no-call rate.

The authors note an association with later-life morbidity in patients with a history of pregnancy loss and RPL (including cardiovascular disease, type 2 diabetes, and mental health disorders), thereby arguing for cffDNA-based testing versus no causal testing; however, no treatment has been proven to be effective at reducing pregnancy loss. ●

After Canada legalized recreational cannabis in 2018, the rate of acute care for cannabis use during pregnancy in Ontario nearly doubled, data indicate.

A population-based study shows that the rate of cannabis-related acute care use during pregnancy increased from 11 per 100,000 pregnancies before legalization to 20 per 100,000 pregnancies afterward: an increase of 82%. Absolute increases were small, however.

“Our findings are consistent with studies highlighting that cannabis use during pregnancy has been increasing in North America, and this study suggests that cannabis legalization might contribute to and accelerate such trends,” study author Daniel Myran, MD, MPH, a public health and preventive medicine physician at the University of Ottawa in Ontario, said in an interview.

University of Ottawa

The study was published online in the Canadian Medical Association Journal.
 

Risks for newborns  

In a 2019 study, 7% of U.S. women reported using cannabis during pregnancy during 2016-2017, which was double the rate of 3.4% for 2002-2003.

Dr. Myran and colleagues hypothesized that legalizing nonmedical cannabis has affected the drug’s use during pregnancy in Ontario. “We also hypothesized that hospital care for cannabis use would be associated with adverse neonatal outcomes, even after adjusting for other important risk factors that may differ between people with and without cannabis use,” he said.

The researchers’ repeated cross-sectional analysis evaluated changes in the number of pregnant people who received acute care from January 2015 to July 2021 among all patients who were eligible for Ontario’s public health coverage. The final study cohort included 691,242 pregnant patients, of whom 533 had at least one pregnancy with cannabis-related acute care visits. These mothers had a mean age of 24 years vs. 30 for their counterparts with no such visits.

Using segmented regression, the researchers compared changes in the quarterly rate of pregnant people with acute care related to cannabis use (the primary outcome) with those of acute care for mental health conditions or for noncannabis substance use (the control conditions).

“Severe morning sickness was a major risk factor for care in the emergency department or hospital for cannabis use,” said Dr. Myran. “Prior work has found that people who use cannabis during pregnancy often state that it was used to manage challenging symptoms of pregnancy such as morning sickness.”

Most acute care events (72.2%) were emergency department visits. The most common reasons for acute care were harmful cannabis use (57.6%), followed by cannabis dependence or withdrawal (21.5%), and acute cannabis intoxication (12.8%).

Compared with pregnancies without acute care, those with acute care related to cannabis had higher rates of adverse neonatal outcomes such as birth before 37 weeks’ gestational age (16.9% vs. 7.2%), birth weight at or below the bottom fifth percentile after adjustment for gestational age (12.1% vs. 4.4%), and neonatal intensive care unit admission in the first 28 days of life (31.5% vs. 13%).

An adjusted analysis found that patients younger than 35 years and those living in rural settings or the lowest-income neighborhoods had higher odds of acute cannabis-related care during pregnancy. Patients who received acute care for any substance use or schizophrenia before pregnancy or who accessed outpatient mental health services before pregnancy had higher risk for cannabis-related acute care during pregnancy. Mothers receiving acute care for cannabis also had higher risk for acute care for hyperemesis gravidarum during pregnancy (30.9%). 

The rate of acute care for other types of substance use such as alcohol and opioids did not change after cannabis legalization, and acute care for mental health conditions such as anxiety and depression during pregnancy declined by 14%, Dr. Myran noted.

“Physicians who care for pregnant people should consider increasing screening for cannabis use during pregnancy,” said Dr. Myran. “In addition, repeated nonstigmatizing screening and counseling may be indicated for higher-risk groups identified in the study, including pregnancies with severe morning sickness.”
 

The U.S. perspective

Commenting on the study, M. Camille Hoffman, MD, MSc, a maternal-fetal medicine specialist at the University of Colorado in Aurora, said that the findings likely indicate that legalization has made cannabis users less reluctant to come forward for urgent care. “They cannot really claim that this is equivalent to more use, just that more people are willing to present,” she said. Dr. Hoffman was not involved in the study.

The Canadian results do not align perfectly with what is seen in the United States. “It does suggest that there may be more cannabinoid hyperemesis being coded as hyperemesis gravidarum, which is a pregnancy-specific condition vs. a cannabis-dependence-related one,” said Dr. Hoffman.

Literature in the United States often includes tobacco use as a covariate, she added. “This study does not appear to do that,” she said. “Rather, it uses any substance use. Because of this, it is difficult to really know the contribution of cannabis to the adverse pregnancy outcomes vs. the combination of tobacco and cannabis.”

Finally, she pointed out, the proportion of those presenting for acute care for substance use in the 2 years before conception was 22% for acute care visits for cannabis vs 1% for no acute care visits. “This suggests to me that this was a highly vulnerable group before the legalization of cannabis as well. The overall absolute difference is nine in total per 100,000 – hardly enough to draw any real conclusions. Again, maybe those nine were simply more willing to come forth with concerns with cannabis being legal.” 

There is no known safe level of cannabis consumption, and its use by pregnant women has been linked to later neurodevelopmental issues in their offspring. A 2022 U.S. study suggested that cannabis exposure in the womb may leave children later in life at risk for autism, psychiatric disorders, and problematic substance abuse, particularly as they enter peak periods of vulnerability in late adolescence.

As to the impact of legalization in certain U.S. states, a 2022 study found that women perceived legalization to mean greater access to cannabis, increased acceptance of use, and greater trust in cannabis retailers. In line with Dr. Hoffman’s view, this study suggested that legalization made pregnant women more willing to discuss cannabis use during pregnancy honestly with their care providers.

In the United States, prenatal cannabis use is still included in definitions of child abuse or neglect and can lead to termination of parental rights, even in states with full legalization.

“These findings highlight the need for ongoing monitoring of markers of cannabis use during pregnancy after legalization,” said Dr. Myran. He also called for effective policies in regions with legal cannabis, such as increased warning labels on cannabis products.

This study was supported by the Canadian Institutes of Health Research and the University of Ottawa site of ICES, which is funded by an annual grant from the Ontario Ministry of Health and Ministry of Long-Term Care. Dr. Myran reports a speaker fee from McMaster University. Dr. Hoffman reports no relevant financial relationships.
 

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

After Canada legalized recreational cannabis in 2018, the rate of acute care for cannabis use during pregnancy in Ontario nearly doubled, data indicate.

A population-based study shows that the rate of cannabis-related acute care use during pregnancy increased from 11 per 100,000 pregnancies before legalization to 20 per 100,000 pregnancies afterward: an increase of 82%. Absolute increases were small, however.

“Our findings are consistent with studies highlighting that cannabis use during pregnancy has been increasing in North America, and this study suggests that cannabis legalization might contribute to and accelerate such trends,” study author Daniel Myran, MD, MPH, a public health and preventive medicine physician at the University of Ottawa in Ontario, said in an interview.

University of Ottawa

The study was published online in the Canadian Medical Association Journal.
 

Risks for newborns  

In a 2019 study, 7% of U.S. women reported using cannabis during pregnancy during 2016-2017, which was double the rate of 3.4% for 2002-2003.

Dr. Myran and colleagues hypothesized that legalizing nonmedical cannabis has affected the drug’s use during pregnancy in Ontario. “We also hypothesized that hospital care for cannabis use would be associated with adverse neonatal outcomes, even after adjusting for other important risk factors that may differ between people with and without cannabis use,” he said.

The researchers’ repeated cross-sectional analysis evaluated changes in the number of pregnant people who received acute care from January 2015 to July 2021 among all patients who were eligible for Ontario’s public health coverage. The final study cohort included 691,242 pregnant patients, of whom 533 had at least one pregnancy with cannabis-related acute care visits. These mothers had a mean age of 24 years vs. 30 for their counterparts with no such visits.

Using segmented regression, the researchers compared changes in the quarterly rate of pregnant people with acute care related to cannabis use (the primary outcome) with those of acute care for mental health conditions or for noncannabis substance use (the control conditions).

“Severe morning sickness was a major risk factor for care in the emergency department or hospital for cannabis use,” said Dr. Myran. “Prior work has found that people who use cannabis during pregnancy often state that it was used to manage challenging symptoms of pregnancy such as morning sickness.”

Most acute care events (72.2%) were emergency department visits. The most common reasons for acute care were harmful cannabis use (57.6%), followed by cannabis dependence or withdrawal (21.5%), and acute cannabis intoxication (12.8%).

Compared with pregnancies without acute care, those with acute care related to cannabis had higher rates of adverse neonatal outcomes such as birth before 37 weeks’ gestational age (16.9% vs. 7.2%), birth weight at or below the bottom fifth percentile after adjustment for gestational age (12.1% vs. 4.4%), and neonatal intensive care unit admission in the first 28 days of life (31.5% vs. 13%).

An adjusted analysis found that patients younger than 35 years and those living in rural settings or the lowest-income neighborhoods had higher odds of acute cannabis-related care during pregnancy. Patients who received acute care for any substance use or schizophrenia before pregnancy or who accessed outpatient mental health services before pregnancy had higher risk for cannabis-related acute care during pregnancy. Mothers receiving acute care for cannabis also had higher risk for acute care for hyperemesis gravidarum during pregnancy (30.9%). 

The rate of acute care for other types of substance use such as alcohol and opioids did not change after cannabis legalization, and acute care for mental health conditions such as anxiety and depression during pregnancy declined by 14%, Dr. Myran noted.

“Physicians who care for pregnant people should consider increasing screening for cannabis use during pregnancy,” said Dr. Myran. “In addition, repeated nonstigmatizing screening and counseling may be indicated for higher-risk groups identified in the study, including pregnancies with severe morning sickness.”
 

The U.S. perspective

Commenting on the study, M. Camille Hoffman, MD, MSc, a maternal-fetal medicine specialist at the University of Colorado in Aurora, said that the findings likely indicate that legalization has made cannabis users less reluctant to come forward for urgent care. “They cannot really claim that this is equivalent to more use, just that more people are willing to present,” she said. Dr. Hoffman was not involved in the study.

The Canadian results do not align perfectly with what is seen in the United States. “It does suggest that there may be more cannabinoid hyperemesis being coded as hyperemesis gravidarum, which is a pregnancy-specific condition vs. a cannabis-dependence-related one,” said Dr. Hoffman.

Literature in the United States often includes tobacco use as a covariate, she added. “This study does not appear to do that,” she said. “Rather, it uses any substance use. Because of this, it is difficult to really know the contribution of cannabis to the adverse pregnancy outcomes vs. the combination of tobacco and cannabis.”

Finally, she pointed out, the proportion of those presenting for acute care for substance use in the 2 years before conception was 22% for acute care visits for cannabis vs 1% for no acute care visits. “This suggests to me that this was a highly vulnerable group before the legalization of cannabis as well. The overall absolute difference is nine in total per 100,000 – hardly enough to draw any real conclusions. Again, maybe those nine were simply more willing to come forth with concerns with cannabis being legal.” 

There is no known safe level of cannabis consumption, and its use by pregnant women has been linked to later neurodevelopmental issues in their offspring. A 2022 U.S. study suggested that cannabis exposure in the womb may leave children later in life at risk for autism, psychiatric disorders, and problematic substance abuse, particularly as they enter peak periods of vulnerability in late adolescence.

As to the impact of legalization in certain U.S. states, a 2022 study found that women perceived legalization to mean greater access to cannabis, increased acceptance of use, and greater trust in cannabis retailers. In line with Dr. Hoffman’s view, this study suggested that legalization made pregnant women more willing to discuss cannabis use during pregnancy honestly with their care providers.

In the United States, prenatal cannabis use is still included in definitions of child abuse or neglect and can lead to termination of parental rights, even in states with full legalization.

“These findings highlight the need for ongoing monitoring of markers of cannabis use during pregnancy after legalization,” said Dr. Myran. He also called for effective policies in regions with legal cannabis, such as increased warning labels on cannabis products.

This study was supported by the Canadian Institutes of Health Research and the University of Ottawa site of ICES, which is funded by an annual grant from the Ontario Ministry of Health and Ministry of Long-Term Care. Dr. Myran reports a speaker fee from McMaster University. Dr. Hoffman reports no relevant financial relationships.
 

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

After Canada legalized recreational cannabis in 2018, the rate of acute care for cannabis use during pregnancy in Ontario nearly doubled, data indicate.

A population-based study shows that the rate of cannabis-related acute care use during pregnancy increased from 11 per 100,000 pregnancies before legalization to 20 per 100,000 pregnancies afterward: an increase of 82%. Absolute increases were small, however.

“Our findings are consistent with studies highlighting that cannabis use during pregnancy has been increasing in North America, and this study suggests that cannabis legalization might contribute to and accelerate such trends,” study author Daniel Myran, MD, MPH, a public health and preventive medicine physician at the University of Ottawa in Ontario, said in an interview.

University of Ottawa

The study was published online in the Canadian Medical Association Journal.
 

Risks for newborns  

In a 2019 study, 7% of U.S. women reported using cannabis during pregnancy during 2016-2017, which was double the rate of 3.4% for 2002-2003.

Dr. Myran and colleagues hypothesized that legalizing nonmedical cannabis has affected the drug’s use during pregnancy in Ontario. “We also hypothesized that hospital care for cannabis use would be associated with adverse neonatal outcomes, even after adjusting for other important risk factors that may differ between people with and without cannabis use,” he said.

The researchers’ repeated cross-sectional analysis evaluated changes in the number of pregnant people who received acute care from January 2015 to July 2021 among all patients who were eligible for Ontario’s public health coverage. The final study cohort included 691,242 pregnant patients, of whom 533 had at least one pregnancy with cannabis-related acute care visits. These mothers had a mean age of 24 years vs. 30 for their counterparts with no such visits.

Using segmented regression, the researchers compared changes in the quarterly rate of pregnant people with acute care related to cannabis use (the primary outcome) with those of acute care for mental health conditions or for noncannabis substance use (the control conditions).

“Severe morning sickness was a major risk factor for care in the emergency department or hospital for cannabis use,” said Dr. Myran. “Prior work has found that people who use cannabis during pregnancy often state that it was used to manage challenging symptoms of pregnancy such as morning sickness.”

Most acute care events (72.2%) were emergency department visits. The most common reasons for acute care were harmful cannabis use (57.6%), followed by cannabis dependence or withdrawal (21.5%), and acute cannabis intoxication (12.8%).

Compared with pregnancies without acute care, those with acute care related to cannabis had higher rates of adverse neonatal outcomes such as birth before 37 weeks’ gestational age (16.9% vs. 7.2%), birth weight at or below the bottom fifth percentile after adjustment for gestational age (12.1% vs. 4.4%), and neonatal intensive care unit admission in the first 28 days of life (31.5% vs. 13%).

An adjusted analysis found that patients younger than 35 years and those living in rural settings or the lowest-income neighborhoods had higher odds of acute cannabis-related care during pregnancy. Patients who received acute care for any substance use or schizophrenia before pregnancy or who accessed outpatient mental health services before pregnancy had higher risk for cannabis-related acute care during pregnancy. Mothers receiving acute care for cannabis also had higher risk for acute care for hyperemesis gravidarum during pregnancy (30.9%). 

The rate of acute care for other types of substance use such as alcohol and opioids did not change after cannabis legalization, and acute care for mental health conditions such as anxiety and depression during pregnancy declined by 14%, Dr. Myran noted.

“Physicians who care for pregnant people should consider increasing screening for cannabis use during pregnancy,” said Dr. Myran. “In addition, repeated nonstigmatizing screening and counseling may be indicated for higher-risk groups identified in the study, including pregnancies with severe morning sickness.”
 

The U.S. perspective

Commenting on the study, M. Camille Hoffman, MD, MSc, a maternal-fetal medicine specialist at the University of Colorado in Aurora, said that the findings likely indicate that legalization has made cannabis users less reluctant to come forward for urgent care. “They cannot really claim that this is equivalent to more use, just that more people are willing to present,” she said. Dr. Hoffman was not involved in the study.

The Canadian results do not align perfectly with what is seen in the United States. “It does suggest that there may be more cannabinoid hyperemesis being coded as hyperemesis gravidarum, which is a pregnancy-specific condition vs. a cannabis-dependence-related one,” said Dr. Hoffman.

Literature in the United States often includes tobacco use as a covariate, she added. “This study does not appear to do that,” she said. “Rather, it uses any substance use. Because of this, it is difficult to really know the contribution of cannabis to the adverse pregnancy outcomes vs. the combination of tobacco and cannabis.”

Finally, she pointed out, the proportion of those presenting for acute care for substance use in the 2 years before conception was 22% for acute care visits for cannabis vs 1% for no acute care visits. “This suggests to me that this was a highly vulnerable group before the legalization of cannabis as well. The overall absolute difference is nine in total per 100,000 – hardly enough to draw any real conclusions. Again, maybe those nine were simply more willing to come forth with concerns with cannabis being legal.” 

There is no known safe level of cannabis consumption, and its use by pregnant women has been linked to later neurodevelopmental issues in their offspring. A 2022 U.S. study suggested that cannabis exposure in the womb may leave children later in life at risk for autism, psychiatric disorders, and problematic substance abuse, particularly as they enter peak periods of vulnerability in late adolescence.

As to the impact of legalization in certain U.S. states, a 2022 study found that women perceived legalization to mean greater access to cannabis, increased acceptance of use, and greater trust in cannabis retailers. In line with Dr. Hoffman’s view, this study suggested that legalization made pregnant women more willing to discuss cannabis use during pregnancy honestly with their care providers.

In the United States, prenatal cannabis use is still included in definitions of child abuse or neglect and can lead to termination of parental rights, even in states with full legalization.

“These findings highlight the need for ongoing monitoring of markers of cannabis use during pregnancy after legalization,” said Dr. Myran. He also called for effective policies in regions with legal cannabis, such as increased warning labels on cannabis products.

This study was supported by the Canadian Institutes of Health Research and the University of Ottawa site of ICES, which is funded by an annual grant from the Ontario Ministry of Health and Ministry of Long-Term Care. Dr. Myran reports a speaker fee from McMaster University. Dr. Hoffman reports no relevant financial relationships.
 

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

Fibroids, or leiomyomas, are noncancerous monoclonal tumors of the smooth muscle layer of the uterus. Fibroids occur more frequently in Black patients and their prevalence increases with age. The hormonally responsive nature of fibroids, frequently leading to growth with estrogen and progesterone exposure, makes them of particular concern during pregnancy.

Although most patients with fibroids do not have pregnancy complications directly attributable to their fibroids, prior studies have reported several associations, including painful degeneration, early pregnancy loss, preterm birth, placental abruption, malpresentation, and postpartum hemorrhage. Fibroids may predispose to uterine atony and hemorrhage by disrupting or impairing the synchronization and coordination of uterine contractions. Within the current body of literature, it remains less certain whether certain fibroid characteristics are associated with increased hemorrhage risk.

Prior studies evaluating the association between specific fibroid characteristics and postpartum hemorrhage have yielded inconsistent findings. In our study, we evaluated whether certain fibroid characteristics are associated with hemorrhage requiring blood transfusion. Specifically, our goal was to determine whether larger or more numerous fibroids increase the risk of transfusion.

This was a retrospective cohort study spanning 2019-2022. A total of 4,421 patients were included in this study. Fibroid characteristics were collected, including size, number, and location. Fibroid size was classified as small (< 5 cm), medium (5-10 cm), and large (> 10 cm).

In terms of number of fibroids, there was no significant increase in transfusions when comparing one fibroid to multiple fibroids. When assessing fibroid size, however, we did observe a significant incremental increase in rate of transfusions with increasing fibroid size. Compared to patients with small fibroids (< 5 cm), those with medium fibroids (5-10 cm) were 1.7 times and those with large fibroids (> 10 cm) 2.4 times more likely to experience hemorrhage requiring blood transfusion. In terms of fibroid location, patients with fibroids in the lower uterine segment or cervix were about 1.5 times more likely to have hemorrhage requiring transfusion, compared with those without a fibroid in that location.

This study allows practitioners to better risk-stratify patients from the practical perspective of postpartum hemorrhage requiring transfusions. In pregnant patients with fibroids, the specific fibroid characteristics can help us better anticipate clinically significant postpartum hemorrhage. In such patients, it is important to document specific fibroid characteristics, especially the largest fibroid diameter and fibroid location in the lower uterine segment or cervix. This emphasizes the importance of careful sonographic evaluation and consistent documentation of fibroids in pregnant patients.

Our study helps guide more informed counseling and risk stratification in this population, with increasing risk according to fibroid size and location. Patients with high-risk features, that is, medium or large fibroids and those with fibroids located in the lower uterine segment or cervix, should thus receive counseling about their increased risk of hemorrhage. As providers, we can help ameliorate this risk by optimizing hemoglobin levels of those at increased risk prior to delivery, and by ensuring availability of appropriate resources at the time of delivery.

Dr. Yaghoubian is a maternal-fetal medicine fellow at North Shore University Hospital/Long Island Jewish Medical Center in Manhasset, N.Y., and will be joining the faculty at the same institution. Email Dr. Yaghoubian at yyaghoubian@northwell.edu.

Fibroids, or leiomyomas, are noncancerous monoclonal tumors of the smooth muscle layer of the uterus. Fibroids occur more frequently in Black patients and their prevalence increases with age. The hormonally responsive nature of fibroids, frequently leading to growth with estrogen and progesterone exposure, makes them of particular concern during pregnancy.

Although most patients with fibroids do not have pregnancy complications directly attributable to their fibroids, prior studies have reported several associations, including painful degeneration, early pregnancy loss, preterm birth, placental abruption, malpresentation, and postpartum hemorrhage. Fibroids may predispose to uterine atony and hemorrhage by disrupting or impairing the synchronization and coordination of uterine contractions. Within the current body of literature, it remains less certain whether certain fibroid characteristics are associated with increased hemorrhage risk.

Prior studies evaluating the association between specific fibroid characteristics and postpartum hemorrhage have yielded inconsistent findings. In our study, we evaluated whether certain fibroid characteristics are associated with hemorrhage requiring blood transfusion. Specifically, our goal was to determine whether larger or more numerous fibroids increase the risk of transfusion.

This was a retrospective cohort study spanning 2019-2022. A total of 4,421 patients were included in this study. Fibroid characteristics were collected, including size, number, and location. Fibroid size was classified as small (< 5 cm), medium (5-10 cm), and large (> 10 cm).

In terms of number of fibroids, there was no significant increase in transfusions when comparing one fibroid to multiple fibroids. When assessing fibroid size, however, we did observe a significant incremental increase in rate of transfusions with increasing fibroid size. Compared to patients with small fibroids (< 5 cm), those with medium fibroids (5-10 cm) were 1.7 times and those with large fibroids (> 10 cm) 2.4 times more likely to experience hemorrhage requiring blood transfusion. In terms of fibroid location, patients with fibroids in the lower uterine segment or cervix were about 1.5 times more likely to have hemorrhage requiring transfusion, compared with those without a fibroid in that location.

This study allows practitioners to better risk-stratify patients from the practical perspective of postpartum hemorrhage requiring transfusions. In pregnant patients with fibroids, the specific fibroid characteristics can help us better anticipate clinically significant postpartum hemorrhage. In such patients, it is important to document specific fibroid characteristics, especially the largest fibroid diameter and fibroid location in the lower uterine segment or cervix. This emphasizes the importance of careful sonographic evaluation and consistent documentation of fibroids in pregnant patients.

Our study helps guide more informed counseling and risk stratification in this population, with increasing risk according to fibroid size and location. Patients with high-risk features, that is, medium or large fibroids and those with fibroids located in the lower uterine segment or cervix, should thus receive counseling about their increased risk of hemorrhage. As providers, we can help ameliorate this risk by optimizing hemoglobin levels of those at increased risk prior to delivery, and by ensuring availability of appropriate resources at the time of delivery.

Dr. Yaghoubian is a maternal-fetal medicine fellow at North Shore University Hospital/Long Island Jewish Medical Center in Manhasset, N.Y., and will be joining the faculty at the same institution. Email Dr. Yaghoubian at yyaghoubian@northwell.edu.

Fibroids, or leiomyomas, are noncancerous monoclonal tumors of the smooth muscle layer of the uterus. Fibroids occur more frequently in Black patients and their prevalence increases with age. The hormonally responsive nature of fibroids, frequently leading to growth with estrogen and progesterone exposure, makes them of particular concern during pregnancy.

Although most patients with fibroids do not have pregnancy complications directly attributable to their fibroids, prior studies have reported several associations, including painful degeneration, early pregnancy loss, preterm birth, placental abruption, malpresentation, and postpartum hemorrhage. Fibroids may predispose to uterine atony and hemorrhage by disrupting or impairing the synchronization and coordination of uterine contractions. Within the current body of literature, it remains less certain whether certain fibroid characteristics are associated with increased hemorrhage risk.

Prior studies evaluating the association between specific fibroid characteristics and postpartum hemorrhage have yielded inconsistent findings. In our study, we evaluated whether certain fibroid characteristics are associated with hemorrhage requiring blood transfusion. Specifically, our goal was to determine whether larger or more numerous fibroids increase the risk of transfusion.

This was a retrospective cohort study spanning 2019-2022. A total of 4,421 patients were included in this study. Fibroid characteristics were collected, including size, number, and location. Fibroid size was classified as small (< 5 cm), medium (5-10 cm), and large (> 10 cm).

In terms of number of fibroids, there was no significant increase in transfusions when comparing one fibroid to multiple fibroids. When assessing fibroid size, however, we did observe a significant incremental increase in rate of transfusions with increasing fibroid size. Compared to patients with small fibroids (< 5 cm), those with medium fibroids (5-10 cm) were 1.7 times and those with large fibroids (> 10 cm) 2.4 times more likely to experience hemorrhage requiring blood transfusion. In terms of fibroid location, patients with fibroids in the lower uterine segment or cervix were about 1.5 times more likely to have hemorrhage requiring transfusion, compared with those without a fibroid in that location.

This study allows practitioners to better risk-stratify patients from the practical perspective of postpartum hemorrhage requiring transfusions. In pregnant patients with fibroids, the specific fibroid characteristics can help us better anticipate clinically significant postpartum hemorrhage. In such patients, it is important to document specific fibroid characteristics, especially the largest fibroid diameter and fibroid location in the lower uterine segment or cervix. This emphasizes the importance of careful sonographic evaluation and consistent documentation of fibroids in pregnant patients.

Our study helps guide more informed counseling and risk stratification in this population, with increasing risk according to fibroid size and location. Patients with high-risk features, that is, medium or large fibroids and those with fibroids located in the lower uterine segment or cervix, should thus receive counseling about their increased risk of hemorrhage. As providers, we can help ameliorate this risk by optimizing hemoglobin levels of those at increased risk prior to delivery, and by ensuring availability of appropriate resources at the time of delivery.

Dr. Yaghoubian is a maternal-fetal medicine fellow at North Shore University Hospital/Long Island Jewish Medical Center in Manhasset, N.Y., and will be joining the faculty at the same institution. Email Dr. Yaghoubian at yyaghoubian@northwell.edu.

Postpartum hemorrhage (PPH) is the leading cause of maternal deaths worldwide, particularly in the least developed and developing countries. Of the 14 million female patients affected each year, approximately 70,000 cases result in death. However, according to a new study conducted by the World Health Organization and the University of Birmingham (England), a simple and affordable strategy may reduce the occurrence of severe cases during vaginal delivery.

Using the E-MOTIVE intervention reduced severe cases of PPH by 60%. These cases are defined as entailing blood loss greater than or equal to 1,000 mL in the 24 hours following delivery. This intervention also substantially reduced the need for blood transfusions, which are often costly and difficult to obtain.

In this trial, 80 secondary-level hospitals in Kenya, Nigeria, South Africa, and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual-care group. Researchers identified that, among hospitals and patients with data, a primary outcome event occurred in 1.6% of the patients in the intervention group, compared with 4.3% of those in the usual-care group. In addition, PPH was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group. The treatment bundle was used in 91.2% and 19.4%, respectively.

The E-MOTIVE intervention, which is intended for use by health care professionals, consists of three elements:

• A strategy for early detection of PPH, which allows triggering of the “first response” treatment bundle
• A first response bundle called MOTIVE, which is based on WHO guidelines and consists of uterine massage, oxytocic drugs, tranexamic acid, IV fluids, and examination of the genital tract and escalation
• An implementation strategy that focuses on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley or carry case

During a WHO press conference, study author Arri Coomarasamy, MD, said, “This new approach to treating postpartum hemorrhage could radically improve women’s chances of surviving childbirth globally, helping them get the treatment they need when they need it.”

Dr. Coomarasamy, who is also co-director of the WHO Collaborating Centre on Global Women’s Health at the University of Birmingham, added, “Time is of the essence when responding to postpartum bleeding, so interventions that eliminate delays in diagnosis or treatment should be game-changers for maternal health.”
 

PPH a ‘preventable’ problem

In Brazil, maternal mortality is still one of the most significant challenges in public health. In recent years, the COVID-19 pandemic exacerbated the difficulties and weaknesses in the health care system for pregnant women and new mothers.

The maternal mortality ratio (MMR) is the number of maternal deaths per 100,000 live births from any cause related to or aggravated by pregnancy or its management (excluding accidental or incidental causes) during pregnancy and childbirth or within 42 days of termination of pregnancy. In 2021, the MMR was 113. This figure was almost double the 55.3 maternal deaths per 100,000 live births reported in 2019, which was before the pandemic. Preliminary data from the Brazilian Ministry of Health collected by the Brazilian Obstetric Observatory (OOBr) indicate that the MMR in 2022 decreased to 50.6 maternal deaths per 100,000 live births. However, these numbers could increase, because the maternal mortality committees are still reviewing cases.

Rossana Pulcineli Vieira Francisco, MD, PhD, a professor of obstetrics and gynecology at the University of São Paulo School of Medicine and obstetrics coordinator of the OOBr, affirmed that although these numbers have dropped, they are still much higher than the targets set by health authorities. Brazil is a participant of the UN agreement that aims to reduce MMR to a maximum of 30 maternal deaths per 100,000 live births per year by 2030. “We still have a long way to go to reach this goal within the next 7 years,” Dr. Francisco warned.

She compared rates in Brazil with those of more developed regions. According to the data, the mean MMR in Europe is 13 maternal deaths per 100,000 live births. “Portugal was shocked when maternal deaths surpassed 20 [maternal deaths per 100,000 live births in 2020] amidst the COVID-19 pandemic. The ratio in Brazil, even before the pandemic, was 55,” she said.

“Maternal mortality and infant mortality ratios are powerful indicators of the quality of the health care system,” added the OOBr coordinator, who asserted that investing in primary and prenatal care is essential. Dr. Francisco also pointed out the preventable nature of maternal mortality in Brazil. “The three main causes of direct maternal mortality in Brazil are high blood pressure, postpartum hemorrhage, and infection, particularly in the postpartum period. These issues are all considered preventable.”

Although it is difficult to prevent preeclampsia, hospital care and maternity care measures can significantly reduce the number of deaths caused by this condition. “For high blood pressure, what we most miss is having specialized prenatal care for at-risk women when the problem is diagnosed during pregnancy.”

Regarding PPH, Dr. Francisco calls attention to the importance of training teams to treat the problem. “In Brazil, the lack of training [for professionals] is still a serious problem.”

According to her, investments in rapid response systems are also needed. “As the baby needs nutrients and oxygen, the uterus becomes full of blood vessels at the end of pregnancy. As a result, a PPH leads to significant blood loss. In Brazil, some hospitals don’t even have blood bags. And in some cases, there may not be enough time to get a blood bag from somewhere else.”

Dr. Francisco also points out that, although it may not be feasible for all of Brazil’s health care units to have blood banks, integrated structures could be created to facilitate access to blood in case of emergency.

A grant from the Bill & Melinda Gates Foundation supported the E-MOTIVE project.

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

Postpartum hemorrhage (PPH) is the leading cause of maternal deaths worldwide, particularly in the least developed and developing countries. Of the 14 million female patients affected each year, approximately 70,000 cases result in death. However, according to a new study conducted by the World Health Organization and the University of Birmingham (England), a simple and affordable strategy may reduce the occurrence of severe cases during vaginal delivery.

Using the E-MOTIVE intervention reduced severe cases of PPH by 60%. These cases are defined as entailing blood loss greater than or equal to 1,000 mL in the 24 hours following delivery. This intervention also substantially reduced the need for blood transfusions, which are often costly and difficult to obtain.

In this trial, 80 secondary-level hospitals in Kenya, Nigeria, South Africa, and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual-care group. Researchers identified that, among hospitals and patients with data, a primary outcome event occurred in 1.6% of the patients in the intervention group, compared with 4.3% of those in the usual-care group. In addition, PPH was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group. The treatment bundle was used in 91.2% and 19.4%, respectively.

The E-MOTIVE intervention, which is intended for use by health care professionals, consists of three elements:

• A strategy for early detection of PPH, which allows triggering of the “first response” treatment bundle
• A first response bundle called MOTIVE, which is based on WHO guidelines and consists of uterine massage, oxytocic drugs, tranexamic acid, IV fluids, and examination of the genital tract and escalation
• An implementation strategy that focuses on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley or carry case

During a WHO press conference, study author Arri Coomarasamy, MD, said, “This new approach to treating postpartum hemorrhage could radically improve women’s chances of surviving childbirth globally, helping them get the treatment they need when they need it.”

Dr. Coomarasamy, who is also co-director of the WHO Collaborating Centre on Global Women’s Health at the University of Birmingham, added, “Time is of the essence when responding to postpartum bleeding, so interventions that eliminate delays in diagnosis or treatment should be game-changers for maternal health.”
 

PPH a ‘preventable’ problem

In Brazil, maternal mortality is still one of the most significant challenges in public health. In recent years, the COVID-19 pandemic exacerbated the difficulties and weaknesses in the health care system for pregnant women and new mothers.

The maternal mortality ratio (MMR) is the number of maternal deaths per 100,000 live births from any cause related to or aggravated by pregnancy or its management (excluding accidental or incidental causes) during pregnancy and childbirth or within 42 days of termination of pregnancy. In 2021, the MMR was 113. This figure was almost double the 55.3 maternal deaths per 100,000 live births reported in 2019, which was before the pandemic. Preliminary data from the Brazilian Ministry of Health collected by the Brazilian Obstetric Observatory (OOBr) indicate that the MMR in 2022 decreased to 50.6 maternal deaths per 100,000 live births. However, these numbers could increase, because the maternal mortality committees are still reviewing cases.

Rossana Pulcineli Vieira Francisco, MD, PhD, a professor of obstetrics and gynecology at the University of São Paulo School of Medicine and obstetrics coordinator of the OOBr, affirmed that although these numbers have dropped, they are still much higher than the targets set by health authorities. Brazil is a participant of the UN agreement that aims to reduce MMR to a maximum of 30 maternal deaths per 100,000 live births per year by 2030. “We still have a long way to go to reach this goal within the next 7 years,” Dr. Francisco warned.

She compared rates in Brazil with those of more developed regions. According to the data, the mean MMR in Europe is 13 maternal deaths per 100,000 live births. “Portugal was shocked when maternal deaths surpassed 20 [maternal deaths per 100,000 live births in 2020] amidst the COVID-19 pandemic. The ratio in Brazil, even before the pandemic, was 55,” she said.

“Maternal mortality and infant mortality ratios are powerful indicators of the quality of the health care system,” added the OOBr coordinator, who asserted that investing in primary and prenatal care is essential. Dr. Francisco also pointed out the preventable nature of maternal mortality in Brazil. “The three main causes of direct maternal mortality in Brazil are high blood pressure, postpartum hemorrhage, and infection, particularly in the postpartum period. These issues are all considered preventable.”

Although it is difficult to prevent preeclampsia, hospital care and maternity care measures can significantly reduce the number of deaths caused by this condition. “For high blood pressure, what we most miss is having specialized prenatal care for at-risk women when the problem is diagnosed during pregnancy.”

Regarding PPH, Dr. Francisco calls attention to the importance of training teams to treat the problem. “In Brazil, the lack of training [for professionals] is still a serious problem.”

According to her, investments in rapid response systems are also needed. “As the baby needs nutrients and oxygen, the uterus becomes full of blood vessels at the end of pregnancy. As a result, a PPH leads to significant blood loss. In Brazil, some hospitals don’t even have blood bags. And in some cases, there may not be enough time to get a blood bag from somewhere else.”

Dr. Francisco also points out that, although it may not be feasible for all of Brazil’s health care units to have blood banks, integrated structures could be created to facilitate access to blood in case of emergency.

A grant from the Bill & Melinda Gates Foundation supported the E-MOTIVE project.

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

Postpartum hemorrhage (PPH) is the leading cause of maternal deaths worldwide, particularly in the least developed and developing countries. Of the 14 million female patients affected each year, approximately 70,000 cases result in death. However, according to a new study conducted by the World Health Organization and the University of Birmingham (England), a simple and affordable strategy may reduce the occurrence of severe cases during vaginal delivery.

Using the E-MOTIVE intervention reduced severe cases of PPH by 60%. These cases are defined as entailing blood loss greater than or equal to 1,000 mL in the 24 hours following delivery. This intervention also substantially reduced the need for blood transfusions, which are often costly and difficult to obtain.

In this trial, 80 secondary-level hospitals in Kenya, Nigeria, South Africa, and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual-care group. Researchers identified that, among hospitals and patients with data, a primary outcome event occurred in 1.6% of the patients in the intervention group, compared with 4.3% of those in the usual-care group. In addition, PPH was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group. The treatment bundle was used in 91.2% and 19.4%, respectively.

The E-MOTIVE intervention, which is intended for use by health care professionals, consists of three elements:

• A strategy for early detection of PPH, which allows triggering of the “first response” treatment bundle
• A first response bundle called MOTIVE, which is based on WHO guidelines and consists of uterine massage, oxytocic drugs, tranexamic acid, IV fluids, and examination of the genital tract and escalation
• An implementation strategy that focuses on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley or carry case

During a WHO press conference, study author Arri Coomarasamy, MD, said, “This new approach to treating postpartum hemorrhage could radically improve women’s chances of surviving childbirth globally, helping them get the treatment they need when they need it.”

Dr. Coomarasamy, who is also co-director of the WHO Collaborating Centre on Global Women’s Health at the University of Birmingham, added, “Time is of the essence when responding to postpartum bleeding, so interventions that eliminate delays in diagnosis or treatment should be game-changers for maternal health.”
 

PPH a ‘preventable’ problem

In Brazil, maternal mortality is still one of the most significant challenges in public health. In recent years, the COVID-19 pandemic exacerbated the difficulties and weaknesses in the health care system for pregnant women and new mothers.

The maternal mortality ratio (MMR) is the number of maternal deaths per 100,000 live births from any cause related to or aggravated by pregnancy or its management (excluding accidental or incidental causes) during pregnancy and childbirth or within 42 days of termination of pregnancy. In 2021, the MMR was 113. This figure was almost double the 55.3 maternal deaths per 100,000 live births reported in 2019, which was before the pandemic. Preliminary data from the Brazilian Ministry of Health collected by the Brazilian Obstetric Observatory (OOBr) indicate that the MMR in 2022 decreased to 50.6 maternal deaths per 100,000 live births. However, these numbers could increase, because the maternal mortality committees are still reviewing cases.

Rossana Pulcineli Vieira Francisco, MD, PhD, a professor of obstetrics and gynecology at the University of São Paulo School of Medicine and obstetrics coordinator of the OOBr, affirmed that although these numbers have dropped, they are still much higher than the targets set by health authorities. Brazil is a participant of the UN agreement that aims to reduce MMR to a maximum of 30 maternal deaths per 100,000 live births per year by 2030. “We still have a long way to go to reach this goal within the next 7 years,” Dr. Francisco warned.

She compared rates in Brazil with those of more developed regions. According to the data, the mean MMR in Europe is 13 maternal deaths per 100,000 live births. “Portugal was shocked when maternal deaths surpassed 20 [maternal deaths per 100,000 live births in 2020] amidst the COVID-19 pandemic. The ratio in Brazil, even before the pandemic, was 55,” she said.

“Maternal mortality and infant mortality ratios are powerful indicators of the quality of the health care system,” added the OOBr coordinator, who asserted that investing in primary and prenatal care is essential. Dr. Francisco also pointed out the preventable nature of maternal mortality in Brazil. “The three main causes of direct maternal mortality in Brazil are high blood pressure, postpartum hemorrhage, and infection, particularly in the postpartum period. These issues are all considered preventable.”

Although it is difficult to prevent preeclampsia, hospital care and maternity care measures can significantly reduce the number of deaths caused by this condition. “For high blood pressure, what we most miss is having specialized prenatal care for at-risk women when the problem is diagnosed during pregnancy.”

Regarding PPH, Dr. Francisco calls attention to the importance of training teams to treat the problem. “In Brazil, the lack of training [for professionals] is still a serious problem.”

According to her, investments in rapid response systems are also needed. “As the baby needs nutrients and oxygen, the uterus becomes full of blood vessels at the end of pregnancy. As a result, a PPH leads to significant blood loss. In Brazil, some hospitals don’t even have blood bags. And in some cases, there may not be enough time to get a blood bag from somewhere else.”

Dr. Francisco also points out that, although it may not be feasible for all of Brazil’s health care units to have blood banks, integrated structures could be created to facilitate access to blood in case of emergency.

A grant from the Bill & Melinda Gates Foundation supported the E-MOTIVE project.

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

BALTIMORE – Poor prenatal sleep may increase the risk of postpartum depression, and prenatal depression may reduce the likelihood of mothers coming to their prenatal appointments, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Together, the two studies suggest that commonly overlooked experiences in the prenatal period can have negative effects down the line if clinicians aren’t asking patients about them and addressing the issue.

”I think the national conversation around mental health in general will hopefully carry us forward to better supporting the patients who are coming in with preexisting conditions,” lead author Minnie Jang, a 4th-year medical student at Johns Hopkins University, Baltimore, said in an interview.

Most of the attention on mood disorders of pregnancy focus on the postpartum period, but preexisting or new-onset depression during pregnancy deserves more attention, Ms. Jang told attendees. ACOG recommends that clinicians screen all patients at least once during the perinatal period, but that could be anywhere from early pregnancy to the postpartum period. Ms. Jang would like to see recommendations addressing both early pregnancy and the postpartum period.

“I think there’s this framing that postpartum depression is a distinct entity from other mental health conditions whereas it’s really part of a continuum,” Ms. Jang said in an interview.

She retrospectively analyzed the medical records of all pregnant women who completed the Edinburgh Postnatal Depression Scale (EPDS) during their first or second trimesters between 2002 and 2021 at Johns Hopkins Hospital. Among the 718 women who were screened in early pregnancy, 44.6% were Black or African American, 39.7% were white, and 15.7% were of a different race. Nearly all (94%) were not Hispanic/Latino.

Most (59%) were partnered, employed (68%), and had private insurance (58%). Only 7% used tobacco while 11% used alcohol and 6% used illicit drugs.

Twelve percent of the patients scored positive for depression, with a score of at least 10 or an affirmative answer to question 10 regarding self-harm. These women tended to be younger (P = .034), with an median age of 28 at their first visit versus 31 for those who screened negative, and were more likely to be publicly insured (P = .013) and without a partner (P = .005).

Patients who screened positive were more likely to have a history of substance use or history of a previous psychiatric diagnosis (P < .0001 for both). In addition, more patients who screened positive (49%) than those who screened negative (26%) had fetal complications (P < .001).

”There are some interesting subgroups of patients who are screening positive for depressive symptoms early on in pregnancy,” Ms. Jang said. Some come into pregnancy with preexisting mental health conditions while others have situational depressive symptoms, such as the subgroup referred to social work who had diagnosed fetal complications, she said. “Then there’s a whole other group of patients who are developing new symptoms during pregnancy.”

Patients who screened positive tended to start prenatal care later, at a median 12.3 weeks gestational age, than patients who screened negative, at a median 10.7 weeks gestational age (P = .002), the analysis found.

The number of routine prenatal care visits did not significantly differ between those who screened positive and those who screened negative, but patients with positive depression screens were almost half as likely to complete glucose tolerance testing (odds ratio, 0.6) or group B streptococcus testing (OR, 0.56) after adjusting for insurance status, gravidity, and gestational age at the patient’s first visit.

The researchers also identified a significant positive association between higher EPDS scores and the number of labor and delivery triage visits (P = .006). There were no significant differences in the rates of Tdap vaccination or screening for sexually transmitted infections between the two groups.
 

Poor sleep linked to later depression

The other study was prospective, using data from the PATCH Prenatal Care and Maternal and Child Health Outcomes study, which initially “compared health outcomes and satisfaction with prenatal care between patients receiving Centering Pregnancy group prenatal care and patients receiving traditional prenatal care,” the authors explained. This secondary analysis looked at sleep problems and postpartum depression.

“We don’t routinely ask patients about sleep or screen patients for sleeping issues,” lead author Carolyn Sinow, MD, a 4th-year resident at Kaiser Permanente Santa Clara (Calif.) Medical Center, said in an interview. “I think that we need to take sleep complaints more seriously overall, especially in early pregnancy.” While sleep problems in the third trimester often have more to do with discomforts from pregnancy itself, better sleep “in the first and second trimester is something we can really target with good sleep hygiene,” she added.

The 336 pregnant participants were recruited from Health Connect as long as they had a singleton pregnancy, were receiving prenatal care from Kaiser Permanente Northern California, and completed baseline questionnaires about their sleep and depression and anxiety symptoms during their first trimester between August 2020 and April 2021. Those with clinical depression or a high-risk pregnancy were excluded. The participants then completed the questionnaires again between 4 and 8 weeks post partum.

After adjusting for baseline depression and potential confounders, patients with poor sleep quality, indicated by a score greater than 5 on the Pittsburgh Sleep Quality Index (PSQI), were 12% more likely to develop postpartum depression, indicated by a score on the Patient Health Questionnaire depression scale (PHQ-8) of 10 or greater (relative risk, 1.12; 95% confidence interval, 1.01-1.25).

The two aspects of sleep that specifically correlated with postpartum depression were sleep quality and sleep latency, or taking a long time to fall asleep. Those reporting poor sleep quality were twice as likely to develop postpartum depression (relative risk, 2.18; 95% CI, 1.22-3.91), and those who took a while to fall asleep were 52% more likely to develop postpartum depression (RR, 1.52; 95% CI, 1.06-2.17).

Though the study also found prenatal sleep problems correlated with higher postpartum anxiety scores on the General Anxiety Disorder scale (GAD-7), the results were not statistically significant.

Kathleen Morrell, MD, MPH, an ob.gyn. in New York, was not involved in the study and said she was surprised it wasn’t something that had been studied much before because it makes sense.

“I always like it when studies confirm what we think should make sense, so it’s nice to see it,” Dr. Morrell said in an interview. “I think anytime you put something out, research it, and define it with numbers for doctors, that sometimes allows us to [realize], ‘Oh, that’s probably something we should be paying more attention to, especially if we have available treatments for it,’” she added.

“The clinical takeaway is that we really need to be screening for sleep pattern disruptions early in pregnancy, because even though it makes logical sense, it might not be something on our radar to think about,” Dr. Morrell said. “If people aren’t sleeping, well, their mental health is negatively affected.”

The most promising therapy for sleep issues currently is cognitive-behavioral therapy, which can accessed through various apps, Dr. Sinow said in an interview. “There are also safe interventions, such as melatonin and Unisom, that are totally safe in pregnancy that we can use to target sleep in early pregnancy.”

Dr. Morrell added that vitamin B6, often taken for nausea and vomiting during pregnancy, can also sometimes help people sleep and is safe during pregnancy.

“We know that postpartum depression does not necessarily only have a negative effect on the mother, but also has a negative effect on the infant and the family dynamic as well,” Dr. Morrell said. “So, we should be looking and screening for it so that we can offer people potential treatment because we know it can have long-term effects.”

Ms. Jang and Dr. Sinow did not have any disclosures. Dr. Morrell has done training for Nexplanon. Neither study noted external funding.

BALTIMORE – Poor prenatal sleep may increase the risk of postpartum depression, and prenatal depression may reduce the likelihood of mothers coming to their prenatal appointments, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Together, the two studies suggest that commonly overlooked experiences in the prenatal period can have negative effects down the line if clinicians aren’t asking patients about them and addressing the issue.

”I think the national conversation around mental health in general will hopefully carry us forward to better supporting the patients who are coming in with preexisting conditions,” lead author Minnie Jang, a 4th-year medical student at Johns Hopkins University, Baltimore, said in an interview.

Most of the attention on mood disorders of pregnancy focus on the postpartum period, but preexisting or new-onset depression during pregnancy deserves more attention, Ms. Jang told attendees. ACOG recommends that clinicians screen all patients at least once during the perinatal period, but that could be anywhere from early pregnancy to the postpartum period. Ms. Jang would like to see recommendations addressing both early pregnancy and the postpartum period.

“I think there’s this framing that postpartum depression is a distinct entity from other mental health conditions whereas it’s really part of a continuum,” Ms. Jang said in an interview.

She retrospectively analyzed the medical records of all pregnant women who completed the Edinburgh Postnatal Depression Scale (EPDS) during their first or second trimesters between 2002 and 2021 at Johns Hopkins Hospital. Among the 718 women who were screened in early pregnancy, 44.6% were Black or African American, 39.7% were white, and 15.7% were of a different race. Nearly all (94%) were not Hispanic/Latino.

Most (59%) were partnered, employed (68%), and had private insurance (58%). Only 7% used tobacco while 11% used alcohol and 6% used illicit drugs.

Twelve percent of the patients scored positive for depression, with a score of at least 10 or an affirmative answer to question 10 regarding self-harm. These women tended to be younger (P = .034), with an median age of 28 at their first visit versus 31 for those who screened negative, and were more likely to be publicly insured (P = .013) and without a partner (P = .005).

Patients who screened positive were more likely to have a history of substance use or history of a previous psychiatric diagnosis (P < .0001 for both). In addition, more patients who screened positive (49%) than those who screened negative (26%) had fetal complications (P < .001).

”There are some interesting subgroups of patients who are screening positive for depressive symptoms early on in pregnancy,” Ms. Jang said. Some come into pregnancy with preexisting mental health conditions while others have situational depressive symptoms, such as the subgroup referred to social work who had diagnosed fetal complications, she said. “Then there’s a whole other group of patients who are developing new symptoms during pregnancy.”

Patients who screened positive tended to start prenatal care later, at a median 12.3 weeks gestational age, than patients who screened negative, at a median 10.7 weeks gestational age (P = .002), the analysis found.

The number of routine prenatal care visits did not significantly differ between those who screened positive and those who screened negative, but patients with positive depression screens were almost half as likely to complete glucose tolerance testing (odds ratio, 0.6) or group B streptococcus testing (OR, 0.56) after adjusting for insurance status, gravidity, and gestational age at the patient’s first visit.

The researchers also identified a significant positive association between higher EPDS scores and the number of labor and delivery triage visits (P = .006). There were no significant differences in the rates of Tdap vaccination or screening for sexually transmitted infections between the two groups.
 

Poor sleep linked to later depression

The other study was prospective, using data from the PATCH Prenatal Care and Maternal and Child Health Outcomes study, which initially “compared health outcomes and satisfaction with prenatal care between patients receiving Centering Pregnancy group prenatal care and patients receiving traditional prenatal care,” the authors explained. This secondary analysis looked at sleep problems and postpartum depression.

“We don’t routinely ask patients about sleep or screen patients for sleeping issues,” lead author Carolyn Sinow, MD, a 4th-year resident at Kaiser Permanente Santa Clara (Calif.) Medical Center, said in an interview. “I think that we need to take sleep complaints more seriously overall, especially in early pregnancy.” While sleep problems in the third trimester often have more to do with discomforts from pregnancy itself, better sleep “in the first and second trimester is something we can really target with good sleep hygiene,” she added.

The 336 pregnant participants were recruited from Health Connect as long as they had a singleton pregnancy, were receiving prenatal care from Kaiser Permanente Northern California, and completed baseline questionnaires about their sleep and depression and anxiety symptoms during their first trimester between August 2020 and April 2021. Those with clinical depression or a high-risk pregnancy were excluded. The participants then completed the questionnaires again between 4 and 8 weeks post partum.

After adjusting for baseline depression and potential confounders, patients with poor sleep quality, indicated by a score greater than 5 on the Pittsburgh Sleep Quality Index (PSQI), were 12% more likely to develop postpartum depression, indicated by a score on the Patient Health Questionnaire depression scale (PHQ-8) of 10 or greater (relative risk, 1.12; 95% confidence interval, 1.01-1.25).

The two aspects of sleep that specifically correlated with postpartum depression were sleep quality and sleep latency, or taking a long time to fall asleep. Those reporting poor sleep quality were twice as likely to develop postpartum depression (relative risk, 2.18; 95% CI, 1.22-3.91), and those who took a while to fall asleep were 52% more likely to develop postpartum depression (RR, 1.52; 95% CI, 1.06-2.17).

Though the study also found prenatal sleep problems correlated with higher postpartum anxiety scores on the General Anxiety Disorder scale (GAD-7), the results were not statistically significant.

Kathleen Morrell, MD, MPH, an ob.gyn. in New York, was not involved in the study and said she was surprised it wasn’t something that had been studied much before because it makes sense.

“I always like it when studies confirm what we think should make sense, so it’s nice to see it,” Dr. Morrell said in an interview. “I think anytime you put something out, research it, and define it with numbers for doctors, that sometimes allows us to [realize], ‘Oh, that’s probably something we should be paying more attention to, especially if we have available treatments for it,’” she added.

“The clinical takeaway is that we really need to be screening for sleep pattern disruptions early in pregnancy, because even though it makes logical sense, it might not be something on our radar to think about,” Dr. Morrell said. “If people aren’t sleeping, well, their mental health is negatively affected.”

The most promising therapy for sleep issues currently is cognitive-behavioral therapy, which can accessed through various apps, Dr. Sinow said in an interview. “There are also safe interventions, such as melatonin and Unisom, that are totally safe in pregnancy that we can use to target sleep in early pregnancy.”

Dr. Morrell added that vitamin B6, often taken for nausea and vomiting during pregnancy, can also sometimes help people sleep and is safe during pregnancy.

“We know that postpartum depression does not necessarily only have a negative effect on the mother, but also has a negative effect on the infant and the family dynamic as well,” Dr. Morrell said. “So, we should be looking and screening for it so that we can offer people potential treatment because we know it can have long-term effects.”

Ms. Jang and Dr. Sinow did not have any disclosures. Dr. Morrell has done training for Nexplanon. Neither study noted external funding.

BALTIMORE – Poor prenatal sleep may increase the risk of postpartum depression, and prenatal depression may reduce the likelihood of mothers coming to their prenatal appointments, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Together, the two studies suggest that commonly overlooked experiences in the prenatal period can have negative effects down the line if clinicians aren’t asking patients about them and addressing the issue.

”I think the national conversation around mental health in general will hopefully carry us forward to better supporting the patients who are coming in with preexisting conditions,” lead author Minnie Jang, a 4th-year medical student at Johns Hopkins University, Baltimore, said in an interview.

Most of the attention on mood disorders of pregnancy focus on the postpartum period, but preexisting or new-onset depression during pregnancy deserves more attention, Ms. Jang told attendees. ACOG recommends that clinicians screen all patients at least once during the perinatal period, but that could be anywhere from early pregnancy to the postpartum period. Ms. Jang would like to see recommendations addressing both early pregnancy and the postpartum period.

“I think there’s this framing that postpartum depression is a distinct entity from other mental health conditions whereas it’s really part of a continuum,” Ms. Jang said in an interview.

She retrospectively analyzed the medical records of all pregnant women who completed the Edinburgh Postnatal Depression Scale (EPDS) during their first or second trimesters between 2002 and 2021 at Johns Hopkins Hospital. Among the 718 women who were screened in early pregnancy, 44.6% were Black or African American, 39.7% were white, and 15.7% were of a different race. Nearly all (94%) were not Hispanic/Latino.

Most (59%) were partnered, employed (68%), and had private insurance (58%). Only 7% used tobacco while 11% used alcohol and 6% used illicit drugs.

Twelve percent of the patients scored positive for depression, with a score of at least 10 or an affirmative answer to question 10 regarding self-harm. These women tended to be younger (P = .034), with an median age of 28 at their first visit versus 31 for those who screened negative, and were more likely to be publicly insured (P = .013) and without a partner (P = .005).

Patients who screened positive were more likely to have a history of substance use or history of a previous psychiatric diagnosis (P < .0001 for both). In addition, more patients who screened positive (49%) than those who screened negative (26%) had fetal complications (P < .001).

”There are some interesting subgroups of patients who are screening positive for depressive symptoms early on in pregnancy,” Ms. Jang said. Some come into pregnancy with preexisting mental health conditions while others have situational depressive symptoms, such as the subgroup referred to social work who had diagnosed fetal complications, she said. “Then there’s a whole other group of patients who are developing new symptoms during pregnancy.”

Patients who screened positive tended to start prenatal care later, at a median 12.3 weeks gestational age, than patients who screened negative, at a median 10.7 weeks gestational age (P = .002), the analysis found.

The number of routine prenatal care visits did not significantly differ between those who screened positive and those who screened negative, but patients with positive depression screens were almost half as likely to complete glucose tolerance testing (odds ratio, 0.6) or group B streptococcus testing (OR, 0.56) after adjusting for insurance status, gravidity, and gestational age at the patient’s first visit.

The researchers also identified a significant positive association between higher EPDS scores and the number of labor and delivery triage visits (P = .006). There were no significant differences in the rates of Tdap vaccination or screening for sexually transmitted infections between the two groups.
 

Poor sleep linked to later depression

The other study was prospective, using data from the PATCH Prenatal Care and Maternal and Child Health Outcomes study, which initially “compared health outcomes and satisfaction with prenatal care between patients receiving Centering Pregnancy group prenatal care and patients receiving traditional prenatal care,” the authors explained. This secondary analysis looked at sleep problems and postpartum depression.

“We don’t routinely ask patients about sleep or screen patients for sleeping issues,” lead author Carolyn Sinow, MD, a 4th-year resident at Kaiser Permanente Santa Clara (Calif.) Medical Center, said in an interview. “I think that we need to take sleep complaints more seriously overall, especially in early pregnancy.” While sleep problems in the third trimester often have more to do with discomforts from pregnancy itself, better sleep “in the first and second trimester is something we can really target with good sleep hygiene,” she added.

The 336 pregnant participants were recruited from Health Connect as long as they had a singleton pregnancy, were receiving prenatal care from Kaiser Permanente Northern California, and completed baseline questionnaires about their sleep and depression and anxiety symptoms during their first trimester between August 2020 and April 2021. Those with clinical depression or a high-risk pregnancy were excluded. The participants then completed the questionnaires again between 4 and 8 weeks post partum.

After adjusting for baseline depression and potential confounders, patients with poor sleep quality, indicated by a score greater than 5 on the Pittsburgh Sleep Quality Index (PSQI), were 12% more likely to develop postpartum depression, indicated by a score on the Patient Health Questionnaire depression scale (PHQ-8) of 10 or greater (relative risk, 1.12; 95% confidence interval, 1.01-1.25).

The two aspects of sleep that specifically correlated with postpartum depression were sleep quality and sleep latency, or taking a long time to fall asleep. Those reporting poor sleep quality were twice as likely to develop postpartum depression (relative risk, 2.18; 95% CI, 1.22-3.91), and those who took a while to fall asleep were 52% more likely to develop postpartum depression (RR, 1.52; 95% CI, 1.06-2.17).

Though the study also found prenatal sleep problems correlated with higher postpartum anxiety scores on the General Anxiety Disorder scale (GAD-7), the results were not statistically significant.

Kathleen Morrell, MD, MPH, an ob.gyn. in New York, was not involved in the study and said she was surprised it wasn’t something that had been studied much before because it makes sense.

“I always like it when studies confirm what we think should make sense, so it’s nice to see it,” Dr. Morrell said in an interview. “I think anytime you put something out, research it, and define it with numbers for doctors, that sometimes allows us to [realize], ‘Oh, that’s probably something we should be paying more attention to, especially if we have available treatments for it,’” she added.

“The clinical takeaway is that we really need to be screening for sleep pattern disruptions early in pregnancy, because even though it makes logical sense, it might not be something on our radar to think about,” Dr. Morrell said. “If people aren’t sleeping, well, their mental health is negatively affected.”

The most promising therapy for sleep issues currently is cognitive-behavioral therapy, which can accessed through various apps, Dr. Sinow said in an interview. “There are also safe interventions, such as melatonin and Unisom, that are totally safe in pregnancy that we can use to target sleep in early pregnancy.”

Dr. Morrell added that vitamin B6, often taken for nausea and vomiting during pregnancy, can also sometimes help people sleep and is safe during pregnancy.

“We know that postpartum depression does not necessarily only have a negative effect on the mother, but also has a negative effect on the infant and the family dynamic as well,” Dr. Morrell said. “So, we should be looking and screening for it so that we can offer people potential treatment because we know it can have long-term effects.”

Ms. Jang and Dr. Sinow did not have any disclosures. Dr. Morrell has done training for Nexplanon. Neither study noted external funding.

COVID-19 boosters are not linked to an increased chance of miscarriage, according to a new study in JAMA Network Open.

Researchers were seeking to learn whether a booster in early pregnancy, before 20 weeks, was associated with greater likelihood of spontaneous abortion.

They examined more than 100,000 pregnancies at 6-19 weeks from eight health systems in the Vaccine Safety Datalink (VSD). They found that receiving a COVID-19 booster shot in a 28-day or 42-day exposure window did not increase the chances of miscarriage.

“These findings support the safety of COVID-19 booster vaccination in early pregnancy,” they wrote.

The VSD is a collaboration between the Centers for Disease Control and Prevention’s Immunization Safety Office and large health care systems. The “observational, case-control, surveillance study” was conducted from Nov. 1, 2021, to June 12, 2022.

“COVID infection during pregnancy increases risk of poor outcomes, yet many people who are pregnant or thinking about getting pregnant are hesitant to get a booster dose because of questions about safety,” said Elyse Kharbanda, MD, senior investigator at HealthPartners Institute and lead author of the study in a press release.

The University of Minnesota reported that “previous studies have shown COIVD-19 primary vaccination is safe in pregnancy and not associated with an increased risk for miscarriage. Several studies have also shown COVID-19 can be more severe in pregnancy and lead to worse outcomes for the mother.”

The study was funded by the CDC. Five study authors reported conflicts of interest with Pfizer, Merck, GlaxoSmithKline, AbbVie, and Sanofi Pasteur.

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

COVID-19 boosters are not linked to an increased chance of miscarriage, according to a new study in JAMA Network Open.

Researchers were seeking to learn whether a booster in early pregnancy, before 20 weeks, was associated with greater likelihood of spontaneous abortion.

They examined more than 100,000 pregnancies at 6-19 weeks from eight health systems in the Vaccine Safety Datalink (VSD). They found that receiving a COVID-19 booster shot in a 28-day or 42-day exposure window did not increase the chances of miscarriage.

“These findings support the safety of COVID-19 booster vaccination in early pregnancy,” they wrote.

The VSD is a collaboration between the Centers for Disease Control and Prevention’s Immunization Safety Office and large health care systems. The “observational, case-control, surveillance study” was conducted from Nov. 1, 2021, to June 12, 2022.

“COVID infection during pregnancy increases risk of poor outcomes, yet many people who are pregnant or thinking about getting pregnant are hesitant to get a booster dose because of questions about safety,” said Elyse Kharbanda, MD, senior investigator at HealthPartners Institute and lead author of the study in a press release.

The University of Minnesota reported that “previous studies have shown COIVD-19 primary vaccination is safe in pregnancy and not associated with an increased risk for miscarriage. Several studies have also shown COVID-19 can be more severe in pregnancy and lead to worse outcomes for the mother.”

The study was funded by the CDC. Five study authors reported conflicts of interest with Pfizer, Merck, GlaxoSmithKline, AbbVie, and Sanofi Pasteur.

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

COVID-19 boosters are not linked to an increased chance of miscarriage, according to a new study in JAMA Network Open.

Researchers were seeking to learn whether a booster in early pregnancy, before 20 weeks, was associated with greater likelihood of spontaneous abortion.

They examined more than 100,000 pregnancies at 6-19 weeks from eight health systems in the Vaccine Safety Datalink (VSD). They found that receiving a COVID-19 booster shot in a 28-day or 42-day exposure window did not increase the chances of miscarriage.

“These findings support the safety of COVID-19 booster vaccination in early pregnancy,” they wrote.

The VSD is a collaboration between the Centers for Disease Control and Prevention’s Immunization Safety Office and large health care systems. The “observational, case-control, surveillance study” was conducted from Nov. 1, 2021, to June 12, 2022.

“COVID infection during pregnancy increases risk of poor outcomes, yet many people who are pregnant or thinking about getting pregnant are hesitant to get a booster dose because of questions about safety,” said Elyse Kharbanda, MD, senior investigator at HealthPartners Institute and lead author of the study in a press release.

The University of Minnesota reported that “previous studies have shown COIVD-19 primary vaccination is safe in pregnancy and not associated with an increased risk for miscarriage. Several studies have also shown COVID-19 can be more severe in pregnancy and lead to worse outcomes for the mother.”

The study was funded by the CDC. Five study authors reported conflicts of interest with Pfizer, Merck, GlaxoSmithKline, AbbVie, and Sanofi Pasteur.

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

BALTIMORE – Training hospitals that have state or institutional abortion restrictions are less likely to follow the evidence-based standard of care in diagnosing and managing miscarriages, including taking patient preferences into account, according to a cross-sectional study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists and published in Obstetrics & Gynecology.

The results revealed that “abortion restrictions have far-reaching effects on early pregnancy loss care and on resident education,” the researchers concluded.

“Abortion restrictions don’t just affect people seeking abortions; they affect people also suffering from early pregnancy loss,” Aurora Phillips, MD, an ob.gyn. resident at Albany (N.Y.) Medical Center, said in an interview. “It’s harder to make that diagnosis and to be able to offer interventions, and these institutions that had restrictions also were less likely to have mifepristone or office based human aspiration, which are the most efficient and cost-effective interventions that we have.”

For example, less than half the programs surveyed offered mifepristone to help manage a miscarriage, “with availability varying inversely with abortion restrictions,” they found. After considering all characteristics of residency programs, “institutional abortion restrictions and bans were more important than state policies or religious affiliation in determining whether evidence-based early pregnancy loss treatments were available,” the researchers found, though their findings predated the Supreme Court’s Dobbs ruling that overturned Roe v. Wade. “Training institutions with a commitment to evidence-based family planning care and education are able to ensure access to the most evidence-based, cost-effective, and timely treatments for pregnancy loss even in the face of state abortion restrictions, thereby preserving patient safety, physician competency, and health care system sustainability,” they wrote.
 

Reduced access leads to higher risk interventions

An estimated 10%-20% of pregnancies result in early miscarriage, totaling more than one million cases in the U.S. each year. But since treatments for miscarriage often overlap with those for abortion, the researchers wondered whether differences existed in how providers managed miscarriages in states or institutions with strict abortion restrictions versus management in hospitals without restrictions.

They also looked at how closely the management strategies adhered to ACOG’s recommendations, which advise that providers consider both ultrasound imaging and other factors, including clinical reasoning and patient preferences, before diagnosing early pregnancy loss and considering possible interventions.

For imaging guidelines, ACOG endorses the criteria established for ultrasound diagnosis of first trimester pregnancy loss from the Society of Radiologists in 2012. But, the authors note, these guidelines are very conservative, exceeding previous measurements that had a 99%-100% predictive value for pregnancy loss, in the interest of “[prioritizing preservation of] fetal potential over facilitating expeditious care.” Hence the reason ACOG advises providers to include clinical judgment and patient preferences in their approach to care.

”In places where abortion is heavily regulated, clinicians managing miscarriages may cautiously rely on the strictest criteria to differentiate early pregnancy loss from potentially viable pregnancy and may not offer certain treatments commonly associated with abortion,” the authors noted. ACOG recommends surgical aspiration and medical treatment with both mifepristone and misoprostol as the safest and most effective options in managing miscarriages.

“Treating early pregnancy loss without the use of mifepristone is more likely to fail, is more likely to require an unscheduled procedure, and people who choose medication management for their miscarriages are usually trying to avoid a procedure, so that is the downside of not using mifepristone,” coauthor Rachel M. Flink-Bochacki, MD, an associate professor at Albany (N.Y.) Medical Center, said in an interview.

“Office-based uterine aspiration has the same safety profile as uterine aspiration in the operating room minus the risks of anesthesia and also helps patients get in faster because they don’t need to wait for OR time,” Dr. Flink-Bochacki explained. “So again, for a patient who wants an aspiration and does not want to pass the pregnancy at home, not having access to office-based aspiration could lead them to miscarry at home, which has higher risks and is not what they wanted.”
 

Reduced access to miscarriage care options in ‘hostile’ states

Among all 296 U.S. ob.gyn. residency programs that were contacted between November 2021 and January 2022, half (50.3%) responded to the researchers’ survey about their institutional practices around miscarriage, including location of diagnosis, use of ultrasound diagnostic guidelines, treatment options offered by their institution, and institutional restrictions on abortions based on indication.

The survey also collected characteristics of each program, including its state, setting, religious affiliation, and affiliation with the Ryan Training Program in Abortion and Family Planning. The responding sample had similar geographic distribution and state abortion policies as those who did not respond, but the responding programs were slightly more likely to be academic programs and to be affiliated with the Ryan program.

At the time of the study, prior to the Dobbs ruling, more than half the U.S. states had legislation restricting abortion care, and 57% of national teaching hospitals had internal restrictions that limited care based on gestational age and indication, particularly if the indication was elective, the authors reported. The researchers relied on designations from the Guttmacher Institute in December 2020 to categorize states as “hostile” to abortion (very hostile, hostile, and leans hostile) or non-hostile (neutral, leans supportive, supportive, and very supportive).

Most of the programs (80%) had no religious affiliation, but 11% had a Catholic affiliation and 5% had a different Christian affiliation. Institutional policies either had no restrictions on abortion care (38%), had restrictions (39%) based on certain maternal or fetal indications, or completely banned abortion services unless the mother’s life was threatened (23%). Among the Christian-affiliated programs, 60% had bans and 40% had restrictions.

Half (49.7%) of the responding programs relied rigidly on ultrasound criteria before offering any intervention for suspected early pregnancy loss, regardless of patient preferences. The other half (50.3%) incorporated ultrasound criteria and other factors, including clinical judgment and patient preferences, into a holistic determination of what options to present to the patient.

Before accounting for other factors, the researchers found that only a third (33%) of programs in states with severe abortion restrictions considered additional factors besides imaging when offering patients options for miscarriage management. In states without such abortion restrictions, 79% of programs considered both imaging and other factors (P < .001).

In states with “hostile abortion legislation,” only 32% of the programs used mifepristone for miscarriage management, compared with 75% of the programs in states without onerous abortion restrictions (P < .001). The results were similar for use of office-based suction aspiration: Just under half the programs (48%) in states with severe abortion restrictions included this technique as part of standard miscarriage management, compared with 68% of programs in states without such restrictions (P = .014).

Those findings match up with the experience of Cara Heuser, MD, a maternal-fetal medicine specialist from Salt Lake City, who was not involved in this study.

“We had a lot of restrictions even before Roe fell,” including heavy regulation of mifepristone, Dr. Heuser said in an interview. “In non-restricted states, it’s pretty easy to get, but even before Roe in our state, it was very, very difficult to get institutions and individual doctor’s offices to carry mifepristone to treat miscarriages. They were still treating miscarriages in a way that was known to be less effective.” Adding mifepristone to misoprostol reduces the risk of needing an evacuation surgery procedure, she explained, “so adding the mifepristone makes it safer.”
 

Institutional policies had the strongest impact

Before accounting for the state a hospital was in, 27% of institutions with restrictive abortion policies looked at more than imaging in determining how to proceed, compared with 88% of institutions without abortion restrictions that included clinical judgment and patient preferences in their management.

After controlling for state policies and affiliation with a family planning training program or a religious entity, the odds of an institution relying solely on imaging guidelines were over 12 times greater for institutions with abortion restrictions or bans (odds ratio, 12.3; 95% confidence interval, 3.2-47.9). Specifically, the odds were 9 times greater for institutions with restrictions and 27 times greater for institutions with bans.

Only 12% of the institutions without restrictions relied solely on ultrasound criteria, compared with 67% of the institutions with restrictions and 82% of the institutions that banned all abortions except to save the life of the pregnant individual (P < .001).

Only one in four (25%) of the programs with institutional abortion restrictions used mifepristone, compared with 86% of unrestricted programs (P < .001), and 40% of programs with institutional abortion restrictions used office-based aspiration, compared with 81% of unrestricted programs (P < .001).

Without access to all evidence-based treatments, doctors are often forced to choose expectant management for miscarriages. “So you’re kind of forced to have them to pass the pregnancy at home, which can be traumatic for patients” if that’s not what they wanted, Dr. Phillips said.

Dr. Flink-Bochacki further noted that this patient population is already particularly vulnerable.

“Especially for patients with early pregnancy loss, it’s such a feeling of powerlessness already, so the mental state that many of these patients are in is already quite fraught,” Dr. Flink-Bochacki said. “Then to not even have power to choose the interventions that you want or to be able to access interventions in a timely fashion because you’re being held to some arbitrary guideline further takes away the power and further exacerbates the trauma of the experience.”

The biggest factor likely driving the reduced access to those interventions is the fear that the care could be confused with providing an abortion instead of simply managing a miscarriage, Dr. Flink-Bochacki said. “I think that’s why a lot of these programs don’t have mifepristone and don’t offer outpatient uterine aspiration,” she said. “Because those are so widely used in abortion and the connotation is with abortion, they’re just kind of steering clear of it, but meanwhile, patients with pregnancy loss are suffering because they’re being unnecessarily restrictive.”

The research did not use any external funding, and the authors and Dr. Heuser had no disclosures.

BALTIMORE – Training hospitals that have state or institutional abortion restrictions are less likely to follow the evidence-based standard of care in diagnosing and managing miscarriages, including taking patient preferences into account, according to a cross-sectional study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists and published in Obstetrics & Gynecology.

The results revealed that “abortion restrictions have far-reaching effects on early pregnancy loss care and on resident education,” the researchers concluded.

“Abortion restrictions don’t just affect people seeking abortions; they affect people also suffering from early pregnancy loss,” Aurora Phillips, MD, an ob.gyn. resident at Albany (N.Y.) Medical Center, said in an interview. “It’s harder to make that diagnosis and to be able to offer interventions, and these institutions that had restrictions also were less likely to have mifepristone or office based human aspiration, which are the most efficient and cost-effective interventions that we have.”

For example, less than half the programs surveyed offered mifepristone to help manage a miscarriage, “with availability varying inversely with abortion restrictions,” they found. After considering all characteristics of residency programs, “institutional abortion restrictions and bans were more important than state policies or religious affiliation in determining whether evidence-based early pregnancy loss treatments were available,” the researchers found, though their findings predated the Supreme Court’s Dobbs ruling that overturned Roe v. Wade. “Training institutions with a commitment to evidence-based family planning care and education are able to ensure access to the most evidence-based, cost-effective, and timely treatments for pregnancy loss even in the face of state abortion restrictions, thereby preserving patient safety, physician competency, and health care system sustainability,” they wrote.
 

Reduced access leads to higher risk interventions

An estimated 10%-20% of pregnancies result in early miscarriage, totaling more than one million cases in the U.S. each year. But since treatments for miscarriage often overlap with those for abortion, the researchers wondered whether differences existed in how providers managed miscarriages in states or institutions with strict abortion restrictions versus management in hospitals without restrictions.

They also looked at how closely the management strategies adhered to ACOG’s recommendations, which advise that providers consider both ultrasound imaging and other factors, including clinical reasoning and patient preferences, before diagnosing early pregnancy loss and considering possible interventions.

For imaging guidelines, ACOG endorses the criteria established for ultrasound diagnosis of first trimester pregnancy loss from the Society of Radiologists in 2012. But, the authors note, these guidelines are very conservative, exceeding previous measurements that had a 99%-100% predictive value for pregnancy loss, in the interest of “[prioritizing preservation of] fetal potential over facilitating expeditious care.” Hence the reason ACOG advises providers to include clinical judgment and patient preferences in their approach to care.

”In places where abortion is heavily regulated, clinicians managing miscarriages may cautiously rely on the strictest criteria to differentiate early pregnancy loss from potentially viable pregnancy and may not offer certain treatments commonly associated with abortion,” the authors noted. ACOG recommends surgical aspiration and medical treatment with both mifepristone and misoprostol as the safest and most effective options in managing miscarriages.

“Treating early pregnancy loss without the use of mifepristone is more likely to fail, is more likely to require an unscheduled procedure, and people who choose medication management for their miscarriages are usually trying to avoid a procedure, so that is the downside of not using mifepristone,” coauthor Rachel M. Flink-Bochacki, MD, an associate professor at Albany (N.Y.) Medical Center, said in an interview.

“Office-based uterine aspiration has the same safety profile as uterine aspiration in the operating room minus the risks of anesthesia and also helps patients get in faster because they don’t need to wait for OR time,” Dr. Flink-Bochacki explained. “So again, for a patient who wants an aspiration and does not want to pass the pregnancy at home, not having access to office-based aspiration could lead them to miscarry at home, which has higher risks and is not what they wanted.”
 

Reduced access to miscarriage care options in ‘hostile’ states

Among all 296 U.S. ob.gyn. residency programs that were contacted between November 2021 and January 2022, half (50.3%) responded to the researchers’ survey about their institutional practices around miscarriage, including location of diagnosis, use of ultrasound diagnostic guidelines, treatment options offered by their institution, and institutional restrictions on abortions based on indication.

The survey also collected characteristics of each program, including its state, setting, religious affiliation, and affiliation with the Ryan Training Program in Abortion and Family Planning. The responding sample had similar geographic distribution and state abortion policies as those who did not respond, but the responding programs were slightly more likely to be academic programs and to be affiliated with the Ryan program.

At the time of the study, prior to the Dobbs ruling, more than half the U.S. states had legislation restricting abortion care, and 57% of national teaching hospitals had internal restrictions that limited care based on gestational age and indication, particularly if the indication was elective, the authors reported. The researchers relied on designations from the Guttmacher Institute in December 2020 to categorize states as “hostile” to abortion (very hostile, hostile, and leans hostile) or non-hostile (neutral, leans supportive, supportive, and very supportive).

Most of the programs (80%) had no religious affiliation, but 11% had a Catholic affiliation and 5% had a different Christian affiliation. Institutional policies either had no restrictions on abortion care (38%), had restrictions (39%) based on certain maternal or fetal indications, or completely banned abortion services unless the mother’s life was threatened (23%). Among the Christian-affiliated programs, 60% had bans and 40% had restrictions.

Half (49.7%) of the responding programs relied rigidly on ultrasound criteria before offering any intervention for suspected early pregnancy loss, regardless of patient preferences. The other half (50.3%) incorporated ultrasound criteria and other factors, including clinical judgment and patient preferences, into a holistic determination of what options to present to the patient.

Before accounting for other factors, the researchers found that only a third (33%) of programs in states with severe abortion restrictions considered additional factors besides imaging when offering patients options for miscarriage management. In states without such abortion restrictions, 79% of programs considered both imaging and other factors (P < .001).

In states with “hostile abortion legislation,” only 32% of the programs used mifepristone for miscarriage management, compared with 75% of the programs in states without onerous abortion restrictions (P < .001). The results were similar for use of office-based suction aspiration: Just under half the programs (48%) in states with severe abortion restrictions included this technique as part of standard miscarriage management, compared with 68% of programs in states without such restrictions (P = .014).

Those findings match up with the experience of Cara Heuser, MD, a maternal-fetal medicine specialist from Salt Lake City, who was not involved in this study.

“We had a lot of restrictions even before Roe fell,” including heavy regulation of mifepristone, Dr. Heuser said in an interview. “In non-restricted states, it’s pretty easy to get, but even before Roe in our state, it was very, very difficult to get institutions and individual doctor’s offices to carry mifepristone to treat miscarriages. They were still treating miscarriages in a way that was known to be less effective.” Adding mifepristone to misoprostol reduces the risk of needing an evacuation surgery procedure, she explained, “so adding the mifepristone makes it safer.”
 

Institutional policies had the strongest impact

Before accounting for the state a hospital was in, 27% of institutions with restrictive abortion policies looked at more than imaging in determining how to proceed, compared with 88% of institutions without abortion restrictions that included clinical judgment and patient preferences in their management.

After controlling for state policies and affiliation with a family planning training program or a religious entity, the odds of an institution relying solely on imaging guidelines were over 12 times greater for institutions with abortion restrictions or bans (odds ratio, 12.3; 95% confidence interval, 3.2-47.9). Specifically, the odds were 9 times greater for institutions with restrictions and 27 times greater for institutions with bans.

Only 12% of the institutions without restrictions relied solely on ultrasound criteria, compared with 67% of the institutions with restrictions and 82% of the institutions that banned all abortions except to save the life of the pregnant individual (P < .001).

Only one in four (25%) of the programs with institutional abortion restrictions used mifepristone, compared with 86% of unrestricted programs (P < .001), and 40% of programs with institutional abortion restrictions used office-based aspiration, compared with 81% of unrestricted programs (P < .001).

Without access to all evidence-based treatments, doctors are often forced to choose expectant management for miscarriages. “So you’re kind of forced to have them to pass the pregnancy at home, which can be traumatic for patients” if that’s not what they wanted, Dr. Phillips said.

Dr. Flink-Bochacki further noted that this patient population is already particularly vulnerable.

“Especially for patients with early pregnancy loss, it’s such a feeling of powerlessness already, so the mental state that many of these patients are in is already quite fraught,” Dr. Flink-Bochacki said. “Then to not even have power to choose the interventions that you want or to be able to access interventions in a timely fashion because you’re being held to some arbitrary guideline further takes away the power and further exacerbates the trauma of the experience.”

The biggest factor likely driving the reduced access to those interventions is the fear that the care could be confused with providing an abortion instead of simply managing a miscarriage, Dr. Flink-Bochacki said. “I think that’s why a lot of these programs don’t have mifepristone and don’t offer outpatient uterine aspiration,” she said. “Because those are so widely used in abortion and the connotation is with abortion, they’re just kind of steering clear of it, but meanwhile, patients with pregnancy loss are suffering because they’re being unnecessarily restrictive.”

The research did not use any external funding, and the authors and Dr. Heuser had no disclosures.

BALTIMORE – Training hospitals that have state or institutional abortion restrictions are less likely to follow the evidence-based standard of care in diagnosing and managing miscarriages, including taking patient preferences into account, according to a cross-sectional study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists and published in Obstetrics & Gynecology.

The results revealed that “abortion restrictions have far-reaching effects on early pregnancy loss care and on resident education,” the researchers concluded.

“Abortion restrictions don’t just affect people seeking abortions; they affect people also suffering from early pregnancy loss,” Aurora Phillips, MD, an ob.gyn. resident at Albany (N.Y.) Medical Center, said in an interview. “It’s harder to make that diagnosis and to be able to offer interventions, and these institutions that had restrictions also were less likely to have mifepristone or office based human aspiration, which are the most efficient and cost-effective interventions that we have.”

For example, less than half the programs surveyed offered mifepristone to help manage a miscarriage, “with availability varying inversely with abortion restrictions,” they found. After considering all characteristics of residency programs, “institutional abortion restrictions and bans were more important than state policies or religious affiliation in determining whether evidence-based early pregnancy loss treatments were available,” the researchers found, though their findings predated the Supreme Court’s Dobbs ruling that overturned Roe v. Wade. “Training institutions with a commitment to evidence-based family planning care and education are able to ensure access to the most evidence-based, cost-effective, and timely treatments for pregnancy loss even in the face of state abortion restrictions, thereby preserving patient safety, physician competency, and health care system sustainability,” they wrote.
 

Reduced access leads to higher risk interventions

An estimated 10%-20% of pregnancies result in early miscarriage, totaling more than one million cases in the U.S. each year. But since treatments for miscarriage often overlap with those for abortion, the researchers wondered whether differences existed in how providers managed miscarriages in states or institutions with strict abortion restrictions versus management in hospitals without restrictions.

They also looked at how closely the management strategies adhered to ACOG’s recommendations, which advise that providers consider both ultrasound imaging and other factors, including clinical reasoning and patient preferences, before diagnosing early pregnancy loss and considering possible interventions.

For imaging guidelines, ACOG endorses the criteria established for ultrasound diagnosis of first trimester pregnancy loss from the Society of Radiologists in 2012. But, the authors note, these guidelines are very conservative, exceeding previous measurements that had a 99%-100% predictive value for pregnancy loss, in the interest of “[prioritizing preservation of] fetal potential over facilitating expeditious care.” Hence the reason ACOG advises providers to include clinical judgment and patient preferences in their approach to care.

”In places where abortion is heavily regulated, clinicians managing miscarriages may cautiously rely on the strictest criteria to differentiate early pregnancy loss from potentially viable pregnancy and may not offer certain treatments commonly associated with abortion,” the authors noted. ACOG recommends surgical aspiration and medical treatment with both mifepristone and misoprostol as the safest and most effective options in managing miscarriages.

“Treating early pregnancy loss without the use of mifepristone is more likely to fail, is more likely to require an unscheduled procedure, and people who choose medication management for their miscarriages are usually trying to avoid a procedure, so that is the downside of not using mifepristone,” coauthor Rachel M. Flink-Bochacki, MD, an associate professor at Albany (N.Y.) Medical Center, said in an interview.

“Office-based uterine aspiration has the same safety profile as uterine aspiration in the operating room minus the risks of anesthesia and also helps patients get in faster because they don’t need to wait for OR time,” Dr. Flink-Bochacki explained. “So again, for a patient who wants an aspiration and does not want to pass the pregnancy at home, not having access to office-based aspiration could lead them to miscarry at home, which has higher risks and is not what they wanted.”
 

Reduced access to miscarriage care options in ‘hostile’ states

Among all 296 U.S. ob.gyn. residency programs that were contacted between November 2021 and January 2022, half (50.3%) responded to the researchers’ survey about their institutional practices around miscarriage, including location of diagnosis, use of ultrasound diagnostic guidelines, treatment options offered by their institution, and institutional restrictions on abortions based on indication.

The survey also collected characteristics of each program, including its state, setting, religious affiliation, and affiliation with the Ryan Training Program in Abortion and Family Planning. The responding sample had similar geographic distribution and state abortion policies as those who did not respond, but the responding programs were slightly more likely to be academic programs and to be affiliated with the Ryan program.

At the time of the study, prior to the Dobbs ruling, more than half the U.S. states had legislation restricting abortion care, and 57% of national teaching hospitals had internal restrictions that limited care based on gestational age and indication, particularly if the indication was elective, the authors reported. The researchers relied on designations from the Guttmacher Institute in December 2020 to categorize states as “hostile” to abortion (very hostile, hostile, and leans hostile) or non-hostile (neutral, leans supportive, supportive, and very supportive).

Most of the programs (80%) had no religious affiliation, but 11% had a Catholic affiliation and 5% had a different Christian affiliation. Institutional policies either had no restrictions on abortion care (38%), had restrictions (39%) based on certain maternal or fetal indications, or completely banned abortion services unless the mother’s life was threatened (23%). Among the Christian-affiliated programs, 60% had bans and 40% had restrictions.

Half (49.7%) of the responding programs relied rigidly on ultrasound criteria before offering any intervention for suspected early pregnancy loss, regardless of patient preferences. The other half (50.3%) incorporated ultrasound criteria and other factors, including clinical judgment and patient preferences, into a holistic determination of what options to present to the patient.

Before accounting for other factors, the researchers found that only a third (33%) of programs in states with severe abortion restrictions considered additional factors besides imaging when offering patients options for miscarriage management. In states without such abortion restrictions, 79% of programs considered both imaging and other factors (P < .001).

In states with “hostile abortion legislation,” only 32% of the programs used mifepristone for miscarriage management, compared with 75% of the programs in states without onerous abortion restrictions (P < .001). The results were similar for use of office-based suction aspiration: Just under half the programs (48%) in states with severe abortion restrictions included this technique as part of standard miscarriage management, compared with 68% of programs in states without such restrictions (P = .014).

Those findings match up with the experience of Cara Heuser, MD, a maternal-fetal medicine specialist from Salt Lake City, who was not involved in this study.

“We had a lot of restrictions even before Roe fell,” including heavy regulation of mifepristone, Dr. Heuser said in an interview. “In non-restricted states, it’s pretty easy to get, but even before Roe in our state, it was very, very difficult to get institutions and individual doctor’s offices to carry mifepristone to treat miscarriages. They were still treating miscarriages in a way that was known to be less effective.” Adding mifepristone to misoprostol reduces the risk of needing an evacuation surgery procedure, she explained, “so adding the mifepristone makes it safer.”
 

Institutional policies had the strongest impact

Before accounting for the state a hospital was in, 27% of institutions with restrictive abortion policies looked at more than imaging in determining how to proceed, compared with 88% of institutions without abortion restrictions that included clinical judgment and patient preferences in their management.

After controlling for state policies and affiliation with a family planning training program or a religious entity, the odds of an institution relying solely on imaging guidelines were over 12 times greater for institutions with abortion restrictions or bans (odds ratio, 12.3; 95% confidence interval, 3.2-47.9). Specifically, the odds were 9 times greater for institutions with restrictions and 27 times greater for institutions with bans.

Only 12% of the institutions without restrictions relied solely on ultrasound criteria, compared with 67% of the institutions with restrictions and 82% of the institutions that banned all abortions except to save the life of the pregnant individual (P < .001).

Only one in four (25%) of the programs with institutional abortion restrictions used mifepristone, compared with 86% of unrestricted programs (P < .001), and 40% of programs with institutional abortion restrictions used office-based aspiration, compared with 81% of unrestricted programs (P < .001).

Without access to all evidence-based treatments, doctors are often forced to choose expectant management for miscarriages. “So you’re kind of forced to have them to pass the pregnancy at home, which can be traumatic for patients” if that’s not what they wanted, Dr. Phillips said.

Dr. Flink-Bochacki further noted that this patient population is already particularly vulnerable.

“Especially for patients with early pregnancy loss, it’s such a feeling of powerlessness already, so the mental state that many of these patients are in is already quite fraught,” Dr. Flink-Bochacki said. “Then to not even have power to choose the interventions that you want or to be able to access interventions in a timely fashion because you’re being held to some arbitrary guideline further takes away the power and further exacerbates the trauma of the experience.”

The biggest factor likely driving the reduced access to those interventions is the fear that the care could be confused with providing an abortion instead of simply managing a miscarriage, Dr. Flink-Bochacki said. “I think that’s why a lot of these programs don’t have mifepristone and don’t offer outpatient uterine aspiration,” she said. “Because those are so widely used in abortion and the connotation is with abortion, they’re just kind of steering clear of it, but meanwhile, patients with pregnancy loss are suffering because they’re being unnecessarily restrictive.”

The research did not use any external funding, and the authors and Dr. Heuser had no disclosures.