Obstetrics

The use of glucagon-like peptide 1 (GLP-1) agonists within a year had no apparent effect on the number of oocytes retrieved in controlled ovarian hyperstimulation (COH), based on data from 73 patients in a multicenter study.

Obesity rates continue to rise in women of reproductive age and many women are using GLP-1 agonists for weight loss, but data on the effect of these drugs on fertility treatments are lacking, said Victoria K. Lazarov, MD, of Icahn School of Medicine at Mount Sinai, New York City, in an abstract presented at the American Society for Reproductive Medicine (ASRM) 2024 scientific congress.

Clinical opinions regarding the use, duration, and discontinuation of GLP-1 agonists during fertility treatments are variable given the limited research, Lazarov noted in her abstract. More data are needed to standardize patient counseling.

Lazarov and colleagues reviewed data from patients who sought treatment at clinics affiliated with a national fertility network from 2005 to 2023 who also utilized a GLP-1 agonist within 1 year of COH.

The study population included 73 adult women; participants were divided into six groups based on the number of days without GLP-1 agonist use prior to retrieval (0-14, 15-30, 31-60, 61-90, 91-180, and 181-365 days). The primary outcome was oocyte yield following COH.

Overall, the mean oocyte yields were not significantly different across the six timing groups (14.4, 16.2, 16.8, 7.7, 13.8, and 15, respectively; P = .40).

In a secondary subgroup analysis, the researchers found an inverse relationship between oocyte yield and timing of GLP-1 agonist discontinuation in patients with body mass index (BMI) > 35. However, no changes in oocyte yield were observed in patients with BMIs in the normal or overweight range. Neither duration of GLP-1 agonist use or indication for use had a significant effect on oocyte yield across exposure group.

The findings were limited by several factors, including the relatively small study population, especially the small number of patients with obesity. “Additional investigation is needed to clarify potential effects of GLP-1 agonist use on aspiration risk during oocyte retrieval and embryo creation outcomes,” the researchers wrote in their abstract.

However, the results suggest that most women who use GLP-1 agonists experience no significant effects on oocyte retrieval and embryo creation, and that GLP-1 agonists may have a role in improving oocyte yield for obese patients, the researchers concluded.
 

Larger Studies Needed for Real Reassurance

“Infertility patients who are overweight have lower chances for conception and higher risks of pregnancy complications,” Mark Trolice, MD, professor at the University of Central Florida College of Medicine, Orlando, and founder/director of The IVF Center, Winter Park, Florida, said in an interview.

The use of GLP-1 agonists has dramatically increased given the medication’s effectiveness for weight loss, as well as its use to manage diabetes, but the use of GLP-1 agonists in pregnancy is not well known and current recommendations advise discontinuation of the medication for 6-8 weeks prior to conception, said Trolice, who was not involved in the study.

GLP-1 agonist use is associated with lowered blood glucose levels, Trolice said. “Additionally, the medication can delay gastric emptying and suppress appetite, both of which assist in weight management.”

The current study examined whether there was a difference in oocyte retrieval number in women based on days of discontinuation of GLP-1 agonists prior to the procedure, Trolice told this news organization. “Given the drug’s mechanism of action, there is no apparent biological influence that would impact oocyte yield. Consequently, the study outcome is not unexpected.”

The study purports potential reassurance that GLP-1 exposure, regardless of the duration of discontinuation, has no impact on egg retrieval number, said Trolice. However, “Based on the size of the study, to accept the findings as definitive would risk a type II statistical error.”

Two key areas for additional research are urgently needed, Trolice said, namely, the duration of time to discontinue GLP-1 agonists, if at all, prior to conception, and the discontinuation interval, if at all, prior to anesthesia to avoid airway complications.

The American Society of Anesthesiologists advises patients on daily dosing to consider holding GLP-1 agonists on the day of a procedure or surgery, and those on weekly dosing should consider discontinuing the medication 1 week before the procedure or surgery, Trolice noted.

The study received no outside funding. The researchers had no financial conflicts to disclose. Trolice had no financial conflicts to disclose and serves on the editorial advisory board of OB/GYN News.

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

The use of glucagon-like peptide 1 (GLP-1) agonists within a year had no apparent effect on the number of oocytes retrieved in controlled ovarian hyperstimulation (COH), based on data from 73 patients in a multicenter study.

Obesity rates continue to rise in women of reproductive age and many women are using GLP-1 agonists for weight loss, but data on the effect of these drugs on fertility treatments are lacking, said Victoria K. Lazarov, MD, of Icahn School of Medicine at Mount Sinai, New York City, in an abstract presented at the American Society for Reproductive Medicine (ASRM) 2024 scientific congress.

Clinical opinions regarding the use, duration, and discontinuation of GLP-1 agonists during fertility treatments are variable given the limited research, Lazarov noted in her abstract. More data are needed to standardize patient counseling.

Lazarov and colleagues reviewed data from patients who sought treatment at clinics affiliated with a national fertility network from 2005 to 2023 who also utilized a GLP-1 agonist within 1 year of COH.

The study population included 73 adult women; participants were divided into six groups based on the number of days without GLP-1 agonist use prior to retrieval (0-14, 15-30, 31-60, 61-90, 91-180, and 181-365 days). The primary outcome was oocyte yield following COH.

Overall, the mean oocyte yields were not significantly different across the six timing groups (14.4, 16.2, 16.8, 7.7, 13.8, and 15, respectively; P = .40).

In a secondary subgroup analysis, the researchers found an inverse relationship between oocyte yield and timing of GLP-1 agonist discontinuation in patients with body mass index (BMI) > 35. However, no changes in oocyte yield were observed in patients with BMIs in the normal or overweight range. Neither duration of GLP-1 agonist use or indication for use had a significant effect on oocyte yield across exposure group.

The findings were limited by several factors, including the relatively small study population, especially the small number of patients with obesity. “Additional investigation is needed to clarify potential effects of GLP-1 agonist use on aspiration risk during oocyte retrieval and embryo creation outcomes,” the researchers wrote in their abstract.

However, the results suggest that most women who use GLP-1 agonists experience no significant effects on oocyte retrieval and embryo creation, and that GLP-1 agonists may have a role in improving oocyte yield for obese patients, the researchers concluded.
 

Larger Studies Needed for Real Reassurance

“Infertility patients who are overweight have lower chances for conception and higher risks of pregnancy complications,” Mark Trolice, MD, professor at the University of Central Florida College of Medicine, Orlando, and founder/director of The IVF Center, Winter Park, Florida, said in an interview.

The use of GLP-1 agonists has dramatically increased given the medication’s effectiveness for weight loss, as well as its use to manage diabetes, but the use of GLP-1 agonists in pregnancy is not well known and current recommendations advise discontinuation of the medication for 6-8 weeks prior to conception, said Trolice, who was not involved in the study.

GLP-1 agonist use is associated with lowered blood glucose levels, Trolice said. “Additionally, the medication can delay gastric emptying and suppress appetite, both of which assist in weight management.”

The current study examined whether there was a difference in oocyte retrieval number in women based on days of discontinuation of GLP-1 agonists prior to the procedure, Trolice told this news organization. “Given the drug’s mechanism of action, there is no apparent biological influence that would impact oocyte yield. Consequently, the study outcome is not unexpected.”

The study purports potential reassurance that GLP-1 exposure, regardless of the duration of discontinuation, has no impact on egg retrieval number, said Trolice. However, “Based on the size of the study, to accept the findings as definitive would risk a type II statistical error.”

Two key areas for additional research are urgently needed, Trolice said, namely, the duration of time to discontinue GLP-1 agonists, if at all, prior to conception, and the discontinuation interval, if at all, prior to anesthesia to avoid airway complications.

The American Society of Anesthesiologists advises patients on daily dosing to consider holding GLP-1 agonists on the day of a procedure or surgery, and those on weekly dosing should consider discontinuing the medication 1 week before the procedure or surgery, Trolice noted.

The study received no outside funding. The researchers had no financial conflicts to disclose. Trolice had no financial conflicts to disclose and serves on the editorial advisory board of OB/GYN News.

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

The use of glucagon-like peptide 1 (GLP-1) agonists within a year had no apparent effect on the number of oocytes retrieved in controlled ovarian hyperstimulation (COH), based on data from 73 patients in a multicenter study.

Obesity rates continue to rise in women of reproductive age and many women are using GLP-1 agonists for weight loss, but data on the effect of these drugs on fertility treatments are lacking, said Victoria K. Lazarov, MD, of Icahn School of Medicine at Mount Sinai, New York City, in an abstract presented at the American Society for Reproductive Medicine (ASRM) 2024 scientific congress.

Clinical opinions regarding the use, duration, and discontinuation of GLP-1 agonists during fertility treatments are variable given the limited research, Lazarov noted in her abstract. More data are needed to standardize patient counseling.

Lazarov and colleagues reviewed data from patients who sought treatment at clinics affiliated with a national fertility network from 2005 to 2023 who also utilized a GLP-1 agonist within 1 year of COH.

The study population included 73 adult women; participants were divided into six groups based on the number of days without GLP-1 agonist use prior to retrieval (0-14, 15-30, 31-60, 61-90, 91-180, and 181-365 days). The primary outcome was oocyte yield following COH.

Overall, the mean oocyte yields were not significantly different across the six timing groups (14.4, 16.2, 16.8, 7.7, 13.8, and 15, respectively; P = .40).

In a secondary subgroup analysis, the researchers found an inverse relationship between oocyte yield and timing of GLP-1 agonist discontinuation in patients with body mass index (BMI) > 35. However, no changes in oocyte yield were observed in patients with BMIs in the normal or overweight range. Neither duration of GLP-1 agonist use or indication for use had a significant effect on oocyte yield across exposure group.

The findings were limited by several factors, including the relatively small study population, especially the small number of patients with obesity. “Additional investigation is needed to clarify potential effects of GLP-1 agonist use on aspiration risk during oocyte retrieval and embryo creation outcomes,” the researchers wrote in their abstract.

However, the results suggest that most women who use GLP-1 agonists experience no significant effects on oocyte retrieval and embryo creation, and that GLP-1 agonists may have a role in improving oocyte yield for obese patients, the researchers concluded.
 

Larger Studies Needed for Real Reassurance

“Infertility patients who are overweight have lower chances for conception and higher risks of pregnancy complications,” Mark Trolice, MD, professor at the University of Central Florida College of Medicine, Orlando, and founder/director of The IVF Center, Winter Park, Florida, said in an interview.

The use of GLP-1 agonists has dramatically increased given the medication’s effectiveness for weight loss, as well as its use to manage diabetes, but the use of GLP-1 agonists in pregnancy is not well known and current recommendations advise discontinuation of the medication for 6-8 weeks prior to conception, said Trolice, who was not involved in the study.

GLP-1 agonist use is associated with lowered blood glucose levels, Trolice said. “Additionally, the medication can delay gastric emptying and suppress appetite, both of which assist in weight management.”

The current study examined whether there was a difference in oocyte retrieval number in women based on days of discontinuation of GLP-1 agonists prior to the procedure, Trolice told this news organization. “Given the drug’s mechanism of action, there is no apparent biological influence that would impact oocyte yield. Consequently, the study outcome is not unexpected.”

The study purports potential reassurance that GLP-1 exposure, regardless of the duration of discontinuation, has no impact on egg retrieval number, said Trolice. However, “Based on the size of the study, to accept the findings as definitive would risk a type II statistical error.”

Two key areas for additional research are urgently needed, Trolice said, namely, the duration of time to discontinue GLP-1 agonists, if at all, prior to conception, and the discontinuation interval, if at all, prior to anesthesia to avoid airway complications.

The American Society of Anesthesiologists advises patients on daily dosing to consider holding GLP-1 agonists on the day of a procedure or surgery, and those on weekly dosing should consider discontinuing the medication 1 week before the procedure or surgery, Trolice noted.

The study received no outside funding. The researchers had no financial conflicts to disclose. Trolice had no financial conflicts to disclose and serves on the editorial advisory board of OB/GYN News.

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

TOPLINE:

Children of mothers who had obesity or eating disorders before or during pregnancy may face higher risks for neurodevelopmental and psychiatric disorders.

METHODOLOGY:

• Researchers conducted a population-based cohort study to investigate the association of maternal eating disorders and high prepregnancy body mass index (BMI) with psychiatric disorder and neurodevelopmental diagnoses in offspring.
• They used Finnish national registers to assess all live births from 2004 through 2014, with follow-up until 2021.
• Data of 392,098 mothers (mean age, 30.15 years) and 649,956 offspring (48.86% girls) were included.
• Maternal eating disorders and prepregnancy BMI were the main exposures, with 1.60% of mothers having a history of eating disorders; 5.89% were underweight and 53.13% had obesity.
• Diagnoses of children were identified and grouped by ICD-10 codes of mental, behavioral, and neurodevelopmental disorders, mood disorders, anxiety disorders, sleep disorders, attention-deficit/hyperactivity disorder, and conduct disorders, among several others.

TAKEAWAY:

• From birth until 7-17 years of age, 16.43% of offspring were diagnosed with a neurodevelopmental or psychiatric disorder.
• Maternal eating disorders were associated with psychiatric disorders in the offspring, with the largest effect sizes observed for sleep disorders (hazard ratio [HR], 2.36) and social functioning and tic disorders (HR, 2.18; P < .001 for both).
• The offspring of mothers with severe prepregnancy obesity had a more than twofold increased risk for intellectual disabilities (HR, 2.04; 95% CI, 1.83-2.28); being underweight before pregnancy was also linked to many psychiatric disorders in offspring.
• The occurrence of adverse birth outcomes along with maternal eating disorders or high BMI further increased the risk for neurodevelopmental and psychiatric disorders in the offspring.

IN PRACTICE:

“The findings underline the risk of offspring mental illness associated with maternal eating disorders and prepregnancy BMI and suggest the need to consider these exposures clinically to help prevent offspring mental illness,” the authors wrote.

SOURCE:

This study was led by Ida A.K. Nilsson, PhD, of the Department of Molecular Medicine and Surgery at the Karolinska Institutet in Stockholm, Sweden, and was published online in JAMA Network Open.

LIMITATIONS:

A limitation of the study was the relatively short follow-up time, which restricted the inclusion of late-onset psychiatric disorder diagnoses, such as schizophrenia spectrum disorders. Paternal data and genetic information, which may have influenced the interpretation of the data, were not available. Another potential bias was that mothers with eating disorders may have been more perceptive to their child’s eating behavior, leading to greater access to care and diagnosis for these children.

DISCLOSURES:

This work was supported by the Swedish Research Council, the regional agreement on medical training and clinical research between Region Stockholm and the Karolinska Institutet, the Swedish Brain Foundation, and other sources. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Children of mothers who had obesity or eating disorders before or during pregnancy may face higher risks for neurodevelopmental and psychiatric disorders.

METHODOLOGY:

• Researchers conducted a population-based cohort study to investigate the association of maternal eating disorders and high prepregnancy body mass index (BMI) with psychiatric disorder and neurodevelopmental diagnoses in offspring.
• They used Finnish national registers to assess all live births from 2004 through 2014, with follow-up until 2021.
• Data of 392,098 mothers (mean age, 30.15 years) and 649,956 offspring (48.86% girls) were included.
• Maternal eating disorders and prepregnancy BMI were the main exposures, with 1.60% of mothers having a history of eating disorders; 5.89% were underweight and 53.13% had obesity.
• Diagnoses of children were identified and grouped by ICD-10 codes of mental, behavioral, and neurodevelopmental disorders, mood disorders, anxiety disorders, sleep disorders, attention-deficit/hyperactivity disorder, and conduct disorders, among several others.

TAKEAWAY:

• From birth until 7-17 years of age, 16.43% of offspring were diagnosed with a neurodevelopmental or psychiatric disorder.
• Maternal eating disorders were associated with psychiatric disorders in the offspring, with the largest effect sizes observed for sleep disorders (hazard ratio [HR], 2.36) and social functioning and tic disorders (HR, 2.18; P < .001 for both).
• The offspring of mothers with severe prepregnancy obesity had a more than twofold increased risk for intellectual disabilities (HR, 2.04; 95% CI, 1.83-2.28); being underweight before pregnancy was also linked to many psychiatric disorders in offspring.
• The occurrence of adverse birth outcomes along with maternal eating disorders or high BMI further increased the risk for neurodevelopmental and psychiatric disorders in the offspring.

IN PRACTICE:

“The findings underline the risk of offspring mental illness associated with maternal eating disorders and prepregnancy BMI and suggest the need to consider these exposures clinically to help prevent offspring mental illness,” the authors wrote.

SOURCE:

This study was led by Ida A.K. Nilsson, PhD, of the Department of Molecular Medicine and Surgery at the Karolinska Institutet in Stockholm, Sweden, and was published online in JAMA Network Open.

LIMITATIONS:

A limitation of the study was the relatively short follow-up time, which restricted the inclusion of late-onset psychiatric disorder diagnoses, such as schizophrenia spectrum disorders. Paternal data and genetic information, which may have influenced the interpretation of the data, were not available. Another potential bias was that mothers with eating disorders may have been more perceptive to their child’s eating behavior, leading to greater access to care and diagnosis for these children.

DISCLOSURES:

This work was supported by the Swedish Research Council, the regional agreement on medical training and clinical research between Region Stockholm and the Karolinska Institutet, the Swedish Brain Foundation, and other sources. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Children of mothers who had obesity or eating disorders before or during pregnancy may face higher risks for neurodevelopmental and psychiatric disorders.

METHODOLOGY:

• Researchers conducted a population-based cohort study to investigate the association of maternal eating disorders and high prepregnancy body mass index (BMI) with psychiatric disorder and neurodevelopmental diagnoses in offspring.
• They used Finnish national registers to assess all live births from 2004 through 2014, with follow-up until 2021.
• Data of 392,098 mothers (mean age, 30.15 years) and 649,956 offspring (48.86% girls) were included.
• Maternal eating disorders and prepregnancy BMI were the main exposures, with 1.60% of mothers having a history of eating disorders; 5.89% were underweight and 53.13% had obesity.
• Diagnoses of children were identified and grouped by ICD-10 codes of mental, behavioral, and neurodevelopmental disorders, mood disorders, anxiety disorders, sleep disorders, attention-deficit/hyperactivity disorder, and conduct disorders, among several others.

TAKEAWAY:

• From birth until 7-17 years of age, 16.43% of offspring were diagnosed with a neurodevelopmental or psychiatric disorder.
• Maternal eating disorders were associated with psychiatric disorders in the offspring, with the largest effect sizes observed for sleep disorders (hazard ratio [HR], 2.36) and social functioning and tic disorders (HR, 2.18; P < .001 for both).
• The offspring of mothers with severe prepregnancy obesity had a more than twofold increased risk for intellectual disabilities (HR, 2.04; 95% CI, 1.83-2.28); being underweight before pregnancy was also linked to many psychiatric disorders in offspring.
• The occurrence of adverse birth outcomes along with maternal eating disorders or high BMI further increased the risk for neurodevelopmental and psychiatric disorders in the offspring.

IN PRACTICE:

“The findings underline the risk of offspring mental illness associated with maternal eating disorders and prepregnancy BMI and suggest the need to consider these exposures clinically to help prevent offspring mental illness,” the authors wrote.

SOURCE:

This study was led by Ida A.K. Nilsson, PhD, of the Department of Molecular Medicine and Surgery at the Karolinska Institutet in Stockholm, Sweden, and was published online in JAMA Network Open.

LIMITATIONS:

A limitation of the study was the relatively short follow-up time, which restricted the inclusion of late-onset psychiatric disorder diagnoses, such as schizophrenia spectrum disorders. Paternal data and genetic information, which may have influenced the interpretation of the data, were not available. Another potential bias was that mothers with eating disorders may have been more perceptive to their child’s eating behavior, leading to greater access to care and diagnosis for these children.

DISCLOSURES:

This work was supported by the Swedish Research Council, the regional agreement on medical training and clinical research between Region Stockholm and the Karolinska Institutet, the Swedish Brain Foundation, and other sources. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Labor and delivery centers run by family medicine (FM) healthcare providers have a lower cesarean delivery rate and better safety culture than centers led by obstetricians (OBs), based on observational data from Iowa hospitals.

These findings show how FM providers backed up by general surgeons can deliver a high standard of obstetric care, suggesting that this team-based model could address growing maternity care deserts across the United States, lead author Emily White VanGompel, MD, of the University of Illinois College of Medicine in Chicago, and colleagues reported.

“Despite decades of research documenting the high quality of care provided by FM physicians, controversy continues regarding whether family physicians trained in existing FM residency programs should provide intrapartum obstetric care,” the investigators wrote in Annals of Family Medicine.

This controversy, though long-standing, has gained more attention in the past decade with worsening severe maternal morbidity and maternal health disparities in rural areas, along with state-based perinatal quality initiatives to improve care and reduce severe maternal morbidity. These efforts have largely involved obstetric, nursing, and midwifery organizations, with minimal input from FM professionals.

The role of FM in these initiatives therefore remains unexplored.

This is a clear blind spot, according to White VanGompel and colleagues, who noted that 40% of counties in the United States do not have an OB or a midwife, while only 6.5% of counties lack an FM physician. In other words, FM providers may be the most rational — and widely available — specialty to close gaps in obstetric care.
 

Study Reveals Fewer C-Sections, Better Safety Culture Among FM-Led Centers

To explore the viability of an FM-led model, the investigators used a cross-sectional survey to assess the relationship between staffing models and perinatal outcomes. A total of 849 clinicians, including physicians, nurses, and midwives from 39 hospitals, were surveyed as part of a statewide quality improvement initiative designed to reduce cesarean delivery rates. The hospitals were categorized on the basis of the type of physician providing intrapartum care: Some hospitals were staffed exclusively by FM physicians (13), some by OBs only (11), and others by both types of providers (15).

The primary outcome measured was the low-risk cesarean delivery rate, specifically the nulliparous, term, singleton, vertex cesarean delivery rate.

The study found that FM-only hospitals, all of which were located in rural areas with fewer than 1000 annual births, had significantly lower cesarean delivery rates than hospitals with mixed or OB-only staffing. After adjusting for factors such as hospital birth volume, geographic location, patient body mass index, maternal age, and insurance status, FM-only hospitals had an adjusted 34.3% lower rate of cesarean sections than hospitals with both FM and OB physicians (adjusted incidence rate ratio, 0.66; 95% CI, 0.52-0.98).

In addition to lower cesarean delivery rates, the study revealed that hospitals staffed exclusively by FM physicians reported a stronger safety culture, as measured by nurse perceptions of unit norms supporting vaginal birth. Nurses at FM-only hospitals were more likely to endorse safety practices that favored vaginal delivery, a finding that was statistically significant. The study also found that nurses at FM-only hospitals rated overall unit safety culture higher than those at hospitals staffed solely by OBs or a combination of FM physicians and OBs.

“I’m not surprised [by these findings],” said Joedrecka S. Brown Speights, MD, professor and chair of the Department of Family Medicine and Rural Health at Florida State University College of Medicine, Tallahassee.

She noted that the data echo previous reports demonstrating the broader benefits of FM involvement.

“When people get primary care, life is better,” Brown Speights said, citing improved outcomes, greater health equity, and lower overall healthcare costs associated with high-quality primary care.

“That’s what we need for women and for pregnant persons, especially in rural areas,” she said.
 

The Model Itself Could Be the Biggest Finding

According to White VanGompel, the biggest finding from the study is the existence of the team-based model itself — where FM providers lead obstetric care with support from general surgeons.

“Quite honestly, many people around the country, including family physicians like myself, did not know [this model] existed and was thriving in these rural areas that are on the verge of becoming maternity care deserts,” White VanGompel said in an interview. “That makes a huge difference clinically because those are patients that otherwise wouldn’t have access to comprehensive pregnancy care.”

This FM-led model has the added advantage of improving continuity of care, she added, noting that issues like maternal mental health — a major contributor to postpartum morbidity and mortality — are a primary care issue.

“If we are not involved in that patient’s pregnancy care, and we don’t know that they’ve had this postpartum course or they’ve had antepartum depression, it’s very hard for us to then jump in and accurately treat that person,” White VanGompel said. “If we’re involved in the entire course of care, we can make that contribution.”

Emilio A. Russo, MD, Marie Lahasky Professor of Family Medicine and chair of the Department of Family Medicine at Louisiana State University (LSU) Health Sciences Center New Orleans, and program director of the LSU Rural Family Medicine Program, Bogalusa, Louisiana, agreed that FM providers’ more continuous care, along with experience treating both mothers and babies, make them invaluable in the maternity care setting.

“We are missing the opportunity to incorporate family physicians and nurse midwives into the continuum of care for women, especially in these remote areas,” Russo said in an interview. “Family physicians and nurse midwives are the only two [groups] in the health system trained and licensed to care for both mother and baby, and I have to believe that there’s something profoundly important about that.”
 

Barriers May Block FM Providers From Obstetric Practice

In a recent Birth editorial, Simone Hampton, MD, of Carle Health Family Medicine, Urbana, Illinois, explored a key question: Why aren’t we using FM to help confront the maternal mortality crisis in the United States?

Hampton described how obstetric care is often siloed between specialties and barriers, including insufficient training, organizational constraints, and malpractice coverage, deter FM physicians from practicing obstetrics.

In an additional written comment, Hampton suggested that family doctors also face misconceptions about their ability to provide obstetric care, even with rigorous training and a comprehensive skill set.

“We are interested in caring for families,” Hampton said, emphasizing how FM providers are uniquely trained to care for the maternal dyad in a way that OBs are not and often view birth as a more natural process that typically does not require intervention.

Unfortunately, hospital administrators often maintain a different view, Brown Speights said, describing how some centers limit obstetric care privileges exclusively to OBs or require case volume minimums that can be tough to reach in a rural setting.

“If you have low-volume places, you can have a challenge meeting the numbers to keep up the requirements to get credentialed to practice obstetrics at the hospital,” she said, which only exacerbates gaps in maternity care access.

“This type of skill set in a rural place often, by default, represents a lower volume,” Russo said. “So how do the interests of competency and access intersect in this space?”

Generating more data to support the quality of FM-led obstetric models could be the clearest path forward, according to White VanGompel. She suggested that team-based approaches like the one described in the present study deserve further investigation in other hospital systems.

Until then, this gap in maternity care remains an ongoing, and often personal, concern.

“The more I do this quality work, the more I’m in these rooms where I’m the only family physician and I’m surrounded by all of these amazing labor and delivery nurses and obstetricians and maternal-fetal medicine doctors and midwives and doulas,” White VanGompel said. “I’m just constantly asking myself, Why am I the only family doctor in the room?”

This study was supported by the Agency for Healthcare Research and Quality and the North Shore Auxiliary. The Iowa Maternal Quality Care Collaborative is supported by a State Maternal Health Innovation award from the Health Resources and Services Administration. The investigators, Hampton and Brown Speights, disclosed no conflicts of interest.

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

Labor and delivery centers run by family medicine (FM) healthcare providers have a lower cesarean delivery rate and better safety culture than centers led by obstetricians (OBs), based on observational data from Iowa hospitals.

These findings show how FM providers backed up by general surgeons can deliver a high standard of obstetric care, suggesting that this team-based model could address growing maternity care deserts across the United States, lead author Emily White VanGompel, MD, of the University of Illinois College of Medicine in Chicago, and colleagues reported.

“Despite decades of research documenting the high quality of care provided by FM physicians, controversy continues regarding whether family physicians trained in existing FM residency programs should provide intrapartum obstetric care,” the investigators wrote in Annals of Family Medicine.

This controversy, though long-standing, has gained more attention in the past decade with worsening severe maternal morbidity and maternal health disparities in rural areas, along with state-based perinatal quality initiatives to improve care and reduce severe maternal morbidity. These efforts have largely involved obstetric, nursing, and midwifery organizations, with minimal input from FM professionals.

The role of FM in these initiatives therefore remains unexplored.

This is a clear blind spot, according to White VanGompel and colleagues, who noted that 40% of counties in the United States do not have an OB or a midwife, while only 6.5% of counties lack an FM physician. In other words, FM providers may be the most rational — and widely available — specialty to close gaps in obstetric care.
 

Study Reveals Fewer C-Sections, Better Safety Culture Among FM-Led Centers

To explore the viability of an FM-led model, the investigators used a cross-sectional survey to assess the relationship between staffing models and perinatal outcomes. A total of 849 clinicians, including physicians, nurses, and midwives from 39 hospitals, were surveyed as part of a statewide quality improvement initiative designed to reduce cesarean delivery rates. The hospitals were categorized on the basis of the type of physician providing intrapartum care: Some hospitals were staffed exclusively by FM physicians (13), some by OBs only (11), and others by both types of providers (15).

The primary outcome measured was the low-risk cesarean delivery rate, specifically the nulliparous, term, singleton, vertex cesarean delivery rate.

The study found that FM-only hospitals, all of which were located in rural areas with fewer than 1000 annual births, had significantly lower cesarean delivery rates than hospitals with mixed or OB-only staffing. After adjusting for factors such as hospital birth volume, geographic location, patient body mass index, maternal age, and insurance status, FM-only hospitals had an adjusted 34.3% lower rate of cesarean sections than hospitals with both FM and OB physicians (adjusted incidence rate ratio, 0.66; 95% CI, 0.52-0.98).

In addition to lower cesarean delivery rates, the study revealed that hospitals staffed exclusively by FM physicians reported a stronger safety culture, as measured by nurse perceptions of unit norms supporting vaginal birth. Nurses at FM-only hospitals were more likely to endorse safety practices that favored vaginal delivery, a finding that was statistically significant. The study also found that nurses at FM-only hospitals rated overall unit safety culture higher than those at hospitals staffed solely by OBs or a combination of FM physicians and OBs.

“I’m not surprised [by these findings],” said Joedrecka S. Brown Speights, MD, professor and chair of the Department of Family Medicine and Rural Health at Florida State University College of Medicine, Tallahassee.

She noted that the data echo previous reports demonstrating the broader benefits of FM involvement.

“When people get primary care, life is better,” Brown Speights said, citing improved outcomes, greater health equity, and lower overall healthcare costs associated with high-quality primary care.

“That’s what we need for women and for pregnant persons, especially in rural areas,” she said.
 

The Model Itself Could Be the Biggest Finding

According to White VanGompel, the biggest finding from the study is the existence of the team-based model itself — where FM providers lead obstetric care with support from general surgeons.

“Quite honestly, many people around the country, including family physicians like myself, did not know [this model] existed and was thriving in these rural areas that are on the verge of becoming maternity care deserts,” White VanGompel said in an interview. “That makes a huge difference clinically because those are patients that otherwise wouldn’t have access to comprehensive pregnancy care.”

This FM-led model has the added advantage of improving continuity of care, she added, noting that issues like maternal mental health — a major contributor to postpartum morbidity and mortality — are a primary care issue.

“If we are not involved in that patient’s pregnancy care, and we don’t know that they’ve had this postpartum course or they’ve had antepartum depression, it’s very hard for us to then jump in and accurately treat that person,” White VanGompel said. “If we’re involved in the entire course of care, we can make that contribution.”

Emilio A. Russo, MD, Marie Lahasky Professor of Family Medicine and chair of the Department of Family Medicine at Louisiana State University (LSU) Health Sciences Center New Orleans, and program director of the LSU Rural Family Medicine Program, Bogalusa, Louisiana, agreed that FM providers’ more continuous care, along with experience treating both mothers and babies, make them invaluable in the maternity care setting.

“We are missing the opportunity to incorporate family physicians and nurse midwives into the continuum of care for women, especially in these remote areas,” Russo said in an interview. “Family physicians and nurse midwives are the only two [groups] in the health system trained and licensed to care for both mother and baby, and I have to believe that there’s something profoundly important about that.”
 

Barriers May Block FM Providers From Obstetric Practice

In a recent Birth editorial, Simone Hampton, MD, of Carle Health Family Medicine, Urbana, Illinois, explored a key question: Why aren’t we using FM to help confront the maternal mortality crisis in the United States?

Hampton described how obstetric care is often siloed between specialties and barriers, including insufficient training, organizational constraints, and malpractice coverage, deter FM physicians from practicing obstetrics.

In an additional written comment, Hampton suggested that family doctors also face misconceptions about their ability to provide obstetric care, even with rigorous training and a comprehensive skill set.

“We are interested in caring for families,” Hampton said, emphasizing how FM providers are uniquely trained to care for the maternal dyad in a way that OBs are not and often view birth as a more natural process that typically does not require intervention.

Unfortunately, hospital administrators often maintain a different view, Brown Speights said, describing how some centers limit obstetric care privileges exclusively to OBs or require case volume minimums that can be tough to reach in a rural setting.

“If you have low-volume places, you can have a challenge meeting the numbers to keep up the requirements to get credentialed to practice obstetrics at the hospital,” she said, which only exacerbates gaps in maternity care access.

“This type of skill set in a rural place often, by default, represents a lower volume,” Russo said. “So how do the interests of competency and access intersect in this space?”

Generating more data to support the quality of FM-led obstetric models could be the clearest path forward, according to White VanGompel. She suggested that team-based approaches like the one described in the present study deserve further investigation in other hospital systems.

Until then, this gap in maternity care remains an ongoing, and often personal, concern.

“The more I do this quality work, the more I’m in these rooms where I’m the only family physician and I’m surrounded by all of these amazing labor and delivery nurses and obstetricians and maternal-fetal medicine doctors and midwives and doulas,” White VanGompel said. “I’m just constantly asking myself, Why am I the only family doctor in the room?”

This study was supported by the Agency for Healthcare Research and Quality and the North Shore Auxiliary. The Iowa Maternal Quality Care Collaborative is supported by a State Maternal Health Innovation award from the Health Resources and Services Administration. The investigators, Hampton and Brown Speights, disclosed no conflicts of interest.

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

Labor and delivery centers run by family medicine (FM) healthcare providers have a lower cesarean delivery rate and better safety culture than centers led by obstetricians (OBs), based on observational data from Iowa hospitals.

These findings show how FM providers backed up by general surgeons can deliver a high standard of obstetric care, suggesting that this team-based model could address growing maternity care deserts across the United States, lead author Emily White VanGompel, MD, of the University of Illinois College of Medicine in Chicago, and colleagues reported.

“Despite decades of research documenting the high quality of care provided by FM physicians, controversy continues regarding whether family physicians trained in existing FM residency programs should provide intrapartum obstetric care,” the investigators wrote in Annals of Family Medicine.

This controversy, though long-standing, has gained more attention in the past decade with worsening severe maternal morbidity and maternal health disparities in rural areas, along with state-based perinatal quality initiatives to improve care and reduce severe maternal morbidity. These efforts have largely involved obstetric, nursing, and midwifery organizations, with minimal input from FM professionals.

The role of FM in these initiatives therefore remains unexplored.

This is a clear blind spot, according to White VanGompel and colleagues, who noted that 40% of counties in the United States do not have an OB or a midwife, while only 6.5% of counties lack an FM physician. In other words, FM providers may be the most rational — and widely available — specialty to close gaps in obstetric care.
 

Study Reveals Fewer C-Sections, Better Safety Culture Among FM-Led Centers

To explore the viability of an FM-led model, the investigators used a cross-sectional survey to assess the relationship between staffing models and perinatal outcomes. A total of 849 clinicians, including physicians, nurses, and midwives from 39 hospitals, were surveyed as part of a statewide quality improvement initiative designed to reduce cesarean delivery rates. The hospitals were categorized on the basis of the type of physician providing intrapartum care: Some hospitals were staffed exclusively by FM physicians (13), some by OBs only (11), and others by both types of providers (15).

The primary outcome measured was the low-risk cesarean delivery rate, specifically the nulliparous, term, singleton, vertex cesarean delivery rate.

The study found that FM-only hospitals, all of which were located in rural areas with fewer than 1000 annual births, had significantly lower cesarean delivery rates than hospitals with mixed or OB-only staffing. After adjusting for factors such as hospital birth volume, geographic location, patient body mass index, maternal age, and insurance status, FM-only hospitals had an adjusted 34.3% lower rate of cesarean sections than hospitals with both FM and OB physicians (adjusted incidence rate ratio, 0.66; 95% CI, 0.52-0.98).

In addition to lower cesarean delivery rates, the study revealed that hospitals staffed exclusively by FM physicians reported a stronger safety culture, as measured by nurse perceptions of unit norms supporting vaginal birth. Nurses at FM-only hospitals were more likely to endorse safety practices that favored vaginal delivery, a finding that was statistically significant. The study also found that nurses at FM-only hospitals rated overall unit safety culture higher than those at hospitals staffed solely by OBs or a combination of FM physicians and OBs.

“I’m not surprised [by these findings],” said Joedrecka S. Brown Speights, MD, professor and chair of the Department of Family Medicine and Rural Health at Florida State University College of Medicine, Tallahassee.

She noted that the data echo previous reports demonstrating the broader benefits of FM involvement.

“When people get primary care, life is better,” Brown Speights said, citing improved outcomes, greater health equity, and lower overall healthcare costs associated with high-quality primary care.

“That’s what we need for women and for pregnant persons, especially in rural areas,” she said.
 

The Model Itself Could Be the Biggest Finding

According to White VanGompel, the biggest finding from the study is the existence of the team-based model itself — where FM providers lead obstetric care with support from general surgeons.

“Quite honestly, many people around the country, including family physicians like myself, did not know [this model] existed and was thriving in these rural areas that are on the verge of becoming maternity care deserts,” White VanGompel said in an interview. “That makes a huge difference clinically because those are patients that otherwise wouldn’t have access to comprehensive pregnancy care.”

This FM-led model has the added advantage of improving continuity of care, she added, noting that issues like maternal mental health — a major contributor to postpartum morbidity and mortality — are a primary care issue.

“If we are not involved in that patient’s pregnancy care, and we don’t know that they’ve had this postpartum course or they’ve had antepartum depression, it’s very hard for us to then jump in and accurately treat that person,” White VanGompel said. “If we’re involved in the entire course of care, we can make that contribution.”

Emilio A. Russo, MD, Marie Lahasky Professor of Family Medicine and chair of the Department of Family Medicine at Louisiana State University (LSU) Health Sciences Center New Orleans, and program director of the LSU Rural Family Medicine Program, Bogalusa, Louisiana, agreed that FM providers’ more continuous care, along with experience treating both mothers and babies, make them invaluable in the maternity care setting.

“We are missing the opportunity to incorporate family physicians and nurse midwives into the continuum of care for women, especially in these remote areas,” Russo said in an interview. “Family physicians and nurse midwives are the only two [groups] in the health system trained and licensed to care for both mother and baby, and I have to believe that there’s something profoundly important about that.”
 

Barriers May Block FM Providers From Obstetric Practice

In a recent Birth editorial, Simone Hampton, MD, of Carle Health Family Medicine, Urbana, Illinois, explored a key question: Why aren’t we using FM to help confront the maternal mortality crisis in the United States?

Hampton described how obstetric care is often siloed between specialties and barriers, including insufficient training, organizational constraints, and malpractice coverage, deter FM physicians from practicing obstetrics.

In an additional written comment, Hampton suggested that family doctors also face misconceptions about their ability to provide obstetric care, even with rigorous training and a comprehensive skill set.

“We are interested in caring for families,” Hampton said, emphasizing how FM providers are uniquely trained to care for the maternal dyad in a way that OBs are not and often view birth as a more natural process that typically does not require intervention.

Unfortunately, hospital administrators often maintain a different view, Brown Speights said, describing how some centers limit obstetric care privileges exclusively to OBs or require case volume minimums that can be tough to reach in a rural setting.

“If you have low-volume places, you can have a challenge meeting the numbers to keep up the requirements to get credentialed to practice obstetrics at the hospital,” she said, which only exacerbates gaps in maternity care access.

“This type of skill set in a rural place often, by default, represents a lower volume,” Russo said. “So how do the interests of competency and access intersect in this space?”

Generating more data to support the quality of FM-led obstetric models could be the clearest path forward, according to White VanGompel. She suggested that team-based approaches like the one described in the present study deserve further investigation in other hospital systems.

Until then, this gap in maternity care remains an ongoing, and often personal, concern.

“The more I do this quality work, the more I’m in these rooms where I’m the only family physician and I’m surrounded by all of these amazing labor and delivery nurses and obstetricians and maternal-fetal medicine doctors and midwives and doulas,” White VanGompel said. “I’m just constantly asking myself, Why am I the only family doctor in the room?”

This study was supported by the Agency for Healthcare Research and Quality and the North Shore Auxiliary. The Iowa Maternal Quality Care Collaborative is supported by a State Maternal Health Innovation award from the Health Resources and Services Administration. The investigators, Hampton and Brown Speights, disclosed no conflicts of interest.

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

TOPLINE:

Fetuses exposed in utero to SARS-CoV-2 are not at an increased risk for neurodevelopmental problems in early childhood.

METHODOLOGY:

• This prospective study aimed to assess whether in utero exposure to SARS-CoV-2, which causes COVID-19, is associated with abnormal neurodevelopment among children at ages 12, 18, and 24 months.
• It included 2003 pregnant individuals (mean age, 33.3 years) from the ASPIRE cohort who were enrolled before 10 weeks’ gestation and followed through 24 months post partum; 10.8% of them were exposed to SARS-CoV-2 during pregnancy, as determined via self-reported data or dried blood spot cards.
• The birth mothers were required to complete the Ages & Stages Questionnaires, Third Edition (ASQ-3), a validated screening tool for neurodevelopmental delays, at 12, 18, and 24 months postpartum.
• Neurodevelopmental outcomes were available for 1757, 1522, and 1523 children at ages 12, 18, and 24 months, respectively.
• The primary outcome was a score below the cutoff on the ASQ-3 across any of the following developmental domains: Communication, gross motor, fine motor, problem-solving, and social skills.

TAKEAWAY:

• The prevalence of abnormal ASQ-3 scores did not differ between children who were exposed to SARS-CoV-2 in utero and those who were not, at ages 12 (P = .39), 18 (P = .58), and 24 (P = .45) months.
• No association was observed between in utero exposure to SARS-CoV-2 and abnormal ASQ-3 scores among children in any of the age groups.
• The lack of an association between exposure to SARS-CoV-2 during pregnancy and abnormal neurodevelopment remained unchanged even when factors such as preterm delivery and the sex of the infant were considered.
• Supplemental analyses found no difference in risk based on the trimester of infection, presence of fever, or incidence of breakthrough infection following vaccination.

IN PRACTICE:

“In this prospective cohort study of pregnant individuals and offspring, in utero exposure to maternal SARS-CoV-2 infection was not associated with abnormal neurodevelopmental screening scores of children through age 24 months. These findings are critical considering the novelty of the SARS-CoV-2 virus to the human species, the global scale of the initial COVID-19 outbreak, the now-endemic nature of the virus indicating ongoing relevance for pregnant individuals,” the authors of the study wrote. 

“While the scientific consensus resists a link between in utero COVID-19 exposure and impaired offspring neurodevelopment, the question remains whether societal responses to the pandemic impacted developmental trajectories,” the researchers added. “Certain studies comparing infants from a pandemic cohort with historic controls have raised concerns about lower ASQ-3 scores among children living during the pandemic. Critically, socioeconomic factors influence vulnerability, not only to infection itself but also regarding the ability to deploy resources in times of stress (eg, school closures) to mitigate sources of developmental harm. Our data support this theory, with the observed independent protective association of increasing household income with childhood ASQ-3 scores. Additional research is warranted to clarify the potential impact of societal measures on early development and the differential impact of these measures on different communities.”
 

SOURCE:

The study was led by Eleni G. Jaswa, MD, MSc, of the Department of Obstetrics, Gynecology & Reproductive Sciences at the University of California, San Francisco. It was published online in JAMA Network Open.

LIMITATIONS: 

Limitations of the research included the use of self-reported data and dried blood spot cards for determining exposure to SARS-CoV-2, which may have led to misclassification. The ASQ-3 is a modestly sensitive tool for detecting developmental delays that may have affected the study’s power to detect associations. The sample size of this study, while larger than many, may still have been underpowered to detect small differences in neurodevelopmental outcomes.

DISCLOSURES:

The ASPIRE cohort was supported by research grants provided to the University of California, San Francisco, and by the Start Small Foundation, the California Breast Cancer Research Program, the COVID Catalyst Award, and other sources. Some authors reported receiving grants, royalties, and personal fees, serving on medical advisory boards, and having other ties with several institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Fetuses exposed in utero to SARS-CoV-2 are not at an increased risk for neurodevelopmental problems in early childhood.

METHODOLOGY:

• This prospective study aimed to assess whether in utero exposure to SARS-CoV-2, which causes COVID-19, is associated with abnormal neurodevelopment among children at ages 12, 18, and 24 months.
• It included 2003 pregnant individuals (mean age, 33.3 years) from the ASPIRE cohort who were enrolled before 10 weeks’ gestation and followed through 24 months post partum; 10.8% of them were exposed to SARS-CoV-2 during pregnancy, as determined via self-reported data or dried blood spot cards.
• The birth mothers were required to complete the Ages & Stages Questionnaires, Third Edition (ASQ-3), a validated screening tool for neurodevelopmental delays, at 12, 18, and 24 months postpartum.
• Neurodevelopmental outcomes were available for 1757, 1522, and 1523 children at ages 12, 18, and 24 months, respectively.
• The primary outcome was a score below the cutoff on the ASQ-3 across any of the following developmental domains: Communication, gross motor, fine motor, problem-solving, and social skills.

TAKEAWAY:

• The prevalence of abnormal ASQ-3 scores did not differ between children who were exposed to SARS-CoV-2 in utero and those who were not, at ages 12 (P = .39), 18 (P = .58), and 24 (P = .45) months.
• No association was observed between in utero exposure to SARS-CoV-2 and abnormal ASQ-3 scores among children in any of the age groups.
• The lack of an association between exposure to SARS-CoV-2 during pregnancy and abnormal neurodevelopment remained unchanged even when factors such as preterm delivery and the sex of the infant were considered.
• Supplemental analyses found no difference in risk based on the trimester of infection, presence of fever, or incidence of breakthrough infection following vaccination.

IN PRACTICE:

“In this prospective cohort study of pregnant individuals and offspring, in utero exposure to maternal SARS-CoV-2 infection was not associated with abnormal neurodevelopmental screening scores of children through age 24 months. These findings are critical considering the novelty of the SARS-CoV-2 virus to the human species, the global scale of the initial COVID-19 outbreak, the now-endemic nature of the virus indicating ongoing relevance for pregnant individuals,” the authors of the study wrote. 

“While the scientific consensus resists a link between in utero COVID-19 exposure and impaired offspring neurodevelopment, the question remains whether societal responses to the pandemic impacted developmental trajectories,” the researchers added. “Certain studies comparing infants from a pandemic cohort with historic controls have raised concerns about lower ASQ-3 scores among children living during the pandemic. Critically, socioeconomic factors influence vulnerability, not only to infection itself but also regarding the ability to deploy resources in times of stress (eg, school closures) to mitigate sources of developmental harm. Our data support this theory, with the observed independent protective association of increasing household income with childhood ASQ-3 scores. Additional research is warranted to clarify the potential impact of societal measures on early development and the differential impact of these measures on different communities.”
 

SOURCE:

The study was led by Eleni G. Jaswa, MD, MSc, of the Department of Obstetrics, Gynecology & Reproductive Sciences at the University of California, San Francisco. It was published online in JAMA Network Open.

LIMITATIONS: 

Limitations of the research included the use of self-reported data and dried blood spot cards for determining exposure to SARS-CoV-2, which may have led to misclassification. The ASQ-3 is a modestly sensitive tool for detecting developmental delays that may have affected the study’s power to detect associations. The sample size of this study, while larger than many, may still have been underpowered to detect small differences in neurodevelopmental outcomes.

DISCLOSURES:

The ASPIRE cohort was supported by research grants provided to the University of California, San Francisco, and by the Start Small Foundation, the California Breast Cancer Research Program, the COVID Catalyst Award, and other sources. Some authors reported receiving grants, royalties, and personal fees, serving on medical advisory boards, and having other ties with several institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Fetuses exposed in utero to SARS-CoV-2 are not at an increased risk for neurodevelopmental problems in early childhood.

METHODOLOGY:

• This prospective study aimed to assess whether in utero exposure to SARS-CoV-2, which causes COVID-19, is associated with abnormal neurodevelopment among children at ages 12, 18, and 24 months.
• It included 2003 pregnant individuals (mean age, 33.3 years) from the ASPIRE cohort who were enrolled before 10 weeks’ gestation and followed through 24 months post partum; 10.8% of them were exposed to SARS-CoV-2 during pregnancy, as determined via self-reported data or dried blood spot cards.
• The birth mothers were required to complete the Ages & Stages Questionnaires, Third Edition (ASQ-3), a validated screening tool for neurodevelopmental delays, at 12, 18, and 24 months postpartum.
• Neurodevelopmental outcomes were available for 1757, 1522, and 1523 children at ages 12, 18, and 24 months, respectively.
• The primary outcome was a score below the cutoff on the ASQ-3 across any of the following developmental domains: Communication, gross motor, fine motor, problem-solving, and social skills.

TAKEAWAY:

• The prevalence of abnormal ASQ-3 scores did not differ between children who were exposed to SARS-CoV-2 in utero and those who were not, at ages 12 (P = .39), 18 (P = .58), and 24 (P = .45) months.
• No association was observed between in utero exposure to SARS-CoV-2 and abnormal ASQ-3 scores among children in any of the age groups.
• The lack of an association between exposure to SARS-CoV-2 during pregnancy and abnormal neurodevelopment remained unchanged even when factors such as preterm delivery and the sex of the infant were considered.
• Supplemental analyses found no difference in risk based on the trimester of infection, presence of fever, or incidence of breakthrough infection following vaccination.

IN PRACTICE:

“In this prospective cohort study of pregnant individuals and offspring, in utero exposure to maternal SARS-CoV-2 infection was not associated with abnormal neurodevelopmental screening scores of children through age 24 months. These findings are critical considering the novelty of the SARS-CoV-2 virus to the human species, the global scale of the initial COVID-19 outbreak, the now-endemic nature of the virus indicating ongoing relevance for pregnant individuals,” the authors of the study wrote. 

“While the scientific consensus resists a link between in utero COVID-19 exposure and impaired offspring neurodevelopment, the question remains whether societal responses to the pandemic impacted developmental trajectories,” the researchers added. “Certain studies comparing infants from a pandemic cohort with historic controls have raised concerns about lower ASQ-3 scores among children living during the pandemic. Critically, socioeconomic factors influence vulnerability, not only to infection itself but also regarding the ability to deploy resources in times of stress (eg, school closures) to mitigate sources of developmental harm. Our data support this theory, with the observed independent protective association of increasing household income with childhood ASQ-3 scores. Additional research is warranted to clarify the potential impact of societal measures on early development and the differential impact of these measures on different communities.”
 

SOURCE:

The study was led by Eleni G. Jaswa, MD, MSc, of the Department of Obstetrics, Gynecology & Reproductive Sciences at the University of California, San Francisco. It was published online in JAMA Network Open.

LIMITATIONS: 

Limitations of the research included the use of self-reported data and dried blood spot cards for determining exposure to SARS-CoV-2, which may have led to misclassification. The ASQ-3 is a modestly sensitive tool for detecting developmental delays that may have affected the study’s power to detect associations. The sample size of this study, while larger than many, may still have been underpowered to detect small differences in neurodevelopmental outcomes.

DISCLOSURES:

The ASPIRE cohort was supported by research grants provided to the University of California, San Francisco, and by the Start Small Foundation, the California Breast Cancer Research Program, the COVID Catalyst Award, and other sources. Some authors reported receiving grants, royalties, and personal fees, serving on medical advisory boards, and having other ties with several institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Both low and high levels of maternal 25-hydroxy [25(OH)] vitamin D are linked to an increased risk for adverse pregnancy outcomes in women with systemic lupus erythematosus (SLE), with levels of 40-59 ng/mL being associated with the lowest risk.

METHODOLOGY:

• Researchers analyzed 260 pregnancies in the Hopkins Lupus Cohort to examine the association between 25(OH) vitamin D levels and adverse pregnancy outcomes in women with SLE.
• The participants were required to have serum vitamin D levels measured during pregnancy and pregnancy-related outcomes data.
• The 25(OH) vitamin D levels were measured at visits every 6 weeks, and the participants were divided into six subgroups on the basis of the mean 25(OH) vitamin D levels: < 20 ng/dL, 20-29 ng/dL, 30-39 ng/dL, 40-49 ng/dL, 50-59 ng/dL, and ≥ 60 ng/dL.
• The adverse pregnancy outcomes included miscarriage, preterm delivery, and restricted intrauterine growth of the fetus.
• This study used a time-to-event analysis to assess the association between time-varying 25(OH) vitamin D levels and adverse pregnancy outcomes.

TAKEAWAY:

• Adverse pregnancy outcomes were observed in 45.3% of pregnancies; the risks for miscarriage and preterm delivery were significantly different across the six subgroups with varying vitamin D levels (P = .0045 and P = .0007, respectively).
• A U-shaped curve association was observed between vitamin D levels and adverse pregnancy outcomes, with the highest risk seen in patients with the lowest or highest levels of vitamin D during pregnancy, while the lowest risk was seen in those with vitamin D levels between 40 and 59 ng/mL.
• Low 25(OH) vitamin D levels during the second trimester resulted in premature delivery in 9 out of 10 pregnancies; however, a relationship between vitamin D levels in the first trimester and pregnancy outcomes was not observed.
• The time-to-event analysis showed that the U-shaped association between vitamin D levels and adverse pregnancy outcomes was still observed even after accounting for lupus disease activity; however, the elevated risk seen in individuals with the highest levels of vitamin D was no longer statistically significant.

IN PRACTICE:

“We recommend monitoring of maternal serum 25(OH) vitamin D levels throughout SLE pregnancies and supplementing patients with vitamin D insufficiency or deficiency, aiming for 25(OH) vitamin D range of 40-59 ng/mL. Over supplementation should be avoided,” the authors wrote.

SOURCE:

The study was led by Nima Madanchi, MD, Johns Hopkins University, Baltimore, and was published online on September 23, 2024, in Arthritis Care & Research.

LIMITATIONS:

This study could not prove a cause-and-effect relationship between vitamin D levels and adverse pregnancy outcomes. This study included only clinically identified pregnancies, potentially missing very early miscarriages. It also could not adjust for parity due to the unknown parity of the index pregnancy.

DISCLOSURES:

This Hopkins Lupus Cohort was supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Both low and high levels of maternal 25-hydroxy [25(OH)] vitamin D are linked to an increased risk for adverse pregnancy outcomes in women with systemic lupus erythematosus (SLE), with levels of 40-59 ng/mL being associated with the lowest risk.

METHODOLOGY:

• Researchers analyzed 260 pregnancies in the Hopkins Lupus Cohort to examine the association between 25(OH) vitamin D levels and adverse pregnancy outcomes in women with SLE.
• The participants were required to have serum vitamin D levels measured during pregnancy and pregnancy-related outcomes data.
• The 25(OH) vitamin D levels were measured at visits every 6 weeks, and the participants were divided into six subgroups on the basis of the mean 25(OH) vitamin D levels: < 20 ng/dL, 20-29 ng/dL, 30-39 ng/dL, 40-49 ng/dL, 50-59 ng/dL, and ≥ 60 ng/dL.
• The adverse pregnancy outcomes included miscarriage, preterm delivery, and restricted intrauterine growth of the fetus.
• This study used a time-to-event analysis to assess the association between time-varying 25(OH) vitamin D levels and adverse pregnancy outcomes.

TAKEAWAY:

• Adverse pregnancy outcomes were observed in 45.3% of pregnancies; the risks for miscarriage and preterm delivery were significantly different across the six subgroups with varying vitamin D levels (P = .0045 and P = .0007, respectively).
• A U-shaped curve association was observed between vitamin D levels and adverse pregnancy outcomes, with the highest risk seen in patients with the lowest or highest levels of vitamin D during pregnancy, while the lowest risk was seen in those with vitamin D levels between 40 and 59 ng/mL.
• Low 25(OH) vitamin D levels during the second trimester resulted in premature delivery in 9 out of 10 pregnancies; however, a relationship between vitamin D levels in the first trimester and pregnancy outcomes was not observed.
• The time-to-event analysis showed that the U-shaped association between vitamin D levels and adverse pregnancy outcomes was still observed even after accounting for lupus disease activity; however, the elevated risk seen in individuals with the highest levels of vitamin D was no longer statistically significant.

IN PRACTICE:

“We recommend monitoring of maternal serum 25(OH) vitamin D levels throughout SLE pregnancies and supplementing patients with vitamin D insufficiency or deficiency, aiming for 25(OH) vitamin D range of 40-59 ng/mL. Over supplementation should be avoided,” the authors wrote.

SOURCE:

The study was led by Nima Madanchi, MD, Johns Hopkins University, Baltimore, and was published online on September 23, 2024, in Arthritis Care & Research.

LIMITATIONS:

This study could not prove a cause-and-effect relationship between vitamin D levels and adverse pregnancy outcomes. This study included only clinically identified pregnancies, potentially missing very early miscarriages. It also could not adjust for parity due to the unknown parity of the index pregnancy.

DISCLOSURES:

This Hopkins Lupus Cohort was supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Both low and high levels of maternal 25-hydroxy [25(OH)] vitamin D are linked to an increased risk for adverse pregnancy outcomes in women with systemic lupus erythematosus (SLE), with levels of 40-59 ng/mL being associated with the lowest risk.

METHODOLOGY:

• Researchers analyzed 260 pregnancies in the Hopkins Lupus Cohort to examine the association between 25(OH) vitamin D levels and adverse pregnancy outcomes in women with SLE.
• The participants were required to have serum vitamin D levels measured during pregnancy and pregnancy-related outcomes data.
• The 25(OH) vitamin D levels were measured at visits every 6 weeks, and the participants were divided into six subgroups on the basis of the mean 25(OH) vitamin D levels: < 20 ng/dL, 20-29 ng/dL, 30-39 ng/dL, 40-49 ng/dL, 50-59 ng/dL, and ≥ 60 ng/dL.
• The adverse pregnancy outcomes included miscarriage, preterm delivery, and restricted intrauterine growth of the fetus.
• This study used a time-to-event analysis to assess the association between time-varying 25(OH) vitamin D levels and adverse pregnancy outcomes.

TAKEAWAY:

• Adverse pregnancy outcomes were observed in 45.3% of pregnancies; the risks for miscarriage and preterm delivery were significantly different across the six subgroups with varying vitamin D levels (P = .0045 and P = .0007, respectively).
• A U-shaped curve association was observed between vitamin D levels and adverse pregnancy outcomes, with the highest risk seen in patients with the lowest or highest levels of vitamin D during pregnancy, while the lowest risk was seen in those with vitamin D levels between 40 and 59 ng/mL.
• Low 25(OH) vitamin D levels during the second trimester resulted in premature delivery in 9 out of 10 pregnancies; however, a relationship between vitamin D levels in the first trimester and pregnancy outcomes was not observed.
• The time-to-event analysis showed that the U-shaped association between vitamin D levels and adverse pregnancy outcomes was still observed even after accounting for lupus disease activity; however, the elevated risk seen in individuals with the highest levels of vitamin D was no longer statistically significant.

IN PRACTICE:

“We recommend monitoring of maternal serum 25(OH) vitamin D levels throughout SLE pregnancies and supplementing patients with vitamin D insufficiency or deficiency, aiming for 25(OH) vitamin D range of 40-59 ng/mL. Over supplementation should be avoided,” the authors wrote.

SOURCE:

The study was led by Nima Madanchi, MD, Johns Hopkins University, Baltimore, and was published online on September 23, 2024, in Arthritis Care & Research.

LIMITATIONS:

This study could not prove a cause-and-effect relationship between vitamin D levels and adverse pregnancy outcomes. This study included only clinically identified pregnancies, potentially missing very early miscarriages. It also could not adjust for parity due to the unknown parity of the index pregnancy.

DISCLOSURES:

This Hopkins Lupus Cohort was supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

More evidence suggests there is little risk in administering the live rotavirus vaccine to the babies of mothers on biologics during pregnancy for inflammatory bowel disease (IBD).

No adverse events or impairment of the immune system emerged in babies at 7 days, 1 month, and 9 months post vaccination, in findings from a small Canadian study published in Clinical Gastroenterology and Hepatology.

University of Calgary

The study found normal extended immune function testing in infants despite third-trimester maternal biologic therapy and regardless of circulating drug levels. The data provide reassurance about live rotavirus vaccination in this population and may also offer insights into the safety of other live vaccines in biologic-exposed individuals, wrote investigators led by gastroenterologist Cynthia H. Seow, MD, a professor in the Cumming School of Medicine at the University of Calgary in Alberta, Canada.

“Despite the well-established safety and effectiveness of non–live vaccination in individuals with IBD, including those on immunomodulators and biologic therapy, vaccine uptake in pregnant women with IBD and their infants remains suboptimal,” Seow said in an interview. This largely arises from maternal and physician concerns regarding transplacental transfer of IBD therapies and their impact on the safety of vaccination.

“These concerns were heightened after reports emerged of five fatal outcomes following the administration of the live Bacille Calmette-Guérin [BCG] vaccine in biologic-exposed infants. However, it had already been reported that inadvertent administration of the live oral rotavirus vaccine, a very different vaccine in terms of target and mechanism of action, in biologic-exposed individuals had not been associated with significant adverse effects,” she said.

They undertook their analysis with the hypothesis that vaccination would carry low risk, although the live oral vaccine is not currently recommended in biologic-exposed infants. “Yet rotavirus is a leading cause of severe, dehydrating diarrhea in children under the age of 5 years globally, and vaccination has led to significant reductions in hospitalizations and mortality,” Seow added.

Provision of the vaccine to anti–tumor necrosis factor (TNF)–exposed infants has been incorporated into the Canadian Public Health and Immunization guidelines, as the majority of the biologic-exposed infants were exposed to anti-TNF agents. “And with collection of further data, we expect that this will be extended to other biologic agent exposure. These data are important to pregnant women with IBD as they help to normalize their care. Pregnancy is difficult enough without having to remember exceptions to care,” Seow said.

“Before some of the studies came out, broad guidelines recommended that live vaccines should not be used in biologic-exposed infants, but this had been thought to be overly zealous and too conservative, and the risk was thought to be low,” said Elizabeth Spencer, MD, an assistant professor of pediatrics in the Division of Pediatric Gastroenterology at the Icahn School of Medicine at Mount Sinai in New York City, in an interview. Spencer was not involved in the Canadian study.

“At our center, we had some moms on biologics during pregnancy who forgot and had their babies vaccinated for rotavirus, and the babies were all fine,” she said.

The safety of this vaccine has been confirmed by several small studies and recently the PIANO Helmsley Global Consensus on Pregnancy and Inflammatory Bowel Disease, which was presented at Digestive Disease Week 2024. The consensus encompasses preconception counseling and the safety of IBD medications during pregnancy and lactation.

Icahn School of Medicine at Mount Sinai

“Another concern, however, was that giving a live GI bug like rotavirus to babies might overstimulate their immune systems and provoke IBD,” Spencer added. “While a number of population-based studies in the US and Europe showed that was not the case, at least in the general population, there was a suggestion that, down the road, vaccination might be mildly protective against IBD in some cases.”

She added the caveat that these studies were not done in mothers and their babies with IBD, who might be inherently at greater risk for IBD. “So, a question for future research would be, ‘Is immune stimulation of the gut in IBD moms and their babies a good or a bad thing for their gut?’ ”

Spencer conceded that “the data present a bit of a blurry picture, but I think it’s always better just to vaccinate according to the regular schedule. The current data say there is no added risk, but it would be nice to look specifically at risk in moms with IBD and their children.”
 

The Study

The prospective cohort study is a substudy of a larger 2023 one that included biologic use in a range of maternal illnesses, not just IBD.

For the current study, Seow and colleagues identified 57 infants born to 52 mothers with IBD attending a pregnancy clinic at the University of Calgary in the period 2019-2023. Almost 81% of the mothers had Crohn’s disease, and the median duration of IBD was 10 years. The median gestational age at delivery was 39 weeks, and almost 60% of deliveries were vaginal. The infants had been exposed in utero to infliximab (n = 21), adalimumab (n = 19), vedolizumab (n = 10), and ustekinumab (n = 7) in the third trimester.

The 57 biologic-exposed infants underwent standardized clinical assessments, drug concentration, and immune function testing. The live oral rotavirus vaccine series was provided to 50 infants, with the first dose at a median of 13 weeks of age. Immunologic assessments validated for age were normal in all infants despite median infliximab concentrations of 6.1 μg/mL (range, 0.4-28.8 μg/mL), adalimumab concentrations of 1.7 μg/mL (range, 0.7-7.9 μg/mL), ustekinumab concentrations of 0.6 μg/mL (range, 0-1.1), and undetectable for vedolizumab at 10.7 weeks of age.

As anticipated, infant immune function was normal regardless of circulating drug levels.

The overall message, said Seow, is “healthy mum equals healthy baby. Be more concerned regarding active inflammation than active medications. In almost all circumstances, treat to target in pregnancy as you would in the nonpregnant state.” She added, however, that further studies are needed to determine the safety and optimal timing of other live vaccines, such as the BCG, in the presence of biologic therapy.

This study was funded by the Alberta Children’s Hospital Research Institute. Seow reported advisory/speaker’s fees for Janssen, AbbVie, Takeda, Pfizer, Fresenius Kabi, Bristol-Myers Squibb, Pharmascience, and Lilly, as well as funding from Alberta Children’s Hospital Research Institute, Crohn’s and Colitis Canada, the Canadian Institutes of Health Research, and Calgary Health Trust, and data safety monitoring from New South Wales Government Health, Australia. Multiple coauthors disclosed similar consulting or speaker relationships with private industry. Spencer had no competing interests with regard to her comments.

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

More evidence suggests there is little risk in administering the live rotavirus vaccine to the babies of mothers on biologics during pregnancy for inflammatory bowel disease (IBD).

No adverse events or impairment of the immune system emerged in babies at 7 days, 1 month, and 9 months post vaccination, in findings from a small Canadian study published in Clinical Gastroenterology and Hepatology.

University of Calgary

The study found normal extended immune function testing in infants despite third-trimester maternal biologic therapy and regardless of circulating drug levels. The data provide reassurance about live rotavirus vaccination in this population and may also offer insights into the safety of other live vaccines in biologic-exposed individuals, wrote investigators led by gastroenterologist Cynthia H. Seow, MD, a professor in the Cumming School of Medicine at the University of Calgary in Alberta, Canada.

“Despite the well-established safety and effectiveness of non–live vaccination in individuals with IBD, including those on immunomodulators and biologic therapy, vaccine uptake in pregnant women with IBD and their infants remains suboptimal,” Seow said in an interview. This largely arises from maternal and physician concerns regarding transplacental transfer of IBD therapies and their impact on the safety of vaccination.

“These concerns were heightened after reports emerged of five fatal outcomes following the administration of the live Bacille Calmette-Guérin [BCG] vaccine in biologic-exposed infants. However, it had already been reported that inadvertent administration of the live oral rotavirus vaccine, a very different vaccine in terms of target and mechanism of action, in biologic-exposed individuals had not been associated with significant adverse effects,” she said.

They undertook their analysis with the hypothesis that vaccination would carry low risk, although the live oral vaccine is not currently recommended in biologic-exposed infants. “Yet rotavirus is a leading cause of severe, dehydrating diarrhea in children under the age of 5 years globally, and vaccination has led to significant reductions in hospitalizations and mortality,” Seow added.

Provision of the vaccine to anti–tumor necrosis factor (TNF)–exposed infants has been incorporated into the Canadian Public Health and Immunization guidelines, as the majority of the biologic-exposed infants were exposed to anti-TNF agents. “And with collection of further data, we expect that this will be extended to other biologic agent exposure. These data are important to pregnant women with IBD as they help to normalize their care. Pregnancy is difficult enough without having to remember exceptions to care,” Seow said.

“Before some of the studies came out, broad guidelines recommended that live vaccines should not be used in biologic-exposed infants, but this had been thought to be overly zealous and too conservative, and the risk was thought to be low,” said Elizabeth Spencer, MD, an assistant professor of pediatrics in the Division of Pediatric Gastroenterology at the Icahn School of Medicine at Mount Sinai in New York City, in an interview. Spencer was not involved in the Canadian study.

“At our center, we had some moms on biologics during pregnancy who forgot and had their babies vaccinated for rotavirus, and the babies were all fine,” she said.

The safety of this vaccine has been confirmed by several small studies and recently the PIANO Helmsley Global Consensus on Pregnancy and Inflammatory Bowel Disease, which was presented at Digestive Disease Week 2024. The consensus encompasses preconception counseling and the safety of IBD medications during pregnancy and lactation.

Icahn School of Medicine at Mount Sinai

“Another concern, however, was that giving a live GI bug like rotavirus to babies might overstimulate their immune systems and provoke IBD,” Spencer added. “While a number of population-based studies in the US and Europe showed that was not the case, at least in the general population, there was a suggestion that, down the road, vaccination might be mildly protective against IBD in some cases.”

She added the caveat that these studies were not done in mothers and their babies with IBD, who might be inherently at greater risk for IBD. “So, a question for future research would be, ‘Is immune stimulation of the gut in IBD moms and their babies a good or a bad thing for their gut?’ ”

Spencer conceded that “the data present a bit of a blurry picture, but I think it’s always better just to vaccinate according to the regular schedule. The current data say there is no added risk, but it would be nice to look specifically at risk in moms with IBD and their children.”
 

The Study

The prospective cohort study is a substudy of a larger 2023 one that included biologic use in a range of maternal illnesses, not just IBD.

For the current study, Seow and colleagues identified 57 infants born to 52 mothers with IBD attending a pregnancy clinic at the University of Calgary in the period 2019-2023. Almost 81% of the mothers had Crohn’s disease, and the median duration of IBD was 10 years. The median gestational age at delivery was 39 weeks, and almost 60% of deliveries were vaginal. The infants had been exposed in utero to infliximab (n = 21), adalimumab (n = 19), vedolizumab (n = 10), and ustekinumab (n = 7) in the third trimester.

The 57 biologic-exposed infants underwent standardized clinical assessments, drug concentration, and immune function testing. The live oral rotavirus vaccine series was provided to 50 infants, with the first dose at a median of 13 weeks of age. Immunologic assessments validated for age were normal in all infants despite median infliximab concentrations of 6.1 μg/mL (range, 0.4-28.8 μg/mL), adalimumab concentrations of 1.7 μg/mL (range, 0.7-7.9 μg/mL), ustekinumab concentrations of 0.6 μg/mL (range, 0-1.1), and undetectable for vedolizumab at 10.7 weeks of age.

As anticipated, infant immune function was normal regardless of circulating drug levels.

The overall message, said Seow, is “healthy mum equals healthy baby. Be more concerned regarding active inflammation than active medications. In almost all circumstances, treat to target in pregnancy as you would in the nonpregnant state.” She added, however, that further studies are needed to determine the safety and optimal timing of other live vaccines, such as the BCG, in the presence of biologic therapy.

This study was funded by the Alberta Children’s Hospital Research Institute. Seow reported advisory/speaker’s fees for Janssen, AbbVie, Takeda, Pfizer, Fresenius Kabi, Bristol-Myers Squibb, Pharmascience, and Lilly, as well as funding from Alberta Children’s Hospital Research Institute, Crohn’s and Colitis Canada, the Canadian Institutes of Health Research, and Calgary Health Trust, and data safety monitoring from New South Wales Government Health, Australia. Multiple coauthors disclosed similar consulting or speaker relationships with private industry. Spencer had no competing interests with regard to her comments.

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

More evidence suggests there is little risk in administering the live rotavirus vaccine to the babies of mothers on biologics during pregnancy for inflammatory bowel disease (IBD).

No adverse events or impairment of the immune system emerged in babies at 7 days, 1 month, and 9 months post vaccination, in findings from a small Canadian study published in Clinical Gastroenterology and Hepatology.

University of Calgary

The study found normal extended immune function testing in infants despite third-trimester maternal biologic therapy and regardless of circulating drug levels. The data provide reassurance about live rotavirus vaccination in this population and may also offer insights into the safety of other live vaccines in biologic-exposed individuals, wrote investigators led by gastroenterologist Cynthia H. Seow, MD, a professor in the Cumming School of Medicine at the University of Calgary in Alberta, Canada.

“Despite the well-established safety and effectiveness of non–live vaccination in individuals with IBD, including those on immunomodulators and biologic therapy, vaccine uptake in pregnant women with IBD and their infants remains suboptimal,” Seow said in an interview. This largely arises from maternal and physician concerns regarding transplacental transfer of IBD therapies and their impact on the safety of vaccination.

“These concerns were heightened after reports emerged of five fatal outcomes following the administration of the live Bacille Calmette-Guérin [BCG] vaccine in biologic-exposed infants. However, it had already been reported that inadvertent administration of the live oral rotavirus vaccine, a very different vaccine in terms of target and mechanism of action, in biologic-exposed individuals had not been associated with significant adverse effects,” she said.

They undertook their analysis with the hypothesis that vaccination would carry low risk, although the live oral vaccine is not currently recommended in biologic-exposed infants. “Yet rotavirus is a leading cause of severe, dehydrating diarrhea in children under the age of 5 years globally, and vaccination has led to significant reductions in hospitalizations and mortality,” Seow added.

Provision of the vaccine to anti–tumor necrosis factor (TNF)–exposed infants has been incorporated into the Canadian Public Health and Immunization guidelines, as the majority of the biologic-exposed infants were exposed to anti-TNF agents. “And with collection of further data, we expect that this will be extended to other biologic agent exposure. These data are important to pregnant women with IBD as they help to normalize their care. Pregnancy is difficult enough without having to remember exceptions to care,” Seow said.

“Before some of the studies came out, broad guidelines recommended that live vaccines should not be used in biologic-exposed infants, but this had been thought to be overly zealous and too conservative, and the risk was thought to be low,” said Elizabeth Spencer, MD, an assistant professor of pediatrics in the Division of Pediatric Gastroenterology at the Icahn School of Medicine at Mount Sinai in New York City, in an interview. Spencer was not involved in the Canadian study.

“At our center, we had some moms on biologics during pregnancy who forgot and had their babies vaccinated for rotavirus, and the babies were all fine,” she said.

The safety of this vaccine has been confirmed by several small studies and recently the PIANO Helmsley Global Consensus on Pregnancy and Inflammatory Bowel Disease, which was presented at Digestive Disease Week 2024. The consensus encompasses preconception counseling and the safety of IBD medications during pregnancy and lactation.

Icahn School of Medicine at Mount Sinai

“Another concern, however, was that giving a live GI bug like rotavirus to babies might overstimulate their immune systems and provoke IBD,” Spencer added. “While a number of population-based studies in the US and Europe showed that was not the case, at least in the general population, there was a suggestion that, down the road, vaccination might be mildly protective against IBD in some cases.”

She added the caveat that these studies were not done in mothers and their babies with IBD, who might be inherently at greater risk for IBD. “So, a question for future research would be, ‘Is immune stimulation of the gut in IBD moms and their babies a good or a bad thing for their gut?’ ”

Spencer conceded that “the data present a bit of a blurry picture, but I think it’s always better just to vaccinate according to the regular schedule. The current data say there is no added risk, but it would be nice to look specifically at risk in moms with IBD and their children.”
 

The Study

The prospective cohort study is a substudy of a larger 2023 one that included biologic use in a range of maternal illnesses, not just IBD.

For the current study, Seow and colleagues identified 57 infants born to 52 mothers with IBD attending a pregnancy clinic at the University of Calgary in the period 2019-2023. Almost 81% of the mothers had Crohn’s disease, and the median duration of IBD was 10 years. The median gestational age at delivery was 39 weeks, and almost 60% of deliveries were vaginal. The infants had been exposed in utero to infliximab (n = 21), adalimumab (n = 19), vedolizumab (n = 10), and ustekinumab (n = 7) in the third trimester.

The 57 biologic-exposed infants underwent standardized clinical assessments, drug concentration, and immune function testing. The live oral rotavirus vaccine series was provided to 50 infants, with the first dose at a median of 13 weeks of age. Immunologic assessments validated for age were normal in all infants despite median infliximab concentrations of 6.1 μg/mL (range, 0.4-28.8 μg/mL), adalimumab concentrations of 1.7 μg/mL (range, 0.7-7.9 μg/mL), ustekinumab concentrations of 0.6 μg/mL (range, 0-1.1), and undetectable for vedolizumab at 10.7 weeks of age.

As anticipated, infant immune function was normal regardless of circulating drug levels.

The overall message, said Seow, is “healthy mum equals healthy baby. Be more concerned regarding active inflammation than active medications. In almost all circumstances, treat to target in pregnancy as you would in the nonpregnant state.” She added, however, that further studies are needed to determine the safety and optimal timing of other live vaccines, such as the BCG, in the presence of biologic therapy.

This study was funded by the Alberta Children’s Hospital Research Institute. Seow reported advisory/speaker’s fees for Janssen, AbbVie, Takeda, Pfizer, Fresenius Kabi, Bristol-Myers Squibb, Pharmascience, and Lilly, as well as funding from Alberta Children’s Hospital Research Institute, Crohn’s and Colitis Canada, the Canadian Institutes of Health Research, and Calgary Health Trust, and data safety monitoring from New South Wales Government Health, Australia. Multiple coauthors disclosed similar consulting or speaker relationships with private industry. Spencer had no competing interests with regard to her comments.

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

TOPLINE:

Maternal serum folate levels during early to midpregnancy show a U-shaped association with congenital heart disease (CHD) risk in offspring. Both low and high folate levels are linked to an increased risk, with vitamin B12 deficiency and elevated homocysteine levels further exacerbating this risk.

METHODOLOGY:

• Researchers conducted a case-control study with 129 participants with CHD and 516 matched control participants from Guangdong Provincial People’s Hospital in China between 2015 and 2018.
• Maternal serum levels of folate, vitamin B12, and homocysteine were measured at around 16 weeks of gestation using a chemiluminescence microparticle immunoassay.
• CHD was confirmed using echocardiography, and the participants were matched by maternal age at a ratio of 1:4.
• Covariates included periconceptional folic acid supplementation, maternal education, occupation, parity, abortion history, pregnancy complications, and genetic polymorphisms related to folate metabolism.
• Conditional logistic regression was used to assess the associations, with adjustments for various covariates and sensitivity analyses excluding participants with missing genetic data.

TAKEAWAY:

• A U-shaped association was found between maternal serum folate levels and CHD risk in offspring, with both low and high levels linked to increased risk (P < .001).
• Low maternal folate levels were associated with an adjusted odds ratio (aOR) of 3.09 (95% CI, 1.88-5.08) for CHD risk, whereas high levels had an aOR of 1.81 (95% CI, 1.07-3.06).
• Using World Health Organization criteria, folate deficiency (< 5.9 ng/mL) had an aOR of 18.97 (95% CI, 3.87-93.11) and elevated levels (> 20 ng/mL) had an aOR of 5.71 (95% CI, 2.72-11.98) for CHD risk.
• Vitamin B12 deficiency and elevated homocysteine levels further increased the risk associated with both low and high maternal folate levels.

IN PRACTICE:

“Insufficient folate and vitamin B12 can lead to increased homocysteine levels, which is harmful to the cardiovascular system. Thus, homocysteine might act as a central mediator in the relationships between deficiencies in folate and vitamin B12 and the risk of CHD. Additionally, the role of folate extends beyond homocysteine mediation, contributing independently to placental implantation and vascular remodeling, irrespective of vitamin B12 and homocysteine levels,” the authors wrote.

SOURCE:

The study was led by Yanji Qu, PhD, and Jie Li, PhD, Global Health Research Center, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China. It was published online in JAMA Network Open.

LIMITATIONS:

The study’s limitations included the measurement of maternal serum folate levels at a single time point, which may not reflect preconception and early postconception periods. The study’s findings may not be generalizable to other populations as participants were recruited from a single cardiac referral center in Southern China. Additionally, the lack of dietary intake data limited the ability to account for related biases. The sample size, while relatively large for CHD research, may lack sufficient power for stratified analyses.

DISCLOSURES:

One coauthor reported receiving personal fees from Guangdong Cardiovascular Institute outside the submitted work. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Maternal serum folate levels during early to midpregnancy show a U-shaped association with congenital heart disease (CHD) risk in offspring. Both low and high folate levels are linked to an increased risk, with vitamin B12 deficiency and elevated homocysteine levels further exacerbating this risk.

METHODOLOGY:

• Researchers conducted a case-control study with 129 participants with CHD and 516 matched control participants from Guangdong Provincial People’s Hospital in China between 2015 and 2018.
• Maternal serum levels of folate, vitamin B12, and homocysteine were measured at around 16 weeks of gestation using a chemiluminescence microparticle immunoassay.
• CHD was confirmed using echocardiography, and the participants were matched by maternal age at a ratio of 1:4.
• Covariates included periconceptional folic acid supplementation, maternal education, occupation, parity, abortion history, pregnancy complications, and genetic polymorphisms related to folate metabolism.
• Conditional logistic regression was used to assess the associations, with adjustments for various covariates and sensitivity analyses excluding participants with missing genetic data.

TAKEAWAY:

• A U-shaped association was found between maternal serum folate levels and CHD risk in offspring, with both low and high levels linked to increased risk (P < .001).
• Low maternal folate levels were associated with an adjusted odds ratio (aOR) of 3.09 (95% CI, 1.88-5.08) for CHD risk, whereas high levels had an aOR of 1.81 (95% CI, 1.07-3.06).
• Using World Health Organization criteria, folate deficiency (< 5.9 ng/mL) had an aOR of 18.97 (95% CI, 3.87-93.11) and elevated levels (> 20 ng/mL) had an aOR of 5.71 (95% CI, 2.72-11.98) for CHD risk.
• Vitamin B12 deficiency and elevated homocysteine levels further increased the risk associated with both low and high maternal folate levels.

IN PRACTICE:

“Insufficient folate and vitamin B12 can lead to increased homocysteine levels, which is harmful to the cardiovascular system. Thus, homocysteine might act as a central mediator in the relationships between deficiencies in folate and vitamin B12 and the risk of CHD. Additionally, the role of folate extends beyond homocysteine mediation, contributing independently to placental implantation and vascular remodeling, irrespective of vitamin B12 and homocysteine levels,” the authors wrote.

SOURCE:

The study was led by Yanji Qu, PhD, and Jie Li, PhD, Global Health Research Center, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China. It was published online in JAMA Network Open.

LIMITATIONS:

The study’s limitations included the measurement of maternal serum folate levels at a single time point, which may not reflect preconception and early postconception periods. The study’s findings may not be generalizable to other populations as participants were recruited from a single cardiac referral center in Southern China. Additionally, the lack of dietary intake data limited the ability to account for related biases. The sample size, while relatively large for CHD research, may lack sufficient power for stratified analyses.

DISCLOSURES:

One coauthor reported receiving personal fees from Guangdong Cardiovascular Institute outside the submitted work. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Maternal serum folate levels during early to midpregnancy show a U-shaped association with congenital heart disease (CHD) risk in offspring. Both low and high folate levels are linked to an increased risk, with vitamin B12 deficiency and elevated homocysteine levels further exacerbating this risk.

METHODOLOGY:

• Researchers conducted a case-control study with 129 participants with CHD and 516 matched control participants from Guangdong Provincial People’s Hospital in China between 2015 and 2018.
• Maternal serum levels of folate, vitamin B12, and homocysteine were measured at around 16 weeks of gestation using a chemiluminescence microparticle immunoassay.
• CHD was confirmed using echocardiography, and the participants were matched by maternal age at a ratio of 1:4.
• Covariates included periconceptional folic acid supplementation, maternal education, occupation, parity, abortion history, pregnancy complications, and genetic polymorphisms related to folate metabolism.
• Conditional logistic regression was used to assess the associations, with adjustments for various covariates and sensitivity analyses excluding participants with missing genetic data.

TAKEAWAY:

• A U-shaped association was found between maternal serum folate levels and CHD risk in offspring, with both low and high levels linked to increased risk (P < .001).
• Low maternal folate levels were associated with an adjusted odds ratio (aOR) of 3.09 (95% CI, 1.88-5.08) for CHD risk, whereas high levels had an aOR of 1.81 (95% CI, 1.07-3.06).
• Using World Health Organization criteria, folate deficiency (< 5.9 ng/mL) had an aOR of 18.97 (95% CI, 3.87-93.11) and elevated levels (> 20 ng/mL) had an aOR of 5.71 (95% CI, 2.72-11.98) for CHD risk.
• Vitamin B12 deficiency and elevated homocysteine levels further increased the risk associated with both low and high maternal folate levels.

IN PRACTICE:

“Insufficient folate and vitamin B12 can lead to increased homocysteine levels, which is harmful to the cardiovascular system. Thus, homocysteine might act as a central mediator in the relationships between deficiencies in folate and vitamin B12 and the risk of CHD. Additionally, the role of folate extends beyond homocysteine mediation, contributing independently to placental implantation and vascular remodeling, irrespective of vitamin B12 and homocysteine levels,” the authors wrote.

SOURCE:

The study was led by Yanji Qu, PhD, and Jie Li, PhD, Global Health Research Center, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China. It was published online in JAMA Network Open.

LIMITATIONS:

The study’s limitations included the measurement of maternal serum folate levels at a single time point, which may not reflect preconception and early postconception periods. The study’s findings may not be generalizable to other populations as participants were recruited from a single cardiac referral center in Southern China. Additionally, the lack of dietary intake data limited the ability to account for related biases. The sample size, while relatively large for CHD research, may lack sufficient power for stratified analyses.

DISCLOSURES:

One coauthor reported receiving personal fees from Guangdong Cardiovascular Institute outside the submitted work. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Mifepristone plus misoprostol reduces the need for subsequent uterine aspiration and emergency department visits in the management of early pregnancy loss. Despite its effectiveness, mifepristone remains underutilized, with 8.6% of patients receiving it in 2022.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using national insurance claims data of US patients with commercial insurance.
• More than 31,000 pregnant women (mean age, 32.7 years) with a diagnosis of early pregnancy loss between 2015 and 2022 were included.
• The diagnosis of patients included having a missed abortion (72.3%), spontaneous abortion (26.9%), or both (0.8%).
• Researchers compared the outcomes of individuals who received a combination of mifepristone and misoprostol vs those who received misoprostol alone. The outcome measures included the need for subsequent procedural management (uterine aspiration), return visits to the emergency department or an outpatient clinic, hospitalizations, and complications within 6 weeks of initial diagnosis.

TAKEAWAY:

• The use of mifepristone was more common in outpatient clinics than in emergency departments (3.4% vs 0.9%; P < .001).
• The use of mifepristone plus misoprostol vs misoprostol alone was linked to a lower incidence of subsequent procedural management (10.5% vs 14.0%; P = .002) and fewer emergency department visits (3.5% vs 7.9%; P < .001).
• The multivariable analysis showed that the use of mifepristone was linked to decreased odds of subsequent procedural management (adjusted odds ratio, 0.71; 95% CI, 0.57-0.87).
• Despite its effectiveness, mifepristone was used in only 8.6% of those receiving medication management for early pregnancy loss in 2022.

IN PRACTICE:

“Continued efforts are needed to reduce barriers to mifepristone use for medication management of EPL,” the authors wrote.

“Any practitioner who cares for patients experiencing early pregnancy loss should consider mifepristone pretreatment to misoprostol to be the standard of care for medication management. Provision of the evidence-based standard of care with the use of mifepristone for early pregnancy loss is an opportunity to advocate for an essential strategy in improving sexual and reproductive health in the US,” wrote Sarita Sonalkar, MD, MPH, and Rachel McKean, MD, MPH, of the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, in an invited commentary.
 

SOURCE:

The study was led by Lyndsey S. Benson, MD, MS, of the University of Washington School of Medicine, Seattle, and was published online in JAMA Network Open.

LIMITATIONS:

The study was limited by the accuracy of the diagnosis of early pregnancy loss and procedure codes because claims data are intended for billing purposes and may be incomplete or inaccurate. The use of de-identified data meant that specific gestational durations, exact dosing, or routes of misoprostol administration could not be determined. The findings may not be generalizable to those with public insurance or no insurance.

DISCLOSURES:

The study was supported in part by a grant from a Women’s Reproductive Health Research grant from the National Institutes of Health Eunice Kennedy Shriver National Institute for Child Health and Human Development. One author reported serving as an adviser and investigator, while another reported receiving personal fees and serving as an expert witness, contributing editor, and course instructor outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Mifepristone plus misoprostol reduces the need for subsequent uterine aspiration and emergency department visits in the management of early pregnancy loss. Despite its effectiveness, mifepristone remains underutilized, with 8.6% of patients receiving it in 2022.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using national insurance claims data of US patients with commercial insurance.
• More than 31,000 pregnant women (mean age, 32.7 years) with a diagnosis of early pregnancy loss between 2015 and 2022 were included.
• The diagnosis of patients included having a missed abortion (72.3%), spontaneous abortion (26.9%), or both (0.8%).
• Researchers compared the outcomes of individuals who received a combination of mifepristone and misoprostol vs those who received misoprostol alone. The outcome measures included the need for subsequent procedural management (uterine aspiration), return visits to the emergency department or an outpatient clinic, hospitalizations, and complications within 6 weeks of initial diagnosis.

TAKEAWAY:

• The use of mifepristone was more common in outpatient clinics than in emergency departments (3.4% vs 0.9%; P < .001).
• The use of mifepristone plus misoprostol vs misoprostol alone was linked to a lower incidence of subsequent procedural management (10.5% vs 14.0%; P = .002) and fewer emergency department visits (3.5% vs 7.9%; P < .001).
• The multivariable analysis showed that the use of mifepristone was linked to decreased odds of subsequent procedural management (adjusted odds ratio, 0.71; 95% CI, 0.57-0.87).
• Despite its effectiveness, mifepristone was used in only 8.6% of those receiving medication management for early pregnancy loss in 2022.

IN PRACTICE:

“Continued efforts are needed to reduce barriers to mifepristone use for medication management of EPL,” the authors wrote.

“Any practitioner who cares for patients experiencing early pregnancy loss should consider mifepristone pretreatment to misoprostol to be the standard of care for medication management. Provision of the evidence-based standard of care with the use of mifepristone for early pregnancy loss is an opportunity to advocate for an essential strategy in improving sexual and reproductive health in the US,” wrote Sarita Sonalkar, MD, MPH, and Rachel McKean, MD, MPH, of the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, in an invited commentary.
 

SOURCE:

The study was led by Lyndsey S. Benson, MD, MS, of the University of Washington School of Medicine, Seattle, and was published online in JAMA Network Open.

LIMITATIONS:

The study was limited by the accuracy of the diagnosis of early pregnancy loss and procedure codes because claims data are intended for billing purposes and may be incomplete or inaccurate. The use of de-identified data meant that specific gestational durations, exact dosing, or routes of misoprostol administration could not be determined. The findings may not be generalizable to those with public insurance or no insurance.

DISCLOSURES:

The study was supported in part by a grant from a Women’s Reproductive Health Research grant from the National Institutes of Health Eunice Kennedy Shriver National Institute for Child Health and Human Development. One author reported serving as an adviser and investigator, while another reported receiving personal fees and serving as an expert witness, contributing editor, and course instructor outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Mifepristone plus misoprostol reduces the need for subsequent uterine aspiration and emergency department visits in the management of early pregnancy loss. Despite its effectiveness, mifepristone remains underutilized, with 8.6% of patients receiving it in 2022.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using national insurance claims data of US patients with commercial insurance.
• More than 31,000 pregnant women (mean age, 32.7 years) with a diagnosis of early pregnancy loss between 2015 and 2022 were included.
• The diagnosis of patients included having a missed abortion (72.3%), spontaneous abortion (26.9%), or both (0.8%).
• Researchers compared the outcomes of individuals who received a combination of mifepristone and misoprostol vs those who received misoprostol alone. The outcome measures included the need for subsequent procedural management (uterine aspiration), return visits to the emergency department or an outpatient clinic, hospitalizations, and complications within 6 weeks of initial diagnosis.

TAKEAWAY:

• The use of mifepristone was more common in outpatient clinics than in emergency departments (3.4% vs 0.9%; P < .001).
• The use of mifepristone plus misoprostol vs misoprostol alone was linked to a lower incidence of subsequent procedural management (10.5% vs 14.0%; P = .002) and fewer emergency department visits (3.5% vs 7.9%; P < .001).
• The multivariable analysis showed that the use of mifepristone was linked to decreased odds of subsequent procedural management (adjusted odds ratio, 0.71; 95% CI, 0.57-0.87).
• Despite its effectiveness, mifepristone was used in only 8.6% of those receiving medication management for early pregnancy loss in 2022.

IN PRACTICE:

“Continued efforts are needed to reduce barriers to mifepristone use for medication management of EPL,” the authors wrote.

“Any practitioner who cares for patients experiencing early pregnancy loss should consider mifepristone pretreatment to misoprostol to be the standard of care for medication management. Provision of the evidence-based standard of care with the use of mifepristone for early pregnancy loss is an opportunity to advocate for an essential strategy in improving sexual and reproductive health in the US,” wrote Sarita Sonalkar, MD, MPH, and Rachel McKean, MD, MPH, of the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, in an invited commentary.
 

SOURCE:

The study was led by Lyndsey S. Benson, MD, MS, of the University of Washington School of Medicine, Seattle, and was published online in JAMA Network Open.

LIMITATIONS:

The study was limited by the accuracy of the diagnosis of early pregnancy loss and procedure codes because claims data are intended for billing purposes and may be incomplete or inaccurate. The use of de-identified data meant that specific gestational durations, exact dosing, or routes of misoprostol administration could not be determined. The findings may not be generalizable to those with public insurance or no insurance.

DISCLOSURES:

The study was supported in part by a grant from a Women’s Reproductive Health Research grant from the National Institutes of Health Eunice Kennedy Shriver National Institute for Child Health and Human Development. One author reported serving as an adviser and investigator, while another reported receiving personal fees and serving as an expert witness, contributing editor, and course instructor outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Editor’s Note: Sadly, this is the last column in the Master Class Obstetrics series. This award-winning column has been part of Ob.Gyn. News for 20 years. The deep discussion of cutting-edge topics in obstetrics by specialists and researchers will be missed as will the leadership and curation of topics by Dr. E. Albert Reece.
 

Introduction: The Need for Increased Vigilance About Maternal Immunization

Viruses are becoming increasingly prevalent in our world and the consequences of viral infections are implicated in a growing number of disease states. It is well established that certain cancers are caused by viruses and it is increasingly evident that viral infections can trigger the development of chronic illness. In pregnant women, viruses such as cytomegalovirus can cause infection in utero and lead to long-term impairments for the baby.

Likewise, it appears that the virulence of viruses is increasing, whether it be the respiratory syncytial virus (RSV) in children or the severe acute respiratory syndrome (SARS) coronaviruses in adults. Clearly, our environment is changing, with increases in population growth and urbanization, for instance, and an intensification of climate change and its effects. Viruses are part of this changing background.

Dr. Reece is the former Dean of Medicine & University Executive VP, and The Distinguished University and Endowed Professor & Director of the Center for Advanced Research Training and Innovation (CARTI) at the University of Maryland School of Medicine, as well as senior scientist at the Center for Birth Defects Research.

The alarming decline in maternal immunization rates that occurred in the wake of the COVID-19 pandemic means that, now more than ever, we must fully embrace our responsibility to recommend immunizations in pregnancy and to communicate what is known about their efficacy and safety. Data show that vaccination rates drop when we do not offer vaccines in our offices, so whenever possible, we should administer them as well.

The ob.gyn. is the patient’s most trusted person in pregnancy. When patients decline or express hesitancy about vaccines, it is incumbent upon us to ask why. Oftentimes, we can identify areas in which patients lack knowledge or have misperceptions and we can successfully educate the patient or change their perspective or misunderstanding concerning the importance of vaccination for themselves and their babies. (See Table 1.) We can also successfully address concerns about safety.

Dr. Riley

New York Presbyterian

Counseling About Influenza and COVID-19 Vaccination

The COVID-19 pandemic took a toll on vaccination interest/receptivity broadly in pregnant and nonpregnant people. Among pregnant individuals, influenza vaccination coverage declined from 71% in the 2019-2020 influenza season to 56% in the 2021-2022 season, according to data from the Centers for Disease Control and Prevention’s Vaccine Safety Datalink.⁴ Coverage for the 2022-2023 and 2023-2024 influenza seasons was even worse: well under 50%.⁵

Fewer pregnant women have received updated COVID-19 vaccines. Only 13% of pregnant persons overall received the updated 2023-2024 COVID-19 booster vaccine (through March 30, 2024), according to the CDC.⁶

Maternal immunization for influenza has been recommended in the United States since 2004 (part of the recommendation that everyone over the age of 6 months receive an annual flu vaccine), and flu vaccines have been given to millions of pregnant women, but the H1N1 pandemic of 2009 reinforced its value as a priority for prenatal care. Most of the women who became severely ill from the H1N1 virus were young and healthy, without co-existing conditions known to increase risk.⁷

It became clearer during the H1N1 pandemic that pregnancy itself — which is associated with physiologic changes such as decreased lung capacity, increased nasal congestion and changes in the immune system – is its own significant risk factor for severe illness from the influenza virus. This increased risk applies to COVID-19 as well.

As COVID-19 has become endemic, with hospitalizations and deaths not reaching the levels of previous surges — and with mask-wearing and other preventive measures having declined — patients understandably have become more complacent. Some patients are vaccine deniers, but in my practice, these patients are a much smaller group than those who believe COVID-19 “is no big deal,” especially if they have had infections recently.

This is why it’s important to actively listen to concerns and to ask patients who decline a vaccination why they are hesitant. Blanket messages about vaccine efficacy and safety are the first step, but individualized, more pointed conversations based on the patient’s personal experiences and beliefs have become increasingly important.

I routinely tell pregnant patients about the risks of COVID-19 and I explain that it has been difficult to predict who will develop severe illness. Sometimes more conversation is needed. For those who are still hesitant or who tell me they feel protected by a recent infection, for instance, I provide more detail on the unique risks of pregnancy — the fact that “pregnancy is different” — and that natural immunity wanes while the protection afforded by immunization is believed to last longer. Many women are also concerned about the safety of the COVID-19 vaccine, so having safety data at your fingertips is helpful. (See Table 2.)

Dr. Riley

Counseling About RSV Vaccination

Importantly, for the 2024-2025 RSV season, the maternal RSV vaccine (Abrysvo, Pfizer) is recommended only for pregnant women who did not receive the vaccine during the 2023-2024 season. When more research is done and more data are obtained showing how long the immune response persists post vaccination, it may be that the US Food and Drug Administration (FDA) will approve the maternal RSV vaccine for use in every pregnancy.

The later timing of the vaccination recommendation — 32-36 weeks’ gestation — reflects a conservative approach taken by the FDA in response to data from one of the pivotal trials showing a numerical trend toward more preterm deliveries among vaccinated compared with unvaccinated patients. This imbalance in the original trial, which administered the vaccine during 24-36 weeks of gestation, was seen only in low-income countries with no temporal association, however.

In our experience at two Weill Cornell Medical College–associated hospitals we did not see this trend. Our cohort study of almost 3000 pregnant patients who delivered at 32 weeks’ gestation or later found no increased risk of preterm birth among the 35% of patients who received the RSV vaccine during the 2023-2024 RSV season. We also did not see any difference in preeclampsia, in contrast with original trial data that showed a signal for increased risk.¹¹

When fewer than 2 weeks have elapsed between maternal vaccination and delivery, the monoclonal antibody nirsevimab is recommended for the newborn — ideally before the newborn leaves the hospital. Nirsevimab is also recommended for newborns of mothers who decline vaccination or were not candidates (e.g. vaccinated in a previous pregnancy), or when there is concern about the adequacy of the maternal immune response to the vaccine (e.g. in cases of immunosuppression).

While there was a limited supply of the monoclonal antibody last year, limitations are not expected this year, especially after October.

The ultimate goal is that patients choose the vaccine or the immunoglobulin, given the severity of RSV disease. Patient preferences should be considered. However, given that it takes 2 weeks after vaccination for protection to build up, I stress to patients that if they’ve vaccinated themselves, their newborn will leave the hospital with protection. If nirsevimab is relied upon, I explain, their newborn may not be protected for some period of time.
 

Take-home Messages

• When patients decline or are hesitant about vaccines, ask why. Listen actively, and work to correct misperceptions and knowledge gaps.
• Whenever possible, offer vaccines in your practice. Vaccination rates drop when this does not occur.
• COVID-vaccine safety is backed by many studies showing no increase in birth defects, preterm delivery, miscarriage, or stillbirth.
• Pregnant women are more likely to have severe illness from the influenza and SARS-CoV-2 viruses. Vaccines can prevent severe illness and can protect the newborn as well as the mother.
• Recommend/administer the maternal RSV vaccine at 32-36 weeks’ gestation in women who did not receive the vaccine in the 2023-2024 season. If mothers aren’t eligible their babies should be offered nirsevimab.

Dr. Riley is the Given Foundation Professor and Chair of Obstetrics and Gynecology at Weill Cornell Medicine and the obstetrician and gynecologist-in-chief at New York Presbyterian Hospital. She disclosed that she has provided one-time consultations to Pfizer (Abrysvo RSV vaccine) and GSK (cytomegalovirus vaccine), and is providing consultant education on CMV for Moderna. She is chair of ACOG’s task force on immunization and emerging infectious diseases, serves on the medical advisory board for MAVEN, and serves as an editor or editorial board member for several medical publications.



References

1. ACOG Committee Opinion No. 741: Maternal Immunization. Obstet Gynecol. 2018;131(6):e214-e217.

2. Centers for Disease Control and Prevention. COVID-19 Vaccination for People Who are Pregnant or Breastfeeding. https://www.cdc.gov/covid/vaccines/pregnant-or-breastfeeding.html.

3. ACOG Practice Advisory on Maternal Respiratory Syncytial Virus Vaccination, September 2023. (Updated August 2024).4. Irving S et al. Open Forum Infect Dis. 2023;10(Suppl 2):ofad500.1002.

5. Flu Vaccination Dashboard, CDC, National Center for Immunization and Respiratory Diseases.

6. Weekly COVID-19 Vaccination Dashboard, CDC. https://www.cdc.gov/covidvaxview/weekly-dashboard/index.html

7. Louie JK et al. N Engl J Med. 2010;362:27-35. 8. Ciapponi A et al. Vaccine. 2021;39(40):5891-908.

9. Prasad S et al. Nature Communications. 2022;13:2414. 10. Fleming-Dutra KE et al. Obstet Gynecol Clin North Am 2023;50(2):279-97. 11. Mouen S et al. JAMA Network Open 2024;7(7):e2419268.

Editor’s Note: Sadly, this is the last column in the Master Class Obstetrics series. This award-winning column has been part of Ob.Gyn. News for 20 years. The deep discussion of cutting-edge topics in obstetrics by specialists and researchers will be missed as will the leadership and curation of topics by Dr. E. Albert Reece.
 

Introduction: The Need for Increased Vigilance About Maternal Immunization

Viruses are becoming increasingly prevalent in our world and the consequences of viral infections are implicated in a growing number of disease states. It is well established that certain cancers are caused by viruses and it is increasingly evident that viral infections can trigger the development of chronic illness. In pregnant women, viruses such as cytomegalovirus can cause infection in utero and lead to long-term impairments for the baby.

Likewise, it appears that the virulence of viruses is increasing, whether it be the respiratory syncytial virus (RSV) in children or the severe acute respiratory syndrome (SARS) coronaviruses in adults. Clearly, our environment is changing, with increases in population growth and urbanization, for instance, and an intensification of climate change and its effects. Viruses are part of this changing background.

Dr. Reece is the former Dean of Medicine & University Executive VP, and The Distinguished University and Endowed Professor & Director of the Center for Advanced Research Training and Innovation (CARTI) at the University of Maryland School of Medicine, as well as senior scientist at the Center for Birth Defects Research.

The alarming decline in maternal immunization rates that occurred in the wake of the COVID-19 pandemic means that, now more than ever, we must fully embrace our responsibility to recommend immunizations in pregnancy and to communicate what is known about their efficacy and safety. Data show that vaccination rates drop when we do not offer vaccines in our offices, so whenever possible, we should administer them as well.

The ob.gyn. is the patient’s most trusted person in pregnancy. When patients decline or express hesitancy about vaccines, it is incumbent upon us to ask why. Oftentimes, we can identify areas in which patients lack knowledge or have misperceptions and we can successfully educate the patient or change their perspective or misunderstanding concerning the importance of vaccination for themselves and their babies. (See Table 1.) We can also successfully address concerns about safety.

Dr. Riley

New York Presbyterian

Counseling About Influenza and COVID-19 Vaccination

The COVID-19 pandemic took a toll on vaccination interest/receptivity broadly in pregnant and nonpregnant people. Among pregnant individuals, influenza vaccination coverage declined from 71% in the 2019-2020 influenza season to 56% in the 2021-2022 season, according to data from the Centers for Disease Control and Prevention’s Vaccine Safety Datalink.⁴ Coverage for the 2022-2023 and 2023-2024 influenza seasons was even worse: well under 50%.⁵

Fewer pregnant women have received updated COVID-19 vaccines. Only 13% of pregnant persons overall received the updated 2023-2024 COVID-19 booster vaccine (through March 30, 2024), according to the CDC.⁶

Maternal immunization for influenza has been recommended in the United States since 2004 (part of the recommendation that everyone over the age of 6 months receive an annual flu vaccine), and flu vaccines have been given to millions of pregnant women, but the H1N1 pandemic of 2009 reinforced its value as a priority for prenatal care. Most of the women who became severely ill from the H1N1 virus were young and healthy, without co-existing conditions known to increase risk.⁷

It became clearer during the H1N1 pandemic that pregnancy itself — which is associated with physiologic changes such as decreased lung capacity, increased nasal congestion and changes in the immune system – is its own significant risk factor for severe illness from the influenza virus. This increased risk applies to COVID-19 as well.

As COVID-19 has become endemic, with hospitalizations and deaths not reaching the levels of previous surges — and with mask-wearing and other preventive measures having declined — patients understandably have become more complacent. Some patients are vaccine deniers, but in my practice, these patients are a much smaller group than those who believe COVID-19 “is no big deal,” especially if they have had infections recently.

This is why it’s important to actively listen to concerns and to ask patients who decline a vaccination why they are hesitant. Blanket messages about vaccine efficacy and safety are the first step, but individualized, more pointed conversations based on the patient’s personal experiences and beliefs have become increasingly important.

I routinely tell pregnant patients about the risks of COVID-19 and I explain that it has been difficult to predict who will develop severe illness. Sometimes more conversation is needed. For those who are still hesitant or who tell me they feel protected by a recent infection, for instance, I provide more detail on the unique risks of pregnancy — the fact that “pregnancy is different” — and that natural immunity wanes while the protection afforded by immunization is believed to last longer. Many women are also concerned about the safety of the COVID-19 vaccine, so having safety data at your fingertips is helpful. (See Table 2.)

Dr. Riley

Counseling About RSV Vaccination

Importantly, for the 2024-2025 RSV season, the maternal RSV vaccine (Abrysvo, Pfizer) is recommended only for pregnant women who did not receive the vaccine during the 2023-2024 season. When more research is done and more data are obtained showing how long the immune response persists post vaccination, it may be that the US Food and Drug Administration (FDA) will approve the maternal RSV vaccine for use in every pregnancy.

The later timing of the vaccination recommendation — 32-36 weeks’ gestation — reflects a conservative approach taken by the FDA in response to data from one of the pivotal trials showing a numerical trend toward more preterm deliveries among vaccinated compared with unvaccinated patients. This imbalance in the original trial, which administered the vaccine during 24-36 weeks of gestation, was seen only in low-income countries with no temporal association, however.

In our experience at two Weill Cornell Medical College–associated hospitals we did not see this trend. Our cohort study of almost 3000 pregnant patients who delivered at 32 weeks’ gestation or later found no increased risk of preterm birth among the 35% of patients who received the RSV vaccine during the 2023-2024 RSV season. We also did not see any difference in preeclampsia, in contrast with original trial data that showed a signal for increased risk.¹¹

When fewer than 2 weeks have elapsed between maternal vaccination and delivery, the monoclonal antibody nirsevimab is recommended for the newborn — ideally before the newborn leaves the hospital. Nirsevimab is also recommended for newborns of mothers who decline vaccination or were not candidates (e.g. vaccinated in a previous pregnancy), or when there is concern about the adequacy of the maternal immune response to the vaccine (e.g. in cases of immunosuppression).

While there was a limited supply of the monoclonal antibody last year, limitations are not expected this year, especially after October.

The ultimate goal is that patients choose the vaccine or the immunoglobulin, given the severity of RSV disease. Patient preferences should be considered. However, given that it takes 2 weeks after vaccination for protection to build up, I stress to patients that if they’ve vaccinated themselves, their newborn will leave the hospital with protection. If nirsevimab is relied upon, I explain, their newborn may not be protected for some period of time.
 

Take-home Messages

• When patients decline or are hesitant about vaccines, ask why. Listen actively, and work to correct misperceptions and knowledge gaps.
• Whenever possible, offer vaccines in your practice. Vaccination rates drop when this does not occur.
• COVID-vaccine safety is backed by many studies showing no increase in birth defects, preterm delivery, miscarriage, or stillbirth.
• Pregnant women are more likely to have severe illness from the influenza and SARS-CoV-2 viruses. Vaccines can prevent severe illness and can protect the newborn as well as the mother.
• Recommend/administer the maternal RSV vaccine at 32-36 weeks’ gestation in women who did not receive the vaccine in the 2023-2024 season. If mothers aren’t eligible their babies should be offered nirsevimab.

Dr. Riley is the Given Foundation Professor and Chair of Obstetrics and Gynecology at Weill Cornell Medicine and the obstetrician and gynecologist-in-chief at New York Presbyterian Hospital. She disclosed that she has provided one-time consultations to Pfizer (Abrysvo RSV vaccine) and GSK (cytomegalovirus vaccine), and is providing consultant education on CMV for Moderna. She is chair of ACOG’s task force on immunization and emerging infectious diseases, serves on the medical advisory board for MAVEN, and serves as an editor or editorial board member for several medical publications.



References

1. ACOG Committee Opinion No. 741: Maternal Immunization. Obstet Gynecol. 2018;131(6):e214-e217.

2. Centers for Disease Control and Prevention. COVID-19 Vaccination for People Who are Pregnant or Breastfeeding. https://www.cdc.gov/covid/vaccines/pregnant-or-breastfeeding.html.

3. ACOG Practice Advisory on Maternal Respiratory Syncytial Virus Vaccination, September 2023. (Updated August 2024).4. Irving S et al. Open Forum Infect Dis. 2023;10(Suppl 2):ofad500.1002.

5. Flu Vaccination Dashboard, CDC, National Center for Immunization and Respiratory Diseases.

6. Weekly COVID-19 Vaccination Dashboard, CDC. https://www.cdc.gov/covidvaxview/weekly-dashboard/index.html

7. Louie JK et al. N Engl J Med. 2010;362:27-35. 8. Ciapponi A et al. Vaccine. 2021;39(40):5891-908.

9. Prasad S et al. Nature Communications. 2022;13:2414. 10. Fleming-Dutra KE et al. Obstet Gynecol Clin North Am 2023;50(2):279-97. 11. Mouen S et al. JAMA Network Open 2024;7(7):e2419268.

Editor’s Note: Sadly, this is the last column in the Master Class Obstetrics series. This award-winning column has been part of Ob.Gyn. News for 20 years. The deep discussion of cutting-edge topics in obstetrics by specialists and researchers will be missed as will the leadership and curation of topics by Dr. E. Albert Reece.
 

Introduction: The Need for Increased Vigilance About Maternal Immunization

Viruses are becoming increasingly prevalent in our world and the consequences of viral infections are implicated in a growing number of disease states. It is well established that certain cancers are caused by viruses and it is increasingly evident that viral infections can trigger the development of chronic illness. In pregnant women, viruses such as cytomegalovirus can cause infection in utero and lead to long-term impairments for the baby.

Likewise, it appears that the virulence of viruses is increasing, whether it be the respiratory syncytial virus (RSV) in children or the severe acute respiratory syndrome (SARS) coronaviruses in adults. Clearly, our environment is changing, with increases in population growth and urbanization, for instance, and an intensification of climate change and its effects. Viruses are part of this changing background.

Dr. Reece is the former Dean of Medicine & University Executive VP, and The Distinguished University and Endowed Professor & Director of the Center for Advanced Research Training and Innovation (CARTI) at the University of Maryland School of Medicine, as well as senior scientist at the Center for Birth Defects Research.

The alarming decline in maternal immunization rates that occurred in the wake of the COVID-19 pandemic means that, now more than ever, we must fully embrace our responsibility to recommend immunizations in pregnancy and to communicate what is known about their efficacy and safety. Data show that vaccination rates drop when we do not offer vaccines in our offices, so whenever possible, we should administer them as well.

The ob.gyn. is the patient’s most trusted person in pregnancy. When patients decline or express hesitancy about vaccines, it is incumbent upon us to ask why. Oftentimes, we can identify areas in which patients lack knowledge or have misperceptions and we can successfully educate the patient or change their perspective or misunderstanding concerning the importance of vaccination for themselves and their babies. (See Table 1.) We can also successfully address concerns about safety.

Dr. Riley

New York Presbyterian

Counseling About Influenza and COVID-19 Vaccination

The COVID-19 pandemic took a toll on vaccination interest/receptivity broadly in pregnant and nonpregnant people. Among pregnant individuals, influenza vaccination coverage declined from 71% in the 2019-2020 influenza season to 56% in the 2021-2022 season, according to data from the Centers for Disease Control and Prevention’s Vaccine Safety Datalink.⁴ Coverage for the 2022-2023 and 2023-2024 influenza seasons was even worse: well under 50%.⁵

Fewer pregnant women have received updated COVID-19 vaccines. Only 13% of pregnant persons overall received the updated 2023-2024 COVID-19 booster vaccine (through March 30, 2024), according to the CDC.⁶

Maternal immunization for influenza has been recommended in the United States since 2004 (part of the recommendation that everyone over the age of 6 months receive an annual flu vaccine), and flu vaccines have been given to millions of pregnant women, but the H1N1 pandemic of 2009 reinforced its value as a priority for prenatal care. Most of the women who became severely ill from the H1N1 virus were young and healthy, without co-existing conditions known to increase risk.⁷

It became clearer during the H1N1 pandemic that pregnancy itself — which is associated with physiologic changes such as decreased lung capacity, increased nasal congestion and changes in the immune system – is its own significant risk factor for severe illness from the influenza virus. This increased risk applies to COVID-19 as well.

As COVID-19 has become endemic, with hospitalizations and deaths not reaching the levels of previous surges — and with mask-wearing and other preventive measures having declined — patients understandably have become more complacent. Some patients are vaccine deniers, but in my practice, these patients are a much smaller group than those who believe COVID-19 “is no big deal,” especially if they have had infections recently.

This is why it’s important to actively listen to concerns and to ask patients who decline a vaccination why they are hesitant. Blanket messages about vaccine efficacy and safety are the first step, but individualized, more pointed conversations based on the patient’s personal experiences and beliefs have become increasingly important.

I routinely tell pregnant patients about the risks of COVID-19 and I explain that it has been difficult to predict who will develop severe illness. Sometimes more conversation is needed. For those who are still hesitant or who tell me they feel protected by a recent infection, for instance, I provide more detail on the unique risks of pregnancy — the fact that “pregnancy is different” — and that natural immunity wanes while the protection afforded by immunization is believed to last longer. Many women are also concerned about the safety of the COVID-19 vaccine, so having safety data at your fingertips is helpful. (See Table 2.)

Dr. Riley

Counseling About RSV Vaccination

Importantly, for the 2024-2025 RSV season, the maternal RSV vaccine (Abrysvo, Pfizer) is recommended only for pregnant women who did not receive the vaccine during the 2023-2024 season. When more research is done and more data are obtained showing how long the immune response persists post vaccination, it may be that the US Food and Drug Administration (FDA) will approve the maternal RSV vaccine for use in every pregnancy.

The later timing of the vaccination recommendation — 32-36 weeks’ gestation — reflects a conservative approach taken by the FDA in response to data from one of the pivotal trials showing a numerical trend toward more preterm deliveries among vaccinated compared with unvaccinated patients. This imbalance in the original trial, which administered the vaccine during 24-36 weeks of gestation, was seen only in low-income countries with no temporal association, however.

In our experience at two Weill Cornell Medical College–associated hospitals we did not see this trend. Our cohort study of almost 3000 pregnant patients who delivered at 32 weeks’ gestation or later found no increased risk of preterm birth among the 35% of patients who received the RSV vaccine during the 2023-2024 RSV season. We also did not see any difference in preeclampsia, in contrast with original trial data that showed a signal for increased risk.¹¹

When fewer than 2 weeks have elapsed between maternal vaccination and delivery, the monoclonal antibody nirsevimab is recommended for the newborn — ideally before the newborn leaves the hospital. Nirsevimab is also recommended for newborns of mothers who decline vaccination or were not candidates (e.g. vaccinated in a previous pregnancy), or when there is concern about the adequacy of the maternal immune response to the vaccine (e.g. in cases of immunosuppression).

While there was a limited supply of the monoclonal antibody last year, limitations are not expected this year, especially after October.

The ultimate goal is that patients choose the vaccine or the immunoglobulin, given the severity of RSV disease. Patient preferences should be considered. However, given that it takes 2 weeks after vaccination for protection to build up, I stress to patients that if they’ve vaccinated themselves, their newborn will leave the hospital with protection. If nirsevimab is relied upon, I explain, their newborn may not be protected for some period of time.
 

Take-home Messages

• When patients decline or are hesitant about vaccines, ask why. Listen actively, and work to correct misperceptions and knowledge gaps.
• Whenever possible, offer vaccines in your practice. Vaccination rates drop when this does not occur.
• COVID-vaccine safety is backed by many studies showing no increase in birth defects, preterm delivery, miscarriage, or stillbirth.
• Pregnant women are more likely to have severe illness from the influenza and SARS-CoV-2 viruses. Vaccines can prevent severe illness and can protect the newborn as well as the mother.
• Recommend/administer the maternal RSV vaccine at 32-36 weeks’ gestation in women who did not receive the vaccine in the 2023-2024 season. If mothers aren’t eligible their babies should be offered nirsevimab.

Dr. Riley is the Given Foundation Professor and Chair of Obstetrics and Gynecology at Weill Cornell Medicine and the obstetrician and gynecologist-in-chief at New York Presbyterian Hospital. She disclosed that she has provided one-time consultations to Pfizer (Abrysvo RSV vaccine) and GSK (cytomegalovirus vaccine), and is providing consultant education on CMV for Moderna. She is chair of ACOG’s task force on immunization and emerging infectious diseases, serves on the medical advisory board for MAVEN, and serves as an editor or editorial board member for several medical publications.



References

1. ACOG Committee Opinion No. 741: Maternal Immunization. Obstet Gynecol. 2018;131(6):e214-e217.

2. Centers for Disease Control and Prevention. COVID-19 Vaccination for People Who are Pregnant or Breastfeeding. https://www.cdc.gov/covid/vaccines/pregnant-or-breastfeeding.html.

3. ACOG Practice Advisory on Maternal Respiratory Syncytial Virus Vaccination, September 2023. (Updated August 2024).4. Irving S et al. Open Forum Infect Dis. 2023;10(Suppl 2):ofad500.1002.

5. Flu Vaccination Dashboard, CDC, National Center for Immunization and Respiratory Diseases.

6. Weekly COVID-19 Vaccination Dashboard, CDC. https://www.cdc.gov/covidvaxview/weekly-dashboard/index.html

7. Louie JK et al. N Engl J Med. 2010;362:27-35. 8. Ciapponi A et al. Vaccine. 2021;39(40):5891-908.

9. Prasad S et al. Nature Communications. 2022;13:2414. 10. Fleming-Dutra KE et al. Obstet Gynecol Clin North Am 2023;50(2):279-97. 11. Mouen S et al. JAMA Network Open 2024;7(7):e2419268.

TOPLINE:

Gestational supplementation of 1000 IU/d cholecalciferol (vitamin D3) from early pregnancy until delivery increases the bone mineral content, bone mineral density (BMD), and bone mineral apparent density in children at age 6-7 years.

METHODOLOGY:

• The double-blinded, placebo-controlled MAVIDOS trial of gestational vitamin D supplementation previously showed increased BMD at age 4 years (but no difference at birth), and it is unclear how the effect may persist or change over time.
• In the original trial, researchers randomized 1134 pregnant women with singleton pregnancy from three UK hospitals from 2008 to 2014, and the 723 children born to mothers recruited in Southampton were invited to continue in offspring follow-up.
• Mothers were randomly assigned to receive either 1000-IU/d vitamin D or placebo from 14-17 weeks’ gestation until delivery; women in the placebo arm could take up to 400-IU/d vitamin D.
• In this post hoc analysis, among 454 children who were followed up at age 6-7 years, 447 had a usable whole body and lumbar spine dual-energy x-ray absorptiometry scan (placebo group: n = 216; 48% boys; 98% White mothers and vitamin D group: n = 231; 56% boys; 96% White mothers).
• Offspring follow-up measures at birth and 4 and 6-7 years were bone area, bone mineral content, BMD, and bone mineral apparent density, derived from a dual-energy x-ray absorptiometry scan of whole body less head (WBLH), as well as fat and lean mass.

TAKEAWAY:

• The effect of gestational vitamin D supplementation on bone outcomes in children was similar at ages 4 and 6-7 years.
• At age 6-7 years, gestational vitamin D supplementation resulted in higher WBLH bone mineral content (0.15 SD; 95% CI, 0.04-0.26) and BMD (0.18 SD; 95% CI, 0.06-0.31) than placebo.
• The WBLH bone mineral apparent density (0.18 SD; 95% CI, 0.04-0.32) was also higher in the vitamin D group.
• The lean mass was greater in the vitamin D group (0.09 SD; 95% CI, 0.00-0.17) than in the placebo group.

IN PRACTICE:

“These findings suggest that pregnancy vitamin D supplementation may be an important population health strategy to improve bone health,” the authors wrote.

SOURCE:

This study was led by Rebecca J. Moon, PhD, MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton General Hospital, England. It was published online in The American Journal of Clinical Nutrition.

LIMITATIONS: 

Only individuals with baseline vitamin D levels of 25-100 nmol/L were eligible, excluding those with severe deficiency who might have benefited the most from supplementation. The participants were mostly White and well-educated, commonly overweight, which may have limited generalizability to other populations. Only 47% of the original cohort participated in the follow-up phase. Differences in maternal age, smoking status, and education between participants who remained in the study and those who did not may have introduced bias and affected generalizability.

DISCLOSURES:

The study was supported by Versus Arthritis UK, Medical Research Council, Bupa Foundation, and National Institute for Health and Care Research, Southampton Biomedical Research Centre, and other sources. Some authors disclosed receiving travel reimbursement, speaker or lecture fees, honoraria, research funding, or personal or consultancy fees from Alliance for Better Bone Health and various pharmaceutical, biotechnology, medical device, healthcare, and food and nutrition companies outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Gestational supplementation of 1000 IU/d cholecalciferol (vitamin D3) from early pregnancy until delivery increases the bone mineral content, bone mineral density (BMD), and bone mineral apparent density in children at age 6-7 years.

METHODOLOGY:

• The double-blinded, placebo-controlled MAVIDOS trial of gestational vitamin D supplementation previously showed increased BMD at age 4 years (but no difference at birth), and it is unclear how the effect may persist or change over time.
• In the original trial, researchers randomized 1134 pregnant women with singleton pregnancy from three UK hospitals from 2008 to 2014, and the 723 children born to mothers recruited in Southampton were invited to continue in offspring follow-up.
• Mothers were randomly assigned to receive either 1000-IU/d vitamin D or placebo from 14-17 weeks’ gestation until delivery; women in the placebo arm could take up to 400-IU/d vitamin D.
• In this post hoc analysis, among 454 children who were followed up at age 6-7 years, 447 had a usable whole body and lumbar spine dual-energy x-ray absorptiometry scan (placebo group: n = 216; 48% boys; 98% White mothers and vitamin D group: n = 231; 56% boys; 96% White mothers).
• Offspring follow-up measures at birth and 4 and 6-7 years were bone area, bone mineral content, BMD, and bone mineral apparent density, derived from a dual-energy x-ray absorptiometry scan of whole body less head (WBLH), as well as fat and lean mass.

TAKEAWAY:

• The effect of gestational vitamin D supplementation on bone outcomes in children was similar at ages 4 and 6-7 years.
• At age 6-7 years, gestational vitamin D supplementation resulted in higher WBLH bone mineral content (0.15 SD; 95% CI, 0.04-0.26) and BMD (0.18 SD; 95% CI, 0.06-0.31) than placebo.
• The WBLH bone mineral apparent density (0.18 SD; 95% CI, 0.04-0.32) was also higher in the vitamin D group.
• The lean mass was greater in the vitamin D group (0.09 SD; 95% CI, 0.00-0.17) than in the placebo group.

IN PRACTICE:

“These findings suggest that pregnancy vitamin D supplementation may be an important population health strategy to improve bone health,” the authors wrote.

SOURCE:

This study was led by Rebecca J. Moon, PhD, MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton General Hospital, England. It was published online in The American Journal of Clinical Nutrition.

LIMITATIONS: 

Only individuals with baseline vitamin D levels of 25-100 nmol/L were eligible, excluding those with severe deficiency who might have benefited the most from supplementation. The participants were mostly White and well-educated, commonly overweight, which may have limited generalizability to other populations. Only 47% of the original cohort participated in the follow-up phase. Differences in maternal age, smoking status, and education between participants who remained in the study and those who did not may have introduced bias and affected generalizability.

DISCLOSURES:

The study was supported by Versus Arthritis UK, Medical Research Council, Bupa Foundation, and National Institute for Health and Care Research, Southampton Biomedical Research Centre, and other sources. Some authors disclosed receiving travel reimbursement, speaker or lecture fees, honoraria, research funding, or personal or consultancy fees from Alliance for Better Bone Health and various pharmaceutical, biotechnology, medical device, healthcare, and food and nutrition companies outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Gestational supplementation of 1000 IU/d cholecalciferol (vitamin D3) from early pregnancy until delivery increases the bone mineral content, bone mineral density (BMD), and bone mineral apparent density in children at age 6-7 years.

METHODOLOGY:

• The double-blinded, placebo-controlled MAVIDOS trial of gestational vitamin D supplementation previously showed increased BMD at age 4 years (but no difference at birth), and it is unclear how the effect may persist or change over time.
• In the original trial, researchers randomized 1134 pregnant women with singleton pregnancy from three UK hospitals from 2008 to 2014, and the 723 children born to mothers recruited in Southampton were invited to continue in offspring follow-up.
• Mothers were randomly assigned to receive either 1000-IU/d vitamin D or placebo from 14-17 weeks’ gestation until delivery; women in the placebo arm could take up to 400-IU/d vitamin D.
• In this post hoc analysis, among 454 children who were followed up at age 6-7 years, 447 had a usable whole body and lumbar spine dual-energy x-ray absorptiometry scan (placebo group: n = 216; 48% boys; 98% White mothers and vitamin D group: n = 231; 56% boys; 96% White mothers).
• Offspring follow-up measures at birth and 4 and 6-7 years were bone area, bone mineral content, BMD, and bone mineral apparent density, derived from a dual-energy x-ray absorptiometry scan of whole body less head (WBLH), as well as fat and lean mass.

TAKEAWAY:

• The effect of gestational vitamin D supplementation on bone outcomes in children was similar at ages 4 and 6-7 years.
• At age 6-7 years, gestational vitamin D supplementation resulted in higher WBLH bone mineral content (0.15 SD; 95% CI, 0.04-0.26) and BMD (0.18 SD; 95% CI, 0.06-0.31) than placebo.
• The WBLH bone mineral apparent density (0.18 SD; 95% CI, 0.04-0.32) was also higher in the vitamin D group.
• The lean mass was greater in the vitamin D group (0.09 SD; 95% CI, 0.00-0.17) than in the placebo group.

IN PRACTICE:

“These findings suggest that pregnancy vitamin D supplementation may be an important population health strategy to improve bone health,” the authors wrote.

SOURCE:

This study was led by Rebecca J. Moon, PhD, MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton General Hospital, England. It was published online in The American Journal of Clinical Nutrition.

LIMITATIONS: 

Only individuals with baseline vitamin D levels of 25-100 nmol/L were eligible, excluding those with severe deficiency who might have benefited the most from supplementation. The participants were mostly White and well-educated, commonly overweight, which may have limited generalizability to other populations. Only 47% of the original cohort participated in the follow-up phase. Differences in maternal age, smoking status, and education between participants who remained in the study and those who did not may have introduced bias and affected generalizability.

DISCLOSURES:

The study was supported by Versus Arthritis UK, Medical Research Council, Bupa Foundation, and National Institute for Health and Care Research, Southampton Biomedical Research Centre, and other sources. Some authors disclosed receiving travel reimbursement, speaker or lecture fees, honoraria, research funding, or personal or consultancy fees from Alliance for Better Bone Health and various pharmaceutical, biotechnology, medical device, healthcare, and food and nutrition companies outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.