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Hypothyroidism Treatment Does Not Affect Cognitive Decline in Menopausal Women
TOPLINE:
Women with hypothyroidism treated with levothyroxine show no significant cognitive decline across the menopausal transition compared with those without thyroid disease.
METHODOLOGY:
- Levothyroxine, the primary treatment for hypothyroidism, has been linked to perceived cognitive deficits, yet it is unclear whether this is due to the underlying condition being inadequately treated or other factors.
- Using data collected from the Study of Women’s Health Across the Nation, which encompasses five ethnic/racial groups from seven centers across the United States, researchers compared cognitive function over time between women with hypothyroidism treated with levothyroxine and those without thyroid disease.
- Participants underwent cognitive testing across three domains — processing speed, working memory, and episodic memory — which were assessed over a mean follow-up of 13 years.
- Further analyses assessed the impact of abnormal levels of thyroid-stimulating hormone on cognitive outcomes.
TAKEAWAY:
- Of 2033 women included, 227 (mean age, 49.8 years) had levothyroxine-treated hypothyroidism and 1806 (mean age, 50.0 years) did not have thyroid disease; the proportion of women with premenopausal or early perimenopausal status at baseline was higher in the hypothyroidism group (54.2% vs 49.8%; P = .010).
- At baseline, levothyroxine-treated women had higher scores for processing speed (mean score, 56.5 vs 54.4; P = .006) and working memory (mean score, 6.8 vs 6.4; P = .018) than those without thyroid disease; however, no difference in episodic memory was observed between the groups.
- Over the study period, there was no significant difference in cognitive decline between the groups.
- There was no significant effect of levothyroxine-treated hypothyroidism on working memory or episodic memory, although an annual decline in processing speed was observed (P < .001).
- Sensitivity analyses determined that abnormal levels of thyroid-stimulating hormone did not affect cognitive outcomes in women with hypothyroidism.
IN PRACTICE:
When cognitive decline is observed in these patients, the authors advised that “clinicians should resist anchoring on inadequate treatment of hypothyroidism as the cause of these symptoms and may investigate other disease processes (eg, iron deficiency, B12 deficiency, sleep apnea, celiac disease).”
SOURCE:
The study, led by Matthew D. Ettleson, Section of Endocrinology, Diabetes, and Metabolism, University of Chicago, was published online in Thyroid.
LIMITATIONS:
The cognitive assessments in the study were not designed to provide a thorough evaluation of all aspects of cognitive function. The study may not have been adequately powered to detect small effects of levothyroxine-treated hypothyroidism on cognitive outcomes. The higher levels of education attained by the study population may have acted as a protective factor against cognitive decline, potentially biasing the results.
DISCLOSURES:
The Study of Women’s Health Across the Nation was supported by grants from the National Institutes of Health (NIH), DHHS, through the National Institute on Aging, the National Institute of Nursing Research, and the NIH Office of Research on Women’s 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:
Women with hypothyroidism treated with levothyroxine show no significant cognitive decline across the menopausal transition compared with those without thyroid disease.
METHODOLOGY:
- Levothyroxine, the primary treatment for hypothyroidism, has been linked to perceived cognitive deficits, yet it is unclear whether this is due to the underlying condition being inadequately treated or other factors.
- Using data collected from the Study of Women’s Health Across the Nation, which encompasses five ethnic/racial groups from seven centers across the United States, researchers compared cognitive function over time between women with hypothyroidism treated with levothyroxine and those without thyroid disease.
- Participants underwent cognitive testing across three domains — processing speed, working memory, and episodic memory — which were assessed over a mean follow-up of 13 years.
- Further analyses assessed the impact of abnormal levels of thyroid-stimulating hormone on cognitive outcomes.
TAKEAWAY:
- Of 2033 women included, 227 (mean age, 49.8 years) had levothyroxine-treated hypothyroidism and 1806 (mean age, 50.0 years) did not have thyroid disease; the proportion of women with premenopausal or early perimenopausal status at baseline was higher in the hypothyroidism group (54.2% vs 49.8%; P = .010).
- At baseline, levothyroxine-treated women had higher scores for processing speed (mean score, 56.5 vs 54.4; P = .006) and working memory (mean score, 6.8 vs 6.4; P = .018) than those without thyroid disease; however, no difference in episodic memory was observed between the groups.
- Over the study period, there was no significant difference in cognitive decline between the groups.
- There was no significant effect of levothyroxine-treated hypothyroidism on working memory or episodic memory, although an annual decline in processing speed was observed (P < .001).
- Sensitivity analyses determined that abnormal levels of thyroid-stimulating hormone did not affect cognitive outcomes in women with hypothyroidism.
IN PRACTICE:
When cognitive decline is observed in these patients, the authors advised that “clinicians should resist anchoring on inadequate treatment of hypothyroidism as the cause of these symptoms and may investigate other disease processes (eg, iron deficiency, B12 deficiency, sleep apnea, celiac disease).”
SOURCE:
The study, led by Matthew D. Ettleson, Section of Endocrinology, Diabetes, and Metabolism, University of Chicago, was published online in Thyroid.
LIMITATIONS:
The cognitive assessments in the study were not designed to provide a thorough evaluation of all aspects of cognitive function. The study may not have been adequately powered to detect small effects of levothyroxine-treated hypothyroidism on cognitive outcomes. The higher levels of education attained by the study population may have acted as a protective factor against cognitive decline, potentially biasing the results.
DISCLOSURES:
The Study of Women’s Health Across the Nation was supported by grants from the National Institutes of Health (NIH), DHHS, through the National Institute on Aging, the National Institute of Nursing Research, and the NIH Office of Research on Women’s 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:
Women with hypothyroidism treated with levothyroxine show no significant cognitive decline across the menopausal transition compared with those without thyroid disease.
METHODOLOGY:
- Levothyroxine, the primary treatment for hypothyroidism, has been linked to perceived cognitive deficits, yet it is unclear whether this is due to the underlying condition being inadequately treated or other factors.
- Using data collected from the Study of Women’s Health Across the Nation, which encompasses five ethnic/racial groups from seven centers across the United States, researchers compared cognitive function over time between women with hypothyroidism treated with levothyroxine and those without thyroid disease.
- Participants underwent cognitive testing across three domains — processing speed, working memory, and episodic memory — which were assessed over a mean follow-up of 13 years.
- Further analyses assessed the impact of abnormal levels of thyroid-stimulating hormone on cognitive outcomes.
TAKEAWAY:
- Of 2033 women included, 227 (mean age, 49.8 years) had levothyroxine-treated hypothyroidism and 1806 (mean age, 50.0 years) did not have thyroid disease; the proportion of women with premenopausal or early perimenopausal status at baseline was higher in the hypothyroidism group (54.2% vs 49.8%; P = .010).
- At baseline, levothyroxine-treated women had higher scores for processing speed (mean score, 56.5 vs 54.4; P = .006) and working memory (mean score, 6.8 vs 6.4; P = .018) than those without thyroid disease; however, no difference in episodic memory was observed between the groups.
- Over the study period, there was no significant difference in cognitive decline between the groups.
- There was no significant effect of levothyroxine-treated hypothyroidism on working memory or episodic memory, although an annual decline in processing speed was observed (P < .001).
- Sensitivity analyses determined that abnormal levels of thyroid-stimulating hormone did not affect cognitive outcomes in women with hypothyroidism.
IN PRACTICE:
When cognitive decline is observed in these patients, the authors advised that “clinicians should resist anchoring on inadequate treatment of hypothyroidism as the cause of these symptoms and may investigate other disease processes (eg, iron deficiency, B12 deficiency, sleep apnea, celiac disease).”
SOURCE:
The study, led by Matthew D. Ettleson, Section of Endocrinology, Diabetes, and Metabolism, University of Chicago, was published online in Thyroid.
LIMITATIONS:
The cognitive assessments in the study were not designed to provide a thorough evaluation of all aspects of cognitive function. The study may not have been adequately powered to detect small effects of levothyroxine-treated hypothyroidism on cognitive outcomes. The higher levels of education attained by the study population may have acted as a protective factor against cognitive decline, potentially biasing the results.
DISCLOSURES:
The Study of Women’s Health Across the Nation was supported by grants from the National Institutes of Health (NIH), DHHS, through the National Institute on Aging, the National Institute of Nursing Research, and the NIH Office of Research on Women’s 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.
Severe Autoimmune Diseases Linked to Premature Ovarian Insufficiency
TOPLINE:
Women with premature ovarian insufficiency (POI) have a 2.6 times higher prevalence of severe autoimmune diseases before diagnosis and a 2- to 3-fold increased risk for these diseases after diagnosis.
METHODOLOGY:
- Researchers conducted a population-based registry study including 3972 women diagnosed with spontaneous POI between 1988 and 2017.
- A total of 15,708 female population controls matched by age and municipality of residence were included for comparison.
- Autoimmune disease diagnoses were evaluated from childhood until the end of 2017 using the Hospital Discharge Registry.
- Women with a history of cancer or bilateral oophorectomy were excluded from the study.
TAKEAWAY:
- Women with POI had a 2.6 times higher prevalence of severe autoimmune diseases before diagnosis compared to controls (odds ratio [OR], 2.6; 95% CI, 2.2-3.1).
- The prevalence of specific autoimmune diseases such as polyglandular autoimmune diseases (OR, 25.8; 95% CI, 9.0-74.1) and Addison disease (OR, 22.9; 95% CI, 7.9-66.1) was significantly higher in women with POI.
- The standardized incidence ratios for being diagnosed with a severe autoimmune disease after POI diagnosis was 2.8 (95% CI, 2.3-3.4) during the first 3 years, decreasing to 1.3 (95% CI, 1.1-1.6) after 12 years.
- No significant difference was found in the prevalence of diabetes type 1 and ankylosing spondylitis between women with POI and the reference cohort.
IN PRACTICE:
“The study results strengthen the hypothesis that autoimmune mechanisms play an important role in the pathogenesis of POI. Future studies should focus on the immunological mechanism of POI from preventative and curative perspectives,” wrote the authors of the study.
SOURCE:
The study was led by Susanna M. Savukoski, Oulu University Hospital in Finland. It was published online in Human Reproduction.
LIMITATIONS:
The study included only autoimmune disorders diagnosed in specialized health care, which may underestimate the overall prevalence of autoimmune disorders in women with POI. Additionally, the study did not account for confounders such as body mass index and smoking, which are associated with the risk for autoimmune disease and POI.
DISCLOSURES:
Ms. Savukoski received grants from the Finnish Menopause Society, the Finnish Medical Foundation, and the Juho Vainio Foundation. 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 appeared on Medscape.com.
TOPLINE:
Women with premature ovarian insufficiency (POI) have a 2.6 times higher prevalence of severe autoimmune diseases before diagnosis and a 2- to 3-fold increased risk for these diseases after diagnosis.
METHODOLOGY:
- Researchers conducted a population-based registry study including 3972 women diagnosed with spontaneous POI between 1988 and 2017.
- A total of 15,708 female population controls matched by age and municipality of residence were included for comparison.
- Autoimmune disease diagnoses were evaluated from childhood until the end of 2017 using the Hospital Discharge Registry.
- Women with a history of cancer or bilateral oophorectomy were excluded from the study.
TAKEAWAY:
- Women with POI had a 2.6 times higher prevalence of severe autoimmune diseases before diagnosis compared to controls (odds ratio [OR], 2.6; 95% CI, 2.2-3.1).
- The prevalence of specific autoimmune diseases such as polyglandular autoimmune diseases (OR, 25.8; 95% CI, 9.0-74.1) and Addison disease (OR, 22.9; 95% CI, 7.9-66.1) was significantly higher in women with POI.
- The standardized incidence ratios for being diagnosed with a severe autoimmune disease after POI diagnosis was 2.8 (95% CI, 2.3-3.4) during the first 3 years, decreasing to 1.3 (95% CI, 1.1-1.6) after 12 years.
- No significant difference was found in the prevalence of diabetes type 1 and ankylosing spondylitis between women with POI and the reference cohort.
IN PRACTICE:
“The study results strengthen the hypothesis that autoimmune mechanisms play an important role in the pathogenesis of POI. Future studies should focus on the immunological mechanism of POI from preventative and curative perspectives,” wrote the authors of the study.
SOURCE:
The study was led by Susanna M. Savukoski, Oulu University Hospital in Finland. It was published online in Human Reproduction.
LIMITATIONS:
The study included only autoimmune disorders diagnosed in specialized health care, which may underestimate the overall prevalence of autoimmune disorders in women with POI. Additionally, the study did not account for confounders such as body mass index and smoking, which are associated with the risk for autoimmune disease and POI.
DISCLOSURES:
Ms. Savukoski received grants from the Finnish Menopause Society, the Finnish Medical Foundation, and the Juho Vainio Foundation. 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 appeared on Medscape.com.
TOPLINE:
Women with premature ovarian insufficiency (POI) have a 2.6 times higher prevalence of severe autoimmune diseases before diagnosis and a 2- to 3-fold increased risk for these diseases after diagnosis.
METHODOLOGY:
- Researchers conducted a population-based registry study including 3972 women diagnosed with spontaneous POI between 1988 and 2017.
- A total of 15,708 female population controls matched by age and municipality of residence were included for comparison.
- Autoimmune disease diagnoses were evaluated from childhood until the end of 2017 using the Hospital Discharge Registry.
- Women with a history of cancer or bilateral oophorectomy were excluded from the study.
TAKEAWAY:
- Women with POI had a 2.6 times higher prevalence of severe autoimmune diseases before diagnosis compared to controls (odds ratio [OR], 2.6; 95% CI, 2.2-3.1).
- The prevalence of specific autoimmune diseases such as polyglandular autoimmune diseases (OR, 25.8; 95% CI, 9.0-74.1) and Addison disease (OR, 22.9; 95% CI, 7.9-66.1) was significantly higher in women with POI.
- The standardized incidence ratios for being diagnosed with a severe autoimmune disease after POI diagnosis was 2.8 (95% CI, 2.3-3.4) during the first 3 years, decreasing to 1.3 (95% CI, 1.1-1.6) after 12 years.
- No significant difference was found in the prevalence of diabetes type 1 and ankylosing spondylitis between women with POI and the reference cohort.
IN PRACTICE:
“The study results strengthen the hypothesis that autoimmune mechanisms play an important role in the pathogenesis of POI. Future studies should focus on the immunological mechanism of POI from preventative and curative perspectives,” wrote the authors of the study.
SOURCE:
The study was led by Susanna M. Savukoski, Oulu University Hospital in Finland. It was published online in Human Reproduction.
LIMITATIONS:
The study included only autoimmune disorders diagnosed in specialized health care, which may underestimate the overall prevalence of autoimmune disorders in women with POI. Additionally, the study did not account for confounders such as body mass index and smoking, which are associated with the risk for autoimmune disease and POI.
DISCLOSURES:
Ms. Savukoski received grants from the Finnish Menopause Society, the Finnish Medical Foundation, and the Juho Vainio Foundation. 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 appeared on Medscape.com.
Hyperandrogenic PCOS Linked to Lower Pregnancy and Live Birth Rates
TOPLINE:
Women with hyperandrogenic polycystic ovary syndrome (PCOS) have lower pregnancy (29.9%) and live birth rates (20.1%) than those with nonhyperandrogenic PCOS (40.2% and 33.1%, respectively).
METHODOLOGY:
- Researchers conducted a retrospective cohort study of 1376 participants from the PPCOS I and II trials, all meeting National Institutes of Health diagnostic criteria for PCOS.
- Participants were categorized into hyperandrogenic (A and B) and nonhyperandrogenic (D) PCOS phenotypes on the basis of medical interviews, demographics, physical examinations, and laboratory data.
- Outcomes of interest included clinical pregnancy, pregnancy loss, live birth, obstetric complications, and neonatal outcomes.
- Fasting blood samples were analyzed for hormonal assays, and Homeostatic Model Assessment for Insulin Resistance scores were calculated using fasting glucose and insulin values.
TAKEAWAY:
- Participants with hyperandrogenic PCOS had higher body mass index (35.5 ± 8.9 vs 31.9 ± 9.3; P < .001) and fasting insulin levels (21.6 ± 27.7 vs 14.7 ± 15.0 μIU/mL; P < .001) than those with nonhyperandrogenic PCOS.
- Participants with hyperandrogenic PCOS had lower odds of achieving pregnancy (odds ratio [OR], 0.63; 95% CI, 0.44-0.92) and live birth (OR, 0.51; 95% CI, 0.34-0.76) than those with nonhyperandrogenic PCOS.
- No significant differences were found in pregnancy loss rates (23.9% vs 32.3%, P = .06) or neonatal outcomes between the two groups.
- The study lacked the power to detect differences in neonatal outcomes because of the low prevalence of these outcomes.
IN PRACTICE:
“Patients with nonhyperandrogenic PCOS may represent a different disease process with unique morbidities and outcomes and could be counseled differently than hyperandrogenic PCOS,” wrote the authors of the study.
SOURCE:
The study was led by Jessica L. Chan, MD, MSCE, Cedars-Sinai Medical Center in Los Angeles, California. It was published online in Obstetrics & Gynecology.
LIMITATIONS:
The primary limitation of this study was that it is a secondary analysis of previously collected randomized controlled trial data, which may affect the availability of certain information. Additionally, the lower number of participants in the nonhyperandrogenic PCOS group could affect the power of the results. The study was underpowered to detect statistically significant differences in neonatal outcomes because of their low prevalence.
DISCLOSURES:
The study was supported by a grant from the ASRM/NICHD/Duke Clinical Research/Reproductive Scientist Training Program. One coauthor disclosed receiving payments from Celmatix, Ferring Pharmaceuticals, Exeltis, Organon, and Monsanto; another disclosed receiving payments from Ferring Pharmaceuticals. 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:
Women with hyperandrogenic polycystic ovary syndrome (PCOS) have lower pregnancy (29.9%) and live birth rates (20.1%) than those with nonhyperandrogenic PCOS (40.2% and 33.1%, respectively).
METHODOLOGY:
- Researchers conducted a retrospective cohort study of 1376 participants from the PPCOS I and II trials, all meeting National Institutes of Health diagnostic criteria for PCOS.
- Participants were categorized into hyperandrogenic (A and B) and nonhyperandrogenic (D) PCOS phenotypes on the basis of medical interviews, demographics, physical examinations, and laboratory data.
- Outcomes of interest included clinical pregnancy, pregnancy loss, live birth, obstetric complications, and neonatal outcomes.
- Fasting blood samples were analyzed for hormonal assays, and Homeostatic Model Assessment for Insulin Resistance scores were calculated using fasting glucose and insulin values.
TAKEAWAY:
- Participants with hyperandrogenic PCOS had higher body mass index (35.5 ± 8.9 vs 31.9 ± 9.3; P < .001) and fasting insulin levels (21.6 ± 27.7 vs 14.7 ± 15.0 μIU/mL; P < .001) than those with nonhyperandrogenic PCOS.
- Participants with hyperandrogenic PCOS had lower odds of achieving pregnancy (odds ratio [OR], 0.63; 95% CI, 0.44-0.92) and live birth (OR, 0.51; 95% CI, 0.34-0.76) than those with nonhyperandrogenic PCOS.
- No significant differences were found in pregnancy loss rates (23.9% vs 32.3%, P = .06) or neonatal outcomes between the two groups.
- The study lacked the power to detect differences in neonatal outcomes because of the low prevalence of these outcomes.
IN PRACTICE:
“Patients with nonhyperandrogenic PCOS may represent a different disease process with unique morbidities and outcomes and could be counseled differently than hyperandrogenic PCOS,” wrote the authors of the study.
SOURCE:
The study was led by Jessica L. Chan, MD, MSCE, Cedars-Sinai Medical Center in Los Angeles, California. It was published online in Obstetrics & Gynecology.
LIMITATIONS:
The primary limitation of this study was that it is a secondary analysis of previously collected randomized controlled trial data, which may affect the availability of certain information. Additionally, the lower number of participants in the nonhyperandrogenic PCOS group could affect the power of the results. The study was underpowered to detect statistically significant differences in neonatal outcomes because of their low prevalence.
DISCLOSURES:
The study was supported by a grant from the ASRM/NICHD/Duke Clinical Research/Reproductive Scientist Training Program. One coauthor disclosed receiving payments from Celmatix, Ferring Pharmaceuticals, Exeltis, Organon, and Monsanto; another disclosed receiving payments from Ferring Pharmaceuticals. 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:
Women with hyperandrogenic polycystic ovary syndrome (PCOS) have lower pregnancy (29.9%) and live birth rates (20.1%) than those with nonhyperandrogenic PCOS (40.2% and 33.1%, respectively).
METHODOLOGY:
- Researchers conducted a retrospective cohort study of 1376 participants from the PPCOS I and II trials, all meeting National Institutes of Health diagnostic criteria for PCOS.
- Participants were categorized into hyperandrogenic (A and B) and nonhyperandrogenic (D) PCOS phenotypes on the basis of medical interviews, demographics, physical examinations, and laboratory data.
- Outcomes of interest included clinical pregnancy, pregnancy loss, live birth, obstetric complications, and neonatal outcomes.
- Fasting blood samples were analyzed for hormonal assays, and Homeostatic Model Assessment for Insulin Resistance scores were calculated using fasting glucose and insulin values.
TAKEAWAY:
- Participants with hyperandrogenic PCOS had higher body mass index (35.5 ± 8.9 vs 31.9 ± 9.3; P < .001) and fasting insulin levels (21.6 ± 27.7 vs 14.7 ± 15.0 μIU/mL; P < .001) than those with nonhyperandrogenic PCOS.
- Participants with hyperandrogenic PCOS had lower odds of achieving pregnancy (odds ratio [OR], 0.63; 95% CI, 0.44-0.92) and live birth (OR, 0.51; 95% CI, 0.34-0.76) than those with nonhyperandrogenic PCOS.
- No significant differences were found in pregnancy loss rates (23.9% vs 32.3%, P = .06) or neonatal outcomes between the two groups.
- The study lacked the power to detect differences in neonatal outcomes because of the low prevalence of these outcomes.
IN PRACTICE:
“Patients with nonhyperandrogenic PCOS may represent a different disease process with unique morbidities and outcomes and could be counseled differently than hyperandrogenic PCOS,” wrote the authors of the study.
SOURCE:
The study was led by Jessica L. Chan, MD, MSCE, Cedars-Sinai Medical Center in Los Angeles, California. It was published online in Obstetrics & Gynecology.
LIMITATIONS:
The primary limitation of this study was that it is a secondary analysis of previously collected randomized controlled trial data, which may affect the availability of certain information. Additionally, the lower number of participants in the nonhyperandrogenic PCOS group could affect the power of the results. The study was underpowered to detect statistically significant differences in neonatal outcomes because of their low prevalence.
DISCLOSURES:
The study was supported by a grant from the ASRM/NICHD/Duke Clinical Research/Reproductive Scientist Training Program. One coauthor disclosed receiving payments from Celmatix, Ferring Pharmaceuticals, Exeltis, Organon, and Monsanto; another disclosed receiving payments from Ferring Pharmaceuticals. 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.
Heightened Amygdala Activity Tied to Postpartum Depression
MILAN, ITALY — Pregnant women with heightened amygdala activity have a reduced capacity to regulate emotions and report more symptoms of depression than those with lower activity in this brain region, a new imaging study suggested.
If validated, these findings could pave the way for identifying women at higher risk for postpartum depression, said lead researcher Franziska Weinmar, MSc, from the University of Tübingen in Germany.
The study was presented at the 37th European College of Neuropsychopharmacology Congress.
Differences in Brain Activity
During pregnancy and the peripartum period, rising hormone levels create a “psychoneuroendocrinological window of vulnerability” for mental health in which 80% of women can develop transitory “baby blues,” and about one in seven develop more serious postpartum depression, Ms. Weinmar told this news organization.
The study included 47 women — 15 pregnant women and 32 nonpregnant controls. The nonpregnant women had normal menstrual cycles; 16 were in the early follicular phase with low estradiol levels (231.7 pmol/L), and 16 had high estradiol levels (516.6 pmol/L) after administration of estradiol.
To examine brain activity, participants were asked to view negative emotional images while undergoing functional MRI. They were then asked to use cognitive reappraisal to regulate their emotional response to the images.
The findings showed that both pregnant and nonpregnant women were equally successful at emotional regulation, but this process involved different brain activity in pregnant vs their nonpregnant counterpart.
All women had increased left middle frontal gyrus activity when regulating their emotions, but there was a difference in the amygdala between the pregnancy group and controls, Ms. Weinmar noted.
This suggests that pregnant women may have to exert more neural effort in emotional regulation, she said. “And pregnant women with higher amygdala activity were less able to regulate their emotions successfully compared to those with less amygdala activity.”
Linear regression analyses were performed to assess the relation of brain activity during down-regulation, regulation success, and self-reported depression scores, and this showed that higher amygdala activity was also associated with higher depression scores.
“We need to be cautious in interpreting this,” said Ms. Weinmar. “This is a small sample, and we are the first to undertake this work.”
Nonetheless, she said that if the findings are confirmed by larger studies, pregnant women could be assessed “in the waiting room” using existing questionnaires that evaluate emotional regulation.
If a woman has difficulties with emotion regulation, “there are adaptive strategies, like cognitive reappraisal that a counseling psychotherapist can help with,” said Ms. Weinmar.
“I could also imagine group sessions, for example, or online courses,” she said, adding that obstetricians could also be trained to identify these women.
Commenting on the findings in a press release, Susana Carmona, PhD, from Gregorio Marañón Hospital in Madrid, Spain, said research like this is crucial for gaining insight into one of the most intense physiological processes a human can undergo: pregnancy. It’s remarkable how much remains unknown.
“Recently, the FDA [Food and Drug Administration] approved the first treatment for postpartum depression. However, we still have a long way to go in characterizing what happens in the brain during pregnancy, identifying biomarkers that can indicate the risk of developing perinatal mental disorders, and designing strategies to prevent mother and infant suffering during the delicate and critical peripartum period,” Dr. Carmona added.
The study was supported by the Center for Integrative Neuroscience in Tübingen, Germany, and the International Research Training Group “Women’s Mental Health Across the Reproductive Years” (IRTG 2804). Ms. Weinmar and Dr. Carmona reported no relevant disclosures.
A version of this article appeared on Medscape.com.
MILAN, ITALY — Pregnant women with heightened amygdala activity have a reduced capacity to regulate emotions and report more symptoms of depression than those with lower activity in this brain region, a new imaging study suggested.
If validated, these findings could pave the way for identifying women at higher risk for postpartum depression, said lead researcher Franziska Weinmar, MSc, from the University of Tübingen in Germany.
The study was presented at the 37th European College of Neuropsychopharmacology Congress.
Differences in Brain Activity
During pregnancy and the peripartum period, rising hormone levels create a “psychoneuroendocrinological window of vulnerability” for mental health in which 80% of women can develop transitory “baby blues,” and about one in seven develop more serious postpartum depression, Ms. Weinmar told this news organization.
The study included 47 women — 15 pregnant women and 32 nonpregnant controls. The nonpregnant women had normal menstrual cycles; 16 were in the early follicular phase with low estradiol levels (231.7 pmol/L), and 16 had high estradiol levels (516.6 pmol/L) after administration of estradiol.
To examine brain activity, participants were asked to view negative emotional images while undergoing functional MRI. They were then asked to use cognitive reappraisal to regulate their emotional response to the images.
The findings showed that both pregnant and nonpregnant women were equally successful at emotional regulation, but this process involved different brain activity in pregnant vs their nonpregnant counterpart.
All women had increased left middle frontal gyrus activity when regulating their emotions, but there was a difference in the amygdala between the pregnancy group and controls, Ms. Weinmar noted.
This suggests that pregnant women may have to exert more neural effort in emotional regulation, she said. “And pregnant women with higher amygdala activity were less able to regulate their emotions successfully compared to those with less amygdala activity.”
Linear regression analyses were performed to assess the relation of brain activity during down-regulation, regulation success, and self-reported depression scores, and this showed that higher amygdala activity was also associated with higher depression scores.
“We need to be cautious in interpreting this,” said Ms. Weinmar. “This is a small sample, and we are the first to undertake this work.”
Nonetheless, she said that if the findings are confirmed by larger studies, pregnant women could be assessed “in the waiting room” using existing questionnaires that evaluate emotional regulation.
If a woman has difficulties with emotion regulation, “there are adaptive strategies, like cognitive reappraisal that a counseling psychotherapist can help with,” said Ms. Weinmar.
“I could also imagine group sessions, for example, or online courses,” she said, adding that obstetricians could also be trained to identify these women.
Commenting on the findings in a press release, Susana Carmona, PhD, from Gregorio Marañón Hospital in Madrid, Spain, said research like this is crucial for gaining insight into one of the most intense physiological processes a human can undergo: pregnancy. It’s remarkable how much remains unknown.
“Recently, the FDA [Food and Drug Administration] approved the first treatment for postpartum depression. However, we still have a long way to go in characterizing what happens in the brain during pregnancy, identifying biomarkers that can indicate the risk of developing perinatal mental disorders, and designing strategies to prevent mother and infant suffering during the delicate and critical peripartum period,” Dr. Carmona added.
The study was supported by the Center for Integrative Neuroscience in Tübingen, Germany, and the International Research Training Group “Women’s Mental Health Across the Reproductive Years” (IRTG 2804). Ms. Weinmar and Dr. Carmona reported no relevant disclosures.
A version of this article appeared on Medscape.com.
MILAN, ITALY — Pregnant women with heightened amygdala activity have a reduced capacity to regulate emotions and report more symptoms of depression than those with lower activity in this brain region, a new imaging study suggested.
If validated, these findings could pave the way for identifying women at higher risk for postpartum depression, said lead researcher Franziska Weinmar, MSc, from the University of Tübingen in Germany.
The study was presented at the 37th European College of Neuropsychopharmacology Congress.
Differences in Brain Activity
During pregnancy and the peripartum period, rising hormone levels create a “psychoneuroendocrinological window of vulnerability” for mental health in which 80% of women can develop transitory “baby blues,” and about one in seven develop more serious postpartum depression, Ms. Weinmar told this news organization.
The study included 47 women — 15 pregnant women and 32 nonpregnant controls. The nonpregnant women had normal menstrual cycles; 16 were in the early follicular phase with low estradiol levels (231.7 pmol/L), and 16 had high estradiol levels (516.6 pmol/L) after administration of estradiol.
To examine brain activity, participants were asked to view negative emotional images while undergoing functional MRI. They were then asked to use cognitive reappraisal to regulate their emotional response to the images.
The findings showed that both pregnant and nonpregnant women were equally successful at emotional regulation, but this process involved different brain activity in pregnant vs their nonpregnant counterpart.
All women had increased left middle frontal gyrus activity when regulating their emotions, but there was a difference in the amygdala between the pregnancy group and controls, Ms. Weinmar noted.
This suggests that pregnant women may have to exert more neural effort in emotional regulation, she said. “And pregnant women with higher amygdala activity were less able to regulate their emotions successfully compared to those with less amygdala activity.”
Linear regression analyses were performed to assess the relation of brain activity during down-regulation, regulation success, and self-reported depression scores, and this showed that higher amygdala activity was also associated with higher depression scores.
“We need to be cautious in interpreting this,” said Ms. Weinmar. “This is a small sample, and we are the first to undertake this work.”
Nonetheless, she said that if the findings are confirmed by larger studies, pregnant women could be assessed “in the waiting room” using existing questionnaires that evaluate emotional regulation.
If a woman has difficulties with emotion regulation, “there are adaptive strategies, like cognitive reappraisal that a counseling psychotherapist can help with,” said Ms. Weinmar.
“I could also imagine group sessions, for example, or online courses,” she said, adding that obstetricians could also be trained to identify these women.
Commenting on the findings in a press release, Susana Carmona, PhD, from Gregorio Marañón Hospital in Madrid, Spain, said research like this is crucial for gaining insight into one of the most intense physiological processes a human can undergo: pregnancy. It’s remarkable how much remains unknown.
“Recently, the FDA [Food and Drug Administration] approved the first treatment for postpartum depression. However, we still have a long way to go in characterizing what happens in the brain during pregnancy, identifying biomarkers that can indicate the risk of developing perinatal mental disorders, and designing strategies to prevent mother and infant suffering during the delicate and critical peripartum period,” Dr. Carmona added.
The study was supported by the Center for Integrative Neuroscience in Tübingen, Germany, and the International Research Training Group “Women’s Mental Health Across the Reproductive Years” (IRTG 2804). Ms. Weinmar and Dr. Carmona reported no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM ECNP 2024
Diabetes Treatment May Lower Incidence of Uterine Fibroids
TOPLINE:
Diabetes is associated with a lower incidence of uterine fibroids in midlife women receiving diabetes treatment, especially metformin. The association between diabetes and the risk for uterine fibroids may vary based on menopausal status.
METHODOLOGY:
- Previous studies have provided inconsistent evidence regarding associations between the risk for uterine fibroids and markers of cardiometabolic health, such as fasting insulin, fasting glucose, and diabetes.
- Researchers conducted a prospective cohort study to examine the association of fasting levels of cardiometabolic blood biomarkers, diabetes, and diabetes treatment with the incidence of new fibroid diagnoses in midlife women.
- They included participants from the Study of Women’s Health Across the Nation cohort who reported fibroid diagnoses at enrollment and during 13 follow-up visits.
- At all visits, levels of glucose, insulin, and sex hormone–binding globulin (SHBG) were measured in fasting blood samples, and homeostatic model assessment for insulin resistance (HOMA-IR) was calculated.
- Discrete-time survival models were used to estimate the hazard ratios (HRs) for the associations of biomarkers and diabetes with fibroid diagnoses, adjusted for demographics and healthcare utilization.
TAKEAWAY:
- Researchers identified 2570 eligible women (median age, 45 years; 45% perimenopausal women), among whom approximately 3% had diabetes at baseline.
- Diabetes was associated with a 28% lower incidence of new fibroid diagnosis (adjusted HR, 0.72).
- This association was particularly strong among participants with treated diabetes, especially those on metformin, who had a 51% lower incidence of self-reported fibroids than those without diabetes. The estimates, however, had wide CIs suggesting uncertainty.
- Time-varying HOMA-IR and SHBG, insulin, and glucose levels were not significantly associated with the new fibroid diagnosis.
- When stratified by menopausal status, higher HOMA-IR and insulin levels were associated with a greater incidence of fibroid diagnosis during premenopause but not during perimenopause.
IN PRACTICE:
“Our findings contribute to preliminary evidence indicating a protective association between diabetes and risk of incident fibroids,” the authors wrote.
SOURCE:
The study was led by Susanna D. Mitro, Division of Research, Kaiser Permanente, Pleasanton, California, and was published online in The Journal of Clinical Endocrinology & Metabolism.
LIMITATIONS:
The study relied on self-reported fibroid diagnoses, which may result in the misclassification of cases. The sample size of participants with diabetes was small, which resulted in reduced precision and confidence in the findings. The baseline eligibility criteria (midlife participants with an intact uterus and no history of fibroid incidence) may have limited the generalizability of the findings to the wider population at risk for fibroids.
DISCLOSURES:
This study was supported by the National Institutes of Health (NIH), through the National Institute on Aging, the National Institute of Nursing Research, and the NIH Office of Research on Women’s Health. One author reported being a consultant and adviser for various pharmaceutical companies. Two other authors reported receiving salary support and royalties from various pharmaceutical companies and organizations.
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:
Diabetes is associated with a lower incidence of uterine fibroids in midlife women receiving diabetes treatment, especially metformin. The association between diabetes and the risk for uterine fibroids may vary based on menopausal status.
METHODOLOGY:
- Previous studies have provided inconsistent evidence regarding associations between the risk for uterine fibroids and markers of cardiometabolic health, such as fasting insulin, fasting glucose, and diabetes.
- Researchers conducted a prospective cohort study to examine the association of fasting levels of cardiometabolic blood biomarkers, diabetes, and diabetes treatment with the incidence of new fibroid diagnoses in midlife women.
- They included participants from the Study of Women’s Health Across the Nation cohort who reported fibroid diagnoses at enrollment and during 13 follow-up visits.
- At all visits, levels of glucose, insulin, and sex hormone–binding globulin (SHBG) were measured in fasting blood samples, and homeostatic model assessment for insulin resistance (HOMA-IR) was calculated.
- Discrete-time survival models were used to estimate the hazard ratios (HRs) for the associations of biomarkers and diabetes with fibroid diagnoses, adjusted for demographics and healthcare utilization.
TAKEAWAY:
- Researchers identified 2570 eligible women (median age, 45 years; 45% perimenopausal women), among whom approximately 3% had diabetes at baseline.
- Diabetes was associated with a 28% lower incidence of new fibroid diagnosis (adjusted HR, 0.72).
- This association was particularly strong among participants with treated diabetes, especially those on metformin, who had a 51% lower incidence of self-reported fibroids than those without diabetes. The estimates, however, had wide CIs suggesting uncertainty.
- Time-varying HOMA-IR and SHBG, insulin, and glucose levels were not significantly associated with the new fibroid diagnosis.
- When stratified by menopausal status, higher HOMA-IR and insulin levels were associated with a greater incidence of fibroid diagnosis during premenopause but not during perimenopause.
IN PRACTICE:
“Our findings contribute to preliminary evidence indicating a protective association between diabetes and risk of incident fibroids,” the authors wrote.
SOURCE:
The study was led by Susanna D. Mitro, Division of Research, Kaiser Permanente, Pleasanton, California, and was published online in The Journal of Clinical Endocrinology & Metabolism.
LIMITATIONS:
The study relied on self-reported fibroid diagnoses, which may result in the misclassification of cases. The sample size of participants with diabetes was small, which resulted in reduced precision and confidence in the findings. The baseline eligibility criteria (midlife participants with an intact uterus and no history of fibroid incidence) may have limited the generalizability of the findings to the wider population at risk for fibroids.
DISCLOSURES:
This study was supported by the National Institutes of Health (NIH), through the National Institute on Aging, the National Institute of Nursing Research, and the NIH Office of Research on Women’s Health. One author reported being a consultant and adviser for various pharmaceutical companies. Two other authors reported receiving salary support and royalties from various pharmaceutical companies and organizations.
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:
Diabetes is associated with a lower incidence of uterine fibroids in midlife women receiving diabetes treatment, especially metformin. The association between diabetes and the risk for uterine fibroids may vary based on menopausal status.
METHODOLOGY:
- Previous studies have provided inconsistent evidence regarding associations between the risk for uterine fibroids and markers of cardiometabolic health, such as fasting insulin, fasting glucose, and diabetes.
- Researchers conducted a prospective cohort study to examine the association of fasting levels of cardiometabolic blood biomarkers, diabetes, and diabetes treatment with the incidence of new fibroid diagnoses in midlife women.
- They included participants from the Study of Women’s Health Across the Nation cohort who reported fibroid diagnoses at enrollment and during 13 follow-up visits.
- At all visits, levels of glucose, insulin, and sex hormone–binding globulin (SHBG) were measured in fasting blood samples, and homeostatic model assessment for insulin resistance (HOMA-IR) was calculated.
- Discrete-time survival models were used to estimate the hazard ratios (HRs) for the associations of biomarkers and diabetes with fibroid diagnoses, adjusted for demographics and healthcare utilization.
TAKEAWAY:
- Researchers identified 2570 eligible women (median age, 45 years; 45% perimenopausal women), among whom approximately 3% had diabetes at baseline.
- Diabetes was associated with a 28% lower incidence of new fibroid diagnosis (adjusted HR, 0.72).
- This association was particularly strong among participants with treated diabetes, especially those on metformin, who had a 51% lower incidence of self-reported fibroids than those without diabetes. The estimates, however, had wide CIs suggesting uncertainty.
- Time-varying HOMA-IR and SHBG, insulin, and glucose levels were not significantly associated with the new fibroid diagnosis.
- When stratified by menopausal status, higher HOMA-IR and insulin levels were associated with a greater incidence of fibroid diagnosis during premenopause but not during perimenopause.
IN PRACTICE:
“Our findings contribute to preliminary evidence indicating a protective association between diabetes and risk of incident fibroids,” the authors wrote.
SOURCE:
The study was led by Susanna D. Mitro, Division of Research, Kaiser Permanente, Pleasanton, California, and was published online in The Journal of Clinical Endocrinology & Metabolism.
LIMITATIONS:
The study relied on self-reported fibroid diagnoses, which may result in the misclassification of cases. The sample size of participants with diabetes was small, which resulted in reduced precision and confidence in the findings. The baseline eligibility criteria (midlife participants with an intact uterus and no history of fibroid incidence) may have limited the generalizability of the findings to the wider population at risk for fibroids.
DISCLOSURES:
This study was supported by the National Institutes of Health (NIH), through the National Institute on Aging, the National Institute of Nursing Research, and the NIH Office of Research on Women’s Health. One author reported being a consultant and adviser for various pharmaceutical companies. Two other authors reported receiving salary support and royalties from various pharmaceutical companies and organizations.
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.
Severe Maternal Morbidity Three Times Higher in Surrogate Gestational Carriers
Gestational carriers face a significantly higher risk for severe maternal morbidity and other pregnancy complications than those conceiving naturally or via in vitro fertilization (IVF), according to a recent Canadian study.
These findings suggest that more work is needed to ensure careful selection of gestational carriers, reported lead author Maria P. Velez, MD, PhD, of McGill University, Montreal, Quebec, Canada, and colleagues.
“Although a gestational carrier should ideally be a healthy person, with a demonstrated low-risk obstetric history, it is not clear whether this occurs in practice,” the investigators wrote in Annals of Internal Medicine. “Moreover, the risk for maternal and neonatal adversity is largely unknown in this group.”
Study Compared Gestational Carriage With IVF and Unassisted Conception
To address these knowledge gaps, Dr. Velez and colleagues conducted a population-based cohort study in Ontario using linked administrative datasets. All singleton births at more than 20 weeks’ gestation with mothers aged 18-50 years were included from April 2012 to March 2021. Multifetal pregnancies were excluded, as were women with a history of infertility diagnosis without fertility treatment, and those who underwent intrauterine insemination or ovulation induction.
Outcomes were compared across three groups: Unassisted conception, IVF, and gestational carriage. The primary maternal outcome was severe maternal morbidity, defined by a validated composite of 41 unique indicators. The primary infant outcome was severe neonatal morbidity, comprising 19 unique indicators.
Secondary outcomes were hypertensive disorders, elective cesarean delivery, emergent cesarean delivery, preterm birth at less than 37 weeks, preterm birth at more than 32 weeks, and postpartum hemorrhage.
Logistic regression analysis adjusted for a range of covariates, including age, obesity, tobacco/drug dependence, chronic hypertension, and others. The final dataset included 846,124 births by unassisted conception (97.6%), 16,087 by IVF (1.8%), and 806 by gestational carriage (0.1%).
The weighted relative risk (wRR) for severe maternal morbidity was more than three times higher in gestational carriers than in those conceiving naturally (wRR, 3.30; 95% CI, 2.59-4.20) and 86% higher than in those conceiving via IVF (wRR, 1.86; 95% CI, 1.36-2.55). These stem from absolute risks of 2.3%, 4.3%, and 7.8% for unassisted, IVF, and surrogate pregnancies, respectively.
Moreover, surrogates were 75% more likely to have hypertensive disorders, 79% more likely to have preterm birth at less than 37 weeks, and almost three times as likely to have postpartum hemorrhage.
These same three secondary outcomes were also significantly more common when comparing surrogate with IVF pregnancies, albeit to a lesser degree. In contrast, surrogate pregnancies were associated with a 21% lower risk for elective cesarean delivery than IVF pregnancies (wRR, 0.79; 95% CI, 0.68-0.93).
Severe neonatal morbidity was not significantly different between the groups. These findings add to a mixed body of evidence surrounding both maternal and neonatal outcomes with gestational carriers, according to the investigators.
“Prior small studies [by Söderström-Anttila et al. and Swanson et al.] reported varying risks for preterm birth in singleton gestational carriage pregnancies, whereas a recent large US registry reported no increased risk for preterm birth compared with IVF, after accounting for multifetal pregnancy,” they wrote. “This study excluded multifetal pregnancies, a common occurrence after IVF, with reported higher risks for adverse outcomes. Accordingly, adverse maternal and newborn outcomes may have been underestimated herein.”
Causes of Worse Outcomes Remain Unclear
While the present findings suggest greater maternal morbidity among surrogates, potential causes of these adverse outcomes remain unclear.
The investigators suggested that implantation of a nonautologous embryo could be playing a role, as oocyte donation has been linked with an increased risk for hypertensive disorders of pregnancy.
“We don’t know exactly why that can happen,” Dr. Velez said in an interview. “Maybe that embryo can be associated with an immunological response that could be associated with higher morbidity during pregnancy. We need, however, other studies that can continue testing that hypothesis.”
In the meantime, more care is needed in surrogate selection, according to Dr. Velez.
“In our study, we found that there were patients, for example, who had more than three prior C-sections, which is one of the contraindications for gestational carriers, and patients who had more than five [prior] pregnancies, which is also another limitation in the guidelines for choosing these patients,” she said. “Definitely we need to be more vigilant when we accept these gestational carriers.”
But improving surrogate selection may be easier said than done.
The quantitative thresholds cited by Dr. Velez come from the American Society for Reproductive Medicine guidelines. Alternative guidance documents from the Canadian Fertility and Andrology Society and American College of Obstetricians and Gynecologists are less prescriptive; instead, they offer qualitative recommendations concerning obstetric history and risk assessment.
And then there is the regulatory specter looming over the entire field, evidenced by the many times that these publications cite ethical and legal considerations — far more than the average medical guidance document — when making clinical decisions related to surrogacy.
Present Study Offers Much-Needed Data in Understudied Field
According to Kate Swanson, MD, a perinatologist, clinical geneticist, and associate professor at the University of California San Francisco, the present study may help steer medical societies and healthcare providers away from these potential sand traps and toward conversations grounded in scientific data.
“I think one of the reasons that the Society for Maternal-Fetal Medicine and the maternal-fetal medicine community in general hasn’t been interested in this subject is that they see it as a social/ethical/legal issue rather than a medical one,” Dr. Swanson said in an interview. “One of the real benefits of this article is that it shows that this is a medical issue that the obstetric community needs to pay attention to.”
These new data could help guide decisions about risk and candidacy with both potential gestational carriers and intended parents, she said.
Still, it’s hard — if not impossible — to disentangle the medical and legal aspects of surrogacy, as shown when analyzing the present study.
In Canada, where it was conducted, intended parents are forbidden from paying surrogates for their services beyond out-of-pocket costs directly related to pregnancy. Meanwhile, surrogacy laws vary widely across the United States; some states (eg, Louisiana) allow only altruistic surrogacy like Canada, while other states (eg, California) permit commercial surrogacy with no legal limits on compensation.
Dr. Swanson and Dr. Velez offered starkly different views on this topic.
“I think there should be more regulations in terms of compensating [gestational carriers],” Dr. Velez said. “I don’t think being a gestational carrier should be like a job or a way of making a living.”
Dr. Swanson, who has published multiple studies on gestational carriage and experienced the process as an intended parent, said compensation beyond expenses is essential.
“I do think it’s incredibly reasonable to pay someone — a woman is taking on quite a lot of inconvenience and risk — in order to perform this service for another family,” she said. “I think it’s incredibly appropriate to compensate her for all of that.”
Reasons for compensation go beyond the ethical, Dr. Swanson added, and may explain some of the findings from the present study.
“A lot of these gestational carriers [in the present dataset] wouldn’t necessarily meet criteria through the American Society of Reproductive Medicine,” Dr. Swanson said, pointing out surrogates who had never had a pregnancy before or reported the use of tobacco or other drugs. “Really, it shows me that a lot of the people participating as gestational carriers were maybe not ideal candidates. I think one of the reasons that we might see that in this Canadian population is ... that you can’t compensate someone, so I think their pool of people willing to be gestational carriers is a lot smaller, and they may be a little bit less selective sometimes.”
Dr. Velez acknowledged that the present study was limited by a shortage of potentially relevant information concerning the surrogacy selection process, including underlying reasons for becoming a gestational carrier. More work is needed to understand the health and outcomes of these women, she said, including topics ranging from immunologic mechanisms to mental health.
She also called for more discussions surrounding maternal safety, with participation from all stakeholders, including governments, surrogates, intended parents, and physicians too.
This study was funded by the Canadian Institutes of Health Research. The investigators disclosed no conflicts of interest. Dr. Swanson disclosed a relationship with Mitera.
A version of this article first appeared on Medscape.com.
Gestational carriers face a significantly higher risk for severe maternal morbidity and other pregnancy complications than those conceiving naturally or via in vitro fertilization (IVF), according to a recent Canadian study.
These findings suggest that more work is needed to ensure careful selection of gestational carriers, reported lead author Maria P. Velez, MD, PhD, of McGill University, Montreal, Quebec, Canada, and colleagues.
“Although a gestational carrier should ideally be a healthy person, with a demonstrated low-risk obstetric history, it is not clear whether this occurs in practice,” the investigators wrote in Annals of Internal Medicine. “Moreover, the risk for maternal and neonatal adversity is largely unknown in this group.”
Study Compared Gestational Carriage With IVF and Unassisted Conception
To address these knowledge gaps, Dr. Velez and colleagues conducted a population-based cohort study in Ontario using linked administrative datasets. All singleton births at more than 20 weeks’ gestation with mothers aged 18-50 years were included from April 2012 to March 2021. Multifetal pregnancies were excluded, as were women with a history of infertility diagnosis without fertility treatment, and those who underwent intrauterine insemination or ovulation induction.
Outcomes were compared across three groups: Unassisted conception, IVF, and gestational carriage. The primary maternal outcome was severe maternal morbidity, defined by a validated composite of 41 unique indicators. The primary infant outcome was severe neonatal morbidity, comprising 19 unique indicators.
Secondary outcomes were hypertensive disorders, elective cesarean delivery, emergent cesarean delivery, preterm birth at less than 37 weeks, preterm birth at more than 32 weeks, and postpartum hemorrhage.
Logistic regression analysis adjusted for a range of covariates, including age, obesity, tobacco/drug dependence, chronic hypertension, and others. The final dataset included 846,124 births by unassisted conception (97.6%), 16,087 by IVF (1.8%), and 806 by gestational carriage (0.1%).
The weighted relative risk (wRR) for severe maternal morbidity was more than three times higher in gestational carriers than in those conceiving naturally (wRR, 3.30; 95% CI, 2.59-4.20) and 86% higher than in those conceiving via IVF (wRR, 1.86; 95% CI, 1.36-2.55). These stem from absolute risks of 2.3%, 4.3%, and 7.8% for unassisted, IVF, and surrogate pregnancies, respectively.
Moreover, surrogates were 75% more likely to have hypertensive disorders, 79% more likely to have preterm birth at less than 37 weeks, and almost three times as likely to have postpartum hemorrhage.
These same three secondary outcomes were also significantly more common when comparing surrogate with IVF pregnancies, albeit to a lesser degree. In contrast, surrogate pregnancies were associated with a 21% lower risk for elective cesarean delivery than IVF pregnancies (wRR, 0.79; 95% CI, 0.68-0.93).
Severe neonatal morbidity was not significantly different between the groups. These findings add to a mixed body of evidence surrounding both maternal and neonatal outcomes with gestational carriers, according to the investigators.
“Prior small studies [by Söderström-Anttila et al. and Swanson et al.] reported varying risks for preterm birth in singleton gestational carriage pregnancies, whereas a recent large US registry reported no increased risk for preterm birth compared with IVF, after accounting for multifetal pregnancy,” they wrote. “This study excluded multifetal pregnancies, a common occurrence after IVF, with reported higher risks for adverse outcomes. Accordingly, adverse maternal and newborn outcomes may have been underestimated herein.”
Causes of Worse Outcomes Remain Unclear
While the present findings suggest greater maternal morbidity among surrogates, potential causes of these adverse outcomes remain unclear.
The investigators suggested that implantation of a nonautologous embryo could be playing a role, as oocyte donation has been linked with an increased risk for hypertensive disorders of pregnancy.
“We don’t know exactly why that can happen,” Dr. Velez said in an interview. “Maybe that embryo can be associated with an immunological response that could be associated with higher morbidity during pregnancy. We need, however, other studies that can continue testing that hypothesis.”
In the meantime, more care is needed in surrogate selection, according to Dr. Velez.
“In our study, we found that there were patients, for example, who had more than three prior C-sections, which is one of the contraindications for gestational carriers, and patients who had more than five [prior] pregnancies, which is also another limitation in the guidelines for choosing these patients,” she said. “Definitely we need to be more vigilant when we accept these gestational carriers.”
But improving surrogate selection may be easier said than done.
The quantitative thresholds cited by Dr. Velez come from the American Society for Reproductive Medicine guidelines. Alternative guidance documents from the Canadian Fertility and Andrology Society and American College of Obstetricians and Gynecologists are less prescriptive; instead, they offer qualitative recommendations concerning obstetric history and risk assessment.
And then there is the regulatory specter looming over the entire field, evidenced by the many times that these publications cite ethical and legal considerations — far more than the average medical guidance document — when making clinical decisions related to surrogacy.
Present Study Offers Much-Needed Data in Understudied Field
According to Kate Swanson, MD, a perinatologist, clinical geneticist, and associate professor at the University of California San Francisco, the present study may help steer medical societies and healthcare providers away from these potential sand traps and toward conversations grounded in scientific data.
“I think one of the reasons that the Society for Maternal-Fetal Medicine and the maternal-fetal medicine community in general hasn’t been interested in this subject is that they see it as a social/ethical/legal issue rather than a medical one,” Dr. Swanson said in an interview. “One of the real benefits of this article is that it shows that this is a medical issue that the obstetric community needs to pay attention to.”
These new data could help guide decisions about risk and candidacy with both potential gestational carriers and intended parents, she said.
Still, it’s hard — if not impossible — to disentangle the medical and legal aspects of surrogacy, as shown when analyzing the present study.
In Canada, where it was conducted, intended parents are forbidden from paying surrogates for their services beyond out-of-pocket costs directly related to pregnancy. Meanwhile, surrogacy laws vary widely across the United States; some states (eg, Louisiana) allow only altruistic surrogacy like Canada, while other states (eg, California) permit commercial surrogacy with no legal limits on compensation.
Dr. Swanson and Dr. Velez offered starkly different views on this topic.
“I think there should be more regulations in terms of compensating [gestational carriers],” Dr. Velez said. “I don’t think being a gestational carrier should be like a job or a way of making a living.”
Dr. Swanson, who has published multiple studies on gestational carriage and experienced the process as an intended parent, said compensation beyond expenses is essential.
“I do think it’s incredibly reasonable to pay someone — a woman is taking on quite a lot of inconvenience and risk — in order to perform this service for another family,” she said. “I think it’s incredibly appropriate to compensate her for all of that.”
Reasons for compensation go beyond the ethical, Dr. Swanson added, and may explain some of the findings from the present study.
“A lot of these gestational carriers [in the present dataset] wouldn’t necessarily meet criteria through the American Society of Reproductive Medicine,” Dr. Swanson said, pointing out surrogates who had never had a pregnancy before or reported the use of tobacco or other drugs. “Really, it shows me that a lot of the people participating as gestational carriers were maybe not ideal candidates. I think one of the reasons that we might see that in this Canadian population is ... that you can’t compensate someone, so I think their pool of people willing to be gestational carriers is a lot smaller, and they may be a little bit less selective sometimes.”
Dr. Velez acknowledged that the present study was limited by a shortage of potentially relevant information concerning the surrogacy selection process, including underlying reasons for becoming a gestational carrier. More work is needed to understand the health and outcomes of these women, she said, including topics ranging from immunologic mechanisms to mental health.
She also called for more discussions surrounding maternal safety, with participation from all stakeholders, including governments, surrogates, intended parents, and physicians too.
This study was funded by the Canadian Institutes of Health Research. The investigators disclosed no conflicts of interest. Dr. Swanson disclosed a relationship with Mitera.
A version of this article first appeared on Medscape.com.
Gestational carriers face a significantly higher risk for severe maternal morbidity and other pregnancy complications than those conceiving naturally or via in vitro fertilization (IVF), according to a recent Canadian study.
These findings suggest that more work is needed to ensure careful selection of gestational carriers, reported lead author Maria P. Velez, MD, PhD, of McGill University, Montreal, Quebec, Canada, and colleagues.
“Although a gestational carrier should ideally be a healthy person, with a demonstrated low-risk obstetric history, it is not clear whether this occurs in practice,” the investigators wrote in Annals of Internal Medicine. “Moreover, the risk for maternal and neonatal adversity is largely unknown in this group.”
Study Compared Gestational Carriage With IVF and Unassisted Conception
To address these knowledge gaps, Dr. Velez and colleagues conducted a population-based cohort study in Ontario using linked administrative datasets. All singleton births at more than 20 weeks’ gestation with mothers aged 18-50 years were included from April 2012 to March 2021. Multifetal pregnancies were excluded, as were women with a history of infertility diagnosis without fertility treatment, and those who underwent intrauterine insemination or ovulation induction.
Outcomes were compared across three groups: Unassisted conception, IVF, and gestational carriage. The primary maternal outcome was severe maternal morbidity, defined by a validated composite of 41 unique indicators. The primary infant outcome was severe neonatal morbidity, comprising 19 unique indicators.
Secondary outcomes were hypertensive disorders, elective cesarean delivery, emergent cesarean delivery, preterm birth at less than 37 weeks, preterm birth at more than 32 weeks, and postpartum hemorrhage.
Logistic regression analysis adjusted for a range of covariates, including age, obesity, tobacco/drug dependence, chronic hypertension, and others. The final dataset included 846,124 births by unassisted conception (97.6%), 16,087 by IVF (1.8%), and 806 by gestational carriage (0.1%).
The weighted relative risk (wRR) for severe maternal morbidity was more than three times higher in gestational carriers than in those conceiving naturally (wRR, 3.30; 95% CI, 2.59-4.20) and 86% higher than in those conceiving via IVF (wRR, 1.86; 95% CI, 1.36-2.55). These stem from absolute risks of 2.3%, 4.3%, and 7.8% for unassisted, IVF, and surrogate pregnancies, respectively.
Moreover, surrogates were 75% more likely to have hypertensive disorders, 79% more likely to have preterm birth at less than 37 weeks, and almost three times as likely to have postpartum hemorrhage.
These same three secondary outcomes were also significantly more common when comparing surrogate with IVF pregnancies, albeit to a lesser degree. In contrast, surrogate pregnancies were associated with a 21% lower risk for elective cesarean delivery than IVF pregnancies (wRR, 0.79; 95% CI, 0.68-0.93).
Severe neonatal morbidity was not significantly different between the groups. These findings add to a mixed body of evidence surrounding both maternal and neonatal outcomes with gestational carriers, according to the investigators.
“Prior small studies [by Söderström-Anttila et al. and Swanson et al.] reported varying risks for preterm birth in singleton gestational carriage pregnancies, whereas a recent large US registry reported no increased risk for preterm birth compared with IVF, after accounting for multifetal pregnancy,” they wrote. “This study excluded multifetal pregnancies, a common occurrence after IVF, with reported higher risks for adverse outcomes. Accordingly, adverse maternal and newborn outcomes may have been underestimated herein.”
Causes of Worse Outcomes Remain Unclear
While the present findings suggest greater maternal morbidity among surrogates, potential causes of these adverse outcomes remain unclear.
The investigators suggested that implantation of a nonautologous embryo could be playing a role, as oocyte donation has been linked with an increased risk for hypertensive disorders of pregnancy.
“We don’t know exactly why that can happen,” Dr. Velez said in an interview. “Maybe that embryo can be associated with an immunological response that could be associated with higher morbidity during pregnancy. We need, however, other studies that can continue testing that hypothesis.”
In the meantime, more care is needed in surrogate selection, according to Dr. Velez.
“In our study, we found that there were patients, for example, who had more than three prior C-sections, which is one of the contraindications for gestational carriers, and patients who had more than five [prior] pregnancies, which is also another limitation in the guidelines for choosing these patients,” she said. “Definitely we need to be more vigilant when we accept these gestational carriers.”
But improving surrogate selection may be easier said than done.
The quantitative thresholds cited by Dr. Velez come from the American Society for Reproductive Medicine guidelines. Alternative guidance documents from the Canadian Fertility and Andrology Society and American College of Obstetricians and Gynecologists are less prescriptive; instead, they offer qualitative recommendations concerning obstetric history and risk assessment.
And then there is the regulatory specter looming over the entire field, evidenced by the many times that these publications cite ethical and legal considerations — far more than the average medical guidance document — when making clinical decisions related to surrogacy.
Present Study Offers Much-Needed Data in Understudied Field
According to Kate Swanson, MD, a perinatologist, clinical geneticist, and associate professor at the University of California San Francisco, the present study may help steer medical societies and healthcare providers away from these potential sand traps and toward conversations grounded in scientific data.
“I think one of the reasons that the Society for Maternal-Fetal Medicine and the maternal-fetal medicine community in general hasn’t been interested in this subject is that they see it as a social/ethical/legal issue rather than a medical one,” Dr. Swanson said in an interview. “One of the real benefits of this article is that it shows that this is a medical issue that the obstetric community needs to pay attention to.”
These new data could help guide decisions about risk and candidacy with both potential gestational carriers and intended parents, she said.
Still, it’s hard — if not impossible — to disentangle the medical and legal aspects of surrogacy, as shown when analyzing the present study.
In Canada, where it was conducted, intended parents are forbidden from paying surrogates for their services beyond out-of-pocket costs directly related to pregnancy. Meanwhile, surrogacy laws vary widely across the United States; some states (eg, Louisiana) allow only altruistic surrogacy like Canada, while other states (eg, California) permit commercial surrogacy with no legal limits on compensation.
Dr. Swanson and Dr. Velez offered starkly different views on this topic.
“I think there should be more regulations in terms of compensating [gestational carriers],” Dr. Velez said. “I don’t think being a gestational carrier should be like a job or a way of making a living.”
Dr. Swanson, who has published multiple studies on gestational carriage and experienced the process as an intended parent, said compensation beyond expenses is essential.
“I do think it’s incredibly reasonable to pay someone — a woman is taking on quite a lot of inconvenience and risk — in order to perform this service for another family,” she said. “I think it’s incredibly appropriate to compensate her for all of that.”
Reasons for compensation go beyond the ethical, Dr. Swanson added, and may explain some of the findings from the present study.
“A lot of these gestational carriers [in the present dataset] wouldn’t necessarily meet criteria through the American Society of Reproductive Medicine,” Dr. Swanson said, pointing out surrogates who had never had a pregnancy before or reported the use of tobacco or other drugs. “Really, it shows me that a lot of the people participating as gestational carriers were maybe not ideal candidates. I think one of the reasons that we might see that in this Canadian population is ... that you can’t compensate someone, so I think their pool of people willing to be gestational carriers is a lot smaller, and they may be a little bit less selective sometimes.”
Dr. Velez acknowledged that the present study was limited by a shortage of potentially relevant information concerning the surrogacy selection process, including underlying reasons for becoming a gestational carrier. More work is needed to understand the health and outcomes of these women, she said, including topics ranging from immunologic mechanisms to mental health.
She also called for more discussions surrounding maternal safety, with participation from all stakeholders, including governments, surrogates, intended parents, and physicians too.
This study was funded by the Canadian Institutes of Health Research. The investigators disclosed no conflicts of interest. Dr. Swanson disclosed a relationship with Mitera.
A version of this article first appeared on Medscape.com.
Screening Identifies Familial Risk for Hereditary Breast and Ovarian Cancer in Large Health System
TOPLINE:
Electronic health record (EHR)–derived family history identified 29,913 patients with familial risk for hereditary breast and ovarian cancer, but 82% had no evidence of genetic testing. Seven-question family history screening (FHS7)–positive status was associated with a threefold increase in BRCA1/2 positivity and a 44% increase in cancer risk among women.
METHODOLOGY:
- A cross-sectional and retrospective cohort analysis used EHR data from Renown Health in northern Nevada. The study period spanned from January 1, 2018, to February 1, 2024, with data on demographic variables, healthcare utilization, and cancer diagnoses.
- The study aimed to use the FHS7 to identify patients meeting family history criteria for genetic testing (familial risk for hereditary breast and ovarian cancer) in their EHRs; patients meeting the FHS7 criteria were deemed to be FHS7-positive.
- A total of 835,727 patients aged 18-79 years were included, with genotype data available for 38,003 participants from the Healthy Nevada Project, which notified 330 individuals with BRCA1/2 variants of their genetic risk.
- The primary outcomes were the presence of pathogenic or likely pathogenic variants in specific genes and the diagnosis of cancer.
TAKEAWAY:
- FHS7-positive status was associated with a 3.34-fold increase in BRCA1/2 positivity among female participants and a 3.35-fold increase among male participants (95% CI, 2.48-4.47 and 1.93-5.56, respectively).
- Female FHS7-positive participants had a 1.62-fold increase in CHEK2 positivity and a 2.84-fold increase in PALB2 positivity (95% CI, 1.05-2.43 and 1.23-6.16, respectively).
- Age-adjusted cancer incidence rates were higher for FHS7-positive patients, with 367.2 cases per 100,000 per year for women and 309.9 cases per 100,000 per year for men.
- The number needed to test to detect one BRCA1/2-positive patient decreased from 128 to 53 for women and from 119 to 42 for men when prescreening with FHS7.
IN PRACTICE:
“EHR-derived FHS7 identified thousands of patients with familial risk for breast cancer, indicating a substantial gap in genetic testing,” the study authors wrote. “Survey results suggest that most patients who are FHS7-positive in their EHR truly meet family history criteria, but that EHR-derived FHS7 may miss many patients who would be FHS7-positive if approached with a direct questionnaire,” the author wrote.
SOURCE:
The study was led by Daniel Kiser, MS, University of Nevada, Reno School of Medicine. It was published online in JAMA Network Open.
LIMITATIONS:
The study’s observational design may introduce self-selection biases, particularly among Healthy Nevada Project participants. The 21.8% response rate to the survey suggests potential self-selection among respondents. The tendency of less healthy patients to have more data available in their EHRs could influence the authors’ analysis of cancer incidence rates, despite adjustments for healthcare utilization levels.
DISCLOSURES:
Daniel Kiser and Joseph J. Grzymski, PhD, reported holding patents outside the submitted work. Dr. Grzymski also disclosed receiving grants from Gilead Sciences. 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:
Electronic health record (EHR)–derived family history identified 29,913 patients with familial risk for hereditary breast and ovarian cancer, but 82% had no evidence of genetic testing. Seven-question family history screening (FHS7)–positive status was associated with a threefold increase in BRCA1/2 positivity and a 44% increase in cancer risk among women.
METHODOLOGY:
- A cross-sectional and retrospective cohort analysis used EHR data from Renown Health in northern Nevada. The study period spanned from January 1, 2018, to February 1, 2024, with data on demographic variables, healthcare utilization, and cancer diagnoses.
- The study aimed to use the FHS7 to identify patients meeting family history criteria for genetic testing (familial risk for hereditary breast and ovarian cancer) in their EHRs; patients meeting the FHS7 criteria were deemed to be FHS7-positive.
- A total of 835,727 patients aged 18-79 years were included, with genotype data available for 38,003 participants from the Healthy Nevada Project, which notified 330 individuals with BRCA1/2 variants of their genetic risk.
- The primary outcomes were the presence of pathogenic or likely pathogenic variants in specific genes and the diagnosis of cancer.
TAKEAWAY:
- FHS7-positive status was associated with a 3.34-fold increase in BRCA1/2 positivity among female participants and a 3.35-fold increase among male participants (95% CI, 2.48-4.47 and 1.93-5.56, respectively).
- Female FHS7-positive participants had a 1.62-fold increase in CHEK2 positivity and a 2.84-fold increase in PALB2 positivity (95% CI, 1.05-2.43 and 1.23-6.16, respectively).
- Age-adjusted cancer incidence rates were higher for FHS7-positive patients, with 367.2 cases per 100,000 per year for women and 309.9 cases per 100,000 per year for men.
- The number needed to test to detect one BRCA1/2-positive patient decreased from 128 to 53 for women and from 119 to 42 for men when prescreening with FHS7.
IN PRACTICE:
“EHR-derived FHS7 identified thousands of patients with familial risk for breast cancer, indicating a substantial gap in genetic testing,” the study authors wrote. “Survey results suggest that most patients who are FHS7-positive in their EHR truly meet family history criteria, but that EHR-derived FHS7 may miss many patients who would be FHS7-positive if approached with a direct questionnaire,” the author wrote.
SOURCE:
The study was led by Daniel Kiser, MS, University of Nevada, Reno School of Medicine. It was published online in JAMA Network Open.
LIMITATIONS:
The study’s observational design may introduce self-selection biases, particularly among Healthy Nevada Project participants. The 21.8% response rate to the survey suggests potential self-selection among respondents. The tendency of less healthy patients to have more data available in their EHRs could influence the authors’ analysis of cancer incidence rates, despite adjustments for healthcare utilization levels.
DISCLOSURES:
Daniel Kiser and Joseph J. Grzymski, PhD, reported holding patents outside the submitted work. Dr. Grzymski also disclosed receiving grants from Gilead Sciences. 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:
Electronic health record (EHR)–derived family history identified 29,913 patients with familial risk for hereditary breast and ovarian cancer, but 82% had no evidence of genetic testing. Seven-question family history screening (FHS7)–positive status was associated with a threefold increase in BRCA1/2 positivity and a 44% increase in cancer risk among women.
METHODOLOGY:
- A cross-sectional and retrospective cohort analysis used EHR data from Renown Health in northern Nevada. The study period spanned from January 1, 2018, to February 1, 2024, with data on demographic variables, healthcare utilization, and cancer diagnoses.
- The study aimed to use the FHS7 to identify patients meeting family history criteria for genetic testing (familial risk for hereditary breast and ovarian cancer) in their EHRs; patients meeting the FHS7 criteria were deemed to be FHS7-positive.
- A total of 835,727 patients aged 18-79 years were included, with genotype data available for 38,003 participants from the Healthy Nevada Project, which notified 330 individuals with BRCA1/2 variants of their genetic risk.
- The primary outcomes were the presence of pathogenic or likely pathogenic variants in specific genes and the diagnosis of cancer.
TAKEAWAY:
- FHS7-positive status was associated with a 3.34-fold increase in BRCA1/2 positivity among female participants and a 3.35-fold increase among male participants (95% CI, 2.48-4.47 and 1.93-5.56, respectively).
- Female FHS7-positive participants had a 1.62-fold increase in CHEK2 positivity and a 2.84-fold increase in PALB2 positivity (95% CI, 1.05-2.43 and 1.23-6.16, respectively).
- Age-adjusted cancer incidence rates were higher for FHS7-positive patients, with 367.2 cases per 100,000 per year for women and 309.9 cases per 100,000 per year for men.
- The number needed to test to detect one BRCA1/2-positive patient decreased from 128 to 53 for women and from 119 to 42 for men when prescreening with FHS7.
IN PRACTICE:
“EHR-derived FHS7 identified thousands of patients with familial risk for breast cancer, indicating a substantial gap in genetic testing,” the study authors wrote. “Survey results suggest that most patients who are FHS7-positive in their EHR truly meet family history criteria, but that EHR-derived FHS7 may miss many patients who would be FHS7-positive if approached with a direct questionnaire,” the author wrote.
SOURCE:
The study was led by Daniel Kiser, MS, University of Nevada, Reno School of Medicine. It was published online in JAMA Network Open.
LIMITATIONS:
The study’s observational design may introduce self-selection biases, particularly among Healthy Nevada Project participants. The 21.8% response rate to the survey suggests potential self-selection among respondents. The tendency of less healthy patients to have more data available in their EHRs could influence the authors’ analysis of cancer incidence rates, despite adjustments for healthcare utilization levels.
DISCLOSURES:
Daniel Kiser and Joseph J. Grzymski, PhD, reported holding patents outside the submitted work. Dr. Grzymski also disclosed receiving grants from Gilead Sciences. 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.
The Sexual Revolution Has Been Great — For Men
During the month of September, Sexual Health Awareness Month, it may help to notice something: Men and their doctors have significantly more options to help with sexual function than do women and their clinicians. Moreover, .
Not convinced? Let’s take a quick tour.
The New Sexual Revolution and the Growing Anger
Around the time of the release of the book and movie Fifty Shades of Grey, Newsweek put the cultural sensation on its cover.
I bought the magazine at the airport and, while waiting for my plane, showed the story to a woman sitting next to me. “What do you think — is this the new ‘sexual revolution’?” I asked her.
She glanced at the cover and answered as accurately as if she had written the article: “In the ’60s, it became okay for women to have sex; now, it’s okay for women to demand good sex.”
I would add to that: Women are demanding good sex, and they want to define for themselves what “good” means.
That social revolution rages, still.
You would think that the demand would bring a corresponding response in clinical medicine. You would be wrong. Although efforts in some sectors are heroic, overall, the results are lagging the forward movement of women wanting better sex.
The Lag in Sexual Education
To examine the progression of the education of physicians regarding the treatment of female sexual dysfunction (FSD), Codispoti and colleagues examined the curricula of seven medical schools in and around Chicago. They found the following: Only one institution identified all anatomic components of the clitoris — one! Four of the seven discussed the physiology of the female orgasm. Only three of the seven highlighted the prevalence and epidemiology of FSD or the treatments for FSD. Only one of the seven explained how to do a genitourinary physical exam specific to assessing FSD.
When assessing obstetrics and gynecology clinical materials, sexual pleasure, arousal, and libido were not included anywhere in the curricula.
I have been teaching physicians about the therapies I developed (over 5000 clinicians in 50-plus countries over the past 14 years). During those sessions, I often stop the class and ask, “Who in here was taught how to retract the foreskin and examine the penis for phimosis?”
All hands will go up.
Then I will ask, “Who in here was taught in medical school how to retract the clitoral hood and examine the clitoris for phimosis?”
Not once has anyone raised a hand.
The Sex Remedies Gap
When I first published research offering support for using platelet-rich plasma to improve sexual function in women, women had not one drug approved by the US Food and Drug Administration (FDA) for the treatment of sexual dysfunction — none. Men had over 20. Today, men have a growing number of FDA-approved drugs for erectile dysfunction, including the “fils”; women have three.
Women have access to only one FDA-approved medication that primarily affects the genitalia: prasterone. This drug is indicated only for the treatment of pain in postmenopausal women. It does not directly enhance desire or improve orgasms. Said another way, although the incidence of sexual dysfunction is higher in premenopausal women than in other groups, they do not have a single approved medication designed to improve the function of their genitalia.
The other two of the three available drugs — flibanserin and bremelanotide — primarily affect the brain and could accurately be called psychoactive agents. They are available only for premenopausal women to improve desire. Flibanserin resulted in one extra sexual encounter per month on average, and patients are advised to avoid alcohol while using the drug. The other can make you vomit.
I do think all three of these treatments can be of great help to some women. I am not advising their disappearance. But in contrast to what is available to men, they are woefully inadequate.
Historical Perspective
In 1980, the medical establishment believed “most instances of acquired impotence are psychogenic.” Then, with the accidental discovery of the benefits of phosphodiesterase type 5 inhibitors, we realized that most cases of male sexual dysfunction involve the vasculature of the genitalia, not the neuroses of the brain. Yet, our two FDA-approved drugs for women with sexual dysfunction are designed to affect the brain. Women have nothing but off-label therapies to improve the function of the genitalia.
Despite the fact research supports the use of testosterone in women for both libido and orgasm, and despite the fact millions of women are treated with testosterone off-label for the benefit of sexual function, the only widely used FDA-approved class of drugs for women that affects testosterone — birth control pills, by blocking pituitary hormone production (the way they prevent pregnancy) — lowers the production of testosterone.
One might wonder, considering our expanded understanding of the endocrinology of both men and women, at the irony of why it is acceptable to lower the testosterone level of an adolescent girl knowingly, as if her development did not require the hormone (such would never be acceptable in an adolescent male unless sexual transitioning were the goal); yet, we are fearful of giving testosterone to grown women who can no longer make it.
Premenopausal Women: An Orphan Population
The concept of “orphan populations” can partially explain the gap in available therapies between men and women.
Women of childbearing age are risky to study; so, with testosterone, for example, it is safer and cheaper for pharmaceutical companies to prove the benefits for men and ride the profits from the off-label use for women. I don’t mean to condemn the manufacturers of testosterone, only to point out the phenomenon of why up to 30% of the prescriptions written by a primary care physician are off-label; off-label use is common among cardiologists (46%); up to 90% of children in the hospital receive at least one off-label drug; and approval of drugs for premenopausal women is more expensive than approval of drugs for men.
What Can Be Done?
The regrettable situation does not reflect evil intent on the part of regulators, educators, or physicians. But the gap between what women want and what medical education and the pharmaceutical-regulatory complex are providing is intolerably wide.
First, I would recommend a standard, required curriculum for the study of female sexual anatomy and function be established and widely adopted by medical schools. The reproductive system contains different components and a different purpose from the orgasm system, with modest overlap. Both systems should be taught in every medical school.
Second, physicians should be required to undergo a course in understanding their own sexuality. Research demonstrates doctors will avoid conversations about sex, and it seems to me this could be secondary to being uncomfortable with their own sexuality. After all, to talk with a patient about sex, you cannot be fearful of where the conversation may lead.
Third, the FDA might reconsider the requirements for the approval of drugs for FSD. Currently, to approve a drug for men, an objective finding — ie, an erection — can be sufficient. However, a higher bar, “satisfaction,” which is subjective, must be obtained with women.
Regenerative therapies have proved helpful but are not yet widely adopted; more grant money for the study of regenerative therapies would be a good start here.
Finally, by the definition of FSD, a woman must be psychologically distressed. The idea of sex is not pleasure alone. Sexual function affects family relationships, emotional health, confidence, even sleep, as well as the emotional well-being of the children who live in the house. Saying women are wonderfully and mysteriously made may be poetic, but it is not an excuse for not learning more and closing the gaps.
Dr. Runels is medical director of the Cellular Medicine Association, Fairhope, Alabama. He reported conflicts of interest with the Cellular Medicine Association, Runels Research Institute, Institute for Lichen Sclerosus, and Vulvar Health. A version of this article first appeared on Medscape.com.
During the month of September, Sexual Health Awareness Month, it may help to notice something: Men and their doctors have significantly more options to help with sexual function than do women and their clinicians. Moreover, .
Not convinced? Let’s take a quick tour.
The New Sexual Revolution and the Growing Anger
Around the time of the release of the book and movie Fifty Shades of Grey, Newsweek put the cultural sensation on its cover.
I bought the magazine at the airport and, while waiting for my plane, showed the story to a woman sitting next to me. “What do you think — is this the new ‘sexual revolution’?” I asked her.
She glanced at the cover and answered as accurately as if she had written the article: “In the ’60s, it became okay for women to have sex; now, it’s okay for women to demand good sex.”
I would add to that: Women are demanding good sex, and they want to define for themselves what “good” means.
That social revolution rages, still.
You would think that the demand would bring a corresponding response in clinical medicine. You would be wrong. Although efforts in some sectors are heroic, overall, the results are lagging the forward movement of women wanting better sex.
The Lag in Sexual Education
To examine the progression of the education of physicians regarding the treatment of female sexual dysfunction (FSD), Codispoti and colleagues examined the curricula of seven medical schools in and around Chicago. They found the following: Only one institution identified all anatomic components of the clitoris — one! Four of the seven discussed the physiology of the female orgasm. Only three of the seven highlighted the prevalence and epidemiology of FSD or the treatments for FSD. Only one of the seven explained how to do a genitourinary physical exam specific to assessing FSD.
When assessing obstetrics and gynecology clinical materials, sexual pleasure, arousal, and libido were not included anywhere in the curricula.
I have been teaching physicians about the therapies I developed (over 5000 clinicians in 50-plus countries over the past 14 years). During those sessions, I often stop the class and ask, “Who in here was taught how to retract the foreskin and examine the penis for phimosis?”
All hands will go up.
Then I will ask, “Who in here was taught in medical school how to retract the clitoral hood and examine the clitoris for phimosis?”
Not once has anyone raised a hand.
The Sex Remedies Gap
When I first published research offering support for using platelet-rich plasma to improve sexual function in women, women had not one drug approved by the US Food and Drug Administration (FDA) for the treatment of sexual dysfunction — none. Men had over 20. Today, men have a growing number of FDA-approved drugs for erectile dysfunction, including the “fils”; women have three.
Women have access to only one FDA-approved medication that primarily affects the genitalia: prasterone. This drug is indicated only for the treatment of pain in postmenopausal women. It does not directly enhance desire or improve orgasms. Said another way, although the incidence of sexual dysfunction is higher in premenopausal women than in other groups, they do not have a single approved medication designed to improve the function of their genitalia.
The other two of the three available drugs — flibanserin and bremelanotide — primarily affect the brain and could accurately be called psychoactive agents. They are available only for premenopausal women to improve desire. Flibanserin resulted in one extra sexual encounter per month on average, and patients are advised to avoid alcohol while using the drug. The other can make you vomit.
I do think all three of these treatments can be of great help to some women. I am not advising their disappearance. But in contrast to what is available to men, they are woefully inadequate.
Historical Perspective
In 1980, the medical establishment believed “most instances of acquired impotence are psychogenic.” Then, with the accidental discovery of the benefits of phosphodiesterase type 5 inhibitors, we realized that most cases of male sexual dysfunction involve the vasculature of the genitalia, not the neuroses of the brain. Yet, our two FDA-approved drugs for women with sexual dysfunction are designed to affect the brain. Women have nothing but off-label therapies to improve the function of the genitalia.
Despite the fact research supports the use of testosterone in women for both libido and orgasm, and despite the fact millions of women are treated with testosterone off-label for the benefit of sexual function, the only widely used FDA-approved class of drugs for women that affects testosterone — birth control pills, by blocking pituitary hormone production (the way they prevent pregnancy) — lowers the production of testosterone.
One might wonder, considering our expanded understanding of the endocrinology of both men and women, at the irony of why it is acceptable to lower the testosterone level of an adolescent girl knowingly, as if her development did not require the hormone (such would never be acceptable in an adolescent male unless sexual transitioning were the goal); yet, we are fearful of giving testosterone to grown women who can no longer make it.
Premenopausal Women: An Orphan Population
The concept of “orphan populations” can partially explain the gap in available therapies between men and women.
Women of childbearing age are risky to study; so, with testosterone, for example, it is safer and cheaper for pharmaceutical companies to prove the benefits for men and ride the profits from the off-label use for women. I don’t mean to condemn the manufacturers of testosterone, only to point out the phenomenon of why up to 30% of the prescriptions written by a primary care physician are off-label; off-label use is common among cardiologists (46%); up to 90% of children in the hospital receive at least one off-label drug; and approval of drugs for premenopausal women is more expensive than approval of drugs for men.
What Can Be Done?
The regrettable situation does not reflect evil intent on the part of regulators, educators, or physicians. But the gap between what women want and what medical education and the pharmaceutical-regulatory complex are providing is intolerably wide.
First, I would recommend a standard, required curriculum for the study of female sexual anatomy and function be established and widely adopted by medical schools. The reproductive system contains different components and a different purpose from the orgasm system, with modest overlap. Both systems should be taught in every medical school.
Second, physicians should be required to undergo a course in understanding their own sexuality. Research demonstrates doctors will avoid conversations about sex, and it seems to me this could be secondary to being uncomfortable with their own sexuality. After all, to talk with a patient about sex, you cannot be fearful of where the conversation may lead.
Third, the FDA might reconsider the requirements for the approval of drugs for FSD. Currently, to approve a drug for men, an objective finding — ie, an erection — can be sufficient. However, a higher bar, “satisfaction,” which is subjective, must be obtained with women.
Regenerative therapies have proved helpful but are not yet widely adopted; more grant money for the study of regenerative therapies would be a good start here.
Finally, by the definition of FSD, a woman must be psychologically distressed. The idea of sex is not pleasure alone. Sexual function affects family relationships, emotional health, confidence, even sleep, as well as the emotional well-being of the children who live in the house. Saying women are wonderfully and mysteriously made may be poetic, but it is not an excuse for not learning more and closing the gaps.
Dr. Runels is medical director of the Cellular Medicine Association, Fairhope, Alabama. He reported conflicts of interest with the Cellular Medicine Association, Runels Research Institute, Institute for Lichen Sclerosus, and Vulvar Health. A version of this article first appeared on Medscape.com.
During the month of September, Sexual Health Awareness Month, it may help to notice something: Men and their doctors have significantly more options to help with sexual function than do women and their clinicians. Moreover, .
Not convinced? Let’s take a quick tour.
The New Sexual Revolution and the Growing Anger
Around the time of the release of the book and movie Fifty Shades of Grey, Newsweek put the cultural sensation on its cover.
I bought the magazine at the airport and, while waiting for my plane, showed the story to a woman sitting next to me. “What do you think — is this the new ‘sexual revolution’?” I asked her.
She glanced at the cover and answered as accurately as if she had written the article: “In the ’60s, it became okay for women to have sex; now, it’s okay for women to demand good sex.”
I would add to that: Women are demanding good sex, and they want to define for themselves what “good” means.
That social revolution rages, still.
You would think that the demand would bring a corresponding response in clinical medicine. You would be wrong. Although efforts in some sectors are heroic, overall, the results are lagging the forward movement of women wanting better sex.
The Lag in Sexual Education
To examine the progression of the education of physicians regarding the treatment of female sexual dysfunction (FSD), Codispoti and colleagues examined the curricula of seven medical schools in and around Chicago. They found the following: Only one institution identified all anatomic components of the clitoris — one! Four of the seven discussed the physiology of the female orgasm. Only three of the seven highlighted the prevalence and epidemiology of FSD or the treatments for FSD. Only one of the seven explained how to do a genitourinary physical exam specific to assessing FSD.
When assessing obstetrics and gynecology clinical materials, sexual pleasure, arousal, and libido were not included anywhere in the curricula.
I have been teaching physicians about the therapies I developed (over 5000 clinicians in 50-plus countries over the past 14 years). During those sessions, I often stop the class and ask, “Who in here was taught how to retract the foreskin and examine the penis for phimosis?”
All hands will go up.
Then I will ask, “Who in here was taught in medical school how to retract the clitoral hood and examine the clitoris for phimosis?”
Not once has anyone raised a hand.
The Sex Remedies Gap
When I first published research offering support for using platelet-rich plasma to improve sexual function in women, women had not one drug approved by the US Food and Drug Administration (FDA) for the treatment of sexual dysfunction — none. Men had over 20. Today, men have a growing number of FDA-approved drugs for erectile dysfunction, including the “fils”; women have three.
Women have access to only one FDA-approved medication that primarily affects the genitalia: prasterone. This drug is indicated only for the treatment of pain in postmenopausal women. It does not directly enhance desire or improve orgasms. Said another way, although the incidence of sexual dysfunction is higher in premenopausal women than in other groups, they do not have a single approved medication designed to improve the function of their genitalia.
The other two of the three available drugs — flibanserin and bremelanotide — primarily affect the brain and could accurately be called psychoactive agents. They are available only for premenopausal women to improve desire. Flibanserin resulted in one extra sexual encounter per month on average, and patients are advised to avoid alcohol while using the drug. The other can make you vomit.
I do think all three of these treatments can be of great help to some women. I am not advising their disappearance. But in contrast to what is available to men, they are woefully inadequate.
Historical Perspective
In 1980, the medical establishment believed “most instances of acquired impotence are psychogenic.” Then, with the accidental discovery of the benefits of phosphodiesterase type 5 inhibitors, we realized that most cases of male sexual dysfunction involve the vasculature of the genitalia, not the neuroses of the brain. Yet, our two FDA-approved drugs for women with sexual dysfunction are designed to affect the brain. Women have nothing but off-label therapies to improve the function of the genitalia.
Despite the fact research supports the use of testosterone in women for both libido and orgasm, and despite the fact millions of women are treated with testosterone off-label for the benefit of sexual function, the only widely used FDA-approved class of drugs for women that affects testosterone — birth control pills, by blocking pituitary hormone production (the way they prevent pregnancy) — lowers the production of testosterone.
One might wonder, considering our expanded understanding of the endocrinology of both men and women, at the irony of why it is acceptable to lower the testosterone level of an adolescent girl knowingly, as if her development did not require the hormone (such would never be acceptable in an adolescent male unless sexual transitioning were the goal); yet, we are fearful of giving testosterone to grown women who can no longer make it.
Premenopausal Women: An Orphan Population
The concept of “orphan populations” can partially explain the gap in available therapies between men and women.
Women of childbearing age are risky to study; so, with testosterone, for example, it is safer and cheaper for pharmaceutical companies to prove the benefits for men and ride the profits from the off-label use for women. I don’t mean to condemn the manufacturers of testosterone, only to point out the phenomenon of why up to 30% of the prescriptions written by a primary care physician are off-label; off-label use is common among cardiologists (46%); up to 90% of children in the hospital receive at least one off-label drug; and approval of drugs for premenopausal women is more expensive than approval of drugs for men.
What Can Be Done?
The regrettable situation does not reflect evil intent on the part of regulators, educators, or physicians. But the gap between what women want and what medical education and the pharmaceutical-regulatory complex are providing is intolerably wide.
First, I would recommend a standard, required curriculum for the study of female sexual anatomy and function be established and widely adopted by medical schools. The reproductive system contains different components and a different purpose from the orgasm system, with modest overlap. Both systems should be taught in every medical school.
Second, physicians should be required to undergo a course in understanding their own sexuality. Research demonstrates doctors will avoid conversations about sex, and it seems to me this could be secondary to being uncomfortable with their own sexuality. After all, to talk with a patient about sex, you cannot be fearful of where the conversation may lead.
Third, the FDA might reconsider the requirements for the approval of drugs for FSD. Currently, to approve a drug for men, an objective finding — ie, an erection — can be sufficient. However, a higher bar, “satisfaction,” which is subjective, must be obtained with women.
Regenerative therapies have proved helpful but are not yet widely adopted; more grant money for the study of regenerative therapies would be a good start here.
Finally, by the definition of FSD, a woman must be psychologically distressed. The idea of sex is not pleasure alone. Sexual function affects family relationships, emotional health, confidence, even sleep, as well as the emotional well-being of the children who live in the house. Saying women are wonderfully and mysteriously made may be poetic, but it is not an excuse for not learning more and closing the gaps.
Dr. Runels is medical director of the Cellular Medicine Association, Fairhope, Alabama. He reported conflicts of interest with the Cellular Medicine Association, Runels Research Institute, Institute for Lichen Sclerosus, and Vulvar Health. A version of this article first appeared on Medscape.com.
Doulas Support Moms-to-Be and Try to Fit Into the Obstetric Care Team
It’s well known that the United States enjoys the dubious distinction of having the worst maternal morbidity and mortality rates among industrialized nations. Maternal mortality in this country increased by 14% from 2018 to 2020, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.
But a current trend of engaging birth doulas — nonmedical guides offering continuous one-on-one physical and psychological support in the pre-, peri,- and postnatal periods — may be poised to brighten that dismal statistical landscape.
Recent research has shown that mothers matched with a doula are less likely to have a low birth weight baby, less likely to experience a birth complication, and significantly more likely to initiate breastfeeding.
Doula services — even delivered digitally — are seen to lower healthcare costs, reduce cesarean sections, decrease maternal anxiety and depression, and improve communication between healthcare providers and low-income, racially/ethnically diverse pregnant women. Doulas can be especially helpful for mothers dealing with the psychological fallout of miscarriage or stillbirth. They can guide patients in the postpartum period, when problems can arise and when some mothers are lost to medical follow-up, and provide an ongoing source of patient information for the ob.gyn.
“Research has shown that in addition to better outcomes, doula care can shorten labor time and increase patient satisfaction,” said ob.gyn. Layan Alrahmani, MD, in an interview. A maternal-fetal medicine specialist with a focus on high-risk pregnancies among low-income women at Loyola Medicine in Maywood, Illinois, Dr. Alrahmani welcomes doulas to her patients’ antenatal visits.
“Many of my patients who are looking to avoid an epidural will work with a labor doula, in order to stay home as long as possible and to have one-on-one coaching through the pain as things progress,” said Susan Rothenberg, MD, an assistant professor of obstetrics, gynecology, and reproductive science at the Icahn School of Medicine at Mount Sinai and an ob/gyn at Mount Sinai Downtown Union Square in New York City. She added, “When a woman’s partner is squeamish or potentially unavailable, a labor doula can be a great option.”
Another ob.gyn. who enthusiastically embraces doula care is L. Joy Baker, MD, who practices in LaGrange, Georgia, and is affiliated with Wellstar West Georgia Medical Center. “I love it when my patients have a doula. A doula answers a patient’s questions throughout the pregnancy and amplifies the mother’s voice in the medical system and the clinical setting,” Dr. Baker told this news organization.
“They provide important details on patients’ food, housing, and transportation status when the mothers themselves would not bring those up in a short appointment with their doctors,” she said. Dr. Baker called for more recognition of their merit, especially for first-time and high-risk moms.
Efua B. Leke, MD, MPH, an assistant professor at Baylor College of Medicine and chief of obstetrics at Ben Taub Hospital in Houston, Texas, also believes a major benefit of doulas is improved flow of information. “We know that having doulas participate in maternal care can ease communication between pregnant and parturient mothers and their clinical team,” Dr. Leke said. “This is especially important for under-resourced pregnant women for whom morbidity tends to be disparately higher.”
Doulas can also take pressure off embattled ob.gyn. clinical staff. “Our volume of patients is huge, so we have to keep appointments brief,” Dr. Baker said. “The US is currently 8000 ob.gyn.s short, and to make matters worse, we’re seeing more and more obstetrical care deserts.”
Still largely underutilized, doula care is seen by its proponents as important in light of the drastic shortage of ob.gyn.s and the shrinking presence of maternity care in many US counties.
According to a recent March of Dimes report, access to maternity care is waning, with more than 35% of US counties offering no community obstetrical care and 52% providing no maternity care in local hospitals. That translates to long distances and extended travel time for mothers seeking care.
Growth Remains Slow
Although many believe doulas could become part of the solution to the lack of access to maternity care, their acceptance seems to be slow growing. In a 2012 national survey by Declercq and associates, about 6% of mothers used a doula during childbirth, up from 3% in a 2006 national survey. Of those who were familiar with but lacking doula care, just 27% would have chosen to have this service.
“I’d estimate that doulas are still involved in only about 6%-8% of births,” said Shaconna Haley, MA, a certified holistic doula and doula trainer in Atlanta, Georgia.
And are there enough practicing doulas in the United States to put a dent in the current shortfall in pregnancy care? Although no reliable estimate of their numbers exists, a centralized online doula registration service listed 9000 registered practitioners in 2018. Contrast that with the approximately 3.6 million live births in 2023.
Potential for Friction?
Although generally seen as benign and helpful, the presence of a doula can add another layer of people for hard-pressed medical staff to deal with. Can their attendance occasionally lead to an adversarial encounter? Yes, said Dr. Baker, especially in the case of assertive questioning or suggestions directed at medical staff. “There can be some mistrust on the part of clinicians when nonmedical persons start raising concerns and asking questions. Staff can get a little prickly at this.”
In the view of Melissa A. Simon, MD, MPH, a professor of obstetrics and gynecology, preventive medicine, and medical social sciences at Northwestern University Feinberg School of Medicine in Chicago, Illinois, simple, preventable communication breakdown is often the cause of occasional antagonism. “As in all team care approaches, it’s helpful to have upfront conversations with the birthing person, the doula, and any care team members or support people who will be present in the birthing room. These conversations should be about expectations.”
According to Ms. Haley, “As long as the focus stays firmly on the client/patient and not on the other team members, there should be no friction. Medical staff should be aware there will be a doula in attendance and ideally there should be a collaborative team and plan in place before the birth.”
In Dr. Leke’s experience, doulas do not hinder the medical team as long as clinical roles are well clarified and the patient is engaged in her care plan. “Friction can occur when doulas are functioning outside of their scope of practice, such as speaking to the healthcare team on behalf of the mother instead empowering the mother to speak up herself,” she said. “Or, when the healthcare team doesn’t understand the doula’s scope of practice or recognize the doula as a member of the team.”
Added Dr. Rothenberg, “I’ve occasionally run into doulas who imagine I have an ulterior motive when making recommendations to patients when that’s completely untrue. It’s common for women to decide to become doulas because they didn’t feel listened to during their own birthing experience, and for a few of them, it’s hard to not project that onto their clients’ labor situations, creating conflict where it doesn’t need to exist.”
Barriers and Challenges
Unfortunately, the barriers of cost and access remain high for pregnant and birthing mothers from lower socioeconomic echelons who have no or limited insurance. “There also are very few multilingual doulas or doulas from diverse racial-ethnic backgrounds and identities,” Dr. Simon pointed out.
Yet by all indications, Medicaid members who receive doula services experience positive maternal outcomes, even those at higher risk for pregnancy complications.
As for Medicaid coverage of doula services, in a recent Centers for Medicare & Medicaid Services report, just 11 state Medicaid programs were reimbursing doula services, whereas an additional five were in the process of implementing reimbursement.
Doula care is not covered by all private insurance plans either, Dr. Simon said. “Although there are maternity care bundles with payment models that help integrate doula care, and there are ways to use your flexible spending account to cover it.”
Some hospitals may undertake independent initiatives. Dr. Baker’s center is offering antenatal and peripartum doula support for under-resourced mothers thanks to a Health Resources and Services Administration grant.*
But for now, doula services are largely limited to middle- and high-income women able to afford the associated out-of-pocket costs. These mothers are disproportionately White, and the doulas serving them tend to be of the same race and socioeconomic class.
The Future
Dr. Simon foresees an optimal scenario in which a team of doulas works with all birthing persons on a hospital labor floor as well as with a team of clinicians. “It takes a true team approach to ensure an optimal birthing experience and optimal birth outcomes,” she said.
Despite the many challenges ahead, doulas will probably become a permanent fixture in pregnancy, birth, and postpartum care, said Dr. Baker. “Doula care is going to be a game changer, and obstetricians welcome doulas to the obstetrical care team.”
Dr. Alrahmani, Dr. Baker, Ms. Haley, Dr. Leke, Dr. Rothenberg, and Dr. Simon declared no conflicts of interest relevant to their comments.
*This story was updated on October 1, 2024.
A version of this article first appeared on Medscape.com.
It’s well known that the United States enjoys the dubious distinction of having the worst maternal morbidity and mortality rates among industrialized nations. Maternal mortality in this country increased by 14% from 2018 to 2020, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.
But a current trend of engaging birth doulas — nonmedical guides offering continuous one-on-one physical and psychological support in the pre-, peri,- and postnatal periods — may be poised to brighten that dismal statistical landscape.
Recent research has shown that mothers matched with a doula are less likely to have a low birth weight baby, less likely to experience a birth complication, and significantly more likely to initiate breastfeeding.
Doula services — even delivered digitally — are seen to lower healthcare costs, reduce cesarean sections, decrease maternal anxiety and depression, and improve communication between healthcare providers and low-income, racially/ethnically diverse pregnant women. Doulas can be especially helpful for mothers dealing with the psychological fallout of miscarriage or stillbirth. They can guide patients in the postpartum period, when problems can arise and when some mothers are lost to medical follow-up, and provide an ongoing source of patient information for the ob.gyn.
“Research has shown that in addition to better outcomes, doula care can shorten labor time and increase patient satisfaction,” said ob.gyn. Layan Alrahmani, MD, in an interview. A maternal-fetal medicine specialist with a focus on high-risk pregnancies among low-income women at Loyola Medicine in Maywood, Illinois, Dr. Alrahmani welcomes doulas to her patients’ antenatal visits.
“Many of my patients who are looking to avoid an epidural will work with a labor doula, in order to stay home as long as possible and to have one-on-one coaching through the pain as things progress,” said Susan Rothenberg, MD, an assistant professor of obstetrics, gynecology, and reproductive science at the Icahn School of Medicine at Mount Sinai and an ob/gyn at Mount Sinai Downtown Union Square in New York City. She added, “When a woman’s partner is squeamish or potentially unavailable, a labor doula can be a great option.”
Another ob.gyn. who enthusiastically embraces doula care is L. Joy Baker, MD, who practices in LaGrange, Georgia, and is affiliated with Wellstar West Georgia Medical Center. “I love it when my patients have a doula. A doula answers a patient’s questions throughout the pregnancy and amplifies the mother’s voice in the medical system and the clinical setting,” Dr. Baker told this news organization.
“They provide important details on patients’ food, housing, and transportation status when the mothers themselves would not bring those up in a short appointment with their doctors,” she said. Dr. Baker called for more recognition of their merit, especially for first-time and high-risk moms.
Efua B. Leke, MD, MPH, an assistant professor at Baylor College of Medicine and chief of obstetrics at Ben Taub Hospital in Houston, Texas, also believes a major benefit of doulas is improved flow of information. “We know that having doulas participate in maternal care can ease communication between pregnant and parturient mothers and their clinical team,” Dr. Leke said. “This is especially important for under-resourced pregnant women for whom morbidity tends to be disparately higher.”
Doulas can also take pressure off embattled ob.gyn. clinical staff. “Our volume of patients is huge, so we have to keep appointments brief,” Dr. Baker said. “The US is currently 8000 ob.gyn.s short, and to make matters worse, we’re seeing more and more obstetrical care deserts.”
Still largely underutilized, doula care is seen by its proponents as important in light of the drastic shortage of ob.gyn.s and the shrinking presence of maternity care in many US counties.
According to a recent March of Dimes report, access to maternity care is waning, with more than 35% of US counties offering no community obstetrical care and 52% providing no maternity care in local hospitals. That translates to long distances and extended travel time for mothers seeking care.
Growth Remains Slow
Although many believe doulas could become part of the solution to the lack of access to maternity care, their acceptance seems to be slow growing. In a 2012 national survey by Declercq and associates, about 6% of mothers used a doula during childbirth, up from 3% in a 2006 national survey. Of those who were familiar with but lacking doula care, just 27% would have chosen to have this service.
“I’d estimate that doulas are still involved in only about 6%-8% of births,” said Shaconna Haley, MA, a certified holistic doula and doula trainer in Atlanta, Georgia.
And are there enough practicing doulas in the United States to put a dent in the current shortfall in pregnancy care? Although no reliable estimate of their numbers exists, a centralized online doula registration service listed 9000 registered practitioners in 2018. Contrast that with the approximately 3.6 million live births in 2023.
Potential for Friction?
Although generally seen as benign and helpful, the presence of a doula can add another layer of people for hard-pressed medical staff to deal with. Can their attendance occasionally lead to an adversarial encounter? Yes, said Dr. Baker, especially in the case of assertive questioning or suggestions directed at medical staff. “There can be some mistrust on the part of clinicians when nonmedical persons start raising concerns and asking questions. Staff can get a little prickly at this.”
In the view of Melissa A. Simon, MD, MPH, a professor of obstetrics and gynecology, preventive medicine, and medical social sciences at Northwestern University Feinberg School of Medicine in Chicago, Illinois, simple, preventable communication breakdown is often the cause of occasional antagonism. “As in all team care approaches, it’s helpful to have upfront conversations with the birthing person, the doula, and any care team members or support people who will be present in the birthing room. These conversations should be about expectations.”
According to Ms. Haley, “As long as the focus stays firmly on the client/patient and not on the other team members, there should be no friction. Medical staff should be aware there will be a doula in attendance and ideally there should be a collaborative team and plan in place before the birth.”
In Dr. Leke’s experience, doulas do not hinder the medical team as long as clinical roles are well clarified and the patient is engaged in her care plan. “Friction can occur when doulas are functioning outside of their scope of practice, such as speaking to the healthcare team on behalf of the mother instead empowering the mother to speak up herself,” she said. “Or, when the healthcare team doesn’t understand the doula’s scope of practice or recognize the doula as a member of the team.”
Added Dr. Rothenberg, “I’ve occasionally run into doulas who imagine I have an ulterior motive when making recommendations to patients when that’s completely untrue. It’s common for women to decide to become doulas because they didn’t feel listened to during their own birthing experience, and for a few of them, it’s hard to not project that onto their clients’ labor situations, creating conflict where it doesn’t need to exist.”
Barriers and Challenges
Unfortunately, the barriers of cost and access remain high for pregnant and birthing mothers from lower socioeconomic echelons who have no or limited insurance. “There also are very few multilingual doulas or doulas from diverse racial-ethnic backgrounds and identities,” Dr. Simon pointed out.
Yet by all indications, Medicaid members who receive doula services experience positive maternal outcomes, even those at higher risk for pregnancy complications.
As for Medicaid coverage of doula services, in a recent Centers for Medicare & Medicaid Services report, just 11 state Medicaid programs were reimbursing doula services, whereas an additional five were in the process of implementing reimbursement.
Doula care is not covered by all private insurance plans either, Dr. Simon said. “Although there are maternity care bundles with payment models that help integrate doula care, and there are ways to use your flexible spending account to cover it.”
Some hospitals may undertake independent initiatives. Dr. Baker’s center is offering antenatal and peripartum doula support for under-resourced mothers thanks to a Health Resources and Services Administration grant.*
But for now, doula services are largely limited to middle- and high-income women able to afford the associated out-of-pocket costs. These mothers are disproportionately White, and the doulas serving them tend to be of the same race and socioeconomic class.
The Future
Dr. Simon foresees an optimal scenario in which a team of doulas works with all birthing persons on a hospital labor floor as well as with a team of clinicians. “It takes a true team approach to ensure an optimal birthing experience and optimal birth outcomes,” she said.
Despite the many challenges ahead, doulas will probably become a permanent fixture in pregnancy, birth, and postpartum care, said Dr. Baker. “Doula care is going to be a game changer, and obstetricians welcome doulas to the obstetrical care team.”
Dr. Alrahmani, Dr. Baker, Ms. Haley, Dr. Leke, Dr. Rothenberg, and Dr. Simon declared no conflicts of interest relevant to their comments.
*This story was updated on October 1, 2024.
A version of this article first appeared on Medscape.com.
It’s well known that the United States enjoys the dubious distinction of having the worst maternal morbidity and mortality rates among industrialized nations. Maternal mortality in this country increased by 14% from 2018 to 2020, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.
But a current trend of engaging birth doulas — nonmedical guides offering continuous one-on-one physical and psychological support in the pre-, peri,- and postnatal periods — may be poised to brighten that dismal statistical landscape.
Recent research has shown that mothers matched with a doula are less likely to have a low birth weight baby, less likely to experience a birth complication, and significantly more likely to initiate breastfeeding.
Doula services — even delivered digitally — are seen to lower healthcare costs, reduce cesarean sections, decrease maternal anxiety and depression, and improve communication between healthcare providers and low-income, racially/ethnically diverse pregnant women. Doulas can be especially helpful for mothers dealing with the psychological fallout of miscarriage or stillbirth. They can guide patients in the postpartum period, when problems can arise and when some mothers are lost to medical follow-up, and provide an ongoing source of patient information for the ob.gyn.
“Research has shown that in addition to better outcomes, doula care can shorten labor time and increase patient satisfaction,” said ob.gyn. Layan Alrahmani, MD, in an interview. A maternal-fetal medicine specialist with a focus on high-risk pregnancies among low-income women at Loyola Medicine in Maywood, Illinois, Dr. Alrahmani welcomes doulas to her patients’ antenatal visits.
“Many of my patients who are looking to avoid an epidural will work with a labor doula, in order to stay home as long as possible and to have one-on-one coaching through the pain as things progress,” said Susan Rothenberg, MD, an assistant professor of obstetrics, gynecology, and reproductive science at the Icahn School of Medicine at Mount Sinai and an ob/gyn at Mount Sinai Downtown Union Square in New York City. She added, “When a woman’s partner is squeamish or potentially unavailable, a labor doula can be a great option.”
Another ob.gyn. who enthusiastically embraces doula care is L. Joy Baker, MD, who practices in LaGrange, Georgia, and is affiliated with Wellstar West Georgia Medical Center. “I love it when my patients have a doula. A doula answers a patient’s questions throughout the pregnancy and amplifies the mother’s voice in the medical system and the clinical setting,” Dr. Baker told this news organization.
“They provide important details on patients’ food, housing, and transportation status when the mothers themselves would not bring those up in a short appointment with their doctors,” she said. Dr. Baker called for more recognition of their merit, especially for first-time and high-risk moms.
Efua B. Leke, MD, MPH, an assistant professor at Baylor College of Medicine and chief of obstetrics at Ben Taub Hospital in Houston, Texas, also believes a major benefit of doulas is improved flow of information. “We know that having doulas participate in maternal care can ease communication between pregnant and parturient mothers and their clinical team,” Dr. Leke said. “This is especially important for under-resourced pregnant women for whom morbidity tends to be disparately higher.”
Doulas can also take pressure off embattled ob.gyn. clinical staff. “Our volume of patients is huge, so we have to keep appointments brief,” Dr. Baker said. “The US is currently 8000 ob.gyn.s short, and to make matters worse, we’re seeing more and more obstetrical care deserts.”
Still largely underutilized, doula care is seen by its proponents as important in light of the drastic shortage of ob.gyn.s and the shrinking presence of maternity care in many US counties.
According to a recent March of Dimes report, access to maternity care is waning, with more than 35% of US counties offering no community obstetrical care and 52% providing no maternity care in local hospitals. That translates to long distances and extended travel time for mothers seeking care.
Growth Remains Slow
Although many believe doulas could become part of the solution to the lack of access to maternity care, their acceptance seems to be slow growing. In a 2012 national survey by Declercq and associates, about 6% of mothers used a doula during childbirth, up from 3% in a 2006 national survey. Of those who were familiar with but lacking doula care, just 27% would have chosen to have this service.
“I’d estimate that doulas are still involved in only about 6%-8% of births,” said Shaconna Haley, MA, a certified holistic doula and doula trainer in Atlanta, Georgia.
And are there enough practicing doulas in the United States to put a dent in the current shortfall in pregnancy care? Although no reliable estimate of their numbers exists, a centralized online doula registration service listed 9000 registered practitioners in 2018. Contrast that with the approximately 3.6 million live births in 2023.
Potential for Friction?
Although generally seen as benign and helpful, the presence of a doula can add another layer of people for hard-pressed medical staff to deal with. Can their attendance occasionally lead to an adversarial encounter? Yes, said Dr. Baker, especially in the case of assertive questioning or suggestions directed at medical staff. “There can be some mistrust on the part of clinicians when nonmedical persons start raising concerns and asking questions. Staff can get a little prickly at this.”
In the view of Melissa A. Simon, MD, MPH, a professor of obstetrics and gynecology, preventive medicine, and medical social sciences at Northwestern University Feinberg School of Medicine in Chicago, Illinois, simple, preventable communication breakdown is often the cause of occasional antagonism. “As in all team care approaches, it’s helpful to have upfront conversations with the birthing person, the doula, and any care team members or support people who will be present in the birthing room. These conversations should be about expectations.”
According to Ms. Haley, “As long as the focus stays firmly on the client/patient and not on the other team members, there should be no friction. Medical staff should be aware there will be a doula in attendance and ideally there should be a collaborative team and plan in place before the birth.”
In Dr. Leke’s experience, doulas do not hinder the medical team as long as clinical roles are well clarified and the patient is engaged in her care plan. “Friction can occur when doulas are functioning outside of their scope of practice, such as speaking to the healthcare team on behalf of the mother instead empowering the mother to speak up herself,” she said. “Or, when the healthcare team doesn’t understand the doula’s scope of practice or recognize the doula as a member of the team.”
Added Dr. Rothenberg, “I’ve occasionally run into doulas who imagine I have an ulterior motive when making recommendations to patients when that’s completely untrue. It’s common for women to decide to become doulas because they didn’t feel listened to during their own birthing experience, and for a few of them, it’s hard to not project that onto their clients’ labor situations, creating conflict where it doesn’t need to exist.”
Barriers and Challenges
Unfortunately, the barriers of cost and access remain high for pregnant and birthing mothers from lower socioeconomic echelons who have no or limited insurance. “There also are very few multilingual doulas or doulas from diverse racial-ethnic backgrounds and identities,” Dr. Simon pointed out.
Yet by all indications, Medicaid members who receive doula services experience positive maternal outcomes, even those at higher risk for pregnancy complications.
As for Medicaid coverage of doula services, in a recent Centers for Medicare & Medicaid Services report, just 11 state Medicaid programs were reimbursing doula services, whereas an additional five were in the process of implementing reimbursement.
Doula care is not covered by all private insurance plans either, Dr. Simon said. “Although there are maternity care bundles with payment models that help integrate doula care, and there are ways to use your flexible spending account to cover it.”
Some hospitals may undertake independent initiatives. Dr. Baker’s center is offering antenatal and peripartum doula support for under-resourced mothers thanks to a Health Resources and Services Administration grant.*
But for now, doula services are largely limited to middle- and high-income women able to afford the associated out-of-pocket costs. These mothers are disproportionately White, and the doulas serving them tend to be of the same race and socioeconomic class.
The Future
Dr. Simon foresees an optimal scenario in which a team of doulas works with all birthing persons on a hospital labor floor as well as with a team of clinicians. “It takes a true team approach to ensure an optimal birthing experience and optimal birth outcomes,” she said.
Despite the many challenges ahead, doulas will probably become a permanent fixture in pregnancy, birth, and postpartum care, said Dr. Baker. “Doula care is going to be a game changer, and obstetricians welcome doulas to the obstetrical care team.”
Dr. Alrahmani, Dr. Baker, Ms. Haley, Dr. Leke, Dr. Rothenberg, and Dr. Simon declared no conflicts of interest relevant to their comments.
*This story was updated on October 1, 2024.
A version of this article first appeared on Medscape.com.
Does Preconception BMI Affect Time to Pregnancy and Miscarriage Risk?
TOPLINE:
Higher body mass index (BMI) in both partners is linked to lower fecundability and increased subfertility. Overweight and obesity in women are associated with higher odds of miscarriage.
METHODOLOGY:
- Researchers conducted a population-based prospective cohort study in Rotterdam, the Netherlands, from August 9, 2017, to July 1, 2021.
- A total of 3604 women and their partners were included, with follow-up until birth.
- BMI was measured in preconception or early pregnancy, and outcomes included fecundability, subfertility, and miscarriage.
- Fecundability was defined as the probability of conceiving within 1 month and subfertility as time to pregnancy or duration of actively pursuing pregnancy of more than 12 months or use of assisted reproductive technology.
- Miscarriage was defined as pregnancy loss before 22 weeks of gestation.
TAKEAWAY:
- Higher BMI in women and men was associated with lower fecundability: For every unit increase in BMI, fecundability decreased (women, 0.98; 95% CI, 0.97-0.99; men, 0.99; 95% CI, 0.98-1.00).
- Women with overweight (0.88; 95% CI, 0.80-0.98) and obesity (0.72; 95% CI, 0.63-0.82) had lower fecundability than women with normal weight.
- Overweight (1.35; 95% CI, 1.11-1.63) and obesity (1.67; 95% CI, 1.30-2.13) in women were associated with increased odds of subfertility.
- Obesity in men was associated with increased odds of subfertility (1.69; 95% CI, 1.24-2.31).
IN PRACTICE:
“We observed in this cohort study that BMI outside of the normal category in women and men was associated with lower fecundability, subfertility, and increased odds of miscarriage. Optimizing BMI from the preconception period onward in women and men might be an important strategy to improve fertility and pregnancy outcomes,” wrote the authors of the study.
SOURCE:
The study was led by Aline J. Boxem, MD, and Vincent W. V. Jaddoe, MD, PhD, The Generation R Study Group, Erasmus University Medical Centre in Rotterdam, the Netherlands. It was published online in JAMA Network Open.
LIMITATIONS:
The study’s generalizability may be affected by differences between included and excluded participants, who were younger and had a higher BMI. The accuracy of time-to-pregnancy duration may have been impacted by retrospectively answered questionnaires. Residual confounding might still be an issue due to the observational nature of the study.
DISCLOSURES:
Dr. Boxem and Dr. Jaddoe disclosed receiving grants from the Erasmus University Medical Centre, the Erasmus University Rotterdam, and the Netherlands Organisation for Health Research and Development. 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:
Higher body mass index (BMI) in both partners is linked to lower fecundability and increased subfertility. Overweight and obesity in women are associated with higher odds of miscarriage.
METHODOLOGY:
- Researchers conducted a population-based prospective cohort study in Rotterdam, the Netherlands, from August 9, 2017, to July 1, 2021.
- A total of 3604 women and their partners were included, with follow-up until birth.
- BMI was measured in preconception or early pregnancy, and outcomes included fecundability, subfertility, and miscarriage.
- Fecundability was defined as the probability of conceiving within 1 month and subfertility as time to pregnancy or duration of actively pursuing pregnancy of more than 12 months or use of assisted reproductive technology.
- Miscarriage was defined as pregnancy loss before 22 weeks of gestation.
TAKEAWAY:
- Higher BMI in women and men was associated with lower fecundability: For every unit increase in BMI, fecundability decreased (women, 0.98; 95% CI, 0.97-0.99; men, 0.99; 95% CI, 0.98-1.00).
- Women with overweight (0.88; 95% CI, 0.80-0.98) and obesity (0.72; 95% CI, 0.63-0.82) had lower fecundability than women with normal weight.
- Overweight (1.35; 95% CI, 1.11-1.63) and obesity (1.67; 95% CI, 1.30-2.13) in women were associated with increased odds of subfertility.
- Obesity in men was associated with increased odds of subfertility (1.69; 95% CI, 1.24-2.31).
IN PRACTICE:
“We observed in this cohort study that BMI outside of the normal category in women and men was associated with lower fecundability, subfertility, and increased odds of miscarriage. Optimizing BMI from the preconception period onward in women and men might be an important strategy to improve fertility and pregnancy outcomes,” wrote the authors of the study.
SOURCE:
The study was led by Aline J. Boxem, MD, and Vincent W. V. Jaddoe, MD, PhD, The Generation R Study Group, Erasmus University Medical Centre in Rotterdam, the Netherlands. It was published online in JAMA Network Open.
LIMITATIONS:
The study’s generalizability may be affected by differences between included and excluded participants, who were younger and had a higher BMI. The accuracy of time-to-pregnancy duration may have been impacted by retrospectively answered questionnaires. Residual confounding might still be an issue due to the observational nature of the study.
DISCLOSURES:
Dr. Boxem and Dr. Jaddoe disclosed receiving grants from the Erasmus University Medical Centre, the Erasmus University Rotterdam, and the Netherlands Organisation for Health Research and Development. 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:
Higher body mass index (BMI) in both partners is linked to lower fecundability and increased subfertility. Overweight and obesity in women are associated with higher odds of miscarriage.
METHODOLOGY:
- Researchers conducted a population-based prospective cohort study in Rotterdam, the Netherlands, from August 9, 2017, to July 1, 2021.
- A total of 3604 women and their partners were included, with follow-up until birth.
- BMI was measured in preconception or early pregnancy, and outcomes included fecundability, subfertility, and miscarriage.
- Fecundability was defined as the probability of conceiving within 1 month and subfertility as time to pregnancy or duration of actively pursuing pregnancy of more than 12 months or use of assisted reproductive technology.
- Miscarriage was defined as pregnancy loss before 22 weeks of gestation.
TAKEAWAY:
- Higher BMI in women and men was associated with lower fecundability: For every unit increase in BMI, fecundability decreased (women, 0.98; 95% CI, 0.97-0.99; men, 0.99; 95% CI, 0.98-1.00).
- Women with overweight (0.88; 95% CI, 0.80-0.98) and obesity (0.72; 95% CI, 0.63-0.82) had lower fecundability than women with normal weight.
- Overweight (1.35; 95% CI, 1.11-1.63) and obesity (1.67; 95% CI, 1.30-2.13) in women were associated with increased odds of subfertility.
- Obesity in men was associated with increased odds of subfertility (1.69; 95% CI, 1.24-2.31).
IN PRACTICE:
“We observed in this cohort study that BMI outside of the normal category in women and men was associated with lower fecundability, subfertility, and increased odds of miscarriage. Optimizing BMI from the preconception period onward in women and men might be an important strategy to improve fertility and pregnancy outcomes,” wrote the authors of the study.
SOURCE:
The study was led by Aline J. Boxem, MD, and Vincent W. V. Jaddoe, MD, PhD, The Generation R Study Group, Erasmus University Medical Centre in Rotterdam, the Netherlands. It was published online in JAMA Network Open.
LIMITATIONS:
The study’s generalizability may be affected by differences between included and excluded participants, who were younger and had a higher BMI. The accuracy of time-to-pregnancy duration may have been impacted by retrospectively answered questionnaires. Residual confounding might still be an issue due to the observational nature of the study.
DISCLOSURES:
Dr. Boxem and Dr. Jaddoe disclosed receiving grants from the Erasmus University Medical Centre, the Erasmus University Rotterdam, and the Netherlands Organisation for Health Research and Development. 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.