Women's Health

New results from the phase 3 RxPONDER trial add to mounting evidence that most postmenopausal women with early-stage breast cancer derive no added benefits from chemotherapy and can be effectively treated with endocrine therapy alone.

The study, published in The New England Journal of Medicine, conversely shows that premenopausal women do benefit from adjuvant chemotherapy, theorized by many to largely be the result of chemotherapy-induced ovarian function suppression.

The RxPONDER trial results are in line with those from the practice-changing TAILORx trial and underscore that “postmenopausal women with 1 to 3 positive nodes and [a recurrence score] of 0 to 25 can likely safely forgo adjuvant chemotherapy without compromising invasive disease-free survival,” first author Kevin Kalinsky, MD, of the Winship Cancer Institute at Emory University, Atlanta, told this news organization. “This will save tens of thousands of women the time, expense, and potentially harmful side effects that can be associated with chemotherapy infusions.”

However, the authors note, “premenopausal women with 1-3 positive lymph nodes had a significant benefit from chemotherapy.”

The study, conducted by the Southwest Oncology Group (SWOG) Cancer Research Network, involved 5,018 women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with one to three positive axillary lymph nodes – a breast cancer profile that represents approximately 20% of cases in the U.S.

All women had recurrence scores on the 100-point 21-gene breast cancer assay (Oncotype Dx) under 25, which is considered the lowest risk of recurrence. Patients were randomized to treatment with endocrine therapy only (n = 2,507) or chemotherapy followed by endocrine therapy (n = 2,511).

After a median follow-up of 5.3 years, women treated with adjunctive chemotherapy plus endocrine therapy exhibited no significant improvements in invasive disease-free survival compared to those who received endocrine therapy alone.

A prespecified analysis stratifying women by menopausal status underscored those results among postmenopausal women. In this cohort, researchers reported invasive disease-free survival was 91.9% in the endocrine-only group and 91.3% in the chemotherapy group (HR, 1.02; P = .89), indicating no benefit of the adjunctive chemotherapy.

However, among premenopausal women, the invasive disease-free survival rate was significantly higher with the addition of chemotherapy – 89.0% with endocrine-only therapy and 93.9% with both therapies (HR, 0.60; P = .002). Increases in distant relapse-free survival observed in the dual-therapy group similarly favored adding chemotherapy (HR, 0.58; P = .009).

Even when the authors further stratified the women into recurrence scores of 0 to 13 or 14 to 25, the results remained consistent. Postmenopausal women in each of the recurrence score groups continued to show no difference in invasive disease recurrence, new primary cancer, or death from chemotherapy (HR, 1.01 for each score group). Conversely, premenopausal women showed significant improvements in those outcomes when chemotherapy was added to endocrine therapy.

To what degree were the effects observed in premenopausal women the result of chemotherapy-induced ovarian suppression?

“I think it’s fair to say it’s the most interesting question right now in early-stage breast cancer for ER-positive tumors,” Harold Burstein, MD, of the Dana-Farber Cancer Institute and Harvard Medical School, Boston, said during a debate at the recent San Antonio Breast Cancer Symposium.

According to Sibylle Loibl, MD, PhD, when it comes to the use of chemotherapy, “age matters.”

“I strongly believe the biology of tumors is different in younger women with HR-positive/HER2-negative breast cancer,” Dr. Loibl, an associate professor at the University of Frankfurt, said during the debate. “It’s a different disease and the effects of chemotherapy are different.”

In young women, chemotherapy has “a direct cytotoxic effect, which cannot be neglected, and an endocrine effect on ovarian function suppression,” Dr. Loibl added. “I think both are needed in young premenopausal patients.”

According to the RxPONDER authors, “whether a chemotherapy benefit in premenopausal women is due to both direct cytocidal effects and treatment-induced menopause remains unclear,” but they noted that “it is possible that the contribution of these mechanisms may vary according to age.”

Further complicating matters, Dr. Loibl added, is that age appears to be poorly represented in genetic diagnostic tools.

“I think the gene expression profiles we are currently using as standard diagnostic tools do not capture the right biology for our premenopausal patients,” she said. “We have to keep in mind that these tests were designed and validated in postmenopausal patients and were only retrospectively used in premenopausal patients.”

The study was funded by the National Cancer Institute and others. Dr. Loibl has received honoraria from Prime and Chugai and numerous institutional research grants.

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

New results from the phase 3 RxPONDER trial add to mounting evidence that most postmenopausal women with early-stage breast cancer derive no added benefits from chemotherapy and can be effectively treated with endocrine therapy alone.

The study, published in The New England Journal of Medicine, conversely shows that premenopausal women do benefit from adjuvant chemotherapy, theorized by many to largely be the result of chemotherapy-induced ovarian function suppression.

The RxPONDER trial results are in line with those from the practice-changing TAILORx trial and underscore that “postmenopausal women with 1 to 3 positive nodes and [a recurrence score] of 0 to 25 can likely safely forgo adjuvant chemotherapy without compromising invasive disease-free survival,” first author Kevin Kalinsky, MD, of the Winship Cancer Institute at Emory University, Atlanta, told this news organization. “This will save tens of thousands of women the time, expense, and potentially harmful side effects that can be associated with chemotherapy infusions.”

However, the authors note, “premenopausal women with 1-3 positive lymph nodes had a significant benefit from chemotherapy.”

The study, conducted by the Southwest Oncology Group (SWOG) Cancer Research Network, involved 5,018 women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with one to three positive axillary lymph nodes – a breast cancer profile that represents approximately 20% of cases in the U.S.

All women had recurrence scores on the 100-point 21-gene breast cancer assay (Oncotype Dx) under 25, which is considered the lowest risk of recurrence. Patients were randomized to treatment with endocrine therapy only (n = 2,507) or chemotherapy followed by endocrine therapy (n = 2,511).

After a median follow-up of 5.3 years, women treated with adjunctive chemotherapy plus endocrine therapy exhibited no significant improvements in invasive disease-free survival compared to those who received endocrine therapy alone.

A prespecified analysis stratifying women by menopausal status underscored those results among postmenopausal women. In this cohort, researchers reported invasive disease-free survival was 91.9% in the endocrine-only group and 91.3% in the chemotherapy group (HR, 1.02; P = .89), indicating no benefit of the adjunctive chemotherapy.

However, among premenopausal women, the invasive disease-free survival rate was significantly higher with the addition of chemotherapy – 89.0% with endocrine-only therapy and 93.9% with both therapies (HR, 0.60; P = .002). Increases in distant relapse-free survival observed in the dual-therapy group similarly favored adding chemotherapy (HR, 0.58; P = .009).

Even when the authors further stratified the women into recurrence scores of 0 to 13 or 14 to 25, the results remained consistent. Postmenopausal women in each of the recurrence score groups continued to show no difference in invasive disease recurrence, new primary cancer, or death from chemotherapy (HR, 1.01 for each score group). Conversely, premenopausal women showed significant improvements in those outcomes when chemotherapy was added to endocrine therapy.

To what degree were the effects observed in premenopausal women the result of chemotherapy-induced ovarian suppression?

“I think it’s fair to say it’s the most interesting question right now in early-stage breast cancer for ER-positive tumors,” Harold Burstein, MD, of the Dana-Farber Cancer Institute and Harvard Medical School, Boston, said during a debate at the recent San Antonio Breast Cancer Symposium.

According to Sibylle Loibl, MD, PhD, when it comes to the use of chemotherapy, “age matters.”

“I strongly believe the biology of tumors is different in younger women with HR-positive/HER2-negative breast cancer,” Dr. Loibl, an associate professor at the University of Frankfurt, said during the debate. “It’s a different disease and the effects of chemotherapy are different.”

In young women, chemotherapy has “a direct cytotoxic effect, which cannot be neglected, and an endocrine effect on ovarian function suppression,” Dr. Loibl added. “I think both are needed in young premenopausal patients.”

According to the RxPONDER authors, “whether a chemotherapy benefit in premenopausal women is due to both direct cytocidal effects and treatment-induced menopause remains unclear,” but they noted that “it is possible that the contribution of these mechanisms may vary according to age.”

Further complicating matters, Dr. Loibl added, is that age appears to be poorly represented in genetic diagnostic tools.

“I think the gene expression profiles we are currently using as standard diagnostic tools do not capture the right biology for our premenopausal patients,” she said. “We have to keep in mind that these tests were designed and validated in postmenopausal patients and were only retrospectively used in premenopausal patients.”

The study was funded by the National Cancer Institute and others. Dr. Loibl has received honoraria from Prime and Chugai and numerous institutional research grants.

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

New results from the phase 3 RxPONDER trial add to mounting evidence that most postmenopausal women with early-stage breast cancer derive no added benefits from chemotherapy and can be effectively treated with endocrine therapy alone.

The study, published in The New England Journal of Medicine, conversely shows that premenopausal women do benefit from adjuvant chemotherapy, theorized by many to largely be the result of chemotherapy-induced ovarian function suppression.

The RxPONDER trial results are in line with those from the practice-changing TAILORx trial and underscore that “postmenopausal women with 1 to 3 positive nodes and [a recurrence score] of 0 to 25 can likely safely forgo adjuvant chemotherapy without compromising invasive disease-free survival,” first author Kevin Kalinsky, MD, of the Winship Cancer Institute at Emory University, Atlanta, told this news organization. “This will save tens of thousands of women the time, expense, and potentially harmful side effects that can be associated with chemotherapy infusions.”

However, the authors note, “premenopausal women with 1-3 positive lymph nodes had a significant benefit from chemotherapy.”

The study, conducted by the Southwest Oncology Group (SWOG) Cancer Research Network, involved 5,018 women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with one to three positive axillary lymph nodes – a breast cancer profile that represents approximately 20% of cases in the U.S.

All women had recurrence scores on the 100-point 21-gene breast cancer assay (Oncotype Dx) under 25, which is considered the lowest risk of recurrence. Patients were randomized to treatment with endocrine therapy only (n = 2,507) or chemotherapy followed by endocrine therapy (n = 2,511).

After a median follow-up of 5.3 years, women treated with adjunctive chemotherapy plus endocrine therapy exhibited no significant improvements in invasive disease-free survival compared to those who received endocrine therapy alone.

A prespecified analysis stratifying women by menopausal status underscored those results among postmenopausal women. In this cohort, researchers reported invasive disease-free survival was 91.9% in the endocrine-only group and 91.3% in the chemotherapy group (HR, 1.02; P = .89), indicating no benefit of the adjunctive chemotherapy.

However, among premenopausal women, the invasive disease-free survival rate was significantly higher with the addition of chemotherapy – 89.0% with endocrine-only therapy and 93.9% with both therapies (HR, 0.60; P = .002). Increases in distant relapse-free survival observed in the dual-therapy group similarly favored adding chemotherapy (HR, 0.58; P = .009).

Even when the authors further stratified the women into recurrence scores of 0 to 13 or 14 to 25, the results remained consistent. Postmenopausal women in each of the recurrence score groups continued to show no difference in invasive disease recurrence, new primary cancer, or death from chemotherapy (HR, 1.01 for each score group). Conversely, premenopausal women showed significant improvements in those outcomes when chemotherapy was added to endocrine therapy.

To what degree were the effects observed in premenopausal women the result of chemotherapy-induced ovarian suppression?

“I think it’s fair to say it’s the most interesting question right now in early-stage breast cancer for ER-positive tumors,” Harold Burstein, MD, of the Dana-Farber Cancer Institute and Harvard Medical School, Boston, said during a debate at the recent San Antonio Breast Cancer Symposium.

According to Sibylle Loibl, MD, PhD, when it comes to the use of chemotherapy, “age matters.”

“I strongly believe the biology of tumors is different in younger women with HR-positive/HER2-negative breast cancer,” Dr. Loibl, an associate professor at the University of Frankfurt, said during the debate. “It’s a different disease and the effects of chemotherapy are different.”

In young women, chemotherapy has “a direct cytotoxic effect, which cannot be neglected, and an endocrine effect on ovarian function suppression,” Dr. Loibl added. “I think both are needed in young premenopausal patients.”

According to the RxPONDER authors, “whether a chemotherapy benefit in premenopausal women is due to both direct cytocidal effects and treatment-induced menopause remains unclear,” but they noted that “it is possible that the contribution of these mechanisms may vary according to age.”

Further complicating matters, Dr. Loibl added, is that age appears to be poorly represented in genetic diagnostic tools.

“I think the gene expression profiles we are currently using as standard diagnostic tools do not capture the right biology for our premenopausal patients,” she said. “We have to keep in mind that these tests were designed and validated in postmenopausal patients and were only retrospectively used in premenopausal patients.”

The study was funded by the National Cancer Institute and others. Dr. Loibl has received honoraria from Prime and Chugai and numerous institutional research grants.

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

Women with physical, intellectual, and sensory disabilities had higher risk for almost all pregnancy complications, obstetric interventions, and adverse outcomes, including severe maternal morbidity (SMM) and mortality compared to women without disabilities, according to an analysis of a large, retrospective cohort.

The findings, published in JAMA Network Open (2021;4[12]:e2138414 doi: 10.1001/jamanetworkopen.2021.38414), “may be a direct reflection of the challenges women with all types of disabilities face when accessing and receiving care, which is likely compounded by poorer preconception health,” suggested lead author Jessica L. Gleason, PhD, MPH, and co-authors, all from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Md.

“Women with disabilities have long been ignored in obstetric research and clinical practice,” added Hilary K. Brown, PhD, from the University of Toronto, in an accompanying editorial. “Inclusion of disability indicators needs to be the norm – not the exception – in health administrative data so that these disparities can be regularly tracked and addressed.”

The investigators used data from the Consortium on Safe Labor (CSL), a retrospective cohort of deliveries from 12 U.S. clinical centers between Jan. 2002 and Jan. 2008, to analyze obstetric interventions and adverse maternal outcomes in women with and without disabilities.

The analysis included a total of 223,385 women, mean age 27.6 years, of whom 2,074 (0.9%) had a disability, and 221,311 did not. Among those with disabilities, 1,733 (83.5%) were physical, 91 (4.4%) were intellectual, and 250 (12.1%) were sensory. While almost half (49.4%) of the women were White, 22.5% were Black, 17.5% were Hispanic, and 4.1% were Asian or Pacific Islander.

Outcomes were analyzed with three composite measures:

• Pregnancy-related complications (pregnancy-related hypertensive diseases, gestational diabetes, placental abruption, placenta previa, premature rupture of membranes, preterm PROM);
• All labor, delivery, and postpartum complications (chorioamnionitis, hemorrhage, blood transfusion, thromboembolism, postpartum fever, infection, cardiovascular events, cardiomyopathy, and maternal death);
• SMM only, including severe pre-eclampsia/eclampsia, hemorrhage, thromboembolism, fever, infection, cardiomyopathy, and cardiovascular events during labor and delivery.

After adjustment for covariates, women with disabilities had higher risk of pregnancy-related complications. This included a 48% higher risk of mild pre-eclampsia and double the risk of severe pre-eclampsia/eclampsia. The composite risk of any pregnancy complication was 27% higher for women with physical disabilities, 49% higher for women with intellectual disabilities, and 53% higher for women with sensory disabilities.

The findings were similar for labor, delivery, and postpartum complications, showing women with disabilities had higher risk for a range of obstetrical interventions, including cesarean delivery – both planned and intrapartum (aRR, 1.34). Additionally, women with disabilities were less likely to have a cesarean delivery that was “solely clinically indicated” (aRR, 0.79), and more likely to have a cesarean delivery for “softer” mixed indication (aRR, 1.16), “supporting a possible overuse of cesarean delivery among women with disability,” they suggested.

Women with disabilities also had a higher risk of postpartum hemorrhage (aRR, 1.27), blood transfusion (aRR, 1.64), and maternal mortality (aRR, 11.19), as well as individual markers of severe maternal morbidity, such as cardiovascular events (aRR, 4.02), infection (aRR, 2.69), and venous thromboembolism (aRR, 6.08).

The authors speculate that the increased risks for women with disabilities “may be the result of a combination of independent risk factors, including the higher rate of obstetric intervention via cesarean delivery, under-recognition of women with disabilities as a population with higher-risk pregnancies, and lack of health care practitioner knowledge or comfort in managing pregnancies among women with disabilities.”

Dr. Brown noted in her commentary that there is a need for better education of health care professionals in this area. “Given that 12% of reproductive-aged women have a disability, that pregnancy rates are similar among women with and without disabilities, and that women with disabilities are at elevated risk of a range of adverse maternal outcomes, including severe maternal morbidity and maternal mortality, disability modules should be a mandatory component of education for obstetricians and midwives as well as other obstetrical health care professionals.”

Calling the study “a serious wake-up call,” Monika Mitra, PhD, told this publication that the findings highlight the need for “urgent attention” on improving obstetric care for people with disabilities “with a focus on accessibility and inclusion, changing clinical practice to better serve disabled people, integrating disability-related training for health care practitioners, and developing evidence-based interventions to support people with disabilities during this time.” The associate professor and director of the Lurie Institute for Disability Policy, in Brandeis University, Waltham, Mass. said the risk factors for poor outcomes are present early in pregnancy or even preconception. “We know that disabled women report barriers in accessing health care and receive lower-quality care compared to nondisabled women and are more likely to experience poverty, housing and food insecurity, educational and employment barriers, abuse, chronic health conditions, and mental illness than women without disabilities.”

She noted that the study’s sample of people with disabilities was small, and the measure of disability used was based on ICD-9 codes, which captures only severe disabilities. “As noted in the commentary by [Dr.] Brown, our standard sources of health administrative data do not give us the full picture on disability, and we need other, more equitable ways of identifying disability based, for example, on self-reports of activity or participation limitations if we are to be able to understand the effects on obstetric outcomes of health and health care disparities and of social determinants of health. Moreover, researchers have generally not yet begun to incorporate knowledge of the experiences of transgender people during pregnancy, which will impact our measures and study of obstetric outcomes among people with disabilities as well as the language we use.”

The study was supported by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The study authors and Dr. Brown reported no conflicts of interest. Dr. Mitra receives funding from the NICHD and the National Institute on Disability, Independent Living for research on pregnancy outcomes among people with disabilities.

obnews@mdedge.com

Women with physical, intellectual, and sensory disabilities had higher risk for almost all pregnancy complications, obstetric interventions, and adverse outcomes, including severe maternal morbidity (SMM) and mortality compared to women without disabilities, according to an analysis of a large, retrospective cohort.

The findings, published in JAMA Network Open (2021;4[12]:e2138414 doi: 10.1001/jamanetworkopen.2021.38414), “may be a direct reflection of the challenges women with all types of disabilities face when accessing and receiving care, which is likely compounded by poorer preconception health,” suggested lead author Jessica L. Gleason, PhD, MPH, and co-authors, all from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Md.

“Women with disabilities have long been ignored in obstetric research and clinical practice,” added Hilary K. Brown, PhD, from the University of Toronto, in an accompanying editorial. “Inclusion of disability indicators needs to be the norm – not the exception – in health administrative data so that these disparities can be regularly tracked and addressed.”

The investigators used data from the Consortium on Safe Labor (CSL), a retrospective cohort of deliveries from 12 U.S. clinical centers between Jan. 2002 and Jan. 2008, to analyze obstetric interventions and adverse maternal outcomes in women with and without disabilities.

The analysis included a total of 223,385 women, mean age 27.6 years, of whom 2,074 (0.9%) had a disability, and 221,311 did not. Among those with disabilities, 1,733 (83.5%) were physical, 91 (4.4%) were intellectual, and 250 (12.1%) were sensory. While almost half (49.4%) of the women were White, 22.5% were Black, 17.5% were Hispanic, and 4.1% were Asian or Pacific Islander.

Outcomes were analyzed with three composite measures:

• Pregnancy-related complications (pregnancy-related hypertensive diseases, gestational diabetes, placental abruption, placenta previa, premature rupture of membranes, preterm PROM);
• All labor, delivery, and postpartum complications (chorioamnionitis, hemorrhage, blood transfusion, thromboembolism, postpartum fever, infection, cardiovascular events, cardiomyopathy, and maternal death);
• SMM only, including severe pre-eclampsia/eclampsia, hemorrhage, thromboembolism, fever, infection, cardiomyopathy, and cardiovascular events during labor and delivery.

After adjustment for covariates, women with disabilities had higher risk of pregnancy-related complications. This included a 48% higher risk of mild pre-eclampsia and double the risk of severe pre-eclampsia/eclampsia. The composite risk of any pregnancy complication was 27% higher for women with physical disabilities, 49% higher for women with intellectual disabilities, and 53% higher for women with sensory disabilities.

The findings were similar for labor, delivery, and postpartum complications, showing women with disabilities had higher risk for a range of obstetrical interventions, including cesarean delivery – both planned and intrapartum (aRR, 1.34). Additionally, women with disabilities were less likely to have a cesarean delivery that was “solely clinically indicated” (aRR, 0.79), and more likely to have a cesarean delivery for “softer” mixed indication (aRR, 1.16), “supporting a possible overuse of cesarean delivery among women with disability,” they suggested.

Women with disabilities also had a higher risk of postpartum hemorrhage (aRR, 1.27), blood transfusion (aRR, 1.64), and maternal mortality (aRR, 11.19), as well as individual markers of severe maternal morbidity, such as cardiovascular events (aRR, 4.02), infection (aRR, 2.69), and venous thromboembolism (aRR, 6.08).

The authors speculate that the increased risks for women with disabilities “may be the result of a combination of independent risk factors, including the higher rate of obstetric intervention via cesarean delivery, under-recognition of women with disabilities as a population with higher-risk pregnancies, and lack of health care practitioner knowledge or comfort in managing pregnancies among women with disabilities.”

Dr. Brown noted in her commentary that there is a need for better education of health care professionals in this area. “Given that 12% of reproductive-aged women have a disability, that pregnancy rates are similar among women with and without disabilities, and that women with disabilities are at elevated risk of a range of adverse maternal outcomes, including severe maternal morbidity and maternal mortality, disability modules should be a mandatory component of education for obstetricians and midwives as well as other obstetrical health care professionals.”

Calling the study “a serious wake-up call,” Monika Mitra, PhD, told this publication that the findings highlight the need for “urgent attention” on improving obstetric care for people with disabilities “with a focus on accessibility and inclusion, changing clinical practice to better serve disabled people, integrating disability-related training for health care practitioners, and developing evidence-based interventions to support people with disabilities during this time.” The associate professor and director of the Lurie Institute for Disability Policy, in Brandeis University, Waltham, Mass. said the risk factors for poor outcomes are present early in pregnancy or even preconception. “We know that disabled women report barriers in accessing health care and receive lower-quality care compared to nondisabled women and are more likely to experience poverty, housing and food insecurity, educational and employment barriers, abuse, chronic health conditions, and mental illness than women without disabilities.”

She noted that the study’s sample of people with disabilities was small, and the measure of disability used was based on ICD-9 codes, which captures only severe disabilities. “As noted in the commentary by [Dr.] Brown, our standard sources of health administrative data do not give us the full picture on disability, and we need other, more equitable ways of identifying disability based, for example, on self-reports of activity or participation limitations if we are to be able to understand the effects on obstetric outcomes of health and health care disparities and of social determinants of health. Moreover, researchers have generally not yet begun to incorporate knowledge of the experiences of transgender people during pregnancy, which will impact our measures and study of obstetric outcomes among people with disabilities as well as the language we use.”

The study was supported by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The study authors and Dr. Brown reported no conflicts of interest. Dr. Mitra receives funding from the NICHD and the National Institute on Disability, Independent Living for research on pregnancy outcomes among people with disabilities.

obnews@mdedge.com

Women with physical, intellectual, and sensory disabilities had higher risk for almost all pregnancy complications, obstetric interventions, and adverse outcomes, including severe maternal morbidity (SMM) and mortality compared to women without disabilities, according to an analysis of a large, retrospective cohort.

The findings, published in JAMA Network Open (2021;4[12]:e2138414 doi: 10.1001/jamanetworkopen.2021.38414), “may be a direct reflection of the challenges women with all types of disabilities face when accessing and receiving care, which is likely compounded by poorer preconception health,” suggested lead author Jessica L. Gleason, PhD, MPH, and co-authors, all from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Md.

“Women with disabilities have long been ignored in obstetric research and clinical practice,” added Hilary K. Brown, PhD, from the University of Toronto, in an accompanying editorial. “Inclusion of disability indicators needs to be the norm – not the exception – in health administrative data so that these disparities can be regularly tracked and addressed.”

The investigators used data from the Consortium on Safe Labor (CSL), a retrospective cohort of deliveries from 12 U.S. clinical centers between Jan. 2002 and Jan. 2008, to analyze obstetric interventions and adverse maternal outcomes in women with and without disabilities.

The analysis included a total of 223,385 women, mean age 27.6 years, of whom 2,074 (0.9%) had a disability, and 221,311 did not. Among those with disabilities, 1,733 (83.5%) were physical, 91 (4.4%) were intellectual, and 250 (12.1%) were sensory. While almost half (49.4%) of the women were White, 22.5% were Black, 17.5% were Hispanic, and 4.1% were Asian or Pacific Islander.

Outcomes were analyzed with three composite measures:

• Pregnancy-related complications (pregnancy-related hypertensive diseases, gestational diabetes, placental abruption, placenta previa, premature rupture of membranes, preterm PROM);
• All labor, delivery, and postpartum complications (chorioamnionitis, hemorrhage, blood transfusion, thromboembolism, postpartum fever, infection, cardiovascular events, cardiomyopathy, and maternal death);
• SMM only, including severe pre-eclampsia/eclampsia, hemorrhage, thromboembolism, fever, infection, cardiomyopathy, and cardiovascular events during labor and delivery.

After adjustment for covariates, women with disabilities had higher risk of pregnancy-related complications. This included a 48% higher risk of mild pre-eclampsia and double the risk of severe pre-eclampsia/eclampsia. The composite risk of any pregnancy complication was 27% higher for women with physical disabilities, 49% higher for women with intellectual disabilities, and 53% higher for women with sensory disabilities.

The findings were similar for labor, delivery, and postpartum complications, showing women with disabilities had higher risk for a range of obstetrical interventions, including cesarean delivery – both planned and intrapartum (aRR, 1.34). Additionally, women with disabilities were less likely to have a cesarean delivery that was “solely clinically indicated” (aRR, 0.79), and more likely to have a cesarean delivery for “softer” mixed indication (aRR, 1.16), “supporting a possible overuse of cesarean delivery among women with disability,” they suggested.

Women with disabilities also had a higher risk of postpartum hemorrhage (aRR, 1.27), blood transfusion (aRR, 1.64), and maternal mortality (aRR, 11.19), as well as individual markers of severe maternal morbidity, such as cardiovascular events (aRR, 4.02), infection (aRR, 2.69), and venous thromboembolism (aRR, 6.08).

The authors speculate that the increased risks for women with disabilities “may be the result of a combination of independent risk factors, including the higher rate of obstetric intervention via cesarean delivery, under-recognition of women with disabilities as a population with higher-risk pregnancies, and lack of health care practitioner knowledge or comfort in managing pregnancies among women with disabilities.”

Dr. Brown noted in her commentary that there is a need for better education of health care professionals in this area. “Given that 12% of reproductive-aged women have a disability, that pregnancy rates are similar among women with and without disabilities, and that women with disabilities are at elevated risk of a range of adverse maternal outcomes, including severe maternal morbidity and maternal mortality, disability modules should be a mandatory component of education for obstetricians and midwives as well as other obstetrical health care professionals.”

Calling the study “a serious wake-up call,” Monika Mitra, PhD, told this publication that the findings highlight the need for “urgent attention” on improving obstetric care for people with disabilities “with a focus on accessibility and inclusion, changing clinical practice to better serve disabled people, integrating disability-related training for health care practitioners, and developing evidence-based interventions to support people with disabilities during this time.” The associate professor and director of the Lurie Institute for Disability Policy, in Brandeis University, Waltham, Mass. said the risk factors for poor outcomes are present early in pregnancy or even preconception. “We know that disabled women report barriers in accessing health care and receive lower-quality care compared to nondisabled women and are more likely to experience poverty, housing and food insecurity, educational and employment barriers, abuse, chronic health conditions, and mental illness than women without disabilities.”

She noted that the study’s sample of people with disabilities was small, and the measure of disability used was based on ICD-9 codes, which captures only severe disabilities. “As noted in the commentary by [Dr.] Brown, our standard sources of health administrative data do not give us the full picture on disability, and we need other, more equitable ways of identifying disability based, for example, on self-reports of activity or participation limitations if we are to be able to understand the effects on obstetric outcomes of health and health care disparities and of social determinants of health. Moreover, researchers have generally not yet begun to incorporate knowledge of the experiences of transgender people during pregnancy, which will impact our measures and study of obstetric outcomes among people with disabilities as well as the language we use.”

The study was supported by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The study authors and Dr. Brown reported no conflicts of interest. Dr. Mitra receives funding from the NICHD and the National Institute on Disability, Independent Living for research on pregnancy outcomes among people with disabilities.

obnews@mdedge.com

Delayed umbilical cord clamping for at least 60 seconds after birth significantly reduced death or disability in infants of less than 30 weeks’ gestation, according to data from nearly 1,500 infants.

The burden of disability and mortality for babies born before 30 weeks’ gestation remains high, especially in low- and middle-income countries, wrote Kristy P. Robledo, PhD, of the University of Sydney, Australia, and colleagues. Delayed clamping of the umbilical cord is a simple procedure that may improve mortality in this population, but more research is needed; recommended times to delayed clamping range from 30 seconds to 3 minutes, they noted.

In a study published in The Lancet Child & Adolescent Health, the researchers randomized 767 very preterm infants to delayed clamping at least 60 seconds after birth and 764 to immediate clamping. Of these, 384 were multiple births (who were individually randomized), 862 were male, and 505 were born before 27 weeks’ gestation. The primary outcome was death or disability at 2 years of age. Major disability was defined as cerebral palsy, severe visual loss, deafness requiring a hearing aid or cochlear implants, major language or speech problems, or cognitive delay at 2 years corrected age. The median time to clamping was 60 seconds in the delayed group and 5 seconds in the immediate group.

Primary outcome data were available for 1,419 infants. Death or major disability occurred in 29% of infants assigned to delayed clamping compared to 34% of those assigned to immediate clamping (relative risk 0.83, P = .010). The infants were part of the APTS Childhood Follow-Up Study, an open-label superiority trial conducted in Australia and New Zealand.

By age 2 years, 8% of infants in the delayed group and 11% of those in the immediate group had died; 23% and 26%, respectively, met criteria for major disability. The impact of delayed clamping translates to a 30% reduction in relative risk of mortality at 2 years of age, but no significant impact on major disability, the researchers wrote.

The findings were limited by several factors including the unblinded study design, lack of data on heart rate or time to first breath, and the clamping prior to 60 seconds in 26% of infants in the delayed group based on clinical concerns for these specific infants, the researchers noted.

However, the results were strengthened by the large size, low risk of bias, and specific primary outcome, they said. The data support findings from recent systematic reviews and highlight the need for further trials to evaluate delayed clamping at different time points, with larger populations, inclusion of time to first breath and heart rate, and improved measures of disability, the researchers added.

In clinical practice, “Given that aiming to delay cord clamping for 60 seconds or more improved 2-year outcomes and short-term hematological measures with no evidence of significant harm, it seems reasonable to conclude that delayed clamping is appropriate as standard care in very preterm infants,” they concluded.
 

Accepting simple intervention could have great impact

This study is important in light of the overwhelming burden of preterm birth on the health care system and society as a whole, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview.

“Preterm birth is associated with billions in health care costs each year, and a large portion of that money is directed to the complications associated with preterm birth, such as early intervention services, educational support, and ongoing medical care,” Dr. Tanner said. “This study is particularly timely, as we are quickly approaching 2030, the deadline for achieving the United Nations Sustainable Development Goal of ending preventable deaths of newborns and children under 5 years of age,” she said. The goal involves “all countries aiming to reduce neonatal mortality to at least as low as 12 per 1,000 live births and under-5 mortality to at least as low as 25 per 1,000 live births. Effective treatments to reduce infant and child mortality would make strong inroads toward this goal,” she explained.

Dr. Tanner said she was not surprised by the findings because previous studies have shown similar results. “However, the large, multicenter nature of this study provides additional weight to recommendations to delay cord clamping as standard practice,” she said.

“The findings of this study support the recommendations of a number of large organizations,” said Dr. Tanner. “The World Health Organization recommends that the umbilical cord not be clamped earlier than 1 minute after birth in term or preterm infants who do not require positive pressure ventilation. The American College of Obstetricians and Gynecologists and the American Academy of Pediatrics now recommend a delay in umbilical cord clamping in vigorous term and preterm infants for at least 30–60 seconds after birth,” she said. “The Royal College of Obstetricians and Gynaecologists also recommends deferring umbilical cord clamping for healthy term and preterm infants for at least 2 minutes after birth,” she added.  

However, “the delay in adoption of this guidelines in practice appears to be related to some concerns regarding universal adoption of this approach,” Dr. Tanner noted. “Some clinicians have suggested that delayed cord clamping could delay vital neonatal resuscitative efforts, leading to worse neonatal outcomes, but this concern has not been borne out in the data, as all guidelines specifically state that this intervention is for vigorous newborns,” she said. “In fact, in preterm infants, delayed cord clamping is associated with improved transitional circulation, decreased need for blood transfusion, and lower incidence of necrotizing enterocolitis and intraventricular hemorrhage,” Dr. Tanner emphasized. “Additionally, concerns persist that delayed cord clamping could lead to excessive transfusion with resultant polycythemia. Again, no data have supported this claim to date,” she said.

“Finally, some clinicians are concerned that delayed clamping could lead to delay in addressing maternal complications of birth such as hemorrhage, but studies have shown the opposite; delayed umbilical cord clamping has not been associated with an increased risk of postpartum hemorrhage or increased blood loss at delivery, nor has it been with a difference in the need for blood transfusion,” said Dr. Tanner.

Ideally, practitioners will become more comfortable in delaying cord clamping as a routine practice as more data demonstrating the safety and benefit of this easy intervention are disseminated, she said.

Additional research delineating which gestational ages benefit most from delayed cord clamping would help direct education efforts to implement this intervention, Dr. Tanner noted.

The study was funded by the Australian National Health and Medical Research Council. The researchers and Dr. Tanner had no financial conflicts to disclose.

Delayed umbilical cord clamping for at least 60 seconds after birth significantly reduced death or disability in infants of less than 30 weeks’ gestation, according to data from nearly 1,500 infants.

The burden of disability and mortality for babies born before 30 weeks’ gestation remains high, especially in low- and middle-income countries, wrote Kristy P. Robledo, PhD, of the University of Sydney, Australia, and colleagues. Delayed clamping of the umbilical cord is a simple procedure that may improve mortality in this population, but more research is needed; recommended times to delayed clamping range from 30 seconds to 3 minutes, they noted.

In a study published in The Lancet Child & Adolescent Health, the researchers randomized 767 very preterm infants to delayed clamping at least 60 seconds after birth and 764 to immediate clamping. Of these, 384 were multiple births (who were individually randomized), 862 were male, and 505 were born before 27 weeks’ gestation. The primary outcome was death or disability at 2 years of age. Major disability was defined as cerebral palsy, severe visual loss, deafness requiring a hearing aid or cochlear implants, major language or speech problems, or cognitive delay at 2 years corrected age. The median time to clamping was 60 seconds in the delayed group and 5 seconds in the immediate group.

Primary outcome data were available for 1,419 infants. Death or major disability occurred in 29% of infants assigned to delayed clamping compared to 34% of those assigned to immediate clamping (relative risk 0.83, P = .010). The infants were part of the APTS Childhood Follow-Up Study, an open-label superiority trial conducted in Australia and New Zealand.

By age 2 years, 8% of infants in the delayed group and 11% of those in the immediate group had died; 23% and 26%, respectively, met criteria for major disability. The impact of delayed clamping translates to a 30% reduction in relative risk of mortality at 2 years of age, but no significant impact on major disability, the researchers wrote.

The findings were limited by several factors including the unblinded study design, lack of data on heart rate or time to first breath, and the clamping prior to 60 seconds in 26% of infants in the delayed group based on clinical concerns for these specific infants, the researchers noted.

However, the results were strengthened by the large size, low risk of bias, and specific primary outcome, they said. The data support findings from recent systematic reviews and highlight the need for further trials to evaluate delayed clamping at different time points, with larger populations, inclusion of time to first breath and heart rate, and improved measures of disability, the researchers added.

In clinical practice, “Given that aiming to delay cord clamping for 60 seconds or more improved 2-year outcomes and short-term hematological measures with no evidence of significant harm, it seems reasonable to conclude that delayed clamping is appropriate as standard care in very preterm infants,” they concluded.
 

Accepting simple intervention could have great impact

This study is important in light of the overwhelming burden of preterm birth on the health care system and society as a whole, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview.

“Preterm birth is associated with billions in health care costs each year, and a large portion of that money is directed to the complications associated with preterm birth, such as early intervention services, educational support, and ongoing medical care,” Dr. Tanner said. “This study is particularly timely, as we are quickly approaching 2030, the deadline for achieving the United Nations Sustainable Development Goal of ending preventable deaths of newborns and children under 5 years of age,” she said. The goal involves “all countries aiming to reduce neonatal mortality to at least as low as 12 per 1,000 live births and under-5 mortality to at least as low as 25 per 1,000 live births. Effective treatments to reduce infant and child mortality would make strong inroads toward this goal,” she explained.

Dr. Tanner said she was not surprised by the findings because previous studies have shown similar results. “However, the large, multicenter nature of this study provides additional weight to recommendations to delay cord clamping as standard practice,” she said.

“The findings of this study support the recommendations of a number of large organizations,” said Dr. Tanner. “The World Health Organization recommends that the umbilical cord not be clamped earlier than 1 minute after birth in term or preterm infants who do not require positive pressure ventilation. The American College of Obstetricians and Gynecologists and the American Academy of Pediatrics now recommend a delay in umbilical cord clamping in vigorous term and preterm infants for at least 30–60 seconds after birth,” she said. “The Royal College of Obstetricians and Gynaecologists also recommends deferring umbilical cord clamping for healthy term and preterm infants for at least 2 minutes after birth,” she added.  

However, “the delay in adoption of this guidelines in practice appears to be related to some concerns regarding universal adoption of this approach,” Dr. Tanner noted. “Some clinicians have suggested that delayed cord clamping could delay vital neonatal resuscitative efforts, leading to worse neonatal outcomes, but this concern has not been borne out in the data, as all guidelines specifically state that this intervention is for vigorous newborns,” she said. “In fact, in preterm infants, delayed cord clamping is associated with improved transitional circulation, decreased need for blood transfusion, and lower incidence of necrotizing enterocolitis and intraventricular hemorrhage,” Dr. Tanner emphasized. “Additionally, concerns persist that delayed cord clamping could lead to excessive transfusion with resultant polycythemia. Again, no data have supported this claim to date,” she said.

“Finally, some clinicians are concerned that delayed clamping could lead to delay in addressing maternal complications of birth such as hemorrhage, but studies have shown the opposite; delayed umbilical cord clamping has not been associated with an increased risk of postpartum hemorrhage or increased blood loss at delivery, nor has it been with a difference in the need for blood transfusion,” said Dr. Tanner.

Ideally, practitioners will become more comfortable in delaying cord clamping as a routine practice as more data demonstrating the safety and benefit of this easy intervention are disseminated, she said.

Additional research delineating which gestational ages benefit most from delayed cord clamping would help direct education efforts to implement this intervention, Dr. Tanner noted.

The study was funded by the Australian National Health and Medical Research Council. The researchers and Dr. Tanner had no financial conflicts to disclose.

Delayed umbilical cord clamping for at least 60 seconds after birth significantly reduced death or disability in infants of less than 30 weeks’ gestation, according to data from nearly 1,500 infants.

The burden of disability and mortality for babies born before 30 weeks’ gestation remains high, especially in low- and middle-income countries, wrote Kristy P. Robledo, PhD, of the University of Sydney, Australia, and colleagues. Delayed clamping of the umbilical cord is a simple procedure that may improve mortality in this population, but more research is needed; recommended times to delayed clamping range from 30 seconds to 3 minutes, they noted.

In a study published in The Lancet Child & Adolescent Health, the researchers randomized 767 very preterm infants to delayed clamping at least 60 seconds after birth and 764 to immediate clamping. Of these, 384 were multiple births (who were individually randomized), 862 were male, and 505 were born before 27 weeks’ gestation. The primary outcome was death or disability at 2 years of age. Major disability was defined as cerebral palsy, severe visual loss, deafness requiring a hearing aid or cochlear implants, major language or speech problems, or cognitive delay at 2 years corrected age. The median time to clamping was 60 seconds in the delayed group and 5 seconds in the immediate group.

Primary outcome data were available for 1,419 infants. Death or major disability occurred in 29% of infants assigned to delayed clamping compared to 34% of those assigned to immediate clamping (relative risk 0.83, P = .010). The infants were part of the APTS Childhood Follow-Up Study, an open-label superiority trial conducted in Australia and New Zealand.

By age 2 years, 8% of infants in the delayed group and 11% of those in the immediate group had died; 23% and 26%, respectively, met criteria for major disability. The impact of delayed clamping translates to a 30% reduction in relative risk of mortality at 2 years of age, but no significant impact on major disability, the researchers wrote.

The findings were limited by several factors including the unblinded study design, lack of data on heart rate or time to first breath, and the clamping prior to 60 seconds in 26% of infants in the delayed group based on clinical concerns for these specific infants, the researchers noted.

However, the results were strengthened by the large size, low risk of bias, and specific primary outcome, they said. The data support findings from recent systematic reviews and highlight the need for further trials to evaluate delayed clamping at different time points, with larger populations, inclusion of time to first breath and heart rate, and improved measures of disability, the researchers added.

In clinical practice, “Given that aiming to delay cord clamping for 60 seconds or more improved 2-year outcomes and short-term hematological measures with no evidence of significant harm, it seems reasonable to conclude that delayed clamping is appropriate as standard care in very preterm infants,” they concluded.
 

Accepting simple intervention could have great impact

This study is important in light of the overwhelming burden of preterm birth on the health care system and society as a whole, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview.

“Preterm birth is associated with billions in health care costs each year, and a large portion of that money is directed to the complications associated with preterm birth, such as early intervention services, educational support, and ongoing medical care,” Dr. Tanner said. “This study is particularly timely, as we are quickly approaching 2030, the deadline for achieving the United Nations Sustainable Development Goal of ending preventable deaths of newborns and children under 5 years of age,” she said. The goal involves “all countries aiming to reduce neonatal mortality to at least as low as 12 per 1,000 live births and under-5 mortality to at least as low as 25 per 1,000 live births. Effective treatments to reduce infant and child mortality would make strong inroads toward this goal,” she explained.

Dr. Tanner said she was not surprised by the findings because previous studies have shown similar results. “However, the large, multicenter nature of this study provides additional weight to recommendations to delay cord clamping as standard practice,” she said.

“The findings of this study support the recommendations of a number of large organizations,” said Dr. Tanner. “The World Health Organization recommends that the umbilical cord not be clamped earlier than 1 minute after birth in term or preterm infants who do not require positive pressure ventilation. The American College of Obstetricians and Gynecologists and the American Academy of Pediatrics now recommend a delay in umbilical cord clamping in vigorous term and preterm infants for at least 30–60 seconds after birth,” she said. “The Royal College of Obstetricians and Gynaecologists also recommends deferring umbilical cord clamping for healthy term and preterm infants for at least 2 minutes after birth,” she added.  

However, “the delay in adoption of this guidelines in practice appears to be related to some concerns regarding universal adoption of this approach,” Dr. Tanner noted. “Some clinicians have suggested that delayed cord clamping could delay vital neonatal resuscitative efforts, leading to worse neonatal outcomes, but this concern has not been borne out in the data, as all guidelines specifically state that this intervention is for vigorous newborns,” she said. “In fact, in preterm infants, delayed cord clamping is associated with improved transitional circulation, decreased need for blood transfusion, and lower incidence of necrotizing enterocolitis and intraventricular hemorrhage,” Dr. Tanner emphasized. “Additionally, concerns persist that delayed cord clamping could lead to excessive transfusion with resultant polycythemia. Again, no data have supported this claim to date,” she said.

“Finally, some clinicians are concerned that delayed clamping could lead to delay in addressing maternal complications of birth such as hemorrhage, but studies have shown the opposite; delayed umbilical cord clamping has not been associated with an increased risk of postpartum hemorrhage or increased blood loss at delivery, nor has it been with a difference in the need for blood transfusion,” said Dr. Tanner.

Ideally, practitioners will become more comfortable in delaying cord clamping as a routine practice as more data demonstrating the safety and benefit of this easy intervention are disseminated, she said.

Additional research delineating which gestational ages benefit most from delayed cord clamping would help direct education efforts to implement this intervention, Dr. Tanner noted.

The study was funded by the Australian National Health and Medical Research Council. The researchers and Dr. Tanner had no financial conflicts to disclose.

In the United States, nearly 4 million women a year prepare to give birth, looking forward to the joy to come. But for some, the dream turns tragic. About 700 women die each year either during their pregnancy or in the weeks after the birth. And another 60,000 have pregnancy-related or childbirth-related health issues.

Causes of death vary greatly, including hemorrhage during pregnancy or during delivery, heart conditions, and mental health issues such as substance abuse and suicide after the birth.

In 2019, the U.S. maternal death rate was 20.1 per 100,000 women, according to the CDC, significantly higher than the 17.4 per 100,000 recorded in 2018. For Black women, the maternal death rate was more than double the overall – 44 per 100,000 in 2019.

“We have to address our horrendous maternal health care system and also need to address the inequities,” says Laurie Zephyrin, MD, vice president for advancing health equity for the Commonwealth Fund, a foundation supporting independent research on health care issues. “This is an issue that has needed national attention for a long time.”

“If we look overall, our maternal death rate is more than twice that of more than 10 other high-income countries,” she said.

As sobering as the problem is, recent developments have sparked hope that reversing the course is possible. Among them:

U.S. News & World Report, long known for its rankings of hospitals, issued its first ever “Best Hospitals for Maternity” rankings Dec. 7, highlighting facilities that perform well on key quality indicators. It plans to update the report annually.

At the first-ever White House Maternal Health Day of Action on Dec. 7, Vice President Kamala Harris urged a call to action to reduce maternal deaths and pregnancy-related health problems, with extension of postpartum coverage through Medicaid programs, among other actions.

A new hospital designation called ‘’Birthing Friendly” will be established by the Centers for Medicare & Medicaid Services. The label will be given to facilities that take part in a program aimed at improving maternal outcomes and that use patient safety practices.

President Joe Biden’s proposed Build Back Better plan includes maternal health provisions, including $3 billion in new maternal health funding. The money will aim to grow and diversify the workforce caring for pregnant women, coordinate care better, and step up research on maternal health, among other projects.

Ongoing efforts in Congress are aimed at fixing the wide disparities in maternal health affecting Black women. Regardless of income level or education, Black women are at a higher risk of maternal death and other health issues than are White women. A Black woman with a college education is at 60% higher risk of maternal death than a White or Hispanic woman who didn’t graduate high school, according to the Commonwealth Fund.
 

Best hospitals for maternity

For its rankings, U.S. News and World Report reached out to the 2,700 U.S. hospitals that offer maternity services, said Ben Harder, chief of health analysis and managing editor at U.S. News & World Report.

To be recognized, a hospital had to submit data from 2019 and meet the publication’s maternity care standards. The publication received responses from just 571 hospitals, representing about two of every five births in the country.

Of those, 237 were identified as best for maternity.

As to why the response rate was not higher, Mr. Harder cited the reporting burden and says it is understandable. Some hospitals likely did not have the staff available, especially during the pandemic, to gather the data needed to be evaluated by U.S. News & World Report.

On their other evaluations, the rankings are based on Medicare data, “so hospitals don’t have to lift a finger.” He expects more hospitals will respond for their future evaluations of maternity care.

The evaluators focused on five quality measures, making a score based on the cesarean section delivery rate among first-time mothers, early elective delivery rates, unexpected newborn complication rates, breastfeeding rates, and option for vaginal birth after C-section.
 

A call to action: Expand coverage

Speaking at the White House Maternal Health Day of Action, Mrs. Harris told participants: “The challenge is urgent, and it is important, and it will take all of us.”

Being pregnant and giving birth, she said, should not carry such great risks. She zeroed in on systemic inequities in the way women are treated and the dramatic impact maternal death and health issues have on the economy.

“A healthy economy requires healthy mothers and healthy babies,” Mrs. Harris said.

“Before, during, and after childbirth, women in our nation are dying at a higher rate than any other developed nation in our world,” she said, noting that research shows that Black women, Native Americans, and women in rural America more likely to suffer.

A major strategy in the call to action, according to Mrs. Harris, is encouraging states to expand postpartum coverage to pregnant women enrolled in Medicaid or the Children’s Health Insurance Program from the existing 60 days to a full year. Together, these two programs cover over 42% of births in the country, so expanding the coverage is expected to have a great impact.

The 60 days of coverage is not enough, as many deaths and complications happen more than 60 days after childbirth, Mrs. Harris said. The logistics for states to extend coverage were established by the American Rescue Plan and will become available by April 2022. Some states have already extended the postpartum coverage.

According to the Centers for Medicare and Medicaid Services, if every state did adopt an extension, as the Build Back Better Act proposes, the number of Americans getting coverage for a full year after childbirth would about double, extending the coverage for about 720,000 each year.
 

Congressional actions

Congress is working on the issue as well. The Black Maternal Health Momnibus Act of 2021, for instance, proposes several measures, including improving maternal nutrition, expanding affordable housing, and extending the maternal workforce to include more doulas and midwives.

“And for so many women, let’s note doulas are literally a lifeline,” Mrs. Harris said at the White House event.

Doulas are trained to offer women physical, emotional, and informational support before, during, and after childbirth. No reliable statistics are available on their numbers in the United States, but a March of Dimes report estimates that about 9,000 were included in a registration database in 2018.
 

Explaining and fixing the disparities

No one can explain for sure why Black women, in particular, are at higher risk of dying from pregnancy-related complications. Systemic inequity is one likely reason, Mrs. Harris said, noting there are differences in how people are treated based on who they are.

Inherent and unconscious bias in offering women treatment plays a role, experts say. Training could reverse or reduce that bias. Some women of color also may have less access to care, as do women in some rural areas.

According to Mrs. Harris, more than 20 companies and nonprofits have pledged to invest more than $20 million in maternal health efforts in the United States and more than $150 million globally. Among the proposed programs: remote-care monitors in rural areas, better care models for the postpartum period, and improved education programs for maternal health providers.
 

When statistics hit home

Many who work to improve maternal health have gone through issues themselves or had loved ones who did.

Jill Arnold, founder of the Maternal Safety Foundation in Bentonville, Ark., became a consumer advocate after giving birth to her two daughters, now teenagers. With the first birth, Ms. Arnold said she was intensely pressured at the last minute to have a C-section. She held out, resisted, and delivered a healthy baby vaginally.

For her second childbirth, she chose an accredited birth center that allowed her to have a doula and a midwife.

“The care I received was night and day,” she said. “The overwhelming pressure to consent to a C-section wasn’t there.”

She welcomes the information provided by the new U.S. News & World Report rankings as well as the upcoming “Birthing Friendly” designations.

“The onus shouldn’t be on patients, on individuals, on pregnant people to do the research,” Ms. Arnold said.

Rather, women and their partners need information at their fingertips so they can make an informed decision about how to give birth and where.

U.S. Rep. Lauren Underwood (D-Ill.), who cofounded the Black Maternal Health Caucus in April 2019, with Rep. Alma Adams (D-N.C.), wrote a touching blog in the journal Health Affairs to explain her passion in improving maternal health.

Her former classmate, Shalon Irving, who went on to become a CDC epidemiologist, died in February 2017 at age 36, just 3 weeks after giving birth, when she developed complications from high blood pressure.

In the blog, Ms. Underwood cited statistics and provides details of the Black Maternal Health Momnibus Act of 2021, then ends the blog, published in 2020, with an update on how Ms. Irving’s then 3-year-old daughter, raised by her grandmother, is doing. While Soleil is “curious, joyful, and brilliant,” the grandmother told Ms. Underwood that she has also walked into a room and found the little girl clutching a framed photograph of her mother.

The child’s question is understandable and heartbreaking: She wants to know where her mommy is.

“Soleil’s question is my motivation,” Ms. Underwood wrote. “To honor Shalon, and all the women like her who we have lost, let us take the serious and urgent action that is required to save our moms.”

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

In the United States, nearly 4 million women a year prepare to give birth, looking forward to the joy to come. But for some, the dream turns tragic. About 700 women die each year either during their pregnancy or in the weeks after the birth. And another 60,000 have pregnancy-related or childbirth-related health issues.

Causes of death vary greatly, including hemorrhage during pregnancy or during delivery, heart conditions, and mental health issues such as substance abuse and suicide after the birth.

In 2019, the U.S. maternal death rate was 20.1 per 100,000 women, according to the CDC, significantly higher than the 17.4 per 100,000 recorded in 2018. For Black women, the maternal death rate was more than double the overall – 44 per 100,000 in 2019.

“We have to address our horrendous maternal health care system and also need to address the inequities,” says Laurie Zephyrin, MD, vice president for advancing health equity for the Commonwealth Fund, a foundation supporting independent research on health care issues. “This is an issue that has needed national attention for a long time.”

“If we look overall, our maternal death rate is more than twice that of more than 10 other high-income countries,” she said.

As sobering as the problem is, recent developments have sparked hope that reversing the course is possible. Among them:

U.S. News & World Report, long known for its rankings of hospitals, issued its first ever “Best Hospitals for Maternity” rankings Dec. 7, highlighting facilities that perform well on key quality indicators. It plans to update the report annually.

At the first-ever White House Maternal Health Day of Action on Dec. 7, Vice President Kamala Harris urged a call to action to reduce maternal deaths and pregnancy-related health problems, with extension of postpartum coverage through Medicaid programs, among other actions.

A new hospital designation called ‘’Birthing Friendly” will be established by the Centers for Medicare & Medicaid Services. The label will be given to facilities that take part in a program aimed at improving maternal outcomes and that use patient safety practices.

President Joe Biden’s proposed Build Back Better plan includes maternal health provisions, including $3 billion in new maternal health funding. The money will aim to grow and diversify the workforce caring for pregnant women, coordinate care better, and step up research on maternal health, among other projects.

Ongoing efforts in Congress are aimed at fixing the wide disparities in maternal health affecting Black women. Regardless of income level or education, Black women are at a higher risk of maternal death and other health issues than are White women. A Black woman with a college education is at 60% higher risk of maternal death than a White or Hispanic woman who didn’t graduate high school, according to the Commonwealth Fund.
 

Best hospitals for maternity

For its rankings, U.S. News and World Report reached out to the 2,700 U.S. hospitals that offer maternity services, said Ben Harder, chief of health analysis and managing editor at U.S. News & World Report.

To be recognized, a hospital had to submit data from 2019 and meet the publication’s maternity care standards. The publication received responses from just 571 hospitals, representing about two of every five births in the country.

Of those, 237 were identified as best for maternity.

As to why the response rate was not higher, Mr. Harder cited the reporting burden and says it is understandable. Some hospitals likely did not have the staff available, especially during the pandemic, to gather the data needed to be evaluated by U.S. News & World Report.

On their other evaluations, the rankings are based on Medicare data, “so hospitals don’t have to lift a finger.” He expects more hospitals will respond for their future evaluations of maternity care.

The evaluators focused on five quality measures, making a score based on the cesarean section delivery rate among first-time mothers, early elective delivery rates, unexpected newborn complication rates, breastfeeding rates, and option for vaginal birth after C-section.
 

A call to action: Expand coverage

Speaking at the White House Maternal Health Day of Action, Mrs. Harris told participants: “The challenge is urgent, and it is important, and it will take all of us.”

Being pregnant and giving birth, she said, should not carry such great risks. She zeroed in on systemic inequities in the way women are treated and the dramatic impact maternal death and health issues have on the economy.

“A healthy economy requires healthy mothers and healthy babies,” Mrs. Harris said.

“Before, during, and after childbirth, women in our nation are dying at a higher rate than any other developed nation in our world,” she said, noting that research shows that Black women, Native Americans, and women in rural America more likely to suffer.

A major strategy in the call to action, according to Mrs. Harris, is encouraging states to expand postpartum coverage to pregnant women enrolled in Medicaid or the Children’s Health Insurance Program from the existing 60 days to a full year. Together, these two programs cover over 42% of births in the country, so expanding the coverage is expected to have a great impact.

The 60 days of coverage is not enough, as many deaths and complications happen more than 60 days after childbirth, Mrs. Harris said. The logistics for states to extend coverage were established by the American Rescue Plan and will become available by April 2022. Some states have already extended the postpartum coverage.

According to the Centers for Medicare and Medicaid Services, if every state did adopt an extension, as the Build Back Better Act proposes, the number of Americans getting coverage for a full year after childbirth would about double, extending the coverage for about 720,000 each year.
 

Congressional actions

Congress is working on the issue as well. The Black Maternal Health Momnibus Act of 2021, for instance, proposes several measures, including improving maternal nutrition, expanding affordable housing, and extending the maternal workforce to include more doulas and midwives.

“And for so many women, let’s note doulas are literally a lifeline,” Mrs. Harris said at the White House event.

Doulas are trained to offer women physical, emotional, and informational support before, during, and after childbirth. No reliable statistics are available on their numbers in the United States, but a March of Dimes report estimates that about 9,000 were included in a registration database in 2018.
 

Explaining and fixing the disparities

No one can explain for sure why Black women, in particular, are at higher risk of dying from pregnancy-related complications. Systemic inequity is one likely reason, Mrs. Harris said, noting there are differences in how people are treated based on who they are.

Inherent and unconscious bias in offering women treatment plays a role, experts say. Training could reverse or reduce that bias. Some women of color also may have less access to care, as do women in some rural areas.

According to Mrs. Harris, more than 20 companies and nonprofits have pledged to invest more than $20 million in maternal health efforts in the United States and more than $150 million globally. Among the proposed programs: remote-care monitors in rural areas, better care models for the postpartum period, and improved education programs for maternal health providers.
 

When statistics hit home

Many who work to improve maternal health have gone through issues themselves or had loved ones who did.

Jill Arnold, founder of the Maternal Safety Foundation in Bentonville, Ark., became a consumer advocate after giving birth to her two daughters, now teenagers. With the first birth, Ms. Arnold said she was intensely pressured at the last minute to have a C-section. She held out, resisted, and delivered a healthy baby vaginally.

For her second childbirth, she chose an accredited birth center that allowed her to have a doula and a midwife.

“The care I received was night and day,” she said. “The overwhelming pressure to consent to a C-section wasn’t there.”

She welcomes the information provided by the new U.S. News & World Report rankings as well as the upcoming “Birthing Friendly” designations.

“The onus shouldn’t be on patients, on individuals, on pregnant people to do the research,” Ms. Arnold said.

Rather, women and their partners need information at their fingertips so they can make an informed decision about how to give birth and where.

U.S. Rep. Lauren Underwood (D-Ill.), who cofounded the Black Maternal Health Caucus in April 2019, with Rep. Alma Adams (D-N.C.), wrote a touching blog in the journal Health Affairs to explain her passion in improving maternal health.

Her former classmate, Shalon Irving, who went on to become a CDC epidemiologist, died in February 2017 at age 36, just 3 weeks after giving birth, when she developed complications from high blood pressure.

In the blog, Ms. Underwood cited statistics and provides details of the Black Maternal Health Momnibus Act of 2021, then ends the blog, published in 2020, with an update on how Ms. Irving’s then 3-year-old daughter, raised by her grandmother, is doing. While Soleil is “curious, joyful, and brilliant,” the grandmother told Ms. Underwood that she has also walked into a room and found the little girl clutching a framed photograph of her mother.

The child’s question is understandable and heartbreaking: She wants to know where her mommy is.

“Soleil’s question is my motivation,” Ms. Underwood wrote. “To honor Shalon, and all the women like her who we have lost, let us take the serious and urgent action that is required to save our moms.”

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

In the United States, nearly 4 million women a year prepare to give birth, looking forward to the joy to come. But for some, the dream turns tragic. About 700 women die each year either during their pregnancy or in the weeks after the birth. And another 60,000 have pregnancy-related or childbirth-related health issues.

Causes of death vary greatly, including hemorrhage during pregnancy or during delivery, heart conditions, and mental health issues such as substance abuse and suicide after the birth.

In 2019, the U.S. maternal death rate was 20.1 per 100,000 women, according to the CDC, significantly higher than the 17.4 per 100,000 recorded in 2018. For Black women, the maternal death rate was more than double the overall – 44 per 100,000 in 2019.

“We have to address our horrendous maternal health care system and also need to address the inequities,” says Laurie Zephyrin, MD, vice president for advancing health equity for the Commonwealth Fund, a foundation supporting independent research on health care issues. “This is an issue that has needed national attention for a long time.”

“If we look overall, our maternal death rate is more than twice that of more than 10 other high-income countries,” she said.

As sobering as the problem is, recent developments have sparked hope that reversing the course is possible. Among them:

U.S. News & World Report, long known for its rankings of hospitals, issued its first ever “Best Hospitals for Maternity” rankings Dec. 7, highlighting facilities that perform well on key quality indicators. It plans to update the report annually.

At the first-ever White House Maternal Health Day of Action on Dec. 7, Vice President Kamala Harris urged a call to action to reduce maternal deaths and pregnancy-related health problems, with extension of postpartum coverage through Medicaid programs, among other actions.

A new hospital designation called ‘’Birthing Friendly” will be established by the Centers for Medicare & Medicaid Services. The label will be given to facilities that take part in a program aimed at improving maternal outcomes and that use patient safety practices.

President Joe Biden’s proposed Build Back Better plan includes maternal health provisions, including $3 billion in new maternal health funding. The money will aim to grow and diversify the workforce caring for pregnant women, coordinate care better, and step up research on maternal health, among other projects.

Ongoing efforts in Congress are aimed at fixing the wide disparities in maternal health affecting Black women. Regardless of income level or education, Black women are at a higher risk of maternal death and other health issues than are White women. A Black woman with a college education is at 60% higher risk of maternal death than a White or Hispanic woman who didn’t graduate high school, according to the Commonwealth Fund.
 

Best hospitals for maternity

For its rankings, U.S. News and World Report reached out to the 2,700 U.S. hospitals that offer maternity services, said Ben Harder, chief of health analysis and managing editor at U.S. News & World Report.

To be recognized, a hospital had to submit data from 2019 and meet the publication’s maternity care standards. The publication received responses from just 571 hospitals, representing about two of every five births in the country.

Of those, 237 were identified as best for maternity.

As to why the response rate was not higher, Mr. Harder cited the reporting burden and says it is understandable. Some hospitals likely did not have the staff available, especially during the pandemic, to gather the data needed to be evaluated by U.S. News & World Report.

On their other evaluations, the rankings are based on Medicare data, “so hospitals don’t have to lift a finger.” He expects more hospitals will respond for their future evaluations of maternity care.

The evaluators focused on five quality measures, making a score based on the cesarean section delivery rate among first-time mothers, early elective delivery rates, unexpected newborn complication rates, breastfeeding rates, and option for vaginal birth after C-section.
 

A call to action: Expand coverage

Speaking at the White House Maternal Health Day of Action, Mrs. Harris told participants: “The challenge is urgent, and it is important, and it will take all of us.”

Being pregnant and giving birth, she said, should not carry such great risks. She zeroed in on systemic inequities in the way women are treated and the dramatic impact maternal death and health issues have on the economy.

“A healthy economy requires healthy mothers and healthy babies,” Mrs. Harris said.

“Before, during, and after childbirth, women in our nation are dying at a higher rate than any other developed nation in our world,” she said, noting that research shows that Black women, Native Americans, and women in rural America more likely to suffer.

A major strategy in the call to action, according to Mrs. Harris, is encouraging states to expand postpartum coverage to pregnant women enrolled in Medicaid or the Children’s Health Insurance Program from the existing 60 days to a full year. Together, these two programs cover over 42% of births in the country, so expanding the coverage is expected to have a great impact.

The 60 days of coverage is not enough, as many deaths and complications happen more than 60 days after childbirth, Mrs. Harris said. The logistics for states to extend coverage were established by the American Rescue Plan and will become available by April 2022. Some states have already extended the postpartum coverage.

According to the Centers for Medicare and Medicaid Services, if every state did adopt an extension, as the Build Back Better Act proposes, the number of Americans getting coverage for a full year after childbirth would about double, extending the coverage for about 720,000 each year.
 

Congressional actions

Congress is working on the issue as well. The Black Maternal Health Momnibus Act of 2021, for instance, proposes several measures, including improving maternal nutrition, expanding affordable housing, and extending the maternal workforce to include more doulas and midwives.

“And for so many women, let’s note doulas are literally a lifeline,” Mrs. Harris said at the White House event.

Doulas are trained to offer women physical, emotional, and informational support before, during, and after childbirth. No reliable statistics are available on their numbers in the United States, but a March of Dimes report estimates that about 9,000 were included in a registration database in 2018.
 

Explaining and fixing the disparities

No one can explain for sure why Black women, in particular, are at higher risk of dying from pregnancy-related complications. Systemic inequity is one likely reason, Mrs. Harris said, noting there are differences in how people are treated based on who they are.

Inherent and unconscious bias in offering women treatment plays a role, experts say. Training could reverse or reduce that bias. Some women of color also may have less access to care, as do women in some rural areas.

According to Mrs. Harris, more than 20 companies and nonprofits have pledged to invest more than $20 million in maternal health efforts in the United States and more than $150 million globally. Among the proposed programs: remote-care monitors in rural areas, better care models for the postpartum period, and improved education programs for maternal health providers.
 

When statistics hit home

Many who work to improve maternal health have gone through issues themselves or had loved ones who did.

Jill Arnold, founder of the Maternal Safety Foundation in Bentonville, Ark., became a consumer advocate after giving birth to her two daughters, now teenagers. With the first birth, Ms. Arnold said she was intensely pressured at the last minute to have a C-section. She held out, resisted, and delivered a healthy baby vaginally.

For her second childbirth, she chose an accredited birth center that allowed her to have a doula and a midwife.

“The care I received was night and day,” she said. “The overwhelming pressure to consent to a C-section wasn’t there.”

She welcomes the information provided by the new U.S. News & World Report rankings as well as the upcoming “Birthing Friendly” designations.

“The onus shouldn’t be on patients, on individuals, on pregnant people to do the research,” Ms. Arnold said.

Rather, women and their partners need information at their fingertips so they can make an informed decision about how to give birth and where.

U.S. Rep. Lauren Underwood (D-Ill.), who cofounded the Black Maternal Health Caucus in April 2019, with Rep. Alma Adams (D-N.C.), wrote a touching blog in the journal Health Affairs to explain her passion in improving maternal health.

Her former classmate, Shalon Irving, who went on to become a CDC epidemiologist, died in February 2017 at age 36, just 3 weeks after giving birth, when she developed complications from high blood pressure.

In the blog, Ms. Underwood cited statistics and provides details of the Black Maternal Health Momnibus Act of 2021, then ends the blog, published in 2020, with an update on how Ms. Irving’s then 3-year-old daughter, raised by her grandmother, is doing. While Soleil is “curious, joyful, and brilliant,” the grandmother told Ms. Underwood that she has also walked into a room and found the little girl clutching a framed photograph of her mother.

The child’s question is understandable and heartbreaking: She wants to know where her mommy is.

“Soleil’s question is my motivation,” Ms. Underwood wrote. “To honor Shalon, and all the women like her who we have lost, let us take the serious and urgent action that is required to save our moms.”

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

They say you are what you eat, but scientists have long wondered whether breastfeeding babies are what their mothers eat, too. Their question: How much of a nursing mother’s diet eventually plays a role in a child’s food preferences later in life?

The aroma, taste, and makeup of breast milk change from day to day, based mostly on the mother’s diet. But previous research has already shown that the foods a mother eats do not directly translate into the same smells and tastes of that food in breast milk. Some substances from the mother’s diet enter her breast milk, some don’t, and even ones that do may have a different scent or flavor than what the mother experiences.

But a new study suggests that the active ingredient in black pepper makes its way into breast milk and may help the infant develop a tolerance to pepper later. The researchers published their findings in the journal Molecular Nutrition & Food Research.
 

Pinch of pepper

The study authors thought that maybe some food preferences could result from sensory programming that occurs through breast milk in the first few months of life. Though past studies have looked at which odor-producing substances transfer into breast milk, not many have explored specific substances that give food its distinctive flavor, or even what makes up the taste of breast milk. So they decided to investigate what happens when a mother consumes a meal containing three specific compounds: those that give pepper, chili, and ginger their particularly pungent flavors.

The researchers recruited 18 healthy, nonsmoking, nursing mothers who were producing more than enough milk for their baby’s needs. Their breastfeeding children ranged in age from 8 weeks to 1 year old. The women all ate a curry dish after having spent 2 days avoiding onion, garlic, and the spices in the curry. Then they provided pumped breast milk samples at 1, 2, and 3 hours after eating the curry.

Within an hour of the women eating the curry, the scientists were able to detect piperine, the compound that gives black pepper its bite, in the mothers’ breast milk. They did not find the compounds from ginger, chili, or curcumin – the main active ingredient in turmeric – in the breast milk. The piperine remained there for several hours, but there wasn’t enough for an adult to be able to taste it. It wasn’t possible to reliably tell whether the infants could consciously detect the flavor, but the researchers don’t think it’s likely they did.

But the scientists do suggest it’s possible that the piperine in breast milk could regularly activate a protein that detects pungent or potentially harmful substances. This is the same protein that produces the sensation of heat when eating a spicy food. If the piperine frequently activates that protein in a nursing baby at levels too low for the baby to notice, it may increase the baby’s tolerance for similar spicy substances later in life.

Ultimately, the findings suggest that some compounds in a mother’s diet have the potential to influence a child’s taste preferences later.

A version of this story first appeared on WebMD.com.

They say you are what you eat, but scientists have long wondered whether breastfeeding babies are what their mothers eat, too. Their question: How much of a nursing mother’s diet eventually plays a role in a child’s food preferences later in life?

The aroma, taste, and makeup of breast milk change from day to day, based mostly on the mother’s diet. But previous research has already shown that the foods a mother eats do not directly translate into the same smells and tastes of that food in breast milk. Some substances from the mother’s diet enter her breast milk, some don’t, and even ones that do may have a different scent or flavor than what the mother experiences.

But a new study suggests that the active ingredient in black pepper makes its way into breast milk and may help the infant develop a tolerance to pepper later. The researchers published their findings in the journal Molecular Nutrition & Food Research.
 

Pinch of pepper

The study authors thought that maybe some food preferences could result from sensory programming that occurs through breast milk in the first few months of life. Though past studies have looked at which odor-producing substances transfer into breast milk, not many have explored specific substances that give food its distinctive flavor, or even what makes up the taste of breast milk. So they decided to investigate what happens when a mother consumes a meal containing three specific compounds: those that give pepper, chili, and ginger their particularly pungent flavors.

The researchers recruited 18 healthy, nonsmoking, nursing mothers who were producing more than enough milk for their baby’s needs. Their breastfeeding children ranged in age from 8 weeks to 1 year old. The women all ate a curry dish after having spent 2 days avoiding onion, garlic, and the spices in the curry. Then they provided pumped breast milk samples at 1, 2, and 3 hours after eating the curry.

Within an hour of the women eating the curry, the scientists were able to detect piperine, the compound that gives black pepper its bite, in the mothers’ breast milk. They did not find the compounds from ginger, chili, or curcumin – the main active ingredient in turmeric – in the breast milk. The piperine remained there for several hours, but there wasn’t enough for an adult to be able to taste it. It wasn’t possible to reliably tell whether the infants could consciously detect the flavor, but the researchers don’t think it’s likely they did.

But the scientists do suggest it’s possible that the piperine in breast milk could regularly activate a protein that detects pungent or potentially harmful substances. This is the same protein that produces the sensation of heat when eating a spicy food. If the piperine frequently activates that protein in a nursing baby at levels too low for the baby to notice, it may increase the baby’s tolerance for similar spicy substances later in life.

Ultimately, the findings suggest that some compounds in a mother’s diet have the potential to influence a child’s taste preferences later.

A version of this story first appeared on WebMD.com.

They say you are what you eat, but scientists have long wondered whether breastfeeding babies are what their mothers eat, too. Their question: How much of a nursing mother’s diet eventually plays a role in a child’s food preferences later in life?

The aroma, taste, and makeup of breast milk change from day to day, based mostly on the mother’s diet. But previous research has already shown that the foods a mother eats do not directly translate into the same smells and tastes of that food in breast milk. Some substances from the mother’s diet enter her breast milk, some don’t, and even ones that do may have a different scent or flavor than what the mother experiences.

But a new study suggests that the active ingredient in black pepper makes its way into breast milk and may help the infant develop a tolerance to pepper later. The researchers published their findings in the journal Molecular Nutrition & Food Research.
 

Pinch of pepper

The study authors thought that maybe some food preferences could result from sensory programming that occurs through breast milk in the first few months of life. Though past studies have looked at which odor-producing substances transfer into breast milk, not many have explored specific substances that give food its distinctive flavor, or even what makes up the taste of breast milk. So they decided to investigate what happens when a mother consumes a meal containing three specific compounds: those that give pepper, chili, and ginger their particularly pungent flavors.

The researchers recruited 18 healthy, nonsmoking, nursing mothers who were producing more than enough milk for their baby’s needs. Their breastfeeding children ranged in age from 8 weeks to 1 year old. The women all ate a curry dish after having spent 2 days avoiding onion, garlic, and the spices in the curry. Then they provided pumped breast milk samples at 1, 2, and 3 hours after eating the curry.

Within an hour of the women eating the curry, the scientists were able to detect piperine, the compound that gives black pepper its bite, in the mothers’ breast milk. They did not find the compounds from ginger, chili, or curcumin – the main active ingredient in turmeric – in the breast milk. The piperine remained there for several hours, but there wasn’t enough for an adult to be able to taste it. It wasn’t possible to reliably tell whether the infants could consciously detect the flavor, but the researchers don’t think it’s likely they did.

But the scientists do suggest it’s possible that the piperine in breast milk could regularly activate a protein that detects pungent or potentially harmful substances. This is the same protein that produces the sensation of heat when eating a spicy food. If the piperine frequently activates that protein in a nursing baby at levels too low for the baby to notice, it may increase the baby’s tolerance for similar spicy substances later in life.

Ultimately, the findings suggest that some compounds in a mother’s diet have the potential to influence a child’s taste preferences later.

A version of this story first appeared on WebMD.com.

Abortion rates remained stable and adverse events were rare after removal of mifepristone prescribing restrictions in Canada, a new study shows.

“Our study is a signal to other countries that restrictions are not necessary to ensure patient safety,” senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a press release.

“This is the strongest evidence yet that it is safe to provide the abortion pill like most other prescriptions – meaning any doctor or nurse practitioner can prescribe, any pharmacist can dispense, and patients can take the pills if, when, and where they choose,” said lead author Laura Schummers, ScD, a postdoctoral fellow in the same department.

The findings “add to the accumulating evidence that removing restrictions from medication abortion is safe, effective, and improves access,” agreed Eve Espey, MD, professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, who was not part of the research team. “This is additional confirmation that it is safe for patients to receive abortion care medications in the ‘normal’ fashion, through a prescription available at a pharmacy,” she said in an interview.

The study, published in the New England Journal of Medicine, compared medical abortion use, safety, and effectiveness in the province of Ontario before the Canadian availability of mifepristone and after it became available without restrictions that are similar to the Risk Evaluation and Mitigation Strategy (REMS) restrictions in place for mifepristone in the United States.

Using linked administrative health data, the researchers created a population-based cohort of all Ontario residents aged 12-49 years who had received abortion services during the study period. In total, 195,183 abortions were performed in the period before mifepristone was approved (January 2012–December 2016), and 84,032 were performed after it was made available without restrictions (Nov. 7, 2017, through March 15, 2020). The vast majority of these abortions (89.3%) were surgical, with about 10% being medically induced, the authors reported.

The study found that, while the overall abortion rate declined over the study period (from 11.9 to 11.3 per 1,000 female residents), the proportion of medical abortions jumped sharply from 2.2% to 31.4%, and the rate of second-trimester abortions declined from 5.5% of all abortions to 5.1%.

Abortion safety outcomes within 6 weeks of abortion remained stable over the two study periods. This included severe adverse events (0.03% vs. 0.04%) such as blood transfusions, abdominal surgery, admission to an ICU, or sepsis during an abortion-related hospitalization; and complications (0.74% vs. 0.69%,) such as genital tract or pelvic infection, hemorrhage, embolism, shock, renal failure, damage to pelvic organs or tissues, and venous complications among other things.

There were slight declines in overall abortion effectiveness, but ongoing pregnancy rates “remained infrequent,” the authors noted. While there was a modest rise in the rates of subsequent uterine evacuation (from 1.0% to 2.2%), and ongoing intrauterine pregnancy continuing until delivery (from 0.03% to 0.08%), the rate of ectopic pregnancy diagnosed within 6 weeks after the abortion date remained stable (from 0.15% to 0.22%).

Canada was the first country in the world to remove all supplemental restrictions on the dispensing and administration of mifepristone, according to the press release. And while professional organizations have called for the removal of such restrictions “because they impede access to abortion services without improving safety,” high-quality data on this are lacking, they added.

The study’s finding are consistent with existing U.S. and U.K. data showing Food and Drug Administration REMS restrictions requiring abortion care medications to be dispensed in a clinic by a certified provider “are unnecessary and create obstacles to early abortion access,” said Dr. Espey. “For clinicians and patients in the U.S., it’s important to note that the increasing number of legislative restrictions on abortion, including medication abortion, are non–evidence based. Politically motivated false claims of safety concerns are countered by this study and others conducted during the pandemic when both the U.S. and U.K. removed REMS-type restrictions. These studies show that receiving abortion care through usual pharmacy channels and through telemedicine is safe, effective, and reduces barriers to care.”

Dr. Norman reported receiving grants from the Canadian Institutes of Health Research, providing expert witness services to the government of Ontario and Office of the Attorney General, and serving on the board of directors of the Society of Family Planning. No other researchers reported conflicts of interest. Dr. Espey reported no conflicts of interest. The Canadian Institutes of Health Research and the Women’s Health Research Institute with the support of ICES (formerly known as the Institute for Clinical Evaluative Sciences).

Abortion rates remained stable and adverse events were rare after removal of mifepristone prescribing restrictions in Canada, a new study shows.

“Our study is a signal to other countries that restrictions are not necessary to ensure patient safety,” senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a press release.

“This is the strongest evidence yet that it is safe to provide the abortion pill like most other prescriptions – meaning any doctor or nurse practitioner can prescribe, any pharmacist can dispense, and patients can take the pills if, when, and where they choose,” said lead author Laura Schummers, ScD, a postdoctoral fellow in the same department.

The findings “add to the accumulating evidence that removing restrictions from medication abortion is safe, effective, and improves access,” agreed Eve Espey, MD, professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, who was not part of the research team. “This is additional confirmation that it is safe for patients to receive abortion care medications in the ‘normal’ fashion, through a prescription available at a pharmacy,” she said in an interview.

The study, published in the New England Journal of Medicine, compared medical abortion use, safety, and effectiveness in the province of Ontario before the Canadian availability of mifepristone and after it became available without restrictions that are similar to the Risk Evaluation and Mitigation Strategy (REMS) restrictions in place for mifepristone in the United States.

Using linked administrative health data, the researchers created a population-based cohort of all Ontario residents aged 12-49 years who had received abortion services during the study period. In total, 195,183 abortions were performed in the period before mifepristone was approved (January 2012–December 2016), and 84,032 were performed after it was made available without restrictions (Nov. 7, 2017, through March 15, 2020). The vast majority of these abortions (89.3%) were surgical, with about 10% being medically induced, the authors reported.

The study found that, while the overall abortion rate declined over the study period (from 11.9 to 11.3 per 1,000 female residents), the proportion of medical abortions jumped sharply from 2.2% to 31.4%, and the rate of second-trimester abortions declined from 5.5% of all abortions to 5.1%.

Abortion safety outcomes within 6 weeks of abortion remained stable over the two study periods. This included severe adverse events (0.03% vs. 0.04%) such as blood transfusions, abdominal surgery, admission to an ICU, or sepsis during an abortion-related hospitalization; and complications (0.74% vs. 0.69%,) such as genital tract or pelvic infection, hemorrhage, embolism, shock, renal failure, damage to pelvic organs or tissues, and venous complications among other things.

There were slight declines in overall abortion effectiveness, but ongoing pregnancy rates “remained infrequent,” the authors noted. While there was a modest rise in the rates of subsequent uterine evacuation (from 1.0% to 2.2%), and ongoing intrauterine pregnancy continuing until delivery (from 0.03% to 0.08%), the rate of ectopic pregnancy diagnosed within 6 weeks after the abortion date remained stable (from 0.15% to 0.22%).

Canada was the first country in the world to remove all supplemental restrictions on the dispensing and administration of mifepristone, according to the press release. And while professional organizations have called for the removal of such restrictions “because they impede access to abortion services without improving safety,” high-quality data on this are lacking, they added.

The study’s finding are consistent with existing U.S. and U.K. data showing Food and Drug Administration REMS restrictions requiring abortion care medications to be dispensed in a clinic by a certified provider “are unnecessary and create obstacles to early abortion access,” said Dr. Espey. “For clinicians and patients in the U.S., it’s important to note that the increasing number of legislative restrictions on abortion, including medication abortion, are non–evidence based. Politically motivated false claims of safety concerns are countered by this study and others conducted during the pandemic when both the U.S. and U.K. removed REMS-type restrictions. These studies show that receiving abortion care through usual pharmacy channels and through telemedicine is safe, effective, and reduces barriers to care.”

Dr. Norman reported receiving grants from the Canadian Institutes of Health Research, providing expert witness services to the government of Ontario and Office of the Attorney General, and serving on the board of directors of the Society of Family Planning. No other researchers reported conflicts of interest. Dr. Espey reported no conflicts of interest. The Canadian Institutes of Health Research and the Women’s Health Research Institute with the support of ICES (formerly known as the Institute for Clinical Evaluative Sciences).

Abortion rates remained stable and adverse events were rare after removal of mifepristone prescribing restrictions in Canada, a new study shows.

“Our study is a signal to other countries that restrictions are not necessary to ensure patient safety,” senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a press release.

“This is the strongest evidence yet that it is safe to provide the abortion pill like most other prescriptions – meaning any doctor or nurse practitioner can prescribe, any pharmacist can dispense, and patients can take the pills if, when, and where they choose,” said lead author Laura Schummers, ScD, a postdoctoral fellow in the same department.

The findings “add to the accumulating evidence that removing restrictions from medication abortion is safe, effective, and improves access,” agreed Eve Espey, MD, professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, who was not part of the research team. “This is additional confirmation that it is safe for patients to receive abortion care medications in the ‘normal’ fashion, through a prescription available at a pharmacy,” she said in an interview.

The study, published in the New England Journal of Medicine, compared medical abortion use, safety, and effectiveness in the province of Ontario before the Canadian availability of mifepristone and after it became available without restrictions that are similar to the Risk Evaluation and Mitigation Strategy (REMS) restrictions in place for mifepristone in the United States.

Using linked administrative health data, the researchers created a population-based cohort of all Ontario residents aged 12-49 years who had received abortion services during the study period. In total, 195,183 abortions were performed in the period before mifepristone was approved (January 2012–December 2016), and 84,032 were performed after it was made available without restrictions (Nov. 7, 2017, through March 15, 2020). The vast majority of these abortions (89.3%) were surgical, with about 10% being medically induced, the authors reported.

The study found that, while the overall abortion rate declined over the study period (from 11.9 to 11.3 per 1,000 female residents), the proportion of medical abortions jumped sharply from 2.2% to 31.4%, and the rate of second-trimester abortions declined from 5.5% of all abortions to 5.1%.

Abortion safety outcomes within 6 weeks of abortion remained stable over the two study periods. This included severe adverse events (0.03% vs. 0.04%) such as blood transfusions, abdominal surgery, admission to an ICU, or sepsis during an abortion-related hospitalization; and complications (0.74% vs. 0.69%,) such as genital tract or pelvic infection, hemorrhage, embolism, shock, renal failure, damage to pelvic organs or tissues, and venous complications among other things.

There were slight declines in overall abortion effectiveness, but ongoing pregnancy rates “remained infrequent,” the authors noted. While there was a modest rise in the rates of subsequent uterine evacuation (from 1.0% to 2.2%), and ongoing intrauterine pregnancy continuing until delivery (from 0.03% to 0.08%), the rate of ectopic pregnancy diagnosed within 6 weeks after the abortion date remained stable (from 0.15% to 0.22%).

Canada was the first country in the world to remove all supplemental restrictions on the dispensing and administration of mifepristone, according to the press release. And while professional organizations have called for the removal of such restrictions “because they impede access to abortion services without improving safety,” high-quality data on this are lacking, they added.

The study’s finding are consistent with existing U.S. and U.K. data showing Food and Drug Administration REMS restrictions requiring abortion care medications to be dispensed in a clinic by a certified provider “are unnecessary and create obstacles to early abortion access,” said Dr. Espey. “For clinicians and patients in the U.S., it’s important to note that the increasing number of legislative restrictions on abortion, including medication abortion, are non–evidence based. Politically motivated false claims of safety concerns are countered by this study and others conducted during the pandemic when both the U.S. and U.K. removed REMS-type restrictions. These studies show that receiving abortion care through usual pharmacy channels and through telemedicine is safe, effective, and reduces barriers to care.”

Dr. Norman reported receiving grants from the Canadian Institutes of Health Research, providing expert witness services to the government of Ontario and Office of the Attorney General, and serving on the board of directors of the Society of Family Planning. No other researchers reported conflicts of interest. Dr. Espey reported no conflicts of interest. The Canadian Institutes of Health Research and the Women’s Health Research Institute with the support of ICES (formerly known as the Institute for Clinical Evaluative Sciences).

In recent weeks, the Centers for Disease Control and Prevention has greatly expanded recommendations for boosters for vaccinations against COVID-19.

These recommendations have been widened because of the continued emergence of new variants of the virus and the wane of protection over time for both vaccinations and previous disease.

The new recommendations take away some of the questions surrounding eligibility for booster vaccinations while potentially leaving some additional questions. All in all, they provide flexibility for individuals to help protect themselves against the COVID-19 virus, as many are considering celebrating the holidays with friends and family.

The first item that has become clear is that all individuals over 18 are now not only eligible for a booster vaccination a certain time after they have completed their series, but have a recommendation for one.¹

But what about a fourth dose?  There is a possibility that some patients should be receiving one.  For those who require a three-dose series due to a condition that makes them immunocompromised, they should receive their booster vaccination six months after completion of the three-dose series.  This distinction  may cause confusion for some, but is important for those immunocompromised.

Boosters in women who are pregnant

The recommendations also include specific comments about individuals who are pregnant. Although initial studies did not include pregnant individuals, there has been increasing real world data that vaccination against COVID, including booster vaccinations, is safe and recommended. As pregnancy increases the risk of severe disease if infected by COVID-19, both the CDC and the American College of Obstetricians and Gynecologists,² along with other specialty organizations, such as the Royal College of Obstetricians and Gynaecologists, recommend vaccinations for pregnant individuals.

The CDC goes on to describe that there is no evidence of vaccination increasing the risk of infertility. The vaccine protects the pregnant individual and also provides protection to the baby once born. The same is true of breastfeeding individuals.³

I hope that this information allows physicians to feel comfortable recommending vaccinations and boosters to those who are pregnant and breast feeding.
 

Expanded recommendations for those aged 16-17 years

Recently, the CDC also expanded booster recommendations to include those aged 16-17 years, 6 months after completing their vaccine series.

Those under 18 are currently only able to receive the Pfizer-BioNtech vaccine. This new guidance has left some parents wondering if there will also be approval for booster vaccinations soon for those aged 12-16 who are approaching or have reached six months past the initial vaccine.¹

Booster brand for those over 18 years?

Although the recommendation has been simplified for all over age 18 years, there is still a decision to be made about which vaccine to use as the booster.

The recommendations allow individuals to decide which brand of vaccine they would like to have as a booster. They may choose to be vaccinated with the same vaccine they originally received or with a different vaccine. This vaccine flexibility may cause confusion, but ultimately is a good thing as it allows individuals to receive whatever vaccine is available and most convenient. This also allows individuals who have been vaccinated outside of the United States by a different brand of vaccine to also receive a booster vaccination with one of the options available here.
 

Take home message

Overall, the expansion of booster recommendations will help everyone avoid severe disease from COVID-19 infections. Physicians now have more clarity on who should be receiving these vaccines. Along with testing, masking, and appropriate distancing, these recommendations should help prevent severe disease and death from COVID-19.

Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is program director of Northwestern’s McGaw Family Medicine residency program, also in Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at fpnews@mdedge.com.

References

1. COVID-19 Vaccine Booster Shots. Centers for Disease Control and Prevention. 2021 Dec 9.

2. COVID-19 Vaccines and Pregnancy: Conversation Guide. American College of Obstetricians and Gynecologists. 2021 November.

3. COVID-19 Vaccines While Pregnant or Breastfeeding. Centers for Disease Control and Prevention. 2021 Dec 6.

In recent weeks, the Centers for Disease Control and Prevention has greatly expanded recommendations for boosters for vaccinations against COVID-19.

These recommendations have been widened because of the continued emergence of new variants of the virus and the wane of protection over time for both vaccinations and previous disease.

The new recommendations take away some of the questions surrounding eligibility for booster vaccinations while potentially leaving some additional questions. All in all, they provide flexibility for individuals to help protect themselves against the COVID-19 virus, as many are considering celebrating the holidays with friends and family.

The first item that has become clear is that all individuals over 18 are now not only eligible for a booster vaccination a certain time after they have completed their series, but have a recommendation for one.¹

But what about a fourth dose?  There is a possibility that some patients should be receiving one.  For those who require a three-dose series due to a condition that makes them immunocompromised, they should receive their booster vaccination six months after completion of the three-dose series.  This distinction  may cause confusion for some, but is important for those immunocompromised.

Boosters in women who are pregnant

The recommendations also include specific comments about individuals who are pregnant. Although initial studies did not include pregnant individuals, there has been increasing real world data that vaccination against COVID, including booster vaccinations, is safe and recommended. As pregnancy increases the risk of severe disease if infected by COVID-19, both the CDC and the American College of Obstetricians and Gynecologists,² along with other specialty organizations, such as the Royal College of Obstetricians and Gynaecologists, recommend vaccinations for pregnant individuals.

The CDC goes on to describe that there is no evidence of vaccination increasing the risk of infertility. The vaccine protects the pregnant individual and also provides protection to the baby once born. The same is true of breastfeeding individuals.³

I hope that this information allows physicians to feel comfortable recommending vaccinations and boosters to those who are pregnant and breast feeding.
 

Expanded recommendations for those aged 16-17 years

Recently, the CDC also expanded booster recommendations to include those aged 16-17 years, 6 months after completing their vaccine series.

Those under 18 are currently only able to receive the Pfizer-BioNtech vaccine. This new guidance has left some parents wondering if there will also be approval for booster vaccinations soon for those aged 12-16 who are approaching or have reached six months past the initial vaccine.¹

Booster brand for those over 18 years?

Although the recommendation has been simplified for all over age 18 years, there is still a decision to be made about which vaccine to use as the booster.

The recommendations allow individuals to decide which brand of vaccine they would like to have as a booster. They may choose to be vaccinated with the same vaccine they originally received or with a different vaccine. This vaccine flexibility may cause confusion, but ultimately is a good thing as it allows individuals to receive whatever vaccine is available and most convenient. This also allows individuals who have been vaccinated outside of the United States by a different brand of vaccine to also receive a booster vaccination with one of the options available here.
 

Take home message

Overall, the expansion of booster recommendations will help everyone avoid severe disease from COVID-19 infections. Physicians now have more clarity on who should be receiving these vaccines. Along with testing, masking, and appropriate distancing, these recommendations should help prevent severe disease and death from COVID-19.

Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is program director of Northwestern’s McGaw Family Medicine residency program, also in Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at fpnews@mdedge.com.

References

1. COVID-19 Vaccine Booster Shots. Centers for Disease Control and Prevention. 2021 Dec 9.

2. COVID-19 Vaccines and Pregnancy: Conversation Guide. American College of Obstetricians and Gynecologists. 2021 November.

3. COVID-19 Vaccines While Pregnant or Breastfeeding. Centers for Disease Control and Prevention. 2021 Dec 6.

In recent weeks, the Centers for Disease Control and Prevention has greatly expanded recommendations for boosters for vaccinations against COVID-19.

These recommendations have been widened because of the continued emergence of new variants of the virus and the wane of protection over time for both vaccinations and previous disease.

The new recommendations take away some of the questions surrounding eligibility for booster vaccinations while potentially leaving some additional questions. All in all, they provide flexibility for individuals to help protect themselves against the COVID-19 virus, as many are considering celebrating the holidays with friends and family.

The first item that has become clear is that all individuals over 18 are now not only eligible for a booster vaccination a certain time after they have completed their series, but have a recommendation for one.¹

But what about a fourth dose?  There is a possibility that some patients should be receiving one.  For those who require a three-dose series due to a condition that makes them immunocompromised, they should receive their booster vaccination six months after completion of the three-dose series.  This distinction  may cause confusion for some, but is important for those immunocompromised.

Boosters in women who are pregnant

The recommendations also include specific comments about individuals who are pregnant. Although initial studies did not include pregnant individuals, there has been increasing real world data that vaccination against COVID, including booster vaccinations, is safe and recommended. As pregnancy increases the risk of severe disease if infected by COVID-19, both the CDC and the American College of Obstetricians and Gynecologists,² along with other specialty organizations, such as the Royal College of Obstetricians and Gynaecologists, recommend vaccinations for pregnant individuals.

The CDC goes on to describe that there is no evidence of vaccination increasing the risk of infertility. The vaccine protects the pregnant individual and also provides protection to the baby once born. The same is true of breastfeeding individuals.³

I hope that this information allows physicians to feel comfortable recommending vaccinations and boosters to those who are pregnant and breast feeding.
 

Expanded recommendations for those aged 16-17 years

Recently, the CDC also expanded booster recommendations to include those aged 16-17 years, 6 months after completing their vaccine series.

Those under 18 are currently only able to receive the Pfizer-BioNtech vaccine. This new guidance has left some parents wondering if there will also be approval for booster vaccinations soon for those aged 12-16 who are approaching or have reached six months past the initial vaccine.¹

Booster brand for those over 18 years?

Although the recommendation has been simplified for all over age 18 years, there is still a decision to be made about which vaccine to use as the booster.

The recommendations allow individuals to decide which brand of vaccine they would like to have as a booster. They may choose to be vaccinated with the same vaccine they originally received or with a different vaccine. This vaccine flexibility may cause confusion, but ultimately is a good thing as it allows individuals to receive whatever vaccine is available and most convenient. This also allows individuals who have been vaccinated outside of the United States by a different brand of vaccine to also receive a booster vaccination with one of the options available here.
 

Take home message

Overall, the expansion of booster recommendations will help everyone avoid severe disease from COVID-19 infections. Physicians now have more clarity on who should be receiving these vaccines. Along with testing, masking, and appropriate distancing, these recommendations should help prevent severe disease and death from COVID-19.

Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is program director of Northwestern’s McGaw Family Medicine residency program, also in Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at fpnews@mdedge.com.

References

1. COVID-19 Vaccine Booster Shots. Centers for Disease Control and Prevention. 2021 Dec 9.

2. COVID-19 Vaccines and Pregnancy: Conversation Guide. American College of Obstetricians and Gynecologists. 2021 November.

3. COVID-19 Vaccines While Pregnant or Breastfeeding. Centers for Disease Control and Prevention. 2021 Dec 6.

In a highly anticipated decision, the U.S. Supreme Court ruled Dec. 10 that the controversial Texas abortion law that restricts the procedure to women pregnant for 6 weeks or less may continue to be enforced, but allowed for state and federal courts to hear challenges to whether it violates the Constitution.

trekandshoot/thinkstock

As anti-abortion organizations celebrate and abortion rights groups confer on what the decision could mean for women not only in Texas but across the United States, there is another, bigger implication as well.

The Texas law generated a lot of controversy, in part, because it took an unusual approach. In authorizing essentially anyone across the nation to file a lawsuit against a woman in the lone star state who seeks the procedure outside the law, or anyone who assists her -- including healthcare professionals, it opens up the potential for similar legal challenges to other Supreme Court rulings on marriage, guns, and other rights.

The court refused efforts on behalf of abortion providers and the federal government to overturn the law, but said lower courts should determine the law’s ultimate fate. The vote was 5-4, with Chief Justice John Roberts joining the liberal members of the court in dissenting.

The ruling allows abortion rights supporters to sue in state court, where a Texas judge on Dec. 9 ruled the law unconstitutional. He stopped short, however, of issuing an injunction against. Abortion rights opponents have vowed to appeal District Judge David Peeples’ ruling.

A timeline on the case

The law took effect on Sept. 1, 2021. The day before, the Supreme Court did not act to put a hold on the law as requested by abortion rights organizations. As a result, many Texas women seeking the procedure after 6 weeks traveled to nearby states. On Oct. 25, the Court agreed to hear a challenge to the law by the Biden Administration.

The Dec. 10 Supreme Court decision to uphold the Texas law contrasts with a general consensus among many legal observers that the justices were receptive to blocking the law, based on questions and issues the judges raised during oral arguments on Nov. 1, 2021.

A separate legal challenge to abortion rights involves a Mississippi law banning the procedure starting at 15 weeks of pregnancy. The Supreme Court justices scheduled oral arguments in that case for Dec. 1, and are expected to issue a ruling in that case in June 2022.

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

In a highly anticipated decision, the U.S. Supreme Court ruled Dec. 10 that the controversial Texas abortion law that restricts the procedure to women pregnant for 6 weeks or less may continue to be enforced, but allowed for state and federal courts to hear challenges to whether it violates the Constitution.

trekandshoot/thinkstock

As anti-abortion organizations celebrate and abortion rights groups confer on what the decision could mean for women not only in Texas but across the United States, there is another, bigger implication as well.

The Texas law generated a lot of controversy, in part, because it took an unusual approach. In authorizing essentially anyone across the nation to file a lawsuit against a woman in the lone star state who seeks the procedure outside the law, or anyone who assists her -- including healthcare professionals, it opens up the potential for similar legal challenges to other Supreme Court rulings on marriage, guns, and other rights.

The court refused efforts on behalf of abortion providers and the federal government to overturn the law, but said lower courts should determine the law’s ultimate fate. The vote was 5-4, with Chief Justice John Roberts joining the liberal members of the court in dissenting.

The ruling allows abortion rights supporters to sue in state court, where a Texas judge on Dec. 9 ruled the law unconstitutional. He stopped short, however, of issuing an injunction against. Abortion rights opponents have vowed to appeal District Judge David Peeples’ ruling.

A timeline on the case

The law took effect on Sept. 1, 2021. The day before, the Supreme Court did not act to put a hold on the law as requested by abortion rights organizations. As a result, many Texas women seeking the procedure after 6 weeks traveled to nearby states. On Oct. 25, the Court agreed to hear a challenge to the law by the Biden Administration.

The Dec. 10 Supreme Court decision to uphold the Texas law contrasts with a general consensus among many legal observers that the justices were receptive to blocking the law, based on questions and issues the judges raised during oral arguments on Nov. 1, 2021.

A separate legal challenge to abortion rights involves a Mississippi law banning the procedure starting at 15 weeks of pregnancy. The Supreme Court justices scheduled oral arguments in that case for Dec. 1, and are expected to issue a ruling in that case in June 2022.

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

In a highly anticipated decision, the U.S. Supreme Court ruled Dec. 10 that the controversial Texas abortion law that restricts the procedure to women pregnant for 6 weeks or less may continue to be enforced, but allowed for state and federal courts to hear challenges to whether it violates the Constitution.

trekandshoot/thinkstock

As anti-abortion organizations celebrate and abortion rights groups confer on what the decision could mean for women not only in Texas but across the United States, there is another, bigger implication as well.

The Texas law generated a lot of controversy, in part, because it took an unusual approach. In authorizing essentially anyone across the nation to file a lawsuit against a woman in the lone star state who seeks the procedure outside the law, or anyone who assists her -- including healthcare professionals, it opens up the potential for similar legal challenges to other Supreme Court rulings on marriage, guns, and other rights.

The court refused efforts on behalf of abortion providers and the federal government to overturn the law, but said lower courts should determine the law’s ultimate fate. The vote was 5-4, with Chief Justice John Roberts joining the liberal members of the court in dissenting.

The ruling allows abortion rights supporters to sue in state court, where a Texas judge on Dec. 9 ruled the law unconstitutional. He stopped short, however, of issuing an injunction against. Abortion rights opponents have vowed to appeal District Judge David Peeples’ ruling.

A timeline on the case

The law took effect on Sept. 1, 2021. The day before, the Supreme Court did not act to put a hold on the law as requested by abortion rights organizations. As a result, many Texas women seeking the procedure after 6 weeks traveled to nearby states. On Oct. 25, the Court agreed to hear a challenge to the law by the Biden Administration.

The Dec. 10 Supreme Court decision to uphold the Texas law contrasts with a general consensus among many legal observers that the justices were receptive to blocking the law, based on questions and issues the judges raised during oral arguments on Nov. 1, 2021.

A separate legal challenge to abortion rights involves a Mississippi law banning the procedure starting at 15 weeks of pregnancy. The Supreme Court justices scheduled oral arguments in that case for Dec. 1, and are expected to issue a ruling in that case in June 2022.

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

Pregnant women who were at or above the advanced maternal age (AMA) cutoff of 35 years on their due date received significantly more prenatal care, resulting in a slight decline in perinatal mortality, compared with women who were just a few months younger, according to a new study published in JAMA Health Forum. The findings “suggest that clinicians use the cutoff as a heuristic in their clinical recommendations and service provision,” noted lead author Caroline K. Geiger, PhD, who was a PhD student at Harvard University in Cambridge, Mass., during the course of the study, and now works as an associate health economist at Genentech in San Francisco. She and her coauthors suggest a slightly younger AMA cutoff might be beneficial. “Our results suggest that 3.9 perinatal deaths per 1,000 deliveries in this age range could be averted if patients just a few months younger than the AMA cutoff received similar care to those older than the cutoff,” they wrote. “Although the risk of adverse outcomes increases with maternal age, individuals 4 months older or younger than 35 years should not have different underlying risks.”

The cross-sectional study used a national sample of 51,290 commercially insured individuals who were pregnant between 2008 and 2019 and had delivery dates within 120 days of their 35th birthday. Just over half (50.9%) of the individuals were aged 34.7-34.9 years on their expected delivery date – just below the AMA cutoff – while 49.1% were just over the cutoff at age 35.0-35.3 years. A total of 4.7% had multiple gestation, 4.8% had pregestational diabetes, 4.4% had chronic hypertension, and 9.7% had obesity. There was also a subgroup analysis among individuals with low-risk pregnancy (defined as singleton, with no pregestational diabetes, chronic hypertension, or obesity) because they were less likely to have indications for additional prenatal care.

Although there was a slight, nonstatistically significant increase in the overall number of ob.gyn. visits at the AMA cutoff, compared with below it, the percentage of individuals with any maternal-fetal medicine visit increased by 4.27 percentage points (P < .001) at the cutoff. Additionally, while there was a “modest” increase in total ultrasounds (P = .006), there was a significant increase in detailed ultrasounds (P < .001) at the cutoff, and a “substantial” increase in antepartum surveillance (P < .001), the authors reported.

The AMA designation was associated with a 0.39 percentage-point decline in perinatal mortality (P = .04), “however, there were no significant changes in the proportion of individuals with severe maternal morbidity or with preterm birth or low birth weight at age 35 years,” they wrote.

In the subgroup analysis of low-risk pregnancies, “prenatal care services increased substantially at the 35-year cutoff, and in all cases, the increases at age 35 years for this group were larger than for the full sample,” they noted, adding that there was also a “substantially larger” decline in perinatal mortality at the AMA cutoff (P = .002), compared with the full sample.

The authors noted the need for more rigorous evidence on the value and effect of prenatal care guidelines on pregnancy outcomes. “Although pregnancy-related risks increase with maternal age, there is no known abrupt biological increase in underlying risk precisely at age 35 years,” they wrote, adding that “much of the content of prenatal care guidelines has persisted for decades without strong causal evidence to demonstrate its value.”

Their words echo those of Alex F. Peahl, MD, an ob.gyn. and assistant professor at the Institute for Healthcare Policy and Innovation, at the University of Michigan, in Ann Arbor, MI. In a recent review, Dr. Peahl and her colleague Joel D. Howell, MD, PhD, from the same university (Am J Obstet Gynecol. 2021 Apr;224[4]:339-47), note that the COVID-19 pandemic forced a much-needed rethink of prenatal care and its delivery. A look through the history of prenatal care shows “we have treated visit frequency and modality as fixed boxes, into which we must fit an ever-changing set of care recommendations,” they wrote. “We do not have data to support a specific prenatal visit schedule, recommended number of telemedicine visits, or specifications of additional services, and we never have. However, one thing is clear: we are long overdue for new prenatal care delivery guidelines in the United States.”

But when reached for comment on the new study Dr. Peahl cautioned that its conclusions are “limited and warrant future investigation. … While increased prenatal services may explain the improvement in outcomes, several other explanations should be considered,” she told this publication. “Perhaps, maternity care professional behavior differs for patients who are over the age of 35, resulting in increased caution in interpreting test results and symptoms; perhaps patients are more routinely induced at 39 weeks, limiting stillbirth rate; or perhaps patients are more hypervigilant when given the diagnosis of AMA.”

Priya Rajan, MD, agreed that while the paper showed an association between intensified antenatal interventions and decreased perinatal mortality, it did not show a causal relationship. “The study did not include information on other important factors that are also associated with perinatal risk,” noted Dr. Rajan, who is an associate professor in the department of ob.gyn. at Northwestern University in Chicago. Yet, she acknowledged that the findings “support what many clinicians know, which is that age 35 isn’t some tipping point; rather, obstetric risk is influenced by a range of factors, of which age may be one. This study, particularly when considered in the context of other studies and articles we have seen recently, confirms the need for us to rethink how we care for people during pregnancy and post partum. This includes delving further into understanding what aspects of the prenatal care that we provide have the biggest impact for both maternal and perinatal adverse outcomes.”

The study was supported by grant DGE1745303 from the National Science Foundation Graduate Research Fellowship Program. Dr. Geiger reported being a PhD student during the conduction of the study, but had no other disclosures. Dr. Peahl will soon be a consultant for Maven Clinic. Dr. Rajan had no relevant disclosures.

Pregnant women who were at or above the advanced maternal age (AMA) cutoff of 35 years on their due date received significantly more prenatal care, resulting in a slight decline in perinatal mortality, compared with women who were just a few months younger, according to a new study published in JAMA Health Forum. The findings “suggest that clinicians use the cutoff as a heuristic in their clinical recommendations and service provision,” noted lead author Caroline K. Geiger, PhD, who was a PhD student at Harvard University in Cambridge, Mass., during the course of the study, and now works as an associate health economist at Genentech in San Francisco. She and her coauthors suggest a slightly younger AMA cutoff might be beneficial. “Our results suggest that 3.9 perinatal deaths per 1,000 deliveries in this age range could be averted if patients just a few months younger than the AMA cutoff received similar care to those older than the cutoff,” they wrote. “Although the risk of adverse outcomes increases with maternal age, individuals 4 months older or younger than 35 years should not have different underlying risks.”

The cross-sectional study used a national sample of 51,290 commercially insured individuals who were pregnant between 2008 and 2019 and had delivery dates within 120 days of their 35th birthday. Just over half (50.9%) of the individuals were aged 34.7-34.9 years on their expected delivery date – just below the AMA cutoff – while 49.1% were just over the cutoff at age 35.0-35.3 years. A total of 4.7% had multiple gestation, 4.8% had pregestational diabetes, 4.4% had chronic hypertension, and 9.7% had obesity. There was also a subgroup analysis among individuals with low-risk pregnancy (defined as singleton, with no pregestational diabetes, chronic hypertension, or obesity) because they were less likely to have indications for additional prenatal care.

Although there was a slight, nonstatistically significant increase in the overall number of ob.gyn. visits at the AMA cutoff, compared with below it, the percentage of individuals with any maternal-fetal medicine visit increased by 4.27 percentage points (P < .001) at the cutoff. Additionally, while there was a “modest” increase in total ultrasounds (P = .006), there was a significant increase in detailed ultrasounds (P < .001) at the cutoff, and a “substantial” increase in antepartum surveillance (P < .001), the authors reported.

The AMA designation was associated with a 0.39 percentage-point decline in perinatal mortality (P = .04), “however, there were no significant changes in the proportion of individuals with severe maternal morbidity or with preterm birth or low birth weight at age 35 years,” they wrote.

In the subgroup analysis of low-risk pregnancies, “prenatal care services increased substantially at the 35-year cutoff, and in all cases, the increases at age 35 years for this group were larger than for the full sample,” they noted, adding that there was also a “substantially larger” decline in perinatal mortality at the AMA cutoff (P = .002), compared with the full sample.

The authors noted the need for more rigorous evidence on the value and effect of prenatal care guidelines on pregnancy outcomes. “Although pregnancy-related risks increase with maternal age, there is no known abrupt biological increase in underlying risk precisely at age 35 years,” they wrote, adding that “much of the content of prenatal care guidelines has persisted for decades without strong causal evidence to demonstrate its value.”

Their words echo those of Alex F. Peahl, MD, an ob.gyn. and assistant professor at the Institute for Healthcare Policy and Innovation, at the University of Michigan, in Ann Arbor, MI. In a recent review, Dr. Peahl and her colleague Joel D. Howell, MD, PhD, from the same university (Am J Obstet Gynecol. 2021 Apr;224[4]:339-47), note that the COVID-19 pandemic forced a much-needed rethink of prenatal care and its delivery. A look through the history of prenatal care shows “we have treated visit frequency and modality as fixed boxes, into which we must fit an ever-changing set of care recommendations,” they wrote. “We do not have data to support a specific prenatal visit schedule, recommended number of telemedicine visits, or specifications of additional services, and we never have. However, one thing is clear: we are long overdue for new prenatal care delivery guidelines in the United States.”

But when reached for comment on the new study Dr. Peahl cautioned that its conclusions are “limited and warrant future investigation. … While increased prenatal services may explain the improvement in outcomes, several other explanations should be considered,” she told this publication. “Perhaps, maternity care professional behavior differs for patients who are over the age of 35, resulting in increased caution in interpreting test results and symptoms; perhaps patients are more routinely induced at 39 weeks, limiting stillbirth rate; or perhaps patients are more hypervigilant when given the diagnosis of AMA.”

Priya Rajan, MD, agreed that while the paper showed an association between intensified antenatal interventions and decreased perinatal mortality, it did not show a causal relationship. “The study did not include information on other important factors that are also associated with perinatal risk,” noted Dr. Rajan, who is an associate professor in the department of ob.gyn. at Northwestern University in Chicago. Yet, she acknowledged that the findings “support what many clinicians know, which is that age 35 isn’t some tipping point; rather, obstetric risk is influenced by a range of factors, of which age may be one. This study, particularly when considered in the context of other studies and articles we have seen recently, confirms the need for us to rethink how we care for people during pregnancy and post partum. This includes delving further into understanding what aspects of the prenatal care that we provide have the biggest impact for both maternal and perinatal adverse outcomes.”

The study was supported by grant DGE1745303 from the National Science Foundation Graduate Research Fellowship Program. Dr. Geiger reported being a PhD student during the conduction of the study, but had no other disclosures. Dr. Peahl will soon be a consultant for Maven Clinic. Dr. Rajan had no relevant disclosures.

Pregnant women who were at or above the advanced maternal age (AMA) cutoff of 35 years on their due date received significantly more prenatal care, resulting in a slight decline in perinatal mortality, compared with women who were just a few months younger, according to a new study published in JAMA Health Forum. The findings “suggest that clinicians use the cutoff as a heuristic in their clinical recommendations and service provision,” noted lead author Caroline K. Geiger, PhD, who was a PhD student at Harvard University in Cambridge, Mass., during the course of the study, and now works as an associate health economist at Genentech in San Francisco. She and her coauthors suggest a slightly younger AMA cutoff might be beneficial. “Our results suggest that 3.9 perinatal deaths per 1,000 deliveries in this age range could be averted if patients just a few months younger than the AMA cutoff received similar care to those older than the cutoff,” they wrote. “Although the risk of adverse outcomes increases with maternal age, individuals 4 months older or younger than 35 years should not have different underlying risks.”

The cross-sectional study used a national sample of 51,290 commercially insured individuals who were pregnant between 2008 and 2019 and had delivery dates within 120 days of their 35th birthday. Just over half (50.9%) of the individuals were aged 34.7-34.9 years on their expected delivery date – just below the AMA cutoff – while 49.1% were just over the cutoff at age 35.0-35.3 years. A total of 4.7% had multiple gestation, 4.8% had pregestational diabetes, 4.4% had chronic hypertension, and 9.7% had obesity. There was also a subgroup analysis among individuals with low-risk pregnancy (defined as singleton, with no pregestational diabetes, chronic hypertension, or obesity) because they were less likely to have indications for additional prenatal care.

Although there was a slight, nonstatistically significant increase in the overall number of ob.gyn. visits at the AMA cutoff, compared with below it, the percentage of individuals with any maternal-fetal medicine visit increased by 4.27 percentage points (P < .001) at the cutoff. Additionally, while there was a “modest” increase in total ultrasounds (P = .006), there was a significant increase in detailed ultrasounds (P < .001) at the cutoff, and a “substantial” increase in antepartum surveillance (P < .001), the authors reported.

The AMA designation was associated with a 0.39 percentage-point decline in perinatal mortality (P = .04), “however, there were no significant changes in the proportion of individuals with severe maternal morbidity or with preterm birth or low birth weight at age 35 years,” they wrote.

In the subgroup analysis of low-risk pregnancies, “prenatal care services increased substantially at the 35-year cutoff, and in all cases, the increases at age 35 years for this group were larger than for the full sample,” they noted, adding that there was also a “substantially larger” decline in perinatal mortality at the AMA cutoff (P = .002), compared with the full sample.

The authors noted the need for more rigorous evidence on the value and effect of prenatal care guidelines on pregnancy outcomes. “Although pregnancy-related risks increase with maternal age, there is no known abrupt biological increase in underlying risk precisely at age 35 years,” they wrote, adding that “much of the content of prenatal care guidelines has persisted for decades without strong causal evidence to demonstrate its value.”

Their words echo those of Alex F. Peahl, MD, an ob.gyn. and assistant professor at the Institute for Healthcare Policy and Innovation, at the University of Michigan, in Ann Arbor, MI. In a recent review, Dr. Peahl and her colleague Joel D. Howell, MD, PhD, from the same university (Am J Obstet Gynecol. 2021 Apr;224[4]:339-47), note that the COVID-19 pandemic forced a much-needed rethink of prenatal care and its delivery. A look through the history of prenatal care shows “we have treated visit frequency and modality as fixed boxes, into which we must fit an ever-changing set of care recommendations,” they wrote. “We do not have data to support a specific prenatal visit schedule, recommended number of telemedicine visits, or specifications of additional services, and we never have. However, one thing is clear: we are long overdue for new prenatal care delivery guidelines in the United States.”

But when reached for comment on the new study Dr. Peahl cautioned that its conclusions are “limited and warrant future investigation. … While increased prenatal services may explain the improvement in outcomes, several other explanations should be considered,” she told this publication. “Perhaps, maternity care professional behavior differs for patients who are over the age of 35, resulting in increased caution in interpreting test results and symptoms; perhaps patients are more routinely induced at 39 weeks, limiting stillbirth rate; or perhaps patients are more hypervigilant when given the diagnosis of AMA.”

Priya Rajan, MD, agreed that while the paper showed an association between intensified antenatal interventions and decreased perinatal mortality, it did not show a causal relationship. “The study did not include information on other important factors that are also associated with perinatal risk,” noted Dr. Rajan, who is an associate professor in the department of ob.gyn. at Northwestern University in Chicago. Yet, she acknowledged that the findings “support what many clinicians know, which is that age 35 isn’t some tipping point; rather, obstetric risk is influenced by a range of factors, of which age may be one. This study, particularly when considered in the context of other studies and articles we have seen recently, confirms the need for us to rethink how we care for people during pregnancy and post partum. This includes delving further into understanding what aspects of the prenatal care that we provide have the biggest impact for both maternal and perinatal adverse outcomes.”

The study was supported by grant DGE1745303 from the National Science Foundation Graduate Research Fellowship Program. Dr. Geiger reported being a PhD student during the conduction of the study, but had no other disclosures. Dr. Peahl will soon be a consultant for Maven Clinic. Dr. Rajan had no relevant disclosures.

A 42-year-old woman presented to our dermatology center with white scars on both of her ankles. She first noticed the lesions 2 years prior; they were initially erythematous and painful, even when she was at rest. Her past medical history included 3 spontaneous term miscarriages. She denied any prolonged standing or trauma.

On examination, atrophic porcelain-white stellate scars were visible with surrounding hyperpigmentation on the medial aspect of both ankles (FIGURE 1A & 1B). There were no tender erythematous nodules, livedo reticularis, varicosities, or pedal edema present. The dorsalis pedis pulse was well felt and capillary refill time was less than 2 seconds; sensation was intact.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

 

 

Diagnosis: Atrophie blanche

Atrophie blanche is a morphologic feature described as porcelain-white stellate scars with surrounding telangiectasia and hyperpigmentation. The lesions are typically found over the peri-malleolar region and are sequelae of healed erythematous and painful ulcers. The lesions arise from upper dermal, small vessel, thrombotic vasculopathy leading to ischemic rest pain; if left untreated, atrophic white scars eventually develop.

A sign of venous insufficiency or thrombotic vasculopathy

Atrophie blanche may develop following healing of an ulcer due to venous insufficiency or small vessel thrombotic vasculopathy.¹ The incidence of thrombotic vasculopathy is 1:100,000 with a female predominance, and up to 50% of cases are associated with procoagulant conditions.² Thrombotic vasculopathy can be due to an inherited or acquired thrombophilia.¹

Atrophie blanche is an important clue to acquired thrombophilia.

Causes of hereditary thrombophilia include Factor V Leiden/prothrombin mutations, anti-thrombin III/protein C/protein S deficiencies, dysfibrinogenemia, and hyperhomocysteinemia.

Acquired thrombophilia arises from underlying prothrombotic states associated with the Virchow triad: hypercoagulability, blood flow stasis, and endothelial injury. The use of oral contraceptives or hormone replacement therapy, presence of malignancy, and antiphospholipid syndrome (APS) are causes of acquired thrombophilia.²

Obtaining a careful history is crucial

Thorough history-taking and physical examination are required to determine the underlying cause of atrophie blanche.

Continue to: Chronic venous insufficiency

Chronic venous insufficiency is more likely in patients with a history of prolonged standing, obesity, or previous injury/surgery to leg veins. Physical examination would reveal hyperpigmentation, telangiectasia, varicose veins, pedal edema, and venous ulcers.³

Inherited thrombophilia may be at work in patients with a family history of arterial and venous thrombosis (eg, stroke, acute coronary syndrome, or deep vein thromboses).

Acquired thrombophilia should be suspected if there is a history of recurrent miscarriages or malignancy.⁴ Given our patient’s history of miscarriages, we ordered further lab work and found that she had elevated anticardiolipin levels (> 40 U/mL) fulfilling the revised Sapporo criteria⁵ for APS.

Thrombophilia or chronic venous insufficiency? In a patient with a history suggestive of thrombophilia, further work-up should be done before attributing atrophie blanche to healed venous ulcers from chronic venous insufficiency. A skin lesion biopsy could reveal classic changes of thrombotic vasculopathy subjacent to the ulcer, including intraluminal thrombosis, endothelial proliferation, and subintimal hyaline degeneration, as opposed to dermal changes consistent with venous stasis, such as increased siderophages, hemosiderin deposition, erythrocyte extravasation, dermal fibrosis, and adipocytic damage.

Differential diagnosis includes atrophic scarring

The differential diagnosis for hypopigmented atrophic macules and plaques over the lower limbs include atrophic scarring from previous trauma, guttate morphea, extra-genital lichen sclerosus, and tuberculoid leprosy.

Continue to: Atrophic scarring

Atrophic scarring occurs only after trauma.

Guttate morphea lesions are sclerotic and may be depressed.

Extra-genital lichen sclerosus is characterized by polygonal, shiny, ivory-white sclerotic lesions with or without follicular plugging.

Tuberculoid leprosy involves loss of nociception, hypotrichosis, and palpable thickened regional nerves (eg, great auricular, sural, or ulnar nerve).

Treatment requires long-term anticoagulation

Our patient had APS and the mainstay of treatment is long-term systemic anticoagulation along with attentive wound care.⁶ Warfarin is preferred over a direct oral anticoagulant as it is more effective in the prevention of recurrent thrombosis in patients with APS.⁷

Our patient was started on warfarin. Since APS may occur as a primary condition or in the setting of a systemic disease, such as systemic lupus erythematosus, she was referred to a rheumatologist. 

A 42-year-old woman presented to our dermatology center with white scars on both of her ankles. She first noticed the lesions 2 years prior; they were initially erythematous and painful, even when she was at rest. Her past medical history included 3 spontaneous term miscarriages. She denied any prolonged standing or trauma.

On examination, atrophic porcelain-white stellate scars were visible with surrounding hyperpigmentation on the medial aspect of both ankles (FIGURE 1A & 1B). There were no tender erythematous nodules, livedo reticularis, varicosities, or pedal edema present. The dorsalis pedis pulse was well felt and capillary refill time was less than 2 seconds; sensation was intact.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

 

 

Diagnosis: Atrophie blanche

Atrophie blanche is a morphologic feature described as porcelain-white stellate scars with surrounding telangiectasia and hyperpigmentation. The lesions are typically found over the peri-malleolar region and are sequelae of healed erythematous and painful ulcers. The lesions arise from upper dermal, small vessel, thrombotic vasculopathy leading to ischemic rest pain; if left untreated, atrophic white scars eventually develop.

A sign of venous insufficiency or thrombotic vasculopathy

Atrophie blanche may develop following healing of an ulcer due to venous insufficiency or small vessel thrombotic vasculopathy.¹ The incidence of thrombotic vasculopathy is 1:100,000 with a female predominance, and up to 50% of cases are associated with procoagulant conditions.² Thrombotic vasculopathy can be due to an inherited or acquired thrombophilia.¹

Atrophie blanche is an important clue to acquired thrombophilia.

Causes of hereditary thrombophilia include Factor V Leiden/prothrombin mutations, anti-thrombin III/protein C/protein S deficiencies, dysfibrinogenemia, and hyperhomocysteinemia.

Acquired thrombophilia arises from underlying prothrombotic states associated with the Virchow triad: hypercoagulability, blood flow stasis, and endothelial injury. The use of oral contraceptives or hormone replacement therapy, presence of malignancy, and antiphospholipid syndrome (APS) are causes of acquired thrombophilia.²

Obtaining a careful history is crucial

Thorough history-taking and physical examination are required to determine the underlying cause of atrophie blanche.

Continue to: Chronic venous insufficiency

Chronic venous insufficiency is more likely in patients with a history of prolonged standing, obesity, or previous injury/surgery to leg veins. Physical examination would reveal hyperpigmentation, telangiectasia, varicose veins, pedal edema, and venous ulcers.³

Inherited thrombophilia may be at work in patients with a family history of arterial and venous thrombosis (eg, stroke, acute coronary syndrome, or deep vein thromboses).

Acquired thrombophilia should be suspected if there is a history of recurrent miscarriages or malignancy.⁴ Given our patient’s history of miscarriages, we ordered further lab work and found that she had elevated anticardiolipin levels (> 40 U/mL) fulfilling the revised Sapporo criteria⁵ for APS.

Thrombophilia or chronic venous insufficiency? In a patient with a history suggestive of thrombophilia, further work-up should be done before attributing atrophie blanche to healed venous ulcers from chronic venous insufficiency. A skin lesion biopsy could reveal classic changes of thrombotic vasculopathy subjacent to the ulcer, including intraluminal thrombosis, endothelial proliferation, and subintimal hyaline degeneration, as opposed to dermal changes consistent with venous stasis, such as increased siderophages, hemosiderin deposition, erythrocyte extravasation, dermal fibrosis, and adipocytic damage.

Differential diagnosis includes atrophic scarring

The differential diagnosis for hypopigmented atrophic macules and plaques over the lower limbs include atrophic scarring from previous trauma, guttate morphea, extra-genital lichen sclerosus, and tuberculoid leprosy.

Continue to: Atrophic scarring

Atrophic scarring occurs only after trauma.

Guttate morphea lesions are sclerotic and may be depressed.

Extra-genital lichen sclerosus is characterized by polygonal, shiny, ivory-white sclerotic lesions with or without follicular plugging.

Tuberculoid leprosy involves loss of nociception, hypotrichosis, and palpable thickened regional nerves (eg, great auricular, sural, or ulnar nerve).

Treatment requires long-term anticoagulation

Our patient had APS and the mainstay of treatment is long-term systemic anticoagulation along with attentive wound care.⁶ Warfarin is preferred over a direct oral anticoagulant as it is more effective in the prevention of recurrent thrombosis in patients with APS.⁷

Our patient was started on warfarin. Since APS may occur as a primary condition or in the setting of a systemic disease, such as systemic lupus erythematosus, she was referred to a rheumatologist. 

A 42-year-old woman presented to our dermatology center with white scars on both of her ankles. She first noticed the lesions 2 years prior; they were initially erythematous and painful, even when she was at rest. Her past medical history included 3 spontaneous term miscarriages. She denied any prolonged standing or trauma.

On examination, atrophic porcelain-white stellate scars were visible with surrounding hyperpigmentation on the medial aspect of both ankles (FIGURE 1A & 1B). There were no tender erythematous nodules, livedo reticularis, varicosities, or pedal edema present. The dorsalis pedis pulse was well felt and capillary refill time was less than 2 seconds; sensation was intact.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

 

 

Diagnosis: Atrophie blanche

Atrophie blanche is a morphologic feature described as porcelain-white stellate scars with surrounding telangiectasia and hyperpigmentation. The lesions are typically found over the peri-malleolar region and are sequelae of healed erythematous and painful ulcers. The lesions arise from upper dermal, small vessel, thrombotic vasculopathy leading to ischemic rest pain; if left untreated, atrophic white scars eventually develop.

A sign of venous insufficiency or thrombotic vasculopathy

Atrophie blanche may develop following healing of an ulcer due to venous insufficiency or small vessel thrombotic vasculopathy.¹ The incidence of thrombotic vasculopathy is 1:100,000 with a female predominance, and up to 50% of cases are associated with procoagulant conditions.² Thrombotic vasculopathy can be due to an inherited or acquired thrombophilia.¹

Atrophie blanche is an important clue to acquired thrombophilia.

Causes of hereditary thrombophilia include Factor V Leiden/prothrombin mutations, anti-thrombin III/protein C/protein S deficiencies, dysfibrinogenemia, and hyperhomocysteinemia.

Acquired thrombophilia arises from underlying prothrombotic states associated with the Virchow triad: hypercoagulability, blood flow stasis, and endothelial injury. The use of oral contraceptives or hormone replacement therapy, presence of malignancy, and antiphospholipid syndrome (APS) are causes of acquired thrombophilia.²

Obtaining a careful history is crucial

Thorough history-taking and physical examination are required to determine the underlying cause of atrophie blanche.

Continue to: Chronic venous insufficiency

Chronic venous insufficiency is more likely in patients with a history of prolonged standing, obesity, or previous injury/surgery to leg veins. Physical examination would reveal hyperpigmentation, telangiectasia, varicose veins, pedal edema, and venous ulcers.³

Inherited thrombophilia may be at work in patients with a family history of arterial and venous thrombosis (eg, stroke, acute coronary syndrome, or deep vein thromboses).

Acquired thrombophilia should be suspected if there is a history of recurrent miscarriages or malignancy.⁴ Given our patient’s history of miscarriages, we ordered further lab work and found that she had elevated anticardiolipin levels (> 40 U/mL) fulfilling the revised Sapporo criteria⁵ for APS.

Thrombophilia or chronic venous insufficiency? In a patient with a history suggestive of thrombophilia, further work-up should be done before attributing atrophie blanche to healed venous ulcers from chronic venous insufficiency. A skin lesion biopsy could reveal classic changes of thrombotic vasculopathy subjacent to the ulcer, including intraluminal thrombosis, endothelial proliferation, and subintimal hyaline degeneration, as opposed to dermal changes consistent with venous stasis, such as increased siderophages, hemosiderin deposition, erythrocyte extravasation, dermal fibrosis, and adipocytic damage.

Differential diagnosis includes atrophic scarring

The differential diagnosis for hypopigmented atrophic macules and plaques over the lower limbs include atrophic scarring from previous trauma, guttate morphea, extra-genital lichen sclerosus, and tuberculoid leprosy.

Continue to: Atrophic scarring

Atrophic scarring occurs only after trauma.

Guttate morphea lesions are sclerotic and may be depressed.

Extra-genital lichen sclerosus is characterized by polygonal, shiny, ivory-white sclerotic lesions with or without follicular plugging.

Tuberculoid leprosy involves loss of nociception, hypotrichosis, and palpable thickened regional nerves (eg, great auricular, sural, or ulnar nerve).

Treatment requires long-term anticoagulation

Our patient had APS and the mainstay of treatment is long-term systemic anticoagulation along with attentive wound care.⁶ Warfarin is preferred over a direct oral anticoagulant as it is more effective in the prevention of recurrent thrombosis in patients with APS.⁷

Our patient was started on warfarin. Since APS may occur as a primary condition or in the setting of a systemic disease, such as systemic lupus erythematosus, she was referred to a rheumatologist.