Women's Health

Over the past year through early 2019, the US Preventive Services Task Force made 34 recommendations on 19 different topics. Twenty-six were reaffirmations of recommendations made in previous years (TABLE 1¹); the Task Force attempts to reassess topics every 7 years. Two new topics were addressed with 2 new recommendations, and 6 previous recommendations were revised or reversed (TABLE 2^2-9).

This Practice Alert discusses the new and the changed recommendations. (In 2018, the Practice Alert podcast series covered screening for ovarian cancer [April], prostate cancer [June], and cervical cancer [October], and EKG screening for cardiovascular disease [November].) All current Task Force recommendations are available on the USPSTF Web site.¹

New topics

Perinatal depression prevention

The Task Force recommends that clinicians counsel pregnant women and women in the first year postpartum who are at increased risk for perinatal depression, or refer for such services. The recommendation applies to those who are not diagnosed with depression but are at increased risk.

Perinatal depression can negatively affect both mother and child in several ways and occurs at a rate close to 9% during pregnancy and 37% during the first year postpartum.² The interventions studied by the Task Force included cognitive behavioral therapy and interpersonal therapy; most sessions were initiated in the second trimester of pregnancy and varied in number of sessions and intensity. The Task Force includes the following in the list of risks that should prompt a referral: a history of depression, current depressive symptoms that fall short of that needed for a depression diagnosis, low income, adolescent or single parenthood, recent intimate partner violence, elevated anxiety symptoms, physical or sexual abuse, or a history of significant negative life events. (See “Postpartum anxiety: More common than you think,” in the April issue.)

Atrial fibrillation

The Task Force found insufficient evidence to recommend for or against the use of electrocardiography (EKG) to screen for atrial fibrillation (AF).³ Atrial fibrillation is common, affecting 3% of men and 2% of women between the ages of 65 and 69 years, and it increases in prevalence with age.⁴ It is a major risk factor for stroke, although it is commonly first diagnosed after a stroke. Treatment with anticoagulant therapy reduces the incidence of stroke in patients with symptomatic AF, but this treatment is associated with the risk of major bleeding. The problem in screening for AF with EKG is that it is associated with misdiagnosis, over-treatment, and further testing. The Task Force could not find any direct evidence of the totality of benefits and harms of screening asymptomatic adults with EKG, and it raised the possibility that benefit with less harm might be achieved by screening with pulse palpation and heart auscultation, followed by EKG testing of those with an irregular pulse.

Revisions of previous recommendations

Cervical cancer screening

The Task Force continues to recommend screening for cervical cancer in women 21 to 65 years of age.⁵ The major change in the current recommendation is for women ages 30 to 65 years. For this group, the Task Force now recommends screening every 5 years with high-risk human papillomavirus (hrHPV) testing alone as a possible alternative to screening every 3 years with cytology alone. They also halfheartedly endorse co-testing as an option, even though it may result in more tests and procedures compared with either cytology or hrHPV testing alone, with equal effectiveness. For women ages 21 to 29 years, cervical cytology alone every 3 years is still the only recommended regimen.

Skin cancer prevention

The Task Force made 2 revisions to the 2012 recommendation on preventing skin cancer through behavioral counseling to avoid ultraviolet (UV) radiation.⁶ These recommendations continue to focus on those with fair skin. The first revision: The earliest age at which children (through their guardians) can benefit from counseling on UV avoidance has been lowered from age 10 years to 6 months. The second revision: Some adults older than age 24 can also benefit from such counseling if they have fair skin and other skin cancer risks such as using tanning beds, having a history of sunburns or previous skin cancer, having an increased number of nevi (moles) and atypical nevi, having human immunodeficiency virus (HIV) infection, having received an organ transplant, or having a family history of skin cancer.

Continue to: Those at risk...

Those at risk can reduce their chances of skin cancer by using broad-spectrum sunscreens and sun-protective clothing, and by avoiding sun exposure and indoor tanning beds.

Fall prevention

In a reversal of its 2012 recommendation, the Task Force now recommends against the use of vitamin D supplementation to prevent falls in community-dwelling adults 65 years or older.⁷ In a reanalysis of previous studies on this topic, along with new evidence, the Task Force concluded that vitamin D supplementation offers no benefit for preventing falls in adults who are not vitamin D deficient.

Screening for scoliosis in adolescents

In 2004 the USPSTF recommended against screening for idiopathic scoliosis in children and adolescents 10 to 18 years of age. In its most recent review, the Task Force continued to find no direct evidence of the benefit of screening and inadequate evidence on the long-term benefits of reduction in spinal curvature through exercise, surgery, and bracing. However, following a reanalysis of the potential harms of these treatments and the use of a new analytic framework, the Task Force concluded it is not possible at this time to assess the balance of benefits and harms of screening.⁸

Prostate cancer screening

In its most controversial action, the Task Force reversed its 2012 recommendation against routine prostate-specific antigen–based screening for prostate cancer in men ages 55 to 69 years and now lists this as a “C” recommendation.⁹ The potential benefits of screening include preventing 1.3 deaths from prostate cancer per 1000 men screened over 13 years and approximately 3 cases of metastatic prostate cancer. However, no trials have found a reduction in all-cause mortality from screening. Contrast that with the known harms of screening: 15% false positive results over 10 years; 1% hospitalization rate among those undergoing a prostate biopsy; over-diagnosis and resultant treatment of 20% to 50% of men diagnosed with prostate cancer through screening; and incontinence and erectile dysfunction in 20% and 67%, respectively, of men following prostatectomy.⁹

Evidence is insufficient to recommend for or against the use of electrocardiography in screening for atrial fibrillation.

Based on these outcomes, the Task Force “does not recommend screening for prostate cancer unless men express a preference for screening after being informed of and understanding the benefits and risks.”⁹ The Task Force continues to recommend against screening men ages 70 years and older.

Continue to: The change in this recommendation...

The change in this recommendation and its wording present dilemmas for family physicians: whether to discuss potential screening with all men ages 55 to 69; to selectively discuss it with those at high risk (principally African Americans and those with a strong family history of prostate cancer); or to address the issue only if a patient asks about it. In addition, if a man requests screening, how often should it be performed? Most clinical trials have found equal benefit from testing less frequently than every year, with fewer harms. The Task Force provided little or no guidance on these issues.

Final advice: D recommendations

The Task Force reaffirmed that 7 services have either no benefit or cause more harm than benefit (TABLE 1¹). Family physicians should be familiar with these services, as well as all Task Force D recommendations, and avoid recommending them or providing them. High quality preventive care involves both providing services of proven benefit and avoiding those that do not.

Over the past year through early 2019, the US Preventive Services Task Force made 34 recommendations on 19 different topics. Twenty-six were reaffirmations of recommendations made in previous years (TABLE 1¹); the Task Force attempts to reassess topics every 7 years. Two new topics were addressed with 2 new recommendations, and 6 previous recommendations were revised or reversed (TABLE 2^2-9).

This Practice Alert discusses the new and the changed recommendations. (In 2018, the Practice Alert podcast series covered screening for ovarian cancer [April], prostate cancer [June], and cervical cancer [October], and EKG screening for cardiovascular disease [November].) All current Task Force recommendations are available on the USPSTF Web site.¹

New topics

Perinatal depression prevention

The Task Force recommends that clinicians counsel pregnant women and women in the first year postpartum who are at increased risk for perinatal depression, or refer for such services. The recommendation applies to those who are not diagnosed with depression but are at increased risk.

Perinatal depression can negatively affect both mother and child in several ways and occurs at a rate close to 9% during pregnancy and 37% during the first year postpartum.² The interventions studied by the Task Force included cognitive behavioral therapy and interpersonal therapy; most sessions were initiated in the second trimester of pregnancy and varied in number of sessions and intensity. The Task Force includes the following in the list of risks that should prompt a referral: a history of depression, current depressive symptoms that fall short of that needed for a depression diagnosis, low income, adolescent or single parenthood, recent intimate partner violence, elevated anxiety symptoms, physical or sexual abuse, or a history of significant negative life events. (See “Postpartum anxiety: More common than you think,” in the April issue.)

Atrial fibrillation

The Task Force found insufficient evidence to recommend for or against the use of electrocardiography (EKG) to screen for atrial fibrillation (AF).³ Atrial fibrillation is common, affecting 3% of men and 2% of women between the ages of 65 and 69 years, and it increases in prevalence with age.⁴ It is a major risk factor for stroke, although it is commonly first diagnosed after a stroke. Treatment with anticoagulant therapy reduces the incidence of stroke in patients with symptomatic AF, but this treatment is associated with the risk of major bleeding. The problem in screening for AF with EKG is that it is associated with misdiagnosis, over-treatment, and further testing. The Task Force could not find any direct evidence of the totality of benefits and harms of screening asymptomatic adults with EKG, and it raised the possibility that benefit with less harm might be achieved by screening with pulse palpation and heart auscultation, followed by EKG testing of those with an irregular pulse.

Revisions of previous recommendations

Cervical cancer screening

The Task Force continues to recommend screening for cervical cancer in women 21 to 65 years of age.⁵ The major change in the current recommendation is for women ages 30 to 65 years. For this group, the Task Force now recommends screening every 5 years with high-risk human papillomavirus (hrHPV) testing alone as a possible alternative to screening every 3 years with cytology alone. They also halfheartedly endorse co-testing as an option, even though it may result in more tests and procedures compared with either cytology or hrHPV testing alone, with equal effectiveness. For women ages 21 to 29 years, cervical cytology alone every 3 years is still the only recommended regimen.

Skin cancer prevention

The Task Force made 2 revisions to the 2012 recommendation on preventing skin cancer through behavioral counseling to avoid ultraviolet (UV) radiation.⁶ These recommendations continue to focus on those with fair skin. The first revision: The earliest age at which children (through their guardians) can benefit from counseling on UV avoidance has been lowered from age 10 years to 6 months. The second revision: Some adults older than age 24 can also benefit from such counseling if they have fair skin and other skin cancer risks such as using tanning beds, having a history of sunburns or previous skin cancer, having an increased number of nevi (moles) and atypical nevi, having human immunodeficiency virus (HIV) infection, having received an organ transplant, or having a family history of skin cancer.

Continue to: Those at risk...

Those at risk can reduce their chances of skin cancer by using broad-spectrum sunscreens and sun-protective clothing, and by avoiding sun exposure and indoor tanning beds.

Fall prevention

In a reversal of its 2012 recommendation, the Task Force now recommends against the use of vitamin D supplementation to prevent falls in community-dwelling adults 65 years or older.⁷ In a reanalysis of previous studies on this topic, along with new evidence, the Task Force concluded that vitamin D supplementation offers no benefit for preventing falls in adults who are not vitamin D deficient.

Screening for scoliosis in adolescents

In 2004 the USPSTF recommended against screening for idiopathic scoliosis in children and adolescents 10 to 18 years of age. In its most recent review, the Task Force continued to find no direct evidence of the benefit of screening and inadequate evidence on the long-term benefits of reduction in spinal curvature through exercise, surgery, and bracing. However, following a reanalysis of the potential harms of these treatments and the use of a new analytic framework, the Task Force concluded it is not possible at this time to assess the balance of benefits and harms of screening.⁸

Prostate cancer screening

In its most controversial action, the Task Force reversed its 2012 recommendation against routine prostate-specific antigen–based screening for prostate cancer in men ages 55 to 69 years and now lists this as a “C” recommendation.⁹ The potential benefits of screening include preventing 1.3 deaths from prostate cancer per 1000 men screened over 13 years and approximately 3 cases of metastatic prostate cancer. However, no trials have found a reduction in all-cause mortality from screening. Contrast that with the known harms of screening: 15% false positive results over 10 years; 1% hospitalization rate among those undergoing a prostate biopsy; over-diagnosis and resultant treatment of 20% to 50% of men diagnosed with prostate cancer through screening; and incontinence and erectile dysfunction in 20% and 67%, respectively, of men following prostatectomy.⁹

Evidence is insufficient to recommend for or against the use of electrocardiography in screening for atrial fibrillation.

Based on these outcomes, the Task Force “does not recommend screening for prostate cancer unless men express a preference for screening after being informed of and understanding the benefits and risks.”⁹ The Task Force continues to recommend against screening men ages 70 years and older.

Continue to: The change in this recommendation...

The change in this recommendation and its wording present dilemmas for family physicians: whether to discuss potential screening with all men ages 55 to 69; to selectively discuss it with those at high risk (principally African Americans and those with a strong family history of prostate cancer); or to address the issue only if a patient asks about it. In addition, if a man requests screening, how often should it be performed? Most clinical trials have found equal benefit from testing less frequently than every year, with fewer harms. The Task Force provided little or no guidance on these issues.

Final advice: D recommendations

The Task Force reaffirmed that 7 services have either no benefit or cause more harm than benefit (TABLE 1¹). Family physicians should be familiar with these services, as well as all Task Force D recommendations, and avoid recommending them or providing them. High quality preventive care involves both providing services of proven benefit and avoiding those that do not.

Over the past year through early 2019, the US Preventive Services Task Force made 34 recommendations on 19 different topics. Twenty-six were reaffirmations of recommendations made in previous years (TABLE 1¹); the Task Force attempts to reassess topics every 7 years. Two new topics were addressed with 2 new recommendations, and 6 previous recommendations were revised or reversed (TABLE 2^2-9).

This Practice Alert discusses the new and the changed recommendations. (In 2018, the Practice Alert podcast series covered screening for ovarian cancer [April], prostate cancer [June], and cervical cancer [October], and EKG screening for cardiovascular disease [November].) All current Task Force recommendations are available on the USPSTF Web site.¹

New topics

Perinatal depression prevention

The Task Force recommends that clinicians counsel pregnant women and women in the first year postpartum who are at increased risk for perinatal depression, or refer for such services. The recommendation applies to those who are not diagnosed with depression but are at increased risk.

Perinatal depression can negatively affect both mother and child in several ways and occurs at a rate close to 9% during pregnancy and 37% during the first year postpartum.² The interventions studied by the Task Force included cognitive behavioral therapy and interpersonal therapy; most sessions were initiated in the second trimester of pregnancy and varied in number of sessions and intensity. The Task Force includes the following in the list of risks that should prompt a referral: a history of depression, current depressive symptoms that fall short of that needed for a depression diagnosis, low income, adolescent or single parenthood, recent intimate partner violence, elevated anxiety symptoms, physical or sexual abuse, or a history of significant negative life events. (See “Postpartum anxiety: More common than you think,” in the April issue.)

Atrial fibrillation

The Task Force found insufficient evidence to recommend for or against the use of electrocardiography (EKG) to screen for atrial fibrillation (AF).³ Atrial fibrillation is common, affecting 3% of men and 2% of women between the ages of 65 and 69 years, and it increases in prevalence with age.⁴ It is a major risk factor for stroke, although it is commonly first diagnosed after a stroke. Treatment with anticoagulant therapy reduces the incidence of stroke in patients with symptomatic AF, but this treatment is associated with the risk of major bleeding. The problem in screening for AF with EKG is that it is associated with misdiagnosis, over-treatment, and further testing. The Task Force could not find any direct evidence of the totality of benefits and harms of screening asymptomatic adults with EKG, and it raised the possibility that benefit with less harm might be achieved by screening with pulse palpation and heart auscultation, followed by EKG testing of those with an irregular pulse.

Revisions of previous recommendations

Cervical cancer screening

The Task Force continues to recommend screening for cervical cancer in women 21 to 65 years of age.⁵ The major change in the current recommendation is for women ages 30 to 65 years. For this group, the Task Force now recommends screening every 5 years with high-risk human papillomavirus (hrHPV) testing alone as a possible alternative to screening every 3 years with cytology alone. They also halfheartedly endorse co-testing as an option, even though it may result in more tests and procedures compared with either cytology or hrHPV testing alone, with equal effectiveness. For women ages 21 to 29 years, cervical cytology alone every 3 years is still the only recommended regimen.

Skin cancer prevention

The Task Force made 2 revisions to the 2012 recommendation on preventing skin cancer through behavioral counseling to avoid ultraviolet (UV) radiation.⁶ These recommendations continue to focus on those with fair skin. The first revision: The earliest age at which children (through their guardians) can benefit from counseling on UV avoidance has been lowered from age 10 years to 6 months. The second revision: Some adults older than age 24 can also benefit from such counseling if they have fair skin and other skin cancer risks such as using tanning beds, having a history of sunburns or previous skin cancer, having an increased number of nevi (moles) and atypical nevi, having human immunodeficiency virus (HIV) infection, having received an organ transplant, or having a family history of skin cancer.

Continue to: Those at risk...

Those at risk can reduce their chances of skin cancer by using broad-spectrum sunscreens and sun-protective clothing, and by avoiding sun exposure and indoor tanning beds.

Fall prevention

In a reversal of its 2012 recommendation, the Task Force now recommends against the use of vitamin D supplementation to prevent falls in community-dwelling adults 65 years or older.⁷ In a reanalysis of previous studies on this topic, along with new evidence, the Task Force concluded that vitamin D supplementation offers no benefit for preventing falls in adults who are not vitamin D deficient.

Screening for scoliosis in adolescents

In 2004 the USPSTF recommended against screening for idiopathic scoliosis in children and adolescents 10 to 18 years of age. In its most recent review, the Task Force continued to find no direct evidence of the benefit of screening and inadequate evidence on the long-term benefits of reduction in spinal curvature through exercise, surgery, and bracing. However, following a reanalysis of the potential harms of these treatments and the use of a new analytic framework, the Task Force concluded it is not possible at this time to assess the balance of benefits and harms of screening.⁸

Prostate cancer screening

In its most controversial action, the Task Force reversed its 2012 recommendation against routine prostate-specific antigen–based screening for prostate cancer in men ages 55 to 69 years and now lists this as a “C” recommendation.⁹ The potential benefits of screening include preventing 1.3 deaths from prostate cancer per 1000 men screened over 13 years and approximately 3 cases of metastatic prostate cancer. However, no trials have found a reduction in all-cause mortality from screening. Contrast that with the known harms of screening: 15% false positive results over 10 years; 1% hospitalization rate among those undergoing a prostate biopsy; over-diagnosis and resultant treatment of 20% to 50% of men diagnosed with prostate cancer through screening; and incontinence and erectile dysfunction in 20% and 67%, respectively, of men following prostatectomy.⁹

Evidence is insufficient to recommend for or against the use of electrocardiography in screening for atrial fibrillation.

Based on these outcomes, the Task Force “does not recommend screening for prostate cancer unless men express a preference for screening after being informed of and understanding the benefits and risks.”⁹ The Task Force continues to recommend against screening men ages 70 years and older.

Continue to: The change in this recommendation...

The change in this recommendation and its wording present dilemmas for family physicians: whether to discuss potential screening with all men ages 55 to 69; to selectively discuss it with those at high risk (principally African Americans and those with a strong family history of prostate cancer); or to address the issue only if a patient asks about it. In addition, if a man requests screening, how often should it be performed? Most clinical trials have found equal benefit from testing less frequently than every year, with fewer harms. The Task Force provided little or no guidance on these issues.

Final advice: D recommendations

The Task Force reaffirmed that 7 services have either no benefit or cause more harm than benefit (TABLE 1¹). Family physicians should be familiar with these services, as well as all Task Force D recommendations, and avoid recommending them or providing them. High quality preventive care involves both providing services of proven benefit and avoiding those that do not.

Most of the nearly 700 pregnancy-related deaths that occur each year in the United States could be prevented, according to the Centers for Disease Control and Prevention.

Deaths from pregnancy-related complications can occur “up to a year after delivery,” the CDC emphasized in a report released May 7. Indeed, 31% of pregnancy-related deaths happen during pregnancy, 36% happen at delivery or in the week after, and 33% happen 1 week to 1 year post partum. Yet detailed data from 13 state maternal mortality review committees (MMRCs) showed that 60% of such deaths are preventable.

There were 17 pregnancy-related deaths per 100,000 live births during 2011-2015, based on another data source: 3,410 pregnancy-related deaths (an average of 682 deaths per year) in the CDC’s Pregnancy Mortality Surveillance System. That pregnancy-related mortality ratio varied by race/ethnicity, Emily E. Peterson, MD, and the other CDC investigators reported in Morbidity and Mortality Weekly Report: Hispanic (11 deaths per 100,000), white (13), Asian/Pacific Islander (14), American Indian/Alaska Native (33), and black (43).

One aspect of the disparity was addressed by Wanda Barfield, MD, MPH, director of the CDC’s division of reproductive health and assistant surgeon general in the U.S. Public Health Service. “Recent studies have shown that racial and ethnic minority women deliver at different and lower-quality hospitals than white women and that these hospitals disproportionately care for black women at delivery,” she said at a CDC telebriefing.

Analysis of the timing of 2,990 deaths from the Pregnancy Mortality Surveillance System showed that almost a third (31.3%) occurred during pregnancy and 16.9% occurred on the day of delivery. Dr. Peterson and her CDC associates noted that more than half of pregnancy-related deaths, however, took place later: 1-6 days post partum (18.6%), 7-42 days (21.4%), and 43-365 days (11.7%).

The data on preventability were collected by the state MMRCs and included 232 deaths that occurred during 2013-2017. The MMRCs considered deaths preventable if they could be “averted by one or more reasonable changes to patient, community, provider, health facility, and/or system factors.”

“Our new analysis underscores the need for access to quality services, risk awareness, and early diagnosis, but it also highlights opportunities for preventing future pregnancy-related deaths,” Dr. Barfield said. “By identifying and promptly responding to warning signs not just during pregnancy, but even up to a year after delivery, we can save lives.”

[email protected]

SOURCE: MMWR. 2019 May 7;68(early release):1-7.

Most of the nearly 700 pregnancy-related deaths that occur each year in the United States could be prevented, according to the Centers for Disease Control and Prevention.

Deaths from pregnancy-related complications can occur “up to a year after delivery,” the CDC emphasized in a report released May 7. Indeed, 31% of pregnancy-related deaths happen during pregnancy, 36% happen at delivery or in the week after, and 33% happen 1 week to 1 year post partum. Yet detailed data from 13 state maternal mortality review committees (MMRCs) showed that 60% of such deaths are preventable.

There were 17 pregnancy-related deaths per 100,000 live births during 2011-2015, based on another data source: 3,410 pregnancy-related deaths (an average of 682 deaths per year) in the CDC’s Pregnancy Mortality Surveillance System. That pregnancy-related mortality ratio varied by race/ethnicity, Emily E. Peterson, MD, and the other CDC investigators reported in Morbidity and Mortality Weekly Report: Hispanic (11 deaths per 100,000), white (13), Asian/Pacific Islander (14), American Indian/Alaska Native (33), and black (43).

One aspect of the disparity was addressed by Wanda Barfield, MD, MPH, director of the CDC’s division of reproductive health and assistant surgeon general in the U.S. Public Health Service. “Recent studies have shown that racial and ethnic minority women deliver at different and lower-quality hospitals than white women and that these hospitals disproportionately care for black women at delivery,” she said at a CDC telebriefing.

Analysis of the timing of 2,990 deaths from the Pregnancy Mortality Surveillance System showed that almost a third (31.3%) occurred during pregnancy and 16.9% occurred on the day of delivery. Dr. Peterson and her CDC associates noted that more than half of pregnancy-related deaths, however, took place later: 1-6 days post partum (18.6%), 7-42 days (21.4%), and 43-365 days (11.7%).

The data on preventability were collected by the state MMRCs and included 232 deaths that occurred during 2013-2017. The MMRCs considered deaths preventable if they could be “averted by one or more reasonable changes to patient, community, provider, health facility, and/or system factors.”

“Our new analysis underscores the need for access to quality services, risk awareness, and early diagnosis, but it also highlights opportunities for preventing future pregnancy-related deaths,” Dr. Barfield said. “By identifying and promptly responding to warning signs not just during pregnancy, but even up to a year after delivery, we can save lives.”

[email protected]

SOURCE: MMWR. 2019 May 7;68(early release):1-7.

Most of the nearly 700 pregnancy-related deaths that occur each year in the United States could be prevented, according to the Centers for Disease Control and Prevention.

Deaths from pregnancy-related complications can occur “up to a year after delivery,” the CDC emphasized in a report released May 7. Indeed, 31% of pregnancy-related deaths happen during pregnancy, 36% happen at delivery or in the week after, and 33% happen 1 week to 1 year post partum. Yet detailed data from 13 state maternal mortality review committees (MMRCs) showed that 60% of such deaths are preventable.

There were 17 pregnancy-related deaths per 100,000 live births during 2011-2015, based on another data source: 3,410 pregnancy-related deaths (an average of 682 deaths per year) in the CDC’s Pregnancy Mortality Surveillance System. That pregnancy-related mortality ratio varied by race/ethnicity, Emily E. Peterson, MD, and the other CDC investigators reported in Morbidity and Mortality Weekly Report: Hispanic (11 deaths per 100,000), white (13), Asian/Pacific Islander (14), American Indian/Alaska Native (33), and black (43).

One aspect of the disparity was addressed by Wanda Barfield, MD, MPH, director of the CDC’s division of reproductive health and assistant surgeon general in the U.S. Public Health Service. “Recent studies have shown that racial and ethnic minority women deliver at different and lower-quality hospitals than white women and that these hospitals disproportionately care for black women at delivery,” she said at a CDC telebriefing.

Analysis of the timing of 2,990 deaths from the Pregnancy Mortality Surveillance System showed that almost a third (31.3%) occurred during pregnancy and 16.9% occurred on the day of delivery. Dr. Peterson and her CDC associates noted that more than half of pregnancy-related deaths, however, took place later: 1-6 days post partum (18.6%), 7-42 days (21.4%), and 43-365 days (11.7%).

The data on preventability were collected by the state MMRCs and included 232 deaths that occurred during 2013-2017. The MMRCs considered deaths preventable if they could be “averted by one or more reasonable changes to patient, community, provider, health facility, and/or system factors.”

“Our new analysis underscores the need for access to quality services, risk awareness, and early diagnosis, but it also highlights opportunities for preventing future pregnancy-related deaths,” Dr. Barfield said. “By identifying and promptly responding to warning signs not just during pregnancy, but even up to a year after delivery, we can save lives.”

[email protected]

SOURCE: MMWR. 2019 May 7;68(early release):1-7.

NASHVILLE, TENN. – The vast majority of women with menopausal symptoms who completed an online shared decision-making counseling session felt better prepared to discuss treatment options with their provider, a post-intervention survey showed.

Sharon Worcester/MDedge News

Of 36 women who completed the counseling, 72% were able to express a clear preference for a particular treatment. Additionally, 90% to 100% of those who completed the final survey said the various components of the counseling–such as an educational brochure or a telephone call from a research nurse–made them feel more prepared to speak with their provider about treatment options, Sandra Dayaratna, MD, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Among 18 women with vasomotor symptoms, 6 (33%) preferred non-hormone treatment, 7 (39%) preferred hormone treatment, and 5 (28%) were unsure; among 18 with genitourinary symptoms of menopause, 6 (33%) preferred non-prescription treatment, 7 (39%) preferred topical hormone therapy, and 5 (28%) were unsure, Dr. Dayaratna, division director and clinical associate professor at Thomas Jefferson University Hospital and Sidney Kimmel Medical College, Philadelphia, found.

Of women who were not being treated for vasomotor symptoms, 5 (56%) expressed a clear treatment preference after counseling, whereas 8 (80%) of those not receiving treatment for genitourinary symptoms expressed a clear preference. Among 7 women receiving systemic hormone therapy for vasomotor symptoms, 86% preferred this treatment after counseling, and 3 women (50%) receiving topical hormone therapy preferred topical treatment after counseling.

The study included women aged 36-50 years from diverse educational and racial backgrounds who were referred to the counseling program after reporting menopausal symptoms, completing a baseline survey, and providing consent. The counseling, which was adapted from a tool developed at Thomas Jefferson University Hospital for the assessment of patients with colon and cancer or lung cancer, involved an educational brochure that was mailed to participants. It also offered access to an online tool that provided information about systemic hormone therapy, non-hormone prescription therapy, topical hormone treatment, and non-prescription treatment for vasomotor and genitourinary symptoms of menopause.

A research nurse contacted participants by phone and used the online program to review the brochure, clarify treatment preference, and produce a summary of the results.

In an interview, Dr. Dayaratna noted that the concept of “shared decision making” is often misunderstood to mean that patients are provided with information about options and then they make a choice.

Actually, this study demonstrates that shared decision making really involves a “values clarification” component, she explained. In this study, counseling that incorporates this type of shared decision making helped women feel more prepared to speak with their providers about treatment and thus may add value to care of menopausal women, she concluded.

“This is relevant because we know that over 50% of patients within 90 minutes of leaving their doctor’s office have forgotten what they were told, and over 50% do not comply with their treatment prescriptions,” she said. “So if patients can do this process ahead of time, when they come to speak to their physician about their symptoms and selection of medication, it’s a more effective and efficient conversation.”

Further research should evaluate impact on the subsequent office visit, she added.

This study was funded by an educational grant from Pfizer, Inc. and by the National Cancer Institute. Dr. Dayaratna reported having no disclosures.

[email protected]

SOURCE: Dayaratna S et al., ACOG 2019: Abstract 21M.

NASHVILLE, TENN. – The vast majority of women with menopausal symptoms who completed an online shared decision-making counseling session felt better prepared to discuss treatment options with their provider, a post-intervention survey showed.

Sharon Worcester/MDedge News

Of 36 women who completed the counseling, 72% were able to express a clear preference for a particular treatment. Additionally, 90% to 100% of those who completed the final survey said the various components of the counseling–such as an educational brochure or a telephone call from a research nurse–made them feel more prepared to speak with their provider about treatment options, Sandra Dayaratna, MD, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Among 18 women with vasomotor symptoms, 6 (33%) preferred non-hormone treatment, 7 (39%) preferred hormone treatment, and 5 (28%) were unsure; among 18 with genitourinary symptoms of menopause, 6 (33%) preferred non-prescription treatment, 7 (39%) preferred topical hormone therapy, and 5 (28%) were unsure, Dr. Dayaratna, division director and clinical associate professor at Thomas Jefferson University Hospital and Sidney Kimmel Medical College, Philadelphia, found.

Of women who were not being treated for vasomotor symptoms, 5 (56%) expressed a clear treatment preference after counseling, whereas 8 (80%) of those not receiving treatment for genitourinary symptoms expressed a clear preference. Among 7 women receiving systemic hormone therapy for vasomotor symptoms, 86% preferred this treatment after counseling, and 3 women (50%) receiving topical hormone therapy preferred topical treatment after counseling.

The study included women aged 36-50 years from diverse educational and racial backgrounds who were referred to the counseling program after reporting menopausal symptoms, completing a baseline survey, and providing consent. The counseling, which was adapted from a tool developed at Thomas Jefferson University Hospital for the assessment of patients with colon and cancer or lung cancer, involved an educational brochure that was mailed to participants. It also offered access to an online tool that provided information about systemic hormone therapy, non-hormone prescription therapy, topical hormone treatment, and non-prescription treatment for vasomotor and genitourinary symptoms of menopause.

A research nurse contacted participants by phone and used the online program to review the brochure, clarify treatment preference, and produce a summary of the results.

In an interview, Dr. Dayaratna noted that the concept of “shared decision making” is often misunderstood to mean that patients are provided with information about options and then they make a choice.

Actually, this study demonstrates that shared decision making really involves a “values clarification” component, she explained. In this study, counseling that incorporates this type of shared decision making helped women feel more prepared to speak with their providers about treatment and thus may add value to care of menopausal women, she concluded.

“This is relevant because we know that over 50% of patients within 90 minutes of leaving their doctor’s office have forgotten what they were told, and over 50% do not comply with their treatment prescriptions,” she said. “So if patients can do this process ahead of time, when they come to speak to their physician about their symptoms and selection of medication, it’s a more effective and efficient conversation.”

Further research should evaluate impact on the subsequent office visit, she added.

This study was funded by an educational grant from Pfizer, Inc. and by the National Cancer Institute. Dr. Dayaratna reported having no disclosures.

[email protected]

SOURCE: Dayaratna S et al., ACOG 2019: Abstract 21M.

NASHVILLE, TENN. – The vast majority of women with menopausal symptoms who completed an online shared decision-making counseling session felt better prepared to discuss treatment options with their provider, a post-intervention survey showed.

Sharon Worcester/MDedge News

Of 36 women who completed the counseling, 72% were able to express a clear preference for a particular treatment. Additionally, 90% to 100% of those who completed the final survey said the various components of the counseling–such as an educational brochure or a telephone call from a research nurse–made them feel more prepared to speak with their provider about treatment options, Sandra Dayaratna, MD, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Among 18 women with vasomotor symptoms, 6 (33%) preferred non-hormone treatment, 7 (39%) preferred hormone treatment, and 5 (28%) were unsure; among 18 with genitourinary symptoms of menopause, 6 (33%) preferred non-prescription treatment, 7 (39%) preferred topical hormone therapy, and 5 (28%) were unsure, Dr. Dayaratna, division director and clinical associate professor at Thomas Jefferson University Hospital and Sidney Kimmel Medical College, Philadelphia, found.

Of women who were not being treated for vasomotor symptoms, 5 (56%) expressed a clear treatment preference after counseling, whereas 8 (80%) of those not receiving treatment for genitourinary symptoms expressed a clear preference. Among 7 women receiving systemic hormone therapy for vasomotor symptoms, 86% preferred this treatment after counseling, and 3 women (50%) receiving topical hormone therapy preferred topical treatment after counseling.

The study included women aged 36-50 years from diverse educational and racial backgrounds who were referred to the counseling program after reporting menopausal symptoms, completing a baseline survey, and providing consent. The counseling, which was adapted from a tool developed at Thomas Jefferson University Hospital for the assessment of patients with colon and cancer or lung cancer, involved an educational brochure that was mailed to participants. It also offered access to an online tool that provided information about systemic hormone therapy, non-hormone prescription therapy, topical hormone treatment, and non-prescription treatment for vasomotor and genitourinary symptoms of menopause.

A research nurse contacted participants by phone and used the online program to review the brochure, clarify treatment preference, and produce a summary of the results.

In an interview, Dr. Dayaratna noted that the concept of “shared decision making” is often misunderstood to mean that patients are provided with information about options and then they make a choice.

Actually, this study demonstrates that shared decision making really involves a “values clarification” component, she explained. In this study, counseling that incorporates this type of shared decision making helped women feel more prepared to speak with their providers about treatment and thus may add value to care of menopausal women, she concluded.

“This is relevant because we know that over 50% of patients within 90 minutes of leaving their doctor’s office have forgotten what they were told, and over 50% do not comply with their treatment prescriptions,” she said. “So if patients can do this process ahead of time, when they come to speak to their physician about their symptoms and selection of medication, it’s a more effective and efficient conversation.”

Further research should evaluate impact on the subsequent office visit, she added.

This study was funded by an educational grant from Pfizer, Inc. and by the National Cancer Institute. Dr. Dayaratna reported having no disclosures.

[email protected]

SOURCE: Dayaratna S et al., ACOG 2019: Abstract 21M.

NASHVILLE, TENN. – The 52 mg levonorgestrel intrauterine system Liletta, which is currently approved as a contraceptive for up to 5 years of use, remains highly effective and safe for an additional year of use, according to findings from an ongoing 10-year trial.

Sharon Worcester/MDedge News

Of 1,714 women enrolled in the multicenter phase 3 trial and for whom demographic information is available, 379 have completed 6 years of use. Nine pregnancies have occurred to date, including 2 in year 1, 4 in year 2, and 1 each in years 3-5, for a cumulative life-table pregnancy rate through year 6 of 0.87, Carolyn L. Westhoff, MD, MSc, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Six (67%) of the pregnancies were ectopic, noted Dr. Westhoff of Columbia University, N.Y.

Study subjects include 1,568 women aged 16-35 years at enrollment (986 were nulliparous and 433 were obese) and 146 aged 36 to 45 years. All were followed after device placement, with 138 having completed 8 years of use.

Two perforations occurred following device placement–both within the first year, and none have occurred since, Dr. Westhoff noted.

Other adverse events included expulsion in 68 women (4.0%), with 50 of those (73.5%) occurring in the first year of use, and pelvic infection in 15 women (0.9%), with 11 (73.3%) of those occurring after 6 or more months of use.


Only 40 women (2.3%) discontinued the study due to bleeding, and 30 of those (75%) did so in the first 2 years.

The findings show that Liletta is highly effective and safe over 6 years of use in both nulliparous and parous women, and in both non-obese and obese women, Dr. Westhoff concluded. She added that “there were no additional pregnancies in 6 years, and this study will be continuing to look all the way to 10-year effectiveness.”

This study is funded by Medicines360, a non-profit pharmaceutical company. Dr. Westhoff is a consultant or advisory board member for Agile and Cooper Surgical, and a Data and Safety Monitoring Board member for phase 4 studies for Bayer and Merck.

[email protected]

SOURCE: Westhoff C et al., ACOG 2019: Abstract 13M.

NASHVILLE, TENN. – The 52 mg levonorgestrel intrauterine system Liletta, which is currently approved as a contraceptive for up to 5 years of use, remains highly effective and safe for an additional year of use, according to findings from an ongoing 10-year trial.

Sharon Worcester/MDedge News

Of 1,714 women enrolled in the multicenter phase 3 trial and for whom demographic information is available, 379 have completed 6 years of use. Nine pregnancies have occurred to date, including 2 in year 1, 4 in year 2, and 1 each in years 3-5, for a cumulative life-table pregnancy rate through year 6 of 0.87, Carolyn L. Westhoff, MD, MSc, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Six (67%) of the pregnancies were ectopic, noted Dr. Westhoff of Columbia University, N.Y.

Study subjects include 1,568 women aged 16-35 years at enrollment (986 were nulliparous and 433 were obese) and 146 aged 36 to 45 years. All were followed after device placement, with 138 having completed 8 years of use.

Two perforations occurred following device placement–both within the first year, and none have occurred since, Dr. Westhoff noted.

Other adverse events included expulsion in 68 women (4.0%), with 50 of those (73.5%) occurring in the first year of use, and pelvic infection in 15 women (0.9%), with 11 (73.3%) of those occurring after 6 or more months of use.


Only 40 women (2.3%) discontinued the study due to bleeding, and 30 of those (75%) did so in the first 2 years.

The findings show that Liletta is highly effective and safe over 6 years of use in both nulliparous and parous women, and in both non-obese and obese women, Dr. Westhoff concluded. She added that “there were no additional pregnancies in 6 years, and this study will be continuing to look all the way to 10-year effectiveness.”

This study is funded by Medicines360, a non-profit pharmaceutical company. Dr. Westhoff is a consultant or advisory board member for Agile and Cooper Surgical, and a Data and Safety Monitoring Board member for phase 4 studies for Bayer and Merck.

[email protected]

SOURCE: Westhoff C et al., ACOG 2019: Abstract 13M.

NASHVILLE, TENN. – The 52 mg levonorgestrel intrauterine system Liletta, which is currently approved as a contraceptive for up to 5 years of use, remains highly effective and safe for an additional year of use, according to findings from an ongoing 10-year trial.

Sharon Worcester/MDedge News

Of 1,714 women enrolled in the multicenter phase 3 trial and for whom demographic information is available, 379 have completed 6 years of use. Nine pregnancies have occurred to date, including 2 in year 1, 4 in year 2, and 1 each in years 3-5, for a cumulative life-table pregnancy rate through year 6 of 0.87, Carolyn L. Westhoff, MD, MSc, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Six (67%) of the pregnancies were ectopic, noted Dr. Westhoff of Columbia University, N.Y.

Study subjects include 1,568 women aged 16-35 years at enrollment (986 were nulliparous and 433 were obese) and 146 aged 36 to 45 years. All were followed after device placement, with 138 having completed 8 years of use.

Two perforations occurred following device placement–both within the first year, and none have occurred since, Dr. Westhoff noted.

Other adverse events included expulsion in 68 women (4.0%), with 50 of those (73.5%) occurring in the first year of use, and pelvic infection in 15 women (0.9%), with 11 (73.3%) of those occurring after 6 or more months of use.


Only 40 women (2.3%) discontinued the study due to bleeding, and 30 of those (75%) did so in the first 2 years.

The findings show that Liletta is highly effective and safe over 6 years of use in both nulliparous and parous women, and in both non-obese and obese women, Dr. Westhoff concluded. She added that “there were no additional pregnancies in 6 years, and this study will be continuing to look all the way to 10-year effectiveness.”

This study is funded by Medicines360, a non-profit pharmaceutical company. Dr. Westhoff is a consultant or advisory board member for Agile and Cooper Surgical, and a Data and Safety Monitoring Board member for phase 4 studies for Bayer and Merck.

[email protected]

SOURCE: Westhoff C et al., ACOG 2019: Abstract 13M.

PHILADELPHIA – Multiple sclerosis (MS) disease activity may not flare up after pregnancy, according to a study to be presented at the annual meeting of the American Academy of Neurology.

Bonnie Becker/MDedge News

“We did not observe any rebound disease activity,” said Annette Langer-Gould, MD, PhD, and her research colleagues in their report.

The findings contrast with those of 20-year-old studies that first identified a lower risk of relapse during pregnancy but signficant rebound disease activity in the early postpartum period. The initial studies were conducted before disease-modifying treatments (DMTs) were available and before neurologists used MRI to help diagnose MS after one attack, noted Dr. Langer-Gould in a statement.

In the large, contemporary cohort of patients with MS, the annualized relapse rate was 0.39 pre-pregnancy, 0.07-0.14 during pregnancy, 0.27 in the first 3 months postpartum, and 0.37 at 4-6 months postpartum. Exclusive breastfeeding significantly reduced the risk of postpartum relapses by 42% (adjusted hazard ratio = 0.58). Women who supplemented breast milk with formula within 2 months of delivery had the same risk of relapse as women who did not breastfeed, however.

“These results are exciting, as MS is more common among women of childbearing age than in any other group,” said Dr. Langer-Gould, who is regional lead for clinical and translational neuroscience at Kaiser Permanente Southern California in Pasadena, in the statement. “This shows us that women with MS today can have children, breastfeed, and resume their treatment without experiencing an increased risk of relapses during the postpartum period.”

To describe the risk of postpartum relapses and identify potential risk factors for relapse the investigators analyzed prospectively collected data from 466 pregnancies among 375 women with MS from the complete electronic health record at Kaiser Permanente Southern and Northern California between 2008 and 2016. The researchers also used surveys to collect information about treatment history, breastfeeding, and relapses. They used multivariable models to account for intraclass clustering and disease severity.


In 38% of the pregnancies, the mother had not received treatment in the year before conception. In 14.6%, the mother had a clinically isolated syndrome; in 8.4%, the mother had a relapse during pregnancy.

Resuming modestly effective DMTs such as interferon-betas and glatiramer acetate did not affect relapse risk.

In the postpartum year, 26.4% of mothers relapsed, 87% breastfed, 35% breastfed exclusively, and 41.2% resumed using DMT.

The lack of rebound disease activity in this cohort could be related to the high rate of exclusive breastfeeding, as well as the inclusion of women from a population-based setting and the inclusion of women who had incorrectly been diagnosed with MS after a single relapse. Few patients in this cohort had been treated with natalizumab or fingolimod prior to pregnancy, so the study does not address the potential harms of stopping these drugs or the potential benefits of breastfeeding among patients treated with these drugs.

The study was supported by the National Multiple Sclerosis Society. The researchers had no disclosures.

[email protected]

SOURCE: Langer-Gould A et al. AAN 2019, Abstract S6.007.

PHILADELPHIA – Multiple sclerosis (MS) disease activity may not flare up after pregnancy, according to a study to be presented at the annual meeting of the American Academy of Neurology.

Bonnie Becker/MDedge News

“We did not observe any rebound disease activity,” said Annette Langer-Gould, MD, PhD, and her research colleagues in their report.

The findings contrast with those of 20-year-old studies that first identified a lower risk of relapse during pregnancy but signficant rebound disease activity in the early postpartum period. The initial studies were conducted before disease-modifying treatments (DMTs) were available and before neurologists used MRI to help diagnose MS after one attack, noted Dr. Langer-Gould in a statement.

In the large, contemporary cohort of patients with MS, the annualized relapse rate was 0.39 pre-pregnancy, 0.07-0.14 during pregnancy, 0.27 in the first 3 months postpartum, and 0.37 at 4-6 months postpartum. Exclusive breastfeeding significantly reduced the risk of postpartum relapses by 42% (adjusted hazard ratio = 0.58). Women who supplemented breast milk with formula within 2 months of delivery had the same risk of relapse as women who did not breastfeed, however.

“These results are exciting, as MS is more common among women of childbearing age than in any other group,” said Dr. Langer-Gould, who is regional lead for clinical and translational neuroscience at Kaiser Permanente Southern California in Pasadena, in the statement. “This shows us that women with MS today can have children, breastfeed, and resume their treatment without experiencing an increased risk of relapses during the postpartum period.”

To describe the risk of postpartum relapses and identify potential risk factors for relapse the investigators analyzed prospectively collected data from 466 pregnancies among 375 women with MS from the complete electronic health record at Kaiser Permanente Southern and Northern California between 2008 and 2016. The researchers also used surveys to collect information about treatment history, breastfeeding, and relapses. They used multivariable models to account for intraclass clustering and disease severity.


In 38% of the pregnancies, the mother had not received treatment in the year before conception. In 14.6%, the mother had a clinically isolated syndrome; in 8.4%, the mother had a relapse during pregnancy.

Resuming modestly effective DMTs such as interferon-betas and glatiramer acetate did not affect relapse risk.

In the postpartum year, 26.4% of mothers relapsed, 87% breastfed, 35% breastfed exclusively, and 41.2% resumed using DMT.

The lack of rebound disease activity in this cohort could be related to the high rate of exclusive breastfeeding, as well as the inclusion of women from a population-based setting and the inclusion of women who had incorrectly been diagnosed with MS after a single relapse. Few patients in this cohort had been treated with natalizumab or fingolimod prior to pregnancy, so the study does not address the potential harms of stopping these drugs or the potential benefits of breastfeeding among patients treated with these drugs.

The study was supported by the National Multiple Sclerosis Society. The researchers had no disclosures.

[email protected]

SOURCE: Langer-Gould A et al. AAN 2019, Abstract S6.007.

PHILADELPHIA – Multiple sclerosis (MS) disease activity may not flare up after pregnancy, according to a study to be presented at the annual meeting of the American Academy of Neurology.

Bonnie Becker/MDedge News

“We did not observe any rebound disease activity,” said Annette Langer-Gould, MD, PhD, and her research colleagues in their report.

The findings contrast with those of 20-year-old studies that first identified a lower risk of relapse during pregnancy but signficant rebound disease activity in the early postpartum period. The initial studies were conducted before disease-modifying treatments (DMTs) were available and before neurologists used MRI to help diagnose MS after one attack, noted Dr. Langer-Gould in a statement.

In the large, contemporary cohort of patients with MS, the annualized relapse rate was 0.39 pre-pregnancy, 0.07-0.14 during pregnancy, 0.27 in the first 3 months postpartum, and 0.37 at 4-6 months postpartum. Exclusive breastfeeding significantly reduced the risk of postpartum relapses by 42% (adjusted hazard ratio = 0.58). Women who supplemented breast milk with formula within 2 months of delivery had the same risk of relapse as women who did not breastfeed, however.

“These results are exciting, as MS is more common among women of childbearing age than in any other group,” said Dr. Langer-Gould, who is regional lead for clinical and translational neuroscience at Kaiser Permanente Southern California in Pasadena, in the statement. “This shows us that women with MS today can have children, breastfeed, and resume their treatment without experiencing an increased risk of relapses during the postpartum period.”

To describe the risk of postpartum relapses and identify potential risk factors for relapse the investigators analyzed prospectively collected data from 466 pregnancies among 375 women with MS from the complete electronic health record at Kaiser Permanente Southern and Northern California between 2008 and 2016. The researchers also used surveys to collect information about treatment history, breastfeeding, and relapses. They used multivariable models to account for intraclass clustering and disease severity.


In 38% of the pregnancies, the mother had not received treatment in the year before conception. In 14.6%, the mother had a clinically isolated syndrome; in 8.4%, the mother had a relapse during pregnancy.

Resuming modestly effective DMTs such as interferon-betas and glatiramer acetate did not affect relapse risk.

In the postpartum year, 26.4% of mothers relapsed, 87% breastfed, 35% breastfed exclusively, and 41.2% resumed using DMT.

The lack of rebound disease activity in this cohort could be related to the high rate of exclusive breastfeeding, as well as the inclusion of women from a population-based setting and the inclusion of women who had incorrectly been diagnosed with MS after a single relapse. Few patients in this cohort had been treated with natalizumab or fingolimod prior to pregnancy, so the study does not address the potential harms of stopping these drugs or the potential benefits of breastfeeding among patients treated with these drugs.

The study was supported by the National Multiple Sclerosis Society. The researchers had no disclosures.

[email protected]

SOURCE: Langer-Gould A et al. AAN 2019, Abstract S6.007.

NASHVILLE, TENN. – All women should be assessed for cardiovascular disease in the antepartum and postpartum periods using a specific toolkit algorithm, according to new comprehensive guidance from the American College of Obstetricians and Gynecologists.

The toolkit algorithm is called the California Improving Health Care Response to Cardiovascular Disease in Pregnancy and Postpartum Toolkit. It was developed by the Cardiovascular Disease in Pregnancy Postpartum Task Force to serve as a resource for obstetrics, primary care and emergency medicine providers who provide prenatal care or interact with women during the postpartum period. It incldues an overview of clinical assessment and comprehensive management strategies for cardiovascular disease based on risk factors and presenting symptoms.

The guidance also calls for all pregnant and postpartum women with known or suspected CVD to undergo further evaluation by a “Pregnancy Heart Team that includes a cardiologist and maternal–fetal medicine subspecialist, or both, and other subspecialists as necessary.” The guidance was issued in Practice Bulletin 212, Pregnancy and Heart Disease, which is published in the May edition of Obstetrics & Gynecology (Obstet Gynecol. 2019 May;133[5]:e320-e356).


In all, 27 specific recommendations and conclusions relating to screening, diagnosis, and management of CVD for women during the prepregnancy period through the postpartum period are included in the guidance.

ACOG president Lisa Hollier, MD, convened the task force that developed this guidance to address cardiac contributors to maternal mortality, she said during a press briefing at the ACOG annual clinical and scientific meeting.

“When I began my presidency a year ago, my goal was to bring together a multidisciplinary group of clinicians ... to create clinical guidance that would make a difference in the lives of women," said Dr. Hollier, who is also a professor of obstetrics and gynecology at Baylor College of Medicine, Houston. 

Jovanmandic/Getty Images

[email protected]

SOURCE: Hollier L et al., Obstet Gynecol. 2019 May;133[5]:e320-56.

NASHVILLE, TENN. – All women should be assessed for cardiovascular disease in the antepartum and postpartum periods using a specific toolkit algorithm, according to new comprehensive guidance from the American College of Obstetricians and Gynecologists.

The toolkit algorithm is called the California Improving Health Care Response to Cardiovascular Disease in Pregnancy and Postpartum Toolkit. It was developed by the Cardiovascular Disease in Pregnancy Postpartum Task Force to serve as a resource for obstetrics, primary care and emergency medicine providers who provide prenatal care or interact with women during the postpartum period. It incldues an overview of clinical assessment and comprehensive management strategies for cardiovascular disease based on risk factors and presenting symptoms.

The guidance also calls for all pregnant and postpartum women with known or suspected CVD to undergo further evaluation by a “Pregnancy Heart Team that includes a cardiologist and maternal–fetal medicine subspecialist, or both, and other subspecialists as necessary.” The guidance was issued in Practice Bulletin 212, Pregnancy and Heart Disease, which is published in the May edition of Obstetrics & Gynecology (Obstet Gynecol. 2019 May;133[5]:e320-e356).


In all, 27 specific recommendations and conclusions relating to screening, diagnosis, and management of CVD for women during the prepregnancy period through the postpartum period are included in the guidance.

ACOG president Lisa Hollier, MD, convened the task force that developed this guidance to address cardiac contributors to maternal mortality, she said during a press briefing at the ACOG annual clinical and scientific meeting.

“When I began my presidency a year ago, my goal was to bring together a multidisciplinary group of clinicians ... to create clinical guidance that would make a difference in the lives of women," said Dr. Hollier, who is also a professor of obstetrics and gynecology at Baylor College of Medicine, Houston. 

Jovanmandic/Getty Images

[email protected]

SOURCE: Hollier L et al., Obstet Gynecol. 2019 May;133[5]:e320-56.

NASHVILLE, TENN. – All women should be assessed for cardiovascular disease in the antepartum and postpartum periods using a specific toolkit algorithm, according to new comprehensive guidance from the American College of Obstetricians and Gynecologists.

The toolkit algorithm is called the California Improving Health Care Response to Cardiovascular Disease in Pregnancy and Postpartum Toolkit. It was developed by the Cardiovascular Disease in Pregnancy Postpartum Task Force to serve as a resource for obstetrics, primary care and emergency medicine providers who provide prenatal care or interact with women during the postpartum period. It incldues an overview of clinical assessment and comprehensive management strategies for cardiovascular disease based on risk factors and presenting symptoms.

The guidance also calls for all pregnant and postpartum women with known or suspected CVD to undergo further evaluation by a “Pregnancy Heart Team that includes a cardiologist and maternal–fetal medicine subspecialist, or both, and other subspecialists as necessary.” The guidance was issued in Practice Bulletin 212, Pregnancy and Heart Disease, which is published in the May edition of Obstetrics & Gynecology (Obstet Gynecol. 2019 May;133[5]:e320-e356).


In all, 27 specific recommendations and conclusions relating to screening, diagnosis, and management of CVD for women during the prepregnancy period through the postpartum period are included in the guidance.

ACOG president Lisa Hollier, MD, convened the task force that developed this guidance to address cardiac contributors to maternal mortality, she said during a press briefing at the ACOG annual clinical and scientific meeting.

“When I began my presidency a year ago, my goal was to bring together a multidisciplinary group of clinicians ... to create clinical guidance that would make a difference in the lives of women," said Dr. Hollier, who is also a professor of obstetrics and gynecology at Baylor College of Medicine, Houston. 

Jovanmandic/Getty Images

[email protected]

SOURCE: Hollier L et al., Obstet Gynecol. 2019 May;133[5]:e320-56.

The Food and Drug Administration decided to continue to allow U.S. sales of textured breast implants, which have been identified as the cause of a rare but significant cancer, breast implant–associated anaplastic large cell lymphoma.

Mitchel L. Zoler/MDedge News

A statement the agency released on May 2 said “The FDA does not believe that, on the basis of available data and information, the device [textured implants] meets the banning standard set forth in the Federal Food and Drug Cosmetic Act.” Experts have estimated that, by early 2019, more than 500 cases of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) had been reported worldwide, roughly half of them in the United States.

In coming to this decision, following 2 days of public testimony and discussions by an advisory committee in late March, the FDA is bucking the path taken by regulatory bodies of the European Union as well as several other counties. The EU acted in December 2018 to produce the equivalent of a ban on sales of textured breast implants marketed by Allergan. Then in April 2019, the French drug and device regulatory agency expanded this ban to textured breast implants sold by five other companies.

During the FDA advisory committee meeting in March, one of the world’s experts on BIA-ALCL, Mark W. Clemens, MD, a plastic surgeon at MD Anderson Cancer Center in Houston, said that of about 500 case reports received by the FDA, not one had involved a confirmed and “pure” episode of BIA-ALCL linked with a smooth breast implant. A team of experts recently reached the same conclusion when reviewing the reported worldwide incidence of BIA-ALCL in a published review (Plast Reconstr Surg. 2019 March;143[3S]:30S-40S).

Despite these reports, the FDA said in its new statement that “While the majority of women who develop BIA-ALCL have had textured implants, there are known cases in women with smooth-surface breast implants, and many reports do not include the surface texture of the implant at the time of diagnosis.” The agency added that it is “focused on strengthening the evidence generated to help inform future regulatory action.” During the March advisory committee meeting, some members of the panel spoke against a marketing ban on textured implants for reasons such as the modest number of reported cases and because of the importance of having a textured implant option available.

[email protected]

The Food and Drug Administration decided to continue to allow U.S. sales of textured breast implants, which have been identified as the cause of a rare but significant cancer, breast implant–associated anaplastic large cell lymphoma.

Mitchel L. Zoler/MDedge News

A statement the agency released on May 2 said “The FDA does not believe that, on the basis of available data and information, the device [textured implants] meets the banning standard set forth in the Federal Food and Drug Cosmetic Act.” Experts have estimated that, by early 2019, more than 500 cases of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) had been reported worldwide, roughly half of them in the United States.

In coming to this decision, following 2 days of public testimony and discussions by an advisory committee in late March, the FDA is bucking the path taken by regulatory bodies of the European Union as well as several other counties. The EU acted in December 2018 to produce the equivalent of a ban on sales of textured breast implants marketed by Allergan. Then in April 2019, the French drug and device regulatory agency expanded this ban to textured breast implants sold by five other companies.

During the FDA advisory committee meeting in March, one of the world’s experts on BIA-ALCL, Mark W. Clemens, MD, a plastic surgeon at MD Anderson Cancer Center in Houston, said that of about 500 case reports received by the FDA, not one had involved a confirmed and “pure” episode of BIA-ALCL linked with a smooth breast implant. A team of experts recently reached the same conclusion when reviewing the reported worldwide incidence of BIA-ALCL in a published review (Plast Reconstr Surg. 2019 March;143[3S]:30S-40S).

Despite these reports, the FDA said in its new statement that “While the majority of women who develop BIA-ALCL have had textured implants, there are known cases in women with smooth-surface breast implants, and many reports do not include the surface texture of the implant at the time of diagnosis.” The agency added that it is “focused on strengthening the evidence generated to help inform future regulatory action.” During the March advisory committee meeting, some members of the panel spoke against a marketing ban on textured implants for reasons such as the modest number of reported cases and because of the importance of having a textured implant option available.

[email protected]

The Food and Drug Administration decided to continue to allow U.S. sales of textured breast implants, which have been identified as the cause of a rare but significant cancer, breast implant–associated anaplastic large cell lymphoma.

Mitchel L. Zoler/MDedge News

A statement the agency released on May 2 said “The FDA does not believe that, on the basis of available data and information, the device [textured implants] meets the banning standard set forth in the Federal Food and Drug Cosmetic Act.” Experts have estimated that, by early 2019, more than 500 cases of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) had been reported worldwide, roughly half of them in the United States.

In coming to this decision, following 2 days of public testimony and discussions by an advisory committee in late March, the FDA is bucking the path taken by regulatory bodies of the European Union as well as several other counties. The EU acted in December 2018 to produce the equivalent of a ban on sales of textured breast implants marketed by Allergan. Then in April 2019, the French drug and device regulatory agency expanded this ban to textured breast implants sold by five other companies.

During the FDA advisory committee meeting in March, one of the world’s experts on BIA-ALCL, Mark W. Clemens, MD, a plastic surgeon at MD Anderson Cancer Center in Houston, said that of about 500 case reports received by the FDA, not one had involved a confirmed and “pure” episode of BIA-ALCL linked with a smooth breast implant. A team of experts recently reached the same conclusion when reviewing the reported worldwide incidence of BIA-ALCL in a published review (Plast Reconstr Surg. 2019 March;143[3S]:30S-40S).

Despite these reports, the FDA said in its new statement that “While the majority of women who develop BIA-ALCL have had textured implants, there are known cases in women with smooth-surface breast implants, and many reports do not include the surface texture of the implant at the time of diagnosis.” The agency added that it is “focused on strengthening the evidence generated to help inform future regulatory action.” During the March advisory committee meeting, some members of the panel spoke against a marketing ban on textured implants for reasons such as the modest number of reported cases and because of the importance of having a textured implant option available.

[email protected]

Health care professionals may not be compelled to provide medical care, including abortion services or even referrals, if they object on religious or moral grounds under a federal regulation finalized May 2.

The regulation also requires health care entities that receive federal funding to alert their employees to their federal conscience rights.

This final rule “replaces a 2011 rule that has proven inadequate, and ensures that HHS implements the full set of tools appropriate for enforcing the conscience protections passed by Congress,” HHS officials said in a statement. “These federal laws protect providers, individuals, and other health care entities from having to provide, participate in, pay for, provide coverage of, or refer for, services such as abortion, sterilization, or assisted suicide. It also includes conscience protections with respect to advance directives.”

The regulation was first proposed in January 2018, shortly after the formation of the Conscience and Religious Freedom Division within the HHS Office of Civil Rights (OCR).

Application of the regulation extends beyond the clinic and hospital. The regulation notes that, on a case-by-case basis, those providing emergency services such as EMTs or even ambulance drivers could be protected should they choose to exercise their conscience and not provide services based on their religious beliefs.

“With this final rule, the Department seeks to educate protected entities and covered entities as to their legal rights and obligations; to encourage individuals and organizations with religious beliefs or moral convictions to enter, or remain in, the health care industry; and to prevent others from being dissuaded from filing complaints due to prior OCR complaint resolutions or sub-regulatory guidance that no reflect the views of the Department,” according to the regulation.

HHS officials denied accusations that the regulation puts the needs of providers over those of patients.

By “protecting a diversity of beliefs among health care providers, these protections ensure that options are available to patients who desire, and would feel most comfortable with, a provider whose religious beliefs or moral convictions match their own. Even where a patient and provider do not share the same religious beliefs or moral convictions, it is not necessarily the case that patients would want providers to be forced to violate their religious beliefs or moral convictions,” according to the regulation.

However, the American Civil Liberties Union and others see the new regulation as license to discriminate.

“Once again, this administration shows itself to be determined to use religious liberty to harm communities it deems less worthy of equal treatment under the law,” Louise Melling, ACLU deputy legal director, said in a statement. “This rule threatens to prevent people from accessing critical medical care and may endanger people’s lives. Religious liberty is a fundamental right, but it does not include the right to discriminate or harm others. Denying patients health care is not religious liberty. Discriminating against patients based on their gender or gender expression is not religious liberty. Medical standards, not religious beliefs, should guide medical care.”

The regulation does not yet have a scheduled publication date in the Federal Register, nor has it been posted as a preview document on the publication’s website. It will become effective 60 days after publication.

[email protected]

Health care professionals may not be compelled to provide medical care, including abortion services or even referrals, if they object on religious or moral grounds under a federal regulation finalized May 2.

The regulation also requires health care entities that receive federal funding to alert their employees to their federal conscience rights.

This final rule “replaces a 2011 rule that has proven inadequate, and ensures that HHS implements the full set of tools appropriate for enforcing the conscience protections passed by Congress,” HHS officials said in a statement. “These federal laws protect providers, individuals, and other health care entities from having to provide, participate in, pay for, provide coverage of, or refer for, services such as abortion, sterilization, or assisted suicide. It also includes conscience protections with respect to advance directives.”

The regulation was first proposed in January 2018, shortly after the formation of the Conscience and Religious Freedom Division within the HHS Office of Civil Rights (OCR).

Application of the regulation extends beyond the clinic and hospital. The regulation notes that, on a case-by-case basis, those providing emergency services such as EMTs or even ambulance drivers could be protected should they choose to exercise their conscience and not provide services based on their religious beliefs.

“With this final rule, the Department seeks to educate protected entities and covered entities as to their legal rights and obligations; to encourage individuals and organizations with religious beliefs or moral convictions to enter, or remain in, the health care industry; and to prevent others from being dissuaded from filing complaints due to prior OCR complaint resolutions or sub-regulatory guidance that no reflect the views of the Department,” according to the regulation.

HHS officials denied accusations that the regulation puts the needs of providers over those of patients.

By “protecting a diversity of beliefs among health care providers, these protections ensure that options are available to patients who desire, and would feel most comfortable with, a provider whose religious beliefs or moral convictions match their own. Even where a patient and provider do not share the same religious beliefs or moral convictions, it is not necessarily the case that patients would want providers to be forced to violate their religious beliefs or moral convictions,” according to the regulation.

However, the American Civil Liberties Union and others see the new regulation as license to discriminate.

“Once again, this administration shows itself to be determined to use religious liberty to harm communities it deems less worthy of equal treatment under the law,” Louise Melling, ACLU deputy legal director, said in a statement. “This rule threatens to prevent people from accessing critical medical care and may endanger people’s lives. Religious liberty is a fundamental right, but it does not include the right to discriminate or harm others. Denying patients health care is not religious liberty. Discriminating against patients based on their gender or gender expression is not religious liberty. Medical standards, not religious beliefs, should guide medical care.”

The regulation does not yet have a scheduled publication date in the Federal Register, nor has it been posted as a preview document on the publication’s website. It will become effective 60 days after publication.

[email protected]

Health care professionals may not be compelled to provide medical care, including abortion services or even referrals, if they object on religious or moral grounds under a federal regulation finalized May 2.

The regulation also requires health care entities that receive federal funding to alert their employees to their federal conscience rights.

This final rule “replaces a 2011 rule that has proven inadequate, and ensures that HHS implements the full set of tools appropriate for enforcing the conscience protections passed by Congress,” HHS officials said in a statement. “These federal laws protect providers, individuals, and other health care entities from having to provide, participate in, pay for, provide coverage of, or refer for, services such as abortion, sterilization, or assisted suicide. It also includes conscience protections with respect to advance directives.”

The regulation was first proposed in January 2018, shortly after the formation of the Conscience and Religious Freedom Division within the HHS Office of Civil Rights (OCR).

Application of the regulation extends beyond the clinic and hospital. The regulation notes that, on a case-by-case basis, those providing emergency services such as EMTs or even ambulance drivers could be protected should they choose to exercise their conscience and not provide services based on their religious beliefs.

“With this final rule, the Department seeks to educate protected entities and covered entities as to their legal rights and obligations; to encourage individuals and organizations with religious beliefs or moral convictions to enter, or remain in, the health care industry; and to prevent others from being dissuaded from filing complaints due to prior OCR complaint resolutions or sub-regulatory guidance that no reflect the views of the Department,” according to the regulation.

HHS officials denied accusations that the regulation puts the needs of providers over those of patients.

By “protecting a diversity of beliefs among health care providers, these protections ensure that options are available to patients who desire, and would feel most comfortable with, a provider whose religious beliefs or moral convictions match their own. Even where a patient and provider do not share the same religious beliefs or moral convictions, it is not necessarily the case that patients would want providers to be forced to violate their religious beliefs or moral convictions,” according to the regulation.

However, the American Civil Liberties Union and others see the new regulation as license to discriminate.

“Once again, this administration shows itself to be determined to use religious liberty to harm communities it deems less worthy of equal treatment under the law,” Louise Melling, ACLU deputy legal director, said in a statement. “This rule threatens to prevent people from accessing critical medical care and may endanger people’s lives. Religious liberty is a fundamental right, but it does not include the right to discriminate or harm others. Denying patients health care is not religious liberty. Discriminating against patients based on their gender or gender expression is not religious liberty. Medical standards, not religious beliefs, should guide medical care.”

The regulation does not yet have a scheduled publication date in the Federal Register, nor has it been posted as a preview document on the publication’s website. It will become effective 60 days after publication.

[email protected]

For women with symptomatic uterine leiomyomas and abnormal uterine bleeding, ulipristal acetate treatment significantly improved quality of life over placebo, according to a study of the intention-to-treat populations of the randomized, double-blind, phase III VENUS I and VENUS II trials.

Courtesy Wikimedia Commons/Hic et nunc/CC BY-SA 3.0

In these pivotal studies, ulipristal (Ella) at either 5 mg or 10 mg significantly improved both rate of and time to amenorrhea, noted Andrea S. Lukes, MD, of Carolina Women’s Research and Wellness Center in Durham, N.C. To assess effects on quality of life, she and her associates analyzed baseline and 12-week responses to the widely validated Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QOL) questionnaire, which examined factors such as symptom severity, energy and mood, physical and social activities, self-consciousness, and sexual functioning.

Among 589 patients in the analysis, 169 received placebo, 215 received 5 mg ulipristal, and 205 received 10 mg ulipristal. At baseline, average total quality of life scores on UFS-QOL were 33 (standard deviation, 220), 32 (SD, 21), and 36 (SD, 23), respectively, the researchers wrote in Obstetrics & Gynecology.

After 12 weeks of treatment, both doses of ulipristal were associated with significantly greater improvements on all UFS-QOL scales, compared with placebo (P less than .001). For example, on a scale of 0-100, symptom severity improved by a mean of 23 with ulipristal 5 mg and by a mean of 30 with ulipristal 10 mg (both P less than .001 versus placebo).

“Although a small proportion of patients experienced no change or some worsening in these outcomes, the majority of women reported clear improvements; for example, more than 70% of patients in the ulipristal treatment arms achieved a meaningful improvement of 30 or more points on the Revised Activities subscale,” the researchers wrote.

Additionally, significantly greater improvements in physical and social activities were seen for both ulipristal doses, compared with placebo, from baseline to the end of treatment.

The VENUS II trial included two 12-week treatment courses. In this trial, women who switched from ulipristal to placebo experienced some worsening in quality of life, while those who switched from placebo to ulipristal improved their UFS-QOL scores, the investigators said. Patients who stayed on ulipristal throughout continued to benefit from one treatment course to the next.

The researchers concluded that the findings, “taken together with the significant improvements in amenorrhea, suggest that ulipristal is a promising, noninvasive treatment option for women suffering from symptomatic uterine leiomyomas.”

Allergan provided funding. Dr. Lukes disclosed ties to Allergan, AbbVie, Myovant, Merck, and several other companies. Four of the coauthors are employees of Allergan, and the two remaining coauthors had links to a number of pharmaceutical companies.

SOURCE: Lukes AS et al. Obstet Gynecol 2019;133 (5):869-78.

For women with symptomatic uterine leiomyomas and abnormal uterine bleeding, ulipristal acetate treatment significantly improved quality of life over placebo, according to a study of the intention-to-treat populations of the randomized, double-blind, phase III VENUS I and VENUS II trials.

Courtesy Wikimedia Commons/Hic et nunc/CC BY-SA 3.0

In these pivotal studies, ulipristal (Ella) at either 5 mg or 10 mg significantly improved both rate of and time to amenorrhea, noted Andrea S. Lukes, MD, of Carolina Women’s Research and Wellness Center in Durham, N.C. To assess effects on quality of life, she and her associates analyzed baseline and 12-week responses to the widely validated Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QOL) questionnaire, which examined factors such as symptom severity, energy and mood, physical and social activities, self-consciousness, and sexual functioning.

Among 589 patients in the analysis, 169 received placebo, 215 received 5 mg ulipristal, and 205 received 10 mg ulipristal. At baseline, average total quality of life scores on UFS-QOL were 33 (standard deviation, 220), 32 (SD, 21), and 36 (SD, 23), respectively, the researchers wrote in Obstetrics & Gynecology.

After 12 weeks of treatment, both doses of ulipristal were associated with significantly greater improvements on all UFS-QOL scales, compared with placebo (P less than .001). For example, on a scale of 0-100, symptom severity improved by a mean of 23 with ulipristal 5 mg and by a mean of 30 with ulipristal 10 mg (both P less than .001 versus placebo).

“Although a small proportion of patients experienced no change or some worsening in these outcomes, the majority of women reported clear improvements; for example, more than 70% of patients in the ulipristal treatment arms achieved a meaningful improvement of 30 or more points on the Revised Activities subscale,” the researchers wrote.

Additionally, significantly greater improvements in physical and social activities were seen for both ulipristal doses, compared with placebo, from baseline to the end of treatment.

The VENUS II trial included two 12-week treatment courses. In this trial, women who switched from ulipristal to placebo experienced some worsening in quality of life, while those who switched from placebo to ulipristal improved their UFS-QOL scores, the investigators said. Patients who stayed on ulipristal throughout continued to benefit from one treatment course to the next.

The researchers concluded that the findings, “taken together with the significant improvements in amenorrhea, suggest that ulipristal is a promising, noninvasive treatment option for women suffering from symptomatic uterine leiomyomas.”

Allergan provided funding. Dr. Lukes disclosed ties to Allergan, AbbVie, Myovant, Merck, and several other companies. Four of the coauthors are employees of Allergan, and the two remaining coauthors had links to a number of pharmaceutical companies.

SOURCE: Lukes AS et al. Obstet Gynecol 2019;133 (5):869-78.

For women with symptomatic uterine leiomyomas and abnormal uterine bleeding, ulipristal acetate treatment significantly improved quality of life over placebo, according to a study of the intention-to-treat populations of the randomized, double-blind, phase III VENUS I and VENUS II trials.

Courtesy Wikimedia Commons/Hic et nunc/CC BY-SA 3.0

In these pivotal studies, ulipristal (Ella) at either 5 mg or 10 mg significantly improved both rate of and time to amenorrhea, noted Andrea S. Lukes, MD, of Carolina Women’s Research and Wellness Center in Durham, N.C. To assess effects on quality of life, she and her associates analyzed baseline and 12-week responses to the widely validated Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QOL) questionnaire, which examined factors such as symptom severity, energy and mood, physical and social activities, self-consciousness, and sexual functioning.

Among 589 patients in the analysis, 169 received placebo, 215 received 5 mg ulipristal, and 205 received 10 mg ulipristal. At baseline, average total quality of life scores on UFS-QOL were 33 (standard deviation, 220), 32 (SD, 21), and 36 (SD, 23), respectively, the researchers wrote in Obstetrics & Gynecology.

After 12 weeks of treatment, both doses of ulipristal were associated with significantly greater improvements on all UFS-QOL scales, compared with placebo (P less than .001). For example, on a scale of 0-100, symptom severity improved by a mean of 23 with ulipristal 5 mg and by a mean of 30 with ulipristal 10 mg (both P less than .001 versus placebo).

“Although a small proportion of patients experienced no change or some worsening in these outcomes, the majority of women reported clear improvements; for example, more than 70% of patients in the ulipristal treatment arms achieved a meaningful improvement of 30 or more points on the Revised Activities subscale,” the researchers wrote.

Additionally, significantly greater improvements in physical and social activities were seen for both ulipristal doses, compared with placebo, from baseline to the end of treatment.

The VENUS II trial included two 12-week treatment courses. In this trial, women who switched from ulipristal to placebo experienced some worsening in quality of life, while those who switched from placebo to ulipristal improved their UFS-QOL scores, the investigators said. Patients who stayed on ulipristal throughout continued to benefit from one treatment course to the next.

The researchers concluded that the findings, “taken together with the significant improvements in amenorrhea, suggest that ulipristal is a promising, noninvasive treatment option for women suffering from symptomatic uterine leiomyomas.”

Allergan provided funding. Dr. Lukes disclosed ties to Allergan, AbbVie, Myovant, Merck, and several other companies. Four of the coauthors are employees of Allergan, and the two remaining coauthors had links to a number of pharmaceutical companies.

SOURCE: Lukes AS et al. Obstet Gynecol 2019;133 (5):869-78.

External cephalic version in breech pregnancies is more likely to succeed in multiparous women with a lower body mass index (BMI) who have a larger forebag, according to results of a single-center retrospective study.

Writing in Obstetrics & Gynecology, Ofer Isakov, MD, PhD, and colleagues from the Sourasky Medical Center, Tel Aviv, reported the results of a study of 250 women with singleton pregnancies and breech presentation who underwent external cephalic version (ECV) to turn the baby at 36-41 weeks’ gestation.

The overall success rate of the procedure was 65%. However, women with no forebag – the pocket of amniotic fluid in front of the fetal presenting part – had a 3%-10% chance of successful version, while those with a forebag size greater than 1 cm had a 96%-97% probability of success.

Women with a BMI greater than 29 had a very low chance of success, which the authors suggested was likely attributable to a thicker abdominal wall that made manipulation more difficult. However, among women with a BMI of 29 or below, success was significantly associated with forebag size.

Among women with a forebag of 1 cm in size, multiparous women had a significantly higher chance of success than nulliparous women (81%-91% vs. 0%-24%, respectively).

Dr. Isakov and colleagues suggested that the impact of multiparity could relate to late engagement or the relative laxity of the abdomen in women who had experienced previous births.

The authors then developed a decision tree predictive model of success for ECV, which had a prediction accuracy of 92%.

“External version is a simple and effective procedure that can reduce the cesarean delivery rate, but counseling patients on the risks and success rates of version is challenging owing to the lack of validated models to predict success,” Dr. Isakov and colleagues wrote. “The ability to predict the outcome of an ECV attempt may improve the rates of patient consent and prevent the performance of many unpleasant procedures with low chance for success.”

They noted that their success rate was higher than that seen in other studies of ECV and suggested this may be because all the procedures were performed by a single experienced practitioner, and the mean BMI of the cohort was lower than that in earlier studies.

None of the authors declared any relevant financial disclosures, and there was no external funding.

SOURCE: Isakov O et al. Obstet Gynecol. 2019;133:869-78.

External cephalic version in breech pregnancies is more likely to succeed in multiparous women with a lower body mass index (BMI) who have a larger forebag, according to results of a single-center retrospective study.

Writing in Obstetrics & Gynecology, Ofer Isakov, MD, PhD, and colleagues from the Sourasky Medical Center, Tel Aviv, reported the results of a study of 250 women with singleton pregnancies and breech presentation who underwent external cephalic version (ECV) to turn the baby at 36-41 weeks’ gestation.

The overall success rate of the procedure was 65%. However, women with no forebag – the pocket of amniotic fluid in front of the fetal presenting part – had a 3%-10% chance of successful version, while those with a forebag size greater than 1 cm had a 96%-97% probability of success.

Women with a BMI greater than 29 had a very low chance of success, which the authors suggested was likely attributable to a thicker abdominal wall that made manipulation more difficult. However, among women with a BMI of 29 or below, success was significantly associated with forebag size.

Among women with a forebag of 1 cm in size, multiparous women had a significantly higher chance of success than nulliparous women (81%-91% vs. 0%-24%, respectively).

Dr. Isakov and colleagues suggested that the impact of multiparity could relate to late engagement or the relative laxity of the abdomen in women who had experienced previous births.

The authors then developed a decision tree predictive model of success for ECV, which had a prediction accuracy of 92%.

“External version is a simple and effective procedure that can reduce the cesarean delivery rate, but counseling patients on the risks and success rates of version is challenging owing to the lack of validated models to predict success,” Dr. Isakov and colleagues wrote. “The ability to predict the outcome of an ECV attempt may improve the rates of patient consent and prevent the performance of many unpleasant procedures with low chance for success.”

They noted that their success rate was higher than that seen in other studies of ECV and suggested this may be because all the procedures were performed by a single experienced practitioner, and the mean BMI of the cohort was lower than that in earlier studies.

None of the authors declared any relevant financial disclosures, and there was no external funding.

SOURCE: Isakov O et al. Obstet Gynecol. 2019;133:869-78.

External cephalic version in breech pregnancies is more likely to succeed in multiparous women with a lower body mass index (BMI) who have a larger forebag, according to results of a single-center retrospective study.

Writing in Obstetrics & Gynecology, Ofer Isakov, MD, PhD, and colleagues from the Sourasky Medical Center, Tel Aviv, reported the results of a study of 250 women with singleton pregnancies and breech presentation who underwent external cephalic version (ECV) to turn the baby at 36-41 weeks’ gestation.

The overall success rate of the procedure was 65%. However, women with no forebag – the pocket of amniotic fluid in front of the fetal presenting part – had a 3%-10% chance of successful version, while those with a forebag size greater than 1 cm had a 96%-97% probability of success.

Women with a BMI greater than 29 had a very low chance of success, which the authors suggested was likely attributable to a thicker abdominal wall that made manipulation more difficult. However, among women with a BMI of 29 or below, success was significantly associated with forebag size.

Among women with a forebag of 1 cm in size, multiparous women had a significantly higher chance of success than nulliparous women (81%-91% vs. 0%-24%, respectively).

Dr. Isakov and colleagues suggested that the impact of multiparity could relate to late engagement or the relative laxity of the abdomen in women who had experienced previous births.

The authors then developed a decision tree predictive model of success for ECV, which had a prediction accuracy of 92%.

“External version is a simple and effective procedure that can reduce the cesarean delivery rate, but counseling patients on the risks and success rates of version is challenging owing to the lack of validated models to predict success,” Dr. Isakov and colleagues wrote. “The ability to predict the outcome of an ECV attempt may improve the rates of patient consent and prevent the performance of many unpleasant procedures with low chance for success.”

They noted that their success rate was higher than that seen in other studies of ECV and suggested this may be because all the procedures were performed by a single experienced practitioner, and the mean BMI of the cohort was lower than that in earlier studies.

None of the authors declared any relevant financial disclosures, and there was no external funding.

SOURCE: Isakov O et al. Obstet Gynecol. 2019;133:869-78.