Women's Health

Nearly 700 women died from pregnancy-related complications in the United States in 2018, and almost a third of those deaths were associated with cardiovascular disease, according to the latest data from the Centers for Disease Control and Prevention.

Strikingly, studies suggest that up to half of cardiovascular disease–related maternal deaths are preventable, yet CVD remains the leading cause of maternal morbidity and mortality – and the incidence has been rising steadily for 2 decades.

The American College of Obstetricians and Gynecologists says that acquired heart disease is the likely culprit in the rise in incidence of maternal mortality as women enter pregnancy with an increasingly heavy burden of CVD risk factors, including older age, obesity, diabetes, and hypertension.

“They are entering pregnancy while already at risk, and that has led to an increase in morbidity and mortality during pregnancy,” Renee Patrice Bullock-Palmer, MD, a cardiologist and director of the Women’s Heart Center at Deborah Heart and Lung Center in Browns Mills, N.J., explained in an interview. “Unfortunately, among developed countries, the U.S. has the highest rates of maternal morbidity and mortality, and that’s shocking.”

It’s a problem that requires collaboration between obstetricians, cardiologists, and others involved in the care of pregnant women, she said.
 

The data and the depth of the crisis

The maternal mortality rate in 1987 – the year the CDC’s Pregnancy Mortality Surveillance System was implemented – was 7.2 per 100,000 live births. The rate in 2016 was more than double that at 16.9, and the rate in 2018, the most recent year for which data are available, was 17.4 – and significant racial and ethnic disparities in those rates have persisted over time.

In an August 2019 article published on the American Heart Association website, Dr. Bullock-Palmer addressed the cardiovascular state of health for pregnant women and the role of the cardiologists in their care, noting that there is a “role for increased collaboration between the cardiologist and the obstetrician with regards to a pregnancy heart team.”

“It is vital that mothers who are at increased risk for CVD or have established CVD be referred to a cardiologist for cardiovascular assessment and management,” she wrote, adding it is important to raise awareness among ob.gyns. and to improve cardiologists’ recognition of women at risk when they present for care for the first time.

These referrals should be made in the antepartum and early postpartum period, she said in an interview. More attention also must be paid to racial and ethnic disparities, and the role of cardiologists in addressing these disparities.

The CDC has emphasized racial and ethnic disparities in maternal mortality, noting in a 2019 Morbidity and Mortality Weekly report that, compared with white women, black and American Indian/Alaskan Native women aged over 30 years have a 300%-400% higher rate of pregnancy-related deaths (Morb Mortal Wkly Rep. 2019 Sep 6;68[35]:762-5).

With regard to disparities, Dr. Bullock-Palmer said the causes are multifold and may be related to a higher prevalence of CVD risk factors like obesity and hypertension in non-Hispanic black women.

“There may also be limited access to adequate postpartum care in this patient population,” she wrote, adding that some attention has been paid to addressing disparities, but that “there is a lot of work left to be done in resolving these inequities in maternal health care.”

Partnerships across specialties will help in addressing most of the factors associated with CVD and maternal death, she said.

The urgent need for these partnerships is underscored by the latest findings on CVD-related complications in pregnancy. A study published in March 2020 in the Journal of the American College of Cardiology, for example, looked specifically at the incidence of serious cardiac events (SCEs) in pregnant women with heart disease, and whether the events were preventable.

In a prospective cohort of 1,315 pregnancies among women with heart disease, Birgit Pfaller, MD, of the University of Toronto Pregnancy and Heart Disease Research Program, and colleagues found that SCEs occurred in 3.6% of cases (47 women) – most often during the antepartum period – that 49% were preventable, and that 74% were related to provider management factors.

The most common SCEs were cardiac death or arrest, heart failure, arrhythmias, and urgent intervention, and they were more likely to occur in women with acquired heart disease, severe aortic or mitral stenosis, mechanical valves, and systemic ventricular dysfunction. Adverse fetal and neonatal outcomes more than doubled in cases involving SCEs, compared with those without (62% vs. 29%), and adverse obstetric events occurred most often in women with severe preeclampsia.

“The majority of the preventable events occurred due to provider management factors, including: failure to identify the patient condition prior to pregnancy, failure to identify the patient as high risk, late recognition in cardiac deterioration, delay in treatment/intervention, inappropriate treatment, and lack of preconception counseling,” Melinda Davis, MD, of the University of Michigan, Ann Arbor, wrote in a summary and editorial published in the Journal of the American College of Cardiology.

Some preventable events were attributable to patient failure to seek care, noncompliance with care recommendations, and lack of access to care, Dr. Davis noted.

“These findings suggest that provider training, patient education, and health care advocacy are all important interventions to improve outcomes among pregnant women,” she wrote, adding that “the development of multidisciplinary cardio-obstetric clinics at tertiary care centers may also be helpful.”

Dr. Bullock-Palmer added the need for greater risk-prediction tools to the list, explaining that these are needed to assess CVD risk in the prenatal, antenatal, and postnatal period.

“The recently concluded Cardiac Disease in Pregnancy [CARPREG II] study indicated that there were 10 predictors that could be utilized to asses maternal CVD risk,” she noted.

The CARPREG II authors identified five general predictors (prior cardiac events or arrhythmias, poor functional class or cyanosis, high-risk valve disease/left ventricular outflow tract obstruction, systemic ventricular dysfunction, no prior cardiac interventions), four lesion-specific predictors (mechanical valves, high-risk aortopathies, pulmonary hypertension, coronary artery disease), and one delivery-of-care predictor (late pregnancy assessment), and incorporated them into a risk index.

“It is hopeful that these new initiatives will assist providers in improving their ability to appropriately risk stratify women,” Dr. Bullock-Palmer said.

 

Ongoing efforts

Efforts also are ongoing to develop the types of cardio-obstetric clinics mentioned by Dr. Davis and to establish collaborations and “pregnancy heart teams” as attention is increasingly focused on the U.S. maternal mortality crisis.

In fact, such teams are a cornerstone of ACOG’s guidance on pregnancy and heart disease. In May 2019 the college released a Practice Bulletin with 27 specific recommendations and conclusions relating to screening, diagnosis, and management of CVD for women during the prepregnancy period through the postpartum period.

Pregnant women and postpartum women with known or suspected CVD should undergo evaluation by a “pregnancy heart team that includes a cardiologist and maternal-fetal medicine subspecialist, or both, and other subspecialists as necessary,” according to the bulletin.

In a recent interview, Lisa Hollier, MD, immediate past president of ACOG and an instrumental figure in the push to better address maternal mortality – and in particular the cardiovascular contributors to the crisis – said she is “seeing a strengthening of that” with numerous organizations establishing pregnancy health teams.

Dr. Bullock-Palmer said she also is seeing progress, and added that collaboration should be prioritized even in the absence of dedicated pregnancy heart teams and clinics.

“Heart disease in pregnancy requires a multidisciplinary approach. You can’t just see the patient from the cardiac perspective – you also have to interact and team up with the obstetrician who is handling the pregnancy,” she said, adding that, without a dedicated team, coordination takes more effort, but is imperative for improving outcomes. “You have to collaborate at times when it is beyond the expertise of the institution or the physician; you have to know when to refer these higher-risk patients, particularly women with adult congenital heart disease.”

This referral should occur early – preferably in the antenatal period, she added.

The most important thing, however, is “recognizing these women ... even before the pregnancy,” Dr. Bullock-Palmer said, explaining that this can facilitate the necessary management – and in some cases, postponement – of pregnancy for women whose cardiac issues need to be addressed first.

Among other efforts to address maternal mortality are several programs developed by ACOG, and the Heart Outcomes in Pregnancy: Expectations for Mom and Baby Registry (HOPE) project of the Saint Luke’s Health System in Kansas.

“Hopefully the [HOPE] research collaborative ... which aims to address key clinical questions surrounding the preconception period, antenatal care, delivery planning and outcomes, and long-term postpartum care and outcomes of women will help to address the knowledge gaps and disparities in the care of women with heart disease in pregnancy,” Dr. Bullock-Palmer wrote in her article.

CVD-related risks in the post partum

Dr. Bullock-Palmer has particular concern for postpartum follow-up, given the increased risk for future heart disease among women with CVD-related pregnancy complications and the heightened risk of certain CVD-related events in the postpartum period.

That’s a component of the crisis that also was addressed during a press briefing at the 2019 ACOG annual meeting when the Pregnancy and Heart Disease Practice Bulletin was released.

Sharon Worcester/MDedge News

James Martin, MD, chair of ACOG’s Pregnancy and Heart Disease Task Force and a past ACOG president, explained during the briefing that CVD-related risks may accelerate and persist in the days and weeks after delivery, underscoring the need for follow-up and postpartum care.

Cardiomyopathy is a particular concern during this time – it’s the major cause of maternal mortality after 42 days, he noted. An emphasis on postpartum care also is especially important given that some data suggest up to 40% of women don’t return for that care.

“That is a very sad statistic and perhaps it reflects on our need to change payment models so that physicians and patients realize the importance of coming back for continuing care, because this really may be the end of pregnancy, but it is the beginning of the rest of their life,” he said. “And if they have cardiovascular disease or the risk factors ... they are going to possibly become worse over the course of their lifetime.”

[email protected]

Nearly 700 women died from pregnancy-related complications in the United States in 2018, and almost a third of those deaths were associated with cardiovascular disease, according to the latest data from the Centers for Disease Control and Prevention.

Strikingly, studies suggest that up to half of cardiovascular disease–related maternal deaths are preventable, yet CVD remains the leading cause of maternal morbidity and mortality – and the incidence has been rising steadily for 2 decades.

The American College of Obstetricians and Gynecologists says that acquired heart disease is the likely culprit in the rise in incidence of maternal mortality as women enter pregnancy with an increasingly heavy burden of CVD risk factors, including older age, obesity, diabetes, and hypertension.

“They are entering pregnancy while already at risk, and that has led to an increase in morbidity and mortality during pregnancy,” Renee Patrice Bullock-Palmer, MD, a cardiologist and director of the Women’s Heart Center at Deborah Heart and Lung Center in Browns Mills, N.J., explained in an interview. “Unfortunately, among developed countries, the U.S. has the highest rates of maternal morbidity and mortality, and that’s shocking.”

It’s a problem that requires collaboration between obstetricians, cardiologists, and others involved in the care of pregnant women, she said.
 

The data and the depth of the crisis

The maternal mortality rate in 1987 – the year the CDC’s Pregnancy Mortality Surveillance System was implemented – was 7.2 per 100,000 live births. The rate in 2016 was more than double that at 16.9, and the rate in 2018, the most recent year for which data are available, was 17.4 – and significant racial and ethnic disparities in those rates have persisted over time.

In an August 2019 article published on the American Heart Association website, Dr. Bullock-Palmer addressed the cardiovascular state of health for pregnant women and the role of the cardiologists in their care, noting that there is a “role for increased collaboration between the cardiologist and the obstetrician with regards to a pregnancy heart team.”

“It is vital that mothers who are at increased risk for CVD or have established CVD be referred to a cardiologist for cardiovascular assessment and management,” she wrote, adding it is important to raise awareness among ob.gyns. and to improve cardiologists’ recognition of women at risk when they present for care for the first time.

These referrals should be made in the antepartum and early postpartum period, she said in an interview. More attention also must be paid to racial and ethnic disparities, and the role of cardiologists in addressing these disparities.

The CDC has emphasized racial and ethnic disparities in maternal mortality, noting in a 2019 Morbidity and Mortality Weekly report that, compared with white women, black and American Indian/Alaskan Native women aged over 30 years have a 300%-400% higher rate of pregnancy-related deaths (Morb Mortal Wkly Rep. 2019 Sep 6;68[35]:762-5).

With regard to disparities, Dr. Bullock-Palmer said the causes are multifold and may be related to a higher prevalence of CVD risk factors like obesity and hypertension in non-Hispanic black women.

“There may also be limited access to adequate postpartum care in this patient population,” she wrote, adding that some attention has been paid to addressing disparities, but that “there is a lot of work left to be done in resolving these inequities in maternal health care.”

Partnerships across specialties will help in addressing most of the factors associated with CVD and maternal death, she said.

The urgent need for these partnerships is underscored by the latest findings on CVD-related complications in pregnancy. A study published in March 2020 in the Journal of the American College of Cardiology, for example, looked specifically at the incidence of serious cardiac events (SCEs) in pregnant women with heart disease, and whether the events were preventable.

In a prospective cohort of 1,315 pregnancies among women with heart disease, Birgit Pfaller, MD, of the University of Toronto Pregnancy and Heart Disease Research Program, and colleagues found that SCEs occurred in 3.6% of cases (47 women) – most often during the antepartum period – that 49% were preventable, and that 74% were related to provider management factors.

The most common SCEs were cardiac death or arrest, heart failure, arrhythmias, and urgent intervention, and they were more likely to occur in women with acquired heart disease, severe aortic or mitral stenosis, mechanical valves, and systemic ventricular dysfunction. Adverse fetal and neonatal outcomes more than doubled in cases involving SCEs, compared with those without (62% vs. 29%), and adverse obstetric events occurred most often in women with severe preeclampsia.

“The majority of the preventable events occurred due to provider management factors, including: failure to identify the patient condition prior to pregnancy, failure to identify the patient as high risk, late recognition in cardiac deterioration, delay in treatment/intervention, inappropriate treatment, and lack of preconception counseling,” Melinda Davis, MD, of the University of Michigan, Ann Arbor, wrote in a summary and editorial published in the Journal of the American College of Cardiology.

Some preventable events were attributable to patient failure to seek care, noncompliance with care recommendations, and lack of access to care, Dr. Davis noted.

“These findings suggest that provider training, patient education, and health care advocacy are all important interventions to improve outcomes among pregnant women,” she wrote, adding that “the development of multidisciplinary cardio-obstetric clinics at tertiary care centers may also be helpful.”

Dr. Bullock-Palmer added the need for greater risk-prediction tools to the list, explaining that these are needed to assess CVD risk in the prenatal, antenatal, and postnatal period.

“The recently concluded Cardiac Disease in Pregnancy [CARPREG II] study indicated that there were 10 predictors that could be utilized to asses maternal CVD risk,” she noted.

The CARPREG II authors identified five general predictors (prior cardiac events or arrhythmias, poor functional class or cyanosis, high-risk valve disease/left ventricular outflow tract obstruction, systemic ventricular dysfunction, no prior cardiac interventions), four lesion-specific predictors (mechanical valves, high-risk aortopathies, pulmonary hypertension, coronary artery disease), and one delivery-of-care predictor (late pregnancy assessment), and incorporated them into a risk index.

“It is hopeful that these new initiatives will assist providers in improving their ability to appropriately risk stratify women,” Dr. Bullock-Palmer said.

 

Ongoing efforts

Efforts also are ongoing to develop the types of cardio-obstetric clinics mentioned by Dr. Davis and to establish collaborations and “pregnancy heart teams” as attention is increasingly focused on the U.S. maternal mortality crisis.

In fact, such teams are a cornerstone of ACOG’s guidance on pregnancy and heart disease. In May 2019 the college released a Practice Bulletin with 27 specific recommendations and conclusions relating to screening, diagnosis, and management of CVD for women during the prepregnancy period through the postpartum period.

Pregnant women and postpartum women with known or suspected CVD should undergo evaluation by a “pregnancy heart team that includes a cardiologist and maternal-fetal medicine subspecialist, or both, and other subspecialists as necessary,” according to the bulletin.

In a recent interview, Lisa Hollier, MD, immediate past president of ACOG and an instrumental figure in the push to better address maternal mortality – and in particular the cardiovascular contributors to the crisis – said she is “seeing a strengthening of that” with numerous organizations establishing pregnancy health teams.

Dr. Bullock-Palmer said she also is seeing progress, and added that collaboration should be prioritized even in the absence of dedicated pregnancy heart teams and clinics.

“Heart disease in pregnancy requires a multidisciplinary approach. You can’t just see the patient from the cardiac perspective – you also have to interact and team up with the obstetrician who is handling the pregnancy,” she said, adding that, without a dedicated team, coordination takes more effort, but is imperative for improving outcomes. “You have to collaborate at times when it is beyond the expertise of the institution or the physician; you have to know when to refer these higher-risk patients, particularly women with adult congenital heart disease.”

This referral should occur early – preferably in the antenatal period, she added.

The most important thing, however, is “recognizing these women ... even before the pregnancy,” Dr. Bullock-Palmer said, explaining that this can facilitate the necessary management – and in some cases, postponement – of pregnancy for women whose cardiac issues need to be addressed first.

Among other efforts to address maternal mortality are several programs developed by ACOG, and the Heart Outcomes in Pregnancy: Expectations for Mom and Baby Registry (HOPE) project of the Saint Luke’s Health System in Kansas.

“Hopefully the [HOPE] research collaborative ... which aims to address key clinical questions surrounding the preconception period, antenatal care, delivery planning and outcomes, and long-term postpartum care and outcomes of women will help to address the knowledge gaps and disparities in the care of women with heart disease in pregnancy,” Dr. Bullock-Palmer wrote in her article.

CVD-related risks in the post partum

Dr. Bullock-Palmer has particular concern for postpartum follow-up, given the increased risk for future heart disease among women with CVD-related pregnancy complications and the heightened risk of certain CVD-related events in the postpartum period.

That’s a component of the crisis that also was addressed during a press briefing at the 2019 ACOG annual meeting when the Pregnancy and Heart Disease Practice Bulletin was released.

Sharon Worcester/MDedge News

James Martin, MD, chair of ACOG’s Pregnancy and Heart Disease Task Force and a past ACOG president, explained during the briefing that CVD-related risks may accelerate and persist in the days and weeks after delivery, underscoring the need for follow-up and postpartum care.

Cardiomyopathy is a particular concern during this time – it’s the major cause of maternal mortality after 42 days, he noted. An emphasis on postpartum care also is especially important given that some data suggest up to 40% of women don’t return for that care.

“That is a very sad statistic and perhaps it reflects on our need to change payment models so that physicians and patients realize the importance of coming back for continuing care, because this really may be the end of pregnancy, but it is the beginning of the rest of their life,” he said. “And if they have cardiovascular disease or the risk factors ... they are going to possibly become worse over the course of their lifetime.”

[email protected]

Nearly 700 women died from pregnancy-related complications in the United States in 2018, and almost a third of those deaths were associated with cardiovascular disease, according to the latest data from the Centers for Disease Control and Prevention.

Strikingly, studies suggest that up to half of cardiovascular disease–related maternal deaths are preventable, yet CVD remains the leading cause of maternal morbidity and mortality – and the incidence has been rising steadily for 2 decades.

The American College of Obstetricians and Gynecologists says that acquired heart disease is the likely culprit in the rise in incidence of maternal mortality as women enter pregnancy with an increasingly heavy burden of CVD risk factors, including older age, obesity, diabetes, and hypertension.

“They are entering pregnancy while already at risk, and that has led to an increase in morbidity and mortality during pregnancy,” Renee Patrice Bullock-Palmer, MD, a cardiologist and director of the Women’s Heart Center at Deborah Heart and Lung Center in Browns Mills, N.J., explained in an interview. “Unfortunately, among developed countries, the U.S. has the highest rates of maternal morbidity and mortality, and that’s shocking.”

It’s a problem that requires collaboration between obstetricians, cardiologists, and others involved in the care of pregnant women, she said.
 

The data and the depth of the crisis

The maternal mortality rate in 1987 – the year the CDC’s Pregnancy Mortality Surveillance System was implemented – was 7.2 per 100,000 live births. The rate in 2016 was more than double that at 16.9, and the rate in 2018, the most recent year for which data are available, was 17.4 – and significant racial and ethnic disparities in those rates have persisted over time.

In an August 2019 article published on the American Heart Association website, Dr. Bullock-Palmer addressed the cardiovascular state of health for pregnant women and the role of the cardiologists in their care, noting that there is a “role for increased collaboration between the cardiologist and the obstetrician with regards to a pregnancy heart team.”

“It is vital that mothers who are at increased risk for CVD or have established CVD be referred to a cardiologist for cardiovascular assessment and management,” she wrote, adding it is important to raise awareness among ob.gyns. and to improve cardiologists’ recognition of women at risk when they present for care for the first time.

These referrals should be made in the antepartum and early postpartum period, she said in an interview. More attention also must be paid to racial and ethnic disparities, and the role of cardiologists in addressing these disparities.

The CDC has emphasized racial and ethnic disparities in maternal mortality, noting in a 2019 Morbidity and Mortality Weekly report that, compared with white women, black and American Indian/Alaskan Native women aged over 30 years have a 300%-400% higher rate of pregnancy-related deaths (Morb Mortal Wkly Rep. 2019 Sep 6;68[35]:762-5).

With regard to disparities, Dr. Bullock-Palmer said the causes are multifold and may be related to a higher prevalence of CVD risk factors like obesity and hypertension in non-Hispanic black women.

“There may also be limited access to adequate postpartum care in this patient population,” she wrote, adding that some attention has been paid to addressing disparities, but that “there is a lot of work left to be done in resolving these inequities in maternal health care.”

Partnerships across specialties will help in addressing most of the factors associated with CVD and maternal death, she said.

The urgent need for these partnerships is underscored by the latest findings on CVD-related complications in pregnancy. A study published in March 2020 in the Journal of the American College of Cardiology, for example, looked specifically at the incidence of serious cardiac events (SCEs) in pregnant women with heart disease, and whether the events were preventable.

In a prospective cohort of 1,315 pregnancies among women with heart disease, Birgit Pfaller, MD, of the University of Toronto Pregnancy and Heart Disease Research Program, and colleagues found that SCEs occurred in 3.6% of cases (47 women) – most often during the antepartum period – that 49% were preventable, and that 74% were related to provider management factors.

The most common SCEs were cardiac death or arrest, heart failure, arrhythmias, and urgent intervention, and they were more likely to occur in women with acquired heart disease, severe aortic or mitral stenosis, mechanical valves, and systemic ventricular dysfunction. Adverse fetal and neonatal outcomes more than doubled in cases involving SCEs, compared with those without (62% vs. 29%), and adverse obstetric events occurred most often in women with severe preeclampsia.

“The majority of the preventable events occurred due to provider management factors, including: failure to identify the patient condition prior to pregnancy, failure to identify the patient as high risk, late recognition in cardiac deterioration, delay in treatment/intervention, inappropriate treatment, and lack of preconception counseling,” Melinda Davis, MD, of the University of Michigan, Ann Arbor, wrote in a summary and editorial published in the Journal of the American College of Cardiology.

Some preventable events were attributable to patient failure to seek care, noncompliance with care recommendations, and lack of access to care, Dr. Davis noted.

“These findings suggest that provider training, patient education, and health care advocacy are all important interventions to improve outcomes among pregnant women,” she wrote, adding that “the development of multidisciplinary cardio-obstetric clinics at tertiary care centers may also be helpful.”

Dr. Bullock-Palmer added the need for greater risk-prediction tools to the list, explaining that these are needed to assess CVD risk in the prenatal, antenatal, and postnatal period.

“The recently concluded Cardiac Disease in Pregnancy [CARPREG II] study indicated that there were 10 predictors that could be utilized to asses maternal CVD risk,” she noted.

The CARPREG II authors identified five general predictors (prior cardiac events or arrhythmias, poor functional class or cyanosis, high-risk valve disease/left ventricular outflow tract obstruction, systemic ventricular dysfunction, no prior cardiac interventions), four lesion-specific predictors (mechanical valves, high-risk aortopathies, pulmonary hypertension, coronary artery disease), and one delivery-of-care predictor (late pregnancy assessment), and incorporated them into a risk index.

“It is hopeful that these new initiatives will assist providers in improving their ability to appropriately risk stratify women,” Dr. Bullock-Palmer said.

 

Ongoing efforts

Efforts also are ongoing to develop the types of cardio-obstetric clinics mentioned by Dr. Davis and to establish collaborations and “pregnancy heart teams” as attention is increasingly focused on the U.S. maternal mortality crisis.

In fact, such teams are a cornerstone of ACOG’s guidance on pregnancy and heart disease. In May 2019 the college released a Practice Bulletin with 27 specific recommendations and conclusions relating to screening, diagnosis, and management of CVD for women during the prepregnancy period through the postpartum period.

Pregnant women and postpartum women with known or suspected CVD should undergo evaluation by a “pregnancy heart team that includes a cardiologist and maternal-fetal medicine subspecialist, or both, and other subspecialists as necessary,” according to the bulletin.

In a recent interview, Lisa Hollier, MD, immediate past president of ACOG and an instrumental figure in the push to better address maternal mortality – and in particular the cardiovascular contributors to the crisis – said she is “seeing a strengthening of that” with numerous organizations establishing pregnancy health teams.

Dr. Bullock-Palmer said she also is seeing progress, and added that collaboration should be prioritized even in the absence of dedicated pregnancy heart teams and clinics.

“Heart disease in pregnancy requires a multidisciplinary approach. You can’t just see the patient from the cardiac perspective – you also have to interact and team up with the obstetrician who is handling the pregnancy,” she said, adding that, without a dedicated team, coordination takes more effort, but is imperative for improving outcomes. “You have to collaborate at times when it is beyond the expertise of the institution or the physician; you have to know when to refer these higher-risk patients, particularly women with adult congenital heart disease.”

This referral should occur early – preferably in the antenatal period, she added.

The most important thing, however, is “recognizing these women ... even before the pregnancy,” Dr. Bullock-Palmer said, explaining that this can facilitate the necessary management – and in some cases, postponement – of pregnancy for women whose cardiac issues need to be addressed first.

Among other efforts to address maternal mortality are several programs developed by ACOG, and the Heart Outcomes in Pregnancy: Expectations for Mom and Baby Registry (HOPE) project of the Saint Luke’s Health System in Kansas.

“Hopefully the [HOPE] research collaborative ... which aims to address key clinical questions surrounding the preconception period, antenatal care, delivery planning and outcomes, and long-term postpartum care and outcomes of women will help to address the knowledge gaps and disparities in the care of women with heart disease in pregnancy,” Dr. Bullock-Palmer wrote in her article.

CVD-related risks in the post partum

Dr. Bullock-Palmer has particular concern for postpartum follow-up, given the increased risk for future heart disease among women with CVD-related pregnancy complications and the heightened risk of certain CVD-related events in the postpartum period.

That’s a component of the crisis that also was addressed during a press briefing at the 2019 ACOG annual meeting when the Pregnancy and Heart Disease Practice Bulletin was released.

Sharon Worcester/MDedge News

James Martin, MD, chair of ACOG’s Pregnancy and Heart Disease Task Force and a past ACOG president, explained during the briefing that CVD-related risks may accelerate and persist in the days and weeks after delivery, underscoring the need for follow-up and postpartum care.

Cardiomyopathy is a particular concern during this time – it’s the major cause of maternal mortality after 42 days, he noted. An emphasis on postpartum care also is especially important given that some data suggest up to 40% of women don’t return for that care.

“That is a very sad statistic and perhaps it reflects on our need to change payment models so that physicians and patients realize the importance of coming back for continuing care, because this really may be the end of pregnancy, but it is the beginning of the rest of their life,” he said. “And if they have cardiovascular disease or the risk factors ... they are going to possibly become worse over the course of their lifetime.”

[email protected]

Women with HIV had more bone mobilization during lactation, and attenuated skeletal recovery after lactation, compared with HIV-negative women, according to research presented during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

The study “demonstrated that there were reductions as expected in BMD during breastfeeding, and there was recovery at the end of breastfeeding, which was higher among women who were not HIV-infected compared to HIV-infected women,” said Mary Glenn Fowler, MD, speaking in a video presentation during the virtual conference. The differences between women who had HIV and the HIV-negative reference group were statistically significant (P = .003 for lumbar spine and P less than .001 for whole-body aBMD).

“We also saw that for whole-body BMD, there was recovery at the end of breastfeeding for women who were not HIV infected, but a dampened response of recovery for BMD for HIV-infected women,” she went on, adding: “These findings held after adjustment for parity, age, body mass, breastfeeding practices, duration of breastfeeding, use of [injectable medroxyprogesterone acetate], and resumption of menses.”

Dr. Fowler presented the study’s results on behalf of lead author Florence Nabwire, PhD, an investigator scientist in the nutrition and bone health group of the United Kingdom’s Medical Research Council (Cambridge).

Although it’s known that antiretroviral therapy (ART) is associated with bone loss, Dr. Fowler explained that there are only limited data in HIV-positive women who are lactating. It’s important to see what happens during lactation for this group of women because of the potential sequelae later in life of insufficient recovery from the physiological bone mobilization that occurs during lactation. The study looked at changes in areal bone mineral density (aBMD) both during and after lactation for women with HIV living in Uganda who were taking Option B+ ART, a regimen that includes tenofovir, 3TC, and efavirenz. These women were compared with a reference group of HIV-negative women.

In all, 95 women with HIV and 96 HIV negative women were recruited into the study during pregnancy. Participants were followed postpartum at weeks 2, 14, and 26, and at a final visit that occurred 14 weeks after lactation stopped.

In addition to lumbar spine, total hip, and femoral neck aBMD measurements, the investigators also obtained whole body-less-head reading.

For total hip and femoral neck aBMD, the nadir of density was seen at 26 postpartum, when a drop of about 6% was seen from baseline readings. By the final post-lactation visit, women without HIV had recovered to their baseline; for women with HIV, some recovery also occurred, but the effect was dampened, with a persistent bone density deficit of about 3% from baseline. The differences between HIV-positive and HIV-negative women in these measurements were also statistically significant, at P less than .001 for total hip aBMD differences and P = .0008 for femoral neck differences. Again, correction for multiple confounders didn’t attenuate the results, said Dr. Fowler.

“In conclusion, these data showed accentuated mobilization of hip and whole body aBMD during lactation,” said Dr. Fowler, who also noted “slower skeletal recovery post lactation for HIV-infected women.” Clinical implications of these findings aren’t currently known, she said. Further ongoing studies are aiming to tease out both mechanisms and longer-term consequences for the bone health of HIV-infected women and their children, who may also see differences in bone mineral accretion and growth.

Session moderator Risa Hoffman, MD, in introductory remarks, set the findings in some context. “As we know, HIV-positive adults have low bone mineral density, and this appears to be a result of interactions of HIV, traditional risk factors for loss of bone density, and antiretroviral therapy,” said Dr. Hoffman, director of the global health program at the University of California, Los Angeles. She added that previous work had shown that “middle-aged HIV-positive women have higher 10-year fracture incidence compared to their HIV-negative counterparts.” The current study, she said, “has both short- and long-term implications for women as they go through multiple pregnancies and multiple periods of breastfeeding.”

The study was funded by the United Kingdom’s Medical Research Council and Department for International Development as well as the Alborada Trust and the Gates Cambridge Scholarship. The authors reported no conflicts of interest.

[email protected]

SOURCE: Nabwire F et al. CROI 2020, Abstract 768.

Women with HIV had more bone mobilization during lactation, and attenuated skeletal recovery after lactation, compared with HIV-negative women, according to research presented during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

The study “demonstrated that there were reductions as expected in BMD during breastfeeding, and there was recovery at the end of breastfeeding, which was higher among women who were not HIV-infected compared to HIV-infected women,” said Mary Glenn Fowler, MD, speaking in a video presentation during the virtual conference. The differences between women who had HIV and the HIV-negative reference group were statistically significant (P = .003 for lumbar spine and P less than .001 for whole-body aBMD).

“We also saw that for whole-body BMD, there was recovery at the end of breastfeeding for women who were not HIV infected, but a dampened response of recovery for BMD for HIV-infected women,” she went on, adding: “These findings held after adjustment for parity, age, body mass, breastfeeding practices, duration of breastfeeding, use of [injectable medroxyprogesterone acetate], and resumption of menses.”

Dr. Fowler presented the study’s results on behalf of lead author Florence Nabwire, PhD, an investigator scientist in the nutrition and bone health group of the United Kingdom’s Medical Research Council (Cambridge).

Although it’s known that antiretroviral therapy (ART) is associated with bone loss, Dr. Fowler explained that there are only limited data in HIV-positive women who are lactating. It’s important to see what happens during lactation for this group of women because of the potential sequelae later in life of insufficient recovery from the physiological bone mobilization that occurs during lactation. The study looked at changes in areal bone mineral density (aBMD) both during and after lactation for women with HIV living in Uganda who were taking Option B+ ART, a regimen that includes tenofovir, 3TC, and efavirenz. These women were compared with a reference group of HIV-negative women.

In all, 95 women with HIV and 96 HIV negative women were recruited into the study during pregnancy. Participants were followed postpartum at weeks 2, 14, and 26, and at a final visit that occurred 14 weeks after lactation stopped.

In addition to lumbar spine, total hip, and femoral neck aBMD measurements, the investigators also obtained whole body-less-head reading.

For total hip and femoral neck aBMD, the nadir of density was seen at 26 postpartum, when a drop of about 6% was seen from baseline readings. By the final post-lactation visit, women without HIV had recovered to their baseline; for women with HIV, some recovery also occurred, but the effect was dampened, with a persistent bone density deficit of about 3% from baseline. The differences between HIV-positive and HIV-negative women in these measurements were also statistically significant, at P less than .001 for total hip aBMD differences and P = .0008 for femoral neck differences. Again, correction for multiple confounders didn’t attenuate the results, said Dr. Fowler.

“In conclusion, these data showed accentuated mobilization of hip and whole body aBMD during lactation,” said Dr. Fowler, who also noted “slower skeletal recovery post lactation for HIV-infected women.” Clinical implications of these findings aren’t currently known, she said. Further ongoing studies are aiming to tease out both mechanisms and longer-term consequences for the bone health of HIV-infected women and their children, who may also see differences in bone mineral accretion and growth.

Session moderator Risa Hoffman, MD, in introductory remarks, set the findings in some context. “As we know, HIV-positive adults have low bone mineral density, and this appears to be a result of interactions of HIV, traditional risk factors for loss of bone density, and antiretroviral therapy,” said Dr. Hoffman, director of the global health program at the University of California, Los Angeles. She added that previous work had shown that “middle-aged HIV-positive women have higher 10-year fracture incidence compared to their HIV-negative counterparts.” The current study, she said, “has both short- and long-term implications for women as they go through multiple pregnancies and multiple periods of breastfeeding.”

The study was funded by the United Kingdom’s Medical Research Council and Department for International Development as well as the Alborada Trust and the Gates Cambridge Scholarship. The authors reported no conflicts of interest.

[email protected]

SOURCE: Nabwire F et al. CROI 2020, Abstract 768.

Women with HIV had more bone mobilization during lactation, and attenuated skeletal recovery after lactation, compared with HIV-negative women, according to research presented during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

The study “demonstrated that there were reductions as expected in BMD during breastfeeding, and there was recovery at the end of breastfeeding, which was higher among women who were not HIV-infected compared to HIV-infected women,” said Mary Glenn Fowler, MD, speaking in a video presentation during the virtual conference. The differences between women who had HIV and the HIV-negative reference group were statistically significant (P = .003 for lumbar spine and P less than .001 for whole-body aBMD).

“We also saw that for whole-body BMD, there was recovery at the end of breastfeeding for women who were not HIV infected, but a dampened response of recovery for BMD for HIV-infected women,” she went on, adding: “These findings held after adjustment for parity, age, body mass, breastfeeding practices, duration of breastfeeding, use of [injectable medroxyprogesterone acetate], and resumption of menses.”

Dr. Fowler presented the study’s results on behalf of lead author Florence Nabwire, PhD, an investigator scientist in the nutrition and bone health group of the United Kingdom’s Medical Research Council (Cambridge).

Although it’s known that antiretroviral therapy (ART) is associated with bone loss, Dr. Fowler explained that there are only limited data in HIV-positive women who are lactating. It’s important to see what happens during lactation for this group of women because of the potential sequelae later in life of insufficient recovery from the physiological bone mobilization that occurs during lactation. The study looked at changes in areal bone mineral density (aBMD) both during and after lactation for women with HIV living in Uganda who were taking Option B+ ART, a regimen that includes tenofovir, 3TC, and efavirenz. These women were compared with a reference group of HIV-negative women.

In all, 95 women with HIV and 96 HIV negative women were recruited into the study during pregnancy. Participants were followed postpartum at weeks 2, 14, and 26, and at a final visit that occurred 14 weeks after lactation stopped.

In addition to lumbar spine, total hip, and femoral neck aBMD measurements, the investigators also obtained whole body-less-head reading.

For total hip and femoral neck aBMD, the nadir of density was seen at 26 postpartum, when a drop of about 6% was seen from baseline readings. By the final post-lactation visit, women without HIV had recovered to their baseline; for women with HIV, some recovery also occurred, but the effect was dampened, with a persistent bone density deficit of about 3% from baseline. The differences between HIV-positive and HIV-negative women in these measurements were also statistically significant, at P less than .001 for total hip aBMD differences and P = .0008 for femoral neck differences. Again, correction for multiple confounders didn’t attenuate the results, said Dr. Fowler.

“In conclusion, these data showed accentuated mobilization of hip and whole body aBMD during lactation,” said Dr. Fowler, who also noted “slower skeletal recovery post lactation for HIV-infected women.” Clinical implications of these findings aren’t currently known, she said. Further ongoing studies are aiming to tease out both mechanisms and longer-term consequences for the bone health of HIV-infected women and their children, who may also see differences in bone mineral accretion and growth.

Session moderator Risa Hoffman, MD, in introductory remarks, set the findings in some context. “As we know, HIV-positive adults have low bone mineral density, and this appears to be a result of interactions of HIV, traditional risk factors for loss of bone density, and antiretroviral therapy,” said Dr. Hoffman, director of the global health program at the University of California, Los Angeles. She added that previous work had shown that “middle-aged HIV-positive women have higher 10-year fracture incidence compared to their HIV-negative counterparts.” The current study, she said, “has both short- and long-term implications for women as they go through multiple pregnancies and multiple periods of breastfeeding.”

The study was funded by the United Kingdom’s Medical Research Council and Department for International Development as well as the Alborada Trust and the Gates Cambridge Scholarship. The authors reported no conflicts of interest.

[email protected]

SOURCE: Nabwire F et al. CROI 2020, Abstract 768.

Nothing is business as usual during the COVID-19 pandemic, and that includes breast cancer therapy. That’s why two groups have released guidance documents on treating breast cancer patients during the pandemic.

A guidance on surgery, drug therapy, and radiotherapy was created by the COVID-19 Pandemic Breast Cancer Consortium. This guidance is set to be published in Breast Cancer Research and Treatment and can be downloaded from the American College of Surgeons website.

A group from Memorial Sloan Kettering Cancer Center (MSKCC) created a guidance document on radiotherapy for breast cancer patients, and that guidance was recently published in Advances in Radiation Oncology.
 

Prioritizing certain patients and treatments

As hospital beds and clinics fill with coronavirus-infected patients, oncologists must balance the need for timely therapy for their patients with the imperative to protect vulnerable, immunosuppressed patients from exposure and keep clinical resources as free as possible.

“As we’re taking care of breast cancer patients during this unprecedented pandemic, what we’re all trying to do is balance the most effective treatments for our patients against the risk of additional exposures, either from other patients [or] from being outside, and considerations about the safety of our staff,” said Steven Isakoff, MD, PhD, of Massachusetts General Hospital Cancer Center in Boston, who is an author of the COVID-19 Pandemic Breast Cancer Consortium guidance.

The consortium’s guidance recommends prioritizing treatment according to patient needs and the disease type and stage. The three basic categories for considering when to treat are:

• Priority A: Patients who have immediately life-threatening conditions, are clinically unstable, or would experience a significant change in prognosis with even a short delay in treatment.
• Priority B: Deferring treatment for a short time (6-12 weeks) would not impact overall outcomes in these patients.
• Priority C: These patients are stable enough that treatment can be delayed for the duration of the COVID-19 pandemic.

“The consortium highly recommends multidisciplinary discussion regarding priority for elective surgery and adjuvant treatments for your breast cancer patients,” the guidance authors wrote. “The COVID-19 pandemic may vary in severity over time, and these recommendations are subject to change with changing COVID-19 pandemic severity.”

For example, depending on local circumstances, the guidance recommends limiting immediate outpatient visits to patients with potentially unstable conditions such as infection or hematoma. Established patients with new problems or patients with a new diagnosis of noninvasive cancer might be managed with telemedicine visits, and patients who are on follow-up with no new issues or who have benign lesions might have their visits safely postponed.
 

Surgery and drug recommendations

High-priority surgical procedures include operative drainage of a breast abscess in a septic patient and evacuation of expanding hematoma in a hemodynamically unstable patient, according to the consortium guidance.

Other surgical situations are more nuanced. For example, for patients with triple-negative breast cancer (TNBC) or HER2-positive disease, the guidance recommends neoadjuvant chemotherapy or HER2-targeted chemotherapy in some cases. In other cases, institutions may proceed with surgery before chemotherapy, but “these decisions will depend on institutional resources and patient factors,” according to the authors.

The guidance states that chemotherapy and other drug treatments should not be delayed in patients with oncologic emergencies, such as febrile neutropenia, hypercalcemia, intolerable pain, symptomatic pleural effusions, or brain metastases.

In addition, patients with inflammatory breast cancer, TNBC, or HER2-positive breast cancer should receive neoadjuvant/adjuvant chemotherapy. Patients with metastatic disease that is likely to benefit from therapy should start chemotherapy, endocrine therapy, or targeted therapy. And patients who have already started neoadjuvant/adjuvant chemotherapy or oral adjuvant endocrine therapy should continue on these treatments.
 

Radiation therapy recommendations

The consortium guidance recommends administering radiation to patients with bleeding or painful inoperable locoregional disease, those with symptomatic metastatic disease, and patients who progress on neoadjuvant chemotherapy.

In contrast, older patients (aged 65-70 years) with lower-risk, stage I, hormone receptor–positive, HER2-negative cancers who are on adjuvant endocrine therapy can safely defer or omit radiation without affecting their overall survival, according to the guidance. Patients with ductal carcinoma in situ, especially those with estrogen receptor–positive disease on endocrine therapy, can safely omit radiation.

“There are clearly conditions where radiation might reduce the risk of recurrence but not improve overall survival, where a delay in treatment really will have minimal or no impact,” Dr. Isakoff said.

The MSKCC guidance recommends omitting radiation for some patients with favorable-risk disease and truncating or accelerating regimens using hypofractionation for others who require whole-breast radiation or post-mastectomy treatment.

The MSKCC guidance also contains recommendations for prioritization of patients according to disease state and the urgency of care. It divides cases into high, intermediate, and low priority for breast radiotherapy, as follows:

• Tier 1 (high priority): Patients with inflammatory breast cancer, residual node-positive disease after neoadjuvant chemotherapy, four or more positive nodes (N2), recurrent disease, node-positive TNBC, or extensive lymphovascular invasion.
• Tier 2 (intermediate priority): Patients with estrogen receptor–positive disease with one to three positive nodes (N1a), pathologic stage N0 after neoadjuvant chemotherapy, lymphovascular invasion not otherwise specified, or node-negative TNBC.
• Tier 3 (low priority): Patients with early-stage estrogen receptor-positive breast cancer (especially patients of advanced age), patients with ductal carcinoma in situ, or those who otherwise do not meet the criteria for tiers 1 or 2.

The MSKCC guidance also contains recommended hypofractionated or accelerated radiotherapy regimens for partial and whole-breast irradiation, post-mastectomy treatment, and breast and regional node irradiation, including recommended techniques (for example, 3-D conformal or intensity modulated approaches).

The authors of the MSKCC guidance disclosed relationships with eContour, Volastra Therapeutics, Sanofi, the Prostate Cancer Foundation, and Cancer Research UK. The authors of the COVID-19 Pandemic Breast Cancer Consortium guidance did not disclose any conflicts and said there was no funding source for the guidance.

SOURCES: Braunstein LZ et al. Adv Radiat Oncol. 2020 Apr 1. doi:10.1016/j.adro.2020.03.013; Dietz JR et al. 2020 Apr. Recommendations for prioritization, treatment and triage of breast cancer patients during the COVID-19 pandemic. Accepted for publication in Breast Cancer Research and Treatment.

Nothing is business as usual during the COVID-19 pandemic, and that includes breast cancer therapy. That’s why two groups have released guidance documents on treating breast cancer patients during the pandemic.

A guidance on surgery, drug therapy, and radiotherapy was created by the COVID-19 Pandemic Breast Cancer Consortium. This guidance is set to be published in Breast Cancer Research and Treatment and can be downloaded from the American College of Surgeons website.

A group from Memorial Sloan Kettering Cancer Center (MSKCC) created a guidance document on radiotherapy for breast cancer patients, and that guidance was recently published in Advances in Radiation Oncology.
 

Prioritizing certain patients and treatments

As hospital beds and clinics fill with coronavirus-infected patients, oncologists must balance the need for timely therapy for their patients with the imperative to protect vulnerable, immunosuppressed patients from exposure and keep clinical resources as free as possible.

“As we’re taking care of breast cancer patients during this unprecedented pandemic, what we’re all trying to do is balance the most effective treatments for our patients against the risk of additional exposures, either from other patients [or] from being outside, and considerations about the safety of our staff,” said Steven Isakoff, MD, PhD, of Massachusetts General Hospital Cancer Center in Boston, who is an author of the COVID-19 Pandemic Breast Cancer Consortium guidance.

The consortium’s guidance recommends prioritizing treatment according to patient needs and the disease type and stage. The three basic categories for considering when to treat are:

• Priority A: Patients who have immediately life-threatening conditions, are clinically unstable, or would experience a significant change in prognosis with even a short delay in treatment.
• Priority B: Deferring treatment for a short time (6-12 weeks) would not impact overall outcomes in these patients.
• Priority C: These patients are stable enough that treatment can be delayed for the duration of the COVID-19 pandemic.

“The consortium highly recommends multidisciplinary discussion regarding priority for elective surgery and adjuvant treatments for your breast cancer patients,” the guidance authors wrote. “The COVID-19 pandemic may vary in severity over time, and these recommendations are subject to change with changing COVID-19 pandemic severity.”

For example, depending on local circumstances, the guidance recommends limiting immediate outpatient visits to patients with potentially unstable conditions such as infection or hematoma. Established patients with new problems or patients with a new diagnosis of noninvasive cancer might be managed with telemedicine visits, and patients who are on follow-up with no new issues or who have benign lesions might have their visits safely postponed.
 

Surgery and drug recommendations

High-priority surgical procedures include operative drainage of a breast abscess in a septic patient and evacuation of expanding hematoma in a hemodynamically unstable patient, according to the consortium guidance.

Other surgical situations are more nuanced. For example, for patients with triple-negative breast cancer (TNBC) or HER2-positive disease, the guidance recommends neoadjuvant chemotherapy or HER2-targeted chemotherapy in some cases. In other cases, institutions may proceed with surgery before chemotherapy, but “these decisions will depend on institutional resources and patient factors,” according to the authors.

The guidance states that chemotherapy and other drug treatments should not be delayed in patients with oncologic emergencies, such as febrile neutropenia, hypercalcemia, intolerable pain, symptomatic pleural effusions, or brain metastases.

In addition, patients with inflammatory breast cancer, TNBC, or HER2-positive breast cancer should receive neoadjuvant/adjuvant chemotherapy. Patients with metastatic disease that is likely to benefit from therapy should start chemotherapy, endocrine therapy, or targeted therapy. And patients who have already started neoadjuvant/adjuvant chemotherapy or oral adjuvant endocrine therapy should continue on these treatments.
 

Radiation therapy recommendations

The consortium guidance recommends administering radiation to patients with bleeding or painful inoperable locoregional disease, those with symptomatic metastatic disease, and patients who progress on neoadjuvant chemotherapy.

In contrast, older patients (aged 65-70 years) with lower-risk, stage I, hormone receptor–positive, HER2-negative cancers who are on adjuvant endocrine therapy can safely defer or omit radiation without affecting their overall survival, according to the guidance. Patients with ductal carcinoma in situ, especially those with estrogen receptor–positive disease on endocrine therapy, can safely omit radiation.

“There are clearly conditions where radiation might reduce the risk of recurrence but not improve overall survival, where a delay in treatment really will have minimal or no impact,” Dr. Isakoff said.

The MSKCC guidance recommends omitting radiation for some patients with favorable-risk disease and truncating or accelerating regimens using hypofractionation for others who require whole-breast radiation or post-mastectomy treatment.

The MSKCC guidance also contains recommendations for prioritization of patients according to disease state and the urgency of care. It divides cases into high, intermediate, and low priority for breast radiotherapy, as follows:

• Tier 1 (high priority): Patients with inflammatory breast cancer, residual node-positive disease after neoadjuvant chemotherapy, four or more positive nodes (N2), recurrent disease, node-positive TNBC, or extensive lymphovascular invasion.
• Tier 2 (intermediate priority): Patients with estrogen receptor–positive disease with one to three positive nodes (N1a), pathologic stage N0 after neoadjuvant chemotherapy, lymphovascular invasion not otherwise specified, or node-negative TNBC.
• Tier 3 (low priority): Patients with early-stage estrogen receptor-positive breast cancer (especially patients of advanced age), patients with ductal carcinoma in situ, or those who otherwise do not meet the criteria for tiers 1 or 2.

The MSKCC guidance also contains recommended hypofractionated or accelerated radiotherapy regimens for partial and whole-breast irradiation, post-mastectomy treatment, and breast and regional node irradiation, including recommended techniques (for example, 3-D conformal or intensity modulated approaches).

The authors of the MSKCC guidance disclosed relationships with eContour, Volastra Therapeutics, Sanofi, the Prostate Cancer Foundation, and Cancer Research UK. The authors of the COVID-19 Pandemic Breast Cancer Consortium guidance did not disclose any conflicts and said there was no funding source for the guidance.

SOURCES: Braunstein LZ et al. Adv Radiat Oncol. 2020 Apr 1. doi:10.1016/j.adro.2020.03.013; Dietz JR et al. 2020 Apr. Recommendations for prioritization, treatment and triage of breast cancer patients during the COVID-19 pandemic. Accepted for publication in Breast Cancer Research and Treatment.

Nothing is business as usual during the COVID-19 pandemic, and that includes breast cancer therapy. That’s why two groups have released guidance documents on treating breast cancer patients during the pandemic.

A guidance on surgery, drug therapy, and radiotherapy was created by the COVID-19 Pandemic Breast Cancer Consortium. This guidance is set to be published in Breast Cancer Research and Treatment and can be downloaded from the American College of Surgeons website.

A group from Memorial Sloan Kettering Cancer Center (MSKCC) created a guidance document on radiotherapy for breast cancer patients, and that guidance was recently published in Advances in Radiation Oncology.
 

Prioritizing certain patients and treatments

As hospital beds and clinics fill with coronavirus-infected patients, oncologists must balance the need for timely therapy for their patients with the imperative to protect vulnerable, immunosuppressed patients from exposure and keep clinical resources as free as possible.

“As we’re taking care of breast cancer patients during this unprecedented pandemic, what we’re all trying to do is balance the most effective treatments for our patients against the risk of additional exposures, either from other patients [or] from being outside, and considerations about the safety of our staff,” said Steven Isakoff, MD, PhD, of Massachusetts General Hospital Cancer Center in Boston, who is an author of the COVID-19 Pandemic Breast Cancer Consortium guidance.

The consortium’s guidance recommends prioritizing treatment according to patient needs and the disease type and stage. The three basic categories for considering when to treat are:

• Priority A: Patients who have immediately life-threatening conditions, are clinically unstable, or would experience a significant change in prognosis with even a short delay in treatment.
• Priority B: Deferring treatment for a short time (6-12 weeks) would not impact overall outcomes in these patients.
• Priority C: These patients are stable enough that treatment can be delayed for the duration of the COVID-19 pandemic.

“The consortium highly recommends multidisciplinary discussion regarding priority for elective surgery and adjuvant treatments for your breast cancer patients,” the guidance authors wrote. “The COVID-19 pandemic may vary in severity over time, and these recommendations are subject to change with changing COVID-19 pandemic severity.”

For example, depending on local circumstances, the guidance recommends limiting immediate outpatient visits to patients with potentially unstable conditions such as infection or hematoma. Established patients with new problems or patients with a new diagnosis of noninvasive cancer might be managed with telemedicine visits, and patients who are on follow-up with no new issues or who have benign lesions might have their visits safely postponed.
 

Surgery and drug recommendations

High-priority surgical procedures include operative drainage of a breast abscess in a septic patient and evacuation of expanding hematoma in a hemodynamically unstable patient, according to the consortium guidance.

Other surgical situations are more nuanced. For example, for patients with triple-negative breast cancer (TNBC) or HER2-positive disease, the guidance recommends neoadjuvant chemotherapy or HER2-targeted chemotherapy in some cases. In other cases, institutions may proceed with surgery before chemotherapy, but “these decisions will depend on institutional resources and patient factors,” according to the authors.

The guidance states that chemotherapy and other drug treatments should not be delayed in patients with oncologic emergencies, such as febrile neutropenia, hypercalcemia, intolerable pain, symptomatic pleural effusions, or brain metastases.

In addition, patients with inflammatory breast cancer, TNBC, or HER2-positive breast cancer should receive neoadjuvant/adjuvant chemotherapy. Patients with metastatic disease that is likely to benefit from therapy should start chemotherapy, endocrine therapy, or targeted therapy. And patients who have already started neoadjuvant/adjuvant chemotherapy or oral adjuvant endocrine therapy should continue on these treatments.
 

Radiation therapy recommendations

The consortium guidance recommends administering radiation to patients with bleeding or painful inoperable locoregional disease, those with symptomatic metastatic disease, and patients who progress on neoadjuvant chemotherapy.

In contrast, older patients (aged 65-70 years) with lower-risk, stage I, hormone receptor–positive, HER2-negative cancers who are on adjuvant endocrine therapy can safely defer or omit radiation without affecting their overall survival, according to the guidance. Patients with ductal carcinoma in situ, especially those with estrogen receptor–positive disease on endocrine therapy, can safely omit radiation.

“There are clearly conditions where radiation might reduce the risk of recurrence but not improve overall survival, where a delay in treatment really will have minimal or no impact,” Dr. Isakoff said.

The MSKCC guidance recommends omitting radiation for some patients with favorable-risk disease and truncating or accelerating regimens using hypofractionation for others who require whole-breast radiation or post-mastectomy treatment.

The MSKCC guidance also contains recommendations for prioritization of patients according to disease state and the urgency of care. It divides cases into high, intermediate, and low priority for breast radiotherapy, as follows:

• Tier 1 (high priority): Patients with inflammatory breast cancer, residual node-positive disease after neoadjuvant chemotherapy, four or more positive nodes (N2), recurrent disease, node-positive TNBC, or extensive lymphovascular invasion.
• Tier 2 (intermediate priority): Patients with estrogen receptor–positive disease with one to three positive nodes (N1a), pathologic stage N0 after neoadjuvant chemotherapy, lymphovascular invasion not otherwise specified, or node-negative TNBC.
• Tier 3 (low priority): Patients with early-stage estrogen receptor-positive breast cancer (especially patients of advanced age), patients with ductal carcinoma in situ, or those who otherwise do not meet the criteria for tiers 1 or 2.

The MSKCC guidance also contains recommended hypofractionated or accelerated radiotherapy regimens for partial and whole-breast irradiation, post-mastectomy treatment, and breast and regional node irradiation, including recommended techniques (for example, 3-D conformal or intensity modulated approaches).

The authors of the MSKCC guidance disclosed relationships with eContour, Volastra Therapeutics, Sanofi, the Prostate Cancer Foundation, and Cancer Research UK. The authors of the COVID-19 Pandemic Breast Cancer Consortium guidance did not disclose any conflicts and said there was no funding source for the guidance.

SOURCES: Braunstein LZ et al. Adv Radiat Oncol. 2020 Apr 1. doi:10.1016/j.adro.2020.03.013; Dietz JR et al. 2020 Apr. Recommendations for prioritization, treatment and triage of breast cancer patients during the COVID-19 pandemic. Accepted for publication in Breast Cancer Research and Treatment.

Approximately 26% of women with inactive or mild lupus at conception experienced flares at some point during pregnancy, based on data from 384 patients.

zoranm/Getty Images

Active systemic lupus erythematosus (SLE) is a known predictor of poor pregnancy outcomes, including preterm birth, growth restriction, and fetal loss, but predictors of flares during and after pregnancy in women with SLE have not been well studied, wrote Julia Davis-Porada, MD, of the Hospital for Special Surgery, New York, and her colleagues.

In a study published in Arthritis Research & Therapy, the investigators reviewed data from the PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus) study, a prospective study of pregnant women aged 18-45 years. The women were enrolled at less than 12 weeks’ gestation, and participants had a baseline hematocrit greater than 26%. Participants met criteria for inactive or mild/stable disease at the time of conception.

Overall, 20.8% of patients experienced at least one mild or moderate flare and 6.25% had one or more severe flares during pregnancy. Mild to moderate flares and severe flares occurred postpartum (2-6 months after the end of pregnancy) in 22.7% and 1.7% of patients, respectively.

Patients who were younger and those who had lower C4 at baseline and higher Physician Global Assessment scores at baseline were significantly more likely to have at least one flare during pregnancy (P = .003, P = .024, P = .0005, respectively).

In the analysis of postpartum flares, the incidence rates for mild to moderate and severe flares were 0.8 and 0.06 per person-year, respectively. “In contrast to the findings observed for flares that occurred during pregnancy, baseline patient characteristics were not correlated with postpartum flares,” the researchers wrote.

No medications were associated with flares during or after pregnancy.

The study findings were limited by several factors, including the exclusion of SLE patients with current nephritis and those who needed high-dose prednisone; the potential for missed flares; and the lack of postpartum data for approximately 10% of patients, the researchers noted. Also, “since many patients presented to this study only after conception, we have no data to review disease activity prior to pregnancy to determine whether pregnancy per se increased the risk for flare,” they said.

However, the results were strengthened by the large, multiethnic population and prospective study design, and support physicians in reassuring patients with SLE that pregnancy and postpartum flares are unlikely if they plan pregnancy during a time of mild or inactive disease, they concluded.

The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers had no financial conflicts to disclose.

SOURCE: Davis-Porada J et al. Arthritis Res Ther. 2020 Mar 19. doi: 10.1186/s13075-020-2139-9.

Approximately 26% of women with inactive or mild lupus at conception experienced flares at some point during pregnancy, based on data from 384 patients.

zoranm/Getty Images

Active systemic lupus erythematosus (SLE) is a known predictor of poor pregnancy outcomes, including preterm birth, growth restriction, and fetal loss, but predictors of flares during and after pregnancy in women with SLE have not been well studied, wrote Julia Davis-Porada, MD, of the Hospital for Special Surgery, New York, and her colleagues.

In a study published in Arthritis Research & Therapy, the investigators reviewed data from the PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus) study, a prospective study of pregnant women aged 18-45 years. The women were enrolled at less than 12 weeks’ gestation, and participants had a baseline hematocrit greater than 26%. Participants met criteria for inactive or mild/stable disease at the time of conception.

Overall, 20.8% of patients experienced at least one mild or moderate flare and 6.25% had one or more severe flares during pregnancy. Mild to moderate flares and severe flares occurred postpartum (2-6 months after the end of pregnancy) in 22.7% and 1.7% of patients, respectively.

Patients who were younger and those who had lower C4 at baseline and higher Physician Global Assessment scores at baseline were significantly more likely to have at least one flare during pregnancy (P = .003, P = .024, P = .0005, respectively).

In the analysis of postpartum flares, the incidence rates for mild to moderate and severe flares were 0.8 and 0.06 per person-year, respectively. “In contrast to the findings observed for flares that occurred during pregnancy, baseline patient characteristics were not correlated with postpartum flares,” the researchers wrote.

No medications were associated with flares during or after pregnancy.

The study findings were limited by several factors, including the exclusion of SLE patients with current nephritis and those who needed high-dose prednisone; the potential for missed flares; and the lack of postpartum data for approximately 10% of patients, the researchers noted. Also, “since many patients presented to this study only after conception, we have no data to review disease activity prior to pregnancy to determine whether pregnancy per se increased the risk for flare,” they said.

However, the results were strengthened by the large, multiethnic population and prospective study design, and support physicians in reassuring patients with SLE that pregnancy and postpartum flares are unlikely if they plan pregnancy during a time of mild or inactive disease, they concluded.

The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers had no financial conflicts to disclose.

SOURCE: Davis-Porada J et al. Arthritis Res Ther. 2020 Mar 19. doi: 10.1186/s13075-020-2139-9.

Approximately 26% of women with inactive or mild lupus at conception experienced flares at some point during pregnancy, based on data from 384 patients.

zoranm/Getty Images

Active systemic lupus erythematosus (SLE) is a known predictor of poor pregnancy outcomes, including preterm birth, growth restriction, and fetal loss, but predictors of flares during and after pregnancy in women with SLE have not been well studied, wrote Julia Davis-Porada, MD, of the Hospital for Special Surgery, New York, and her colleagues.

In a study published in Arthritis Research & Therapy, the investigators reviewed data from the PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus) study, a prospective study of pregnant women aged 18-45 years. The women were enrolled at less than 12 weeks’ gestation, and participants had a baseline hematocrit greater than 26%. Participants met criteria for inactive or mild/stable disease at the time of conception.

Overall, 20.8% of patients experienced at least one mild or moderate flare and 6.25% had one or more severe flares during pregnancy. Mild to moderate flares and severe flares occurred postpartum (2-6 months after the end of pregnancy) in 22.7% and 1.7% of patients, respectively.

Patients who were younger and those who had lower C4 at baseline and higher Physician Global Assessment scores at baseline were significantly more likely to have at least one flare during pregnancy (P = .003, P = .024, P = .0005, respectively).

In the analysis of postpartum flares, the incidence rates for mild to moderate and severe flares were 0.8 and 0.06 per person-year, respectively. “In contrast to the findings observed for flares that occurred during pregnancy, baseline patient characteristics were not correlated with postpartum flares,” the researchers wrote.

No medications were associated with flares during or after pregnancy.

The study findings were limited by several factors, including the exclusion of SLE patients with current nephritis and those who needed high-dose prednisone; the potential for missed flares; and the lack of postpartum data for approximately 10% of patients, the researchers noted. Also, “since many patients presented to this study only after conception, we have no data to review disease activity prior to pregnancy to determine whether pregnancy per se increased the risk for flare,” they said.

However, the results were strengthened by the large, multiethnic population and prospective study design, and support physicians in reassuring patients with SLE that pregnancy and postpartum flares are unlikely if they plan pregnancy during a time of mild or inactive disease, they concluded.

The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers had no financial conflicts to disclose.

SOURCE: Davis-Porada J et al. Arthritis Res Ther. 2020 Mar 19. doi: 10.1186/s13075-020-2139-9.

ILLUSTRATIVE CASE

A 23-year-old nonpregnant woman, whom you treated 3 times in the past year for cystitis, comes to you for follow-up. She wants to know what she can do to prevent another urinary tract infection other than taking prophylactic antibiotics. Should you recommend that this patient increase her daily water intake to prevent recurrent cystitis?

Urinary tract infection (UTI) is the most common bacterial infection encountered in the ambulatory setting. Half of all women report having had at least 1 UTI by the time they are 32 years old.² Recurrence is also common, with 27% of women having 1 recurrence within 6 months of their first episode.²

Because of growing antimicrobial resistance, the World Health Organization has urged using novel antimicrobial-sparing approaches to infectious diseases.³ Physicians have long recommended behavioral, nonantimicrobial strategies for prevention of recurrent uncomplicated cystitis. Such behavioral recommendations include drinking fluids liberally, urinating after intercourse, not delaying urination, wiping front to back, and avoiding tight-fitting underwear. However, these behavior modification strategies have been studied largely in case-control trials that have yet to find an association between behavior modification and reduced risk of UTI.² Although unproven as a prevention strategy, increasing daily fluid intake has long been a recommendation because of the belief that it helps to dilute and clear bactiuria.⁴ This study is the first non–case-control trial to examine the association between increased fluid intake and decreased UTIs.¹

STUDY SUMMARY

RCT looks at whether more water leads to fewer UTIs

Hooton and colleagues¹ conducted an open-label, randomized controlled trial (RCT) of premenopausal women with recurrent UTIs and low baseline fluid intake and compared increased fluid intake (an additional 1.5 L/d) with no additional fluids. Participants were provided three 500-mL bottles of water per day and were followed for 1 year. Screened women were included if they had 3 or more symptomatic UTIs in the previous year, 1 culture-confirmed UTI, self-reported fluid intake < 1.5 L /d, and were otherwise in good health. Fluid intake was verified by 24-hour urine collection, requiring a volume < 1.2 L and urine osmolality of ≥ 500 mOsm/kg. Exclusion criteria included a history of pyelonephritis within the past year, interstitial cystitis, pregnancy, or current symptoms of UTI.

The primary outcome was frequency of UTI during the study period, defined as 1 urinary symptom and at least 10³ CFU/mL uropathogens in a urine culture. Secondary outcomes included the number of antimicrobial agents used, time to first UTI, mean time interval between cystitis episodes, and adverse events.¹

This is the first RCT to show that increased daily water intake can reduce the risk of recurrent cystitis in premenopausal patients with low fluid intake who are at high risk for UTI.

A total of 140 participants were randomized with 70 in the water group and 70 in the control group. The mean age of the participants was 35.7 years, and the mean number of reported cystitis episodes was 3.3 in the 12 months prior to the study. By the end of the 12-month study period, mean daily fluid intake had increased by 1.7 L above baseline in the water group. During the 12-month study period, the mean (SD) number of cystitis episodes was 1.7 (95% confidence interval [CI], 1.5-1.8) in the water group compared with 3.2 (95% CI, 3-3.4) in the control group, with a difference in means of 1.5 (95% CI, 1.2-1.8; P < .001).

The mean number of antimicrobial agents used for UTI was 1.9 (95% CI, 1.7-2.2) in the water group and 3.6 (95% CI, 3.3-4) in the control group. The median time to first UTI episode was 148 days in the water group compared with 93.5 days in the control group (hazard ratio [HR] = 0.51; 95% CI, 0.36-0.74; P < .001) and the difference in means for the time interval between UTI episodes was 58.4 days (95% CI, 39.4-77.4; P < .001). No serious adverse events were reported.¹

Continue to: WHAT'S NEW

WHAT’S NEW

Proof that increased fluid intake reduces the risk of recurrent UTI

Increasing daily fluid intake is a long-held but previously unproven recommendation. This is the first RCT to show increased daily water intake can reduce the risk of recurrent cystitis in premenopausal patients at high risk for UTI and with low fluid intake. No additional risk of adverse events was found.

CAVEATS

Is there a risk of overhydration?

The study did not address the effect of increasing water intake in women who do not have low-volume fluid intake. Case reports of overhydration emphasize the need to be cautious when making recommendations to hydrate.⁵ It is not known if physicians should screen for fluid intake at baseline to identify those (with low intake) who would be eligible for this intervention.

CHALLENGES TO IMPLEMENTATION

It’s unclear whether the strategy will work without monitoring

The intervention is both low-risk and low-cost to the patient. However, the intervention was supported by home delivery of water and monthly monitoring interventions that are not typical in normal care. Although the clinical intervention of drinking more fluids (primarily water) appears sound, it is not known whether a physician’s recommendation would result in the same adherence and risk reduction as water delivery and monitoring.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A 23-year-old nonpregnant woman, whom you treated 3 times in the past year for cystitis, comes to you for follow-up. She wants to know what she can do to prevent another urinary tract infection other than taking prophylactic antibiotics. Should you recommend that this patient increase her daily water intake to prevent recurrent cystitis?

Urinary tract infection (UTI) is the most common bacterial infection encountered in the ambulatory setting. Half of all women report having had at least 1 UTI by the time they are 32 years old.² Recurrence is also common, with 27% of women having 1 recurrence within 6 months of their first episode.²

Because of growing antimicrobial resistance, the World Health Organization has urged using novel antimicrobial-sparing approaches to infectious diseases.³ Physicians have long recommended behavioral, nonantimicrobial strategies for prevention of recurrent uncomplicated cystitis. Such behavioral recommendations include drinking fluids liberally, urinating after intercourse, not delaying urination, wiping front to back, and avoiding tight-fitting underwear. However, these behavior modification strategies have been studied largely in case-control trials that have yet to find an association between behavior modification and reduced risk of UTI.² Although unproven as a prevention strategy, increasing daily fluid intake has long been a recommendation because of the belief that it helps to dilute and clear bactiuria.⁴ This study is the first non–case-control trial to examine the association between increased fluid intake and decreased UTIs.¹

STUDY SUMMARY

RCT looks at whether more water leads to fewer UTIs

Hooton and colleagues¹ conducted an open-label, randomized controlled trial (RCT) of premenopausal women with recurrent UTIs and low baseline fluid intake and compared increased fluid intake (an additional 1.5 L/d) with no additional fluids. Participants were provided three 500-mL bottles of water per day and were followed for 1 year. Screened women were included if they had 3 or more symptomatic UTIs in the previous year, 1 culture-confirmed UTI, self-reported fluid intake < 1.5 L /d, and were otherwise in good health. Fluid intake was verified by 24-hour urine collection, requiring a volume < 1.2 L and urine osmolality of ≥ 500 mOsm/kg. Exclusion criteria included a history of pyelonephritis within the past year, interstitial cystitis, pregnancy, or current symptoms of UTI.

The primary outcome was frequency of UTI during the study period, defined as 1 urinary symptom and at least 10³ CFU/mL uropathogens in a urine culture. Secondary outcomes included the number of antimicrobial agents used, time to first UTI, mean time interval between cystitis episodes, and adverse events.¹

This is the first RCT to show that increased daily water intake can reduce the risk of recurrent cystitis in premenopausal patients with low fluid intake who are at high risk for UTI.

A total of 140 participants were randomized with 70 in the water group and 70 in the control group. The mean age of the participants was 35.7 years, and the mean number of reported cystitis episodes was 3.3 in the 12 months prior to the study. By the end of the 12-month study period, mean daily fluid intake had increased by 1.7 L above baseline in the water group. During the 12-month study period, the mean (SD) number of cystitis episodes was 1.7 (95% confidence interval [CI], 1.5-1.8) in the water group compared with 3.2 (95% CI, 3-3.4) in the control group, with a difference in means of 1.5 (95% CI, 1.2-1.8; P < .001).

The mean number of antimicrobial agents used for UTI was 1.9 (95% CI, 1.7-2.2) in the water group and 3.6 (95% CI, 3.3-4) in the control group. The median time to first UTI episode was 148 days in the water group compared with 93.5 days in the control group (hazard ratio [HR] = 0.51; 95% CI, 0.36-0.74; P < .001) and the difference in means for the time interval between UTI episodes was 58.4 days (95% CI, 39.4-77.4; P < .001). No serious adverse events were reported.¹

Continue to: WHAT'S NEW

WHAT’S NEW

Proof that increased fluid intake reduces the risk of recurrent UTI

Increasing daily fluid intake is a long-held but previously unproven recommendation. This is the first RCT to show increased daily water intake can reduce the risk of recurrent cystitis in premenopausal patients at high risk for UTI and with low fluid intake. No additional risk of adverse events was found.

CAVEATS

Is there a risk of overhydration?

The study did not address the effect of increasing water intake in women who do not have low-volume fluid intake. Case reports of overhydration emphasize the need to be cautious when making recommendations to hydrate.⁵ It is not known if physicians should screen for fluid intake at baseline to identify those (with low intake) who would be eligible for this intervention.

CHALLENGES TO IMPLEMENTATION

It’s unclear whether the strategy will work without monitoring

The intervention is both low-risk and low-cost to the patient. However, the intervention was supported by home delivery of water and monthly monitoring interventions that are not typical in normal care. Although the clinical intervention of drinking more fluids (primarily water) appears sound, it is not known whether a physician’s recommendation would result in the same adherence and risk reduction as water delivery and monitoring.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A 23-year-old nonpregnant woman, whom you treated 3 times in the past year for cystitis, comes to you for follow-up. She wants to know what she can do to prevent another urinary tract infection other than taking prophylactic antibiotics. Should you recommend that this patient increase her daily water intake to prevent recurrent cystitis?

Urinary tract infection (UTI) is the most common bacterial infection encountered in the ambulatory setting. Half of all women report having had at least 1 UTI by the time they are 32 years old.² Recurrence is also common, with 27% of women having 1 recurrence within 6 months of their first episode.²

Because of growing antimicrobial resistance, the World Health Organization has urged using novel antimicrobial-sparing approaches to infectious diseases.³ Physicians have long recommended behavioral, nonantimicrobial strategies for prevention of recurrent uncomplicated cystitis. Such behavioral recommendations include drinking fluids liberally, urinating after intercourse, not delaying urination, wiping front to back, and avoiding tight-fitting underwear. However, these behavior modification strategies have been studied largely in case-control trials that have yet to find an association between behavior modification and reduced risk of UTI.² Although unproven as a prevention strategy, increasing daily fluid intake has long been a recommendation because of the belief that it helps to dilute and clear bactiuria.⁴ This study is the first non–case-control trial to examine the association between increased fluid intake and decreased UTIs.¹

STUDY SUMMARY

RCT looks at whether more water leads to fewer UTIs

Hooton and colleagues¹ conducted an open-label, randomized controlled trial (RCT) of premenopausal women with recurrent UTIs and low baseline fluid intake and compared increased fluid intake (an additional 1.5 L/d) with no additional fluids. Participants were provided three 500-mL bottles of water per day and were followed for 1 year. Screened women were included if they had 3 or more symptomatic UTIs in the previous year, 1 culture-confirmed UTI, self-reported fluid intake < 1.5 L /d, and were otherwise in good health. Fluid intake was verified by 24-hour urine collection, requiring a volume < 1.2 L and urine osmolality of ≥ 500 mOsm/kg. Exclusion criteria included a history of pyelonephritis within the past year, interstitial cystitis, pregnancy, or current symptoms of UTI.

The primary outcome was frequency of UTI during the study period, defined as 1 urinary symptom and at least 10³ CFU/mL uropathogens in a urine culture. Secondary outcomes included the number of antimicrobial agents used, time to first UTI, mean time interval between cystitis episodes, and adverse events.¹

This is the first RCT to show that increased daily water intake can reduce the risk of recurrent cystitis in premenopausal patients with low fluid intake who are at high risk for UTI.

A total of 140 participants were randomized with 70 in the water group and 70 in the control group. The mean age of the participants was 35.7 years, and the mean number of reported cystitis episodes was 3.3 in the 12 months prior to the study. By the end of the 12-month study period, mean daily fluid intake had increased by 1.7 L above baseline in the water group. During the 12-month study period, the mean (SD) number of cystitis episodes was 1.7 (95% confidence interval [CI], 1.5-1.8) in the water group compared with 3.2 (95% CI, 3-3.4) in the control group, with a difference in means of 1.5 (95% CI, 1.2-1.8; P < .001).

The mean number of antimicrobial agents used for UTI was 1.9 (95% CI, 1.7-2.2) in the water group and 3.6 (95% CI, 3.3-4) in the control group. The median time to first UTI episode was 148 days in the water group compared with 93.5 days in the control group (hazard ratio [HR] = 0.51; 95% CI, 0.36-0.74; P < .001) and the difference in means for the time interval between UTI episodes was 58.4 days (95% CI, 39.4-77.4; P < .001). No serious adverse events were reported.¹

Continue to: WHAT'S NEW

WHAT’S NEW

Proof that increased fluid intake reduces the risk of recurrent UTI

Increasing daily fluid intake is a long-held but previously unproven recommendation. This is the first RCT to show increased daily water intake can reduce the risk of recurrent cystitis in premenopausal patients at high risk for UTI and with low fluid intake. No additional risk of adverse events was found.

CAVEATS

Is there a risk of overhydration?

The study did not address the effect of increasing water intake in women who do not have low-volume fluid intake. Case reports of overhydration emphasize the need to be cautious when making recommendations to hydrate.⁵ It is not known if physicians should screen for fluid intake at baseline to identify those (with low intake) who would be eligible for this intervention.

CHALLENGES TO IMPLEMENTATION

It’s unclear whether the strategy will work without monitoring

The intervention is both low-risk and low-cost to the patient. However, the intervention was supported by home delivery of water and monthly monitoring interventions that are not typical in normal care. Although the clinical intervention of drinking more fluids (primarily water) appears sound, it is not known whether a physician’s recommendation would result in the same adherence and risk reduction as water delivery and monitoring.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

In the latest issue of the Morbidity and Mortality Weekly Report, the Centers for Disease Control and Prevention recommended hepatitis C virus screening for all adults and all pregnant women – during each of their pregnancies – in areas where prevalence of the infection is 0.1% or greater.

That’s essentially the entire United States; there’s no state with a statewide adult prevalence below 0.1%, and “few settings are known to exist” otherwise, the CDC noted (MMWR Recomm Rep. 2020 Apr 10;69(2):1-17).

The agency encouraged providers to consult state or local health departments or the CDC directly to determine local HCV prevalence. “As a general guide ... approximately 59% of anti-HCV positive persons are HCV RNA positive,” indicating active infection, the agency noted.

The advice was an expansion from the CDC’s last universal screening recommendation in 2012, which was limited to people born from 1945 to 1965; the incidence of acute infections has climbed since then and is highest now among younger people, so the guideline needed to be revisited, explained authors led by Sarah Schillie, MD, of the CDC’s Division of Viral Hepatitis, Atlanta.

The U.S. Preventive Services Task Force also recently recommended universal adult screening after previously limiting it to baby boomers.

As for pregnancy, the CDC’s past advice was to screen pregnant women with known risk factors, but that needed to be revisited as well. For one thing, the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America have since recommended testing all pregnant women.

But also, the CDC said, it’s an opportune time for screening because “many women only have access to health care during pregnancy and the immediate postpartum period,” when treatment, if needed, can be started. Plus, HCV status is important for management decisions, such as using amniocentesis in positive women instead of chorionic villus sampling.

The rest of CDC’s 2012 recommendations stand, including screening all people with risk factors and repeating screening while they persist. Also, “any person who requests hepatitis C testing should receive it, regardless of disclosure of risk,” because people might be reluctant to report things like IV drug use, the authors said.

Screening in the guidelines means an HCV antibody test, followed by a nucleic acid test to check for active infection. The CDC encouraged automatic reflex testing, meaning immediately checking antibody positive samples for HCV RNA. RNA in the blood indicates active, replicating virus.

The new recommendations penciled out in modeling, with an incremental cost-effectiveness ratio (ICER) for universal adult screening of approximately $36,000 per quality-adjusted life year (QALY) gained, and an ICER of approximately $15,000 per QALY gained for pregnancy screening, where HCV prevalence is 0.1%; the 0.1% cost/benefit cutpoint was one of the reasons it was chosen as the prevalence threshold. An ICER under $50,000 is the conservative benchmark for cost-effectiveness, the authors noted.

There was no external funding, and the authors had no disclosures.

[email protected]

SOURCE: Schillie S et al. MMWR Recomm Rep. 2020 Apr 10;69[2]:1-17).

In the latest issue of the Morbidity and Mortality Weekly Report, the Centers for Disease Control and Prevention recommended hepatitis C virus screening for all adults and all pregnant women – during each of their pregnancies – in areas where prevalence of the infection is 0.1% or greater.

That’s essentially the entire United States; there’s no state with a statewide adult prevalence below 0.1%, and “few settings are known to exist” otherwise, the CDC noted (MMWR Recomm Rep. 2020 Apr 10;69(2):1-17).

The agency encouraged providers to consult state or local health departments or the CDC directly to determine local HCV prevalence. “As a general guide ... approximately 59% of anti-HCV positive persons are HCV RNA positive,” indicating active infection, the agency noted.

The advice was an expansion from the CDC’s last universal screening recommendation in 2012, which was limited to people born from 1945 to 1965; the incidence of acute infections has climbed since then and is highest now among younger people, so the guideline needed to be revisited, explained authors led by Sarah Schillie, MD, of the CDC’s Division of Viral Hepatitis, Atlanta.

The U.S. Preventive Services Task Force also recently recommended universal adult screening after previously limiting it to baby boomers.

As for pregnancy, the CDC’s past advice was to screen pregnant women with known risk factors, but that needed to be revisited as well. For one thing, the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America have since recommended testing all pregnant women.

But also, the CDC said, it’s an opportune time for screening because “many women only have access to health care during pregnancy and the immediate postpartum period,” when treatment, if needed, can be started. Plus, HCV status is important for management decisions, such as using amniocentesis in positive women instead of chorionic villus sampling.

The rest of CDC’s 2012 recommendations stand, including screening all people with risk factors and repeating screening while they persist. Also, “any person who requests hepatitis C testing should receive it, regardless of disclosure of risk,” because people might be reluctant to report things like IV drug use, the authors said.

Screening in the guidelines means an HCV antibody test, followed by a nucleic acid test to check for active infection. The CDC encouraged automatic reflex testing, meaning immediately checking antibody positive samples for HCV RNA. RNA in the blood indicates active, replicating virus.

The new recommendations penciled out in modeling, with an incremental cost-effectiveness ratio (ICER) for universal adult screening of approximately $36,000 per quality-adjusted life year (QALY) gained, and an ICER of approximately $15,000 per QALY gained for pregnancy screening, where HCV prevalence is 0.1%; the 0.1% cost/benefit cutpoint was one of the reasons it was chosen as the prevalence threshold. An ICER under $50,000 is the conservative benchmark for cost-effectiveness, the authors noted.

There was no external funding, and the authors had no disclosures.

[email protected]

SOURCE: Schillie S et al. MMWR Recomm Rep. 2020 Apr 10;69[2]:1-17).

In the latest issue of the Morbidity and Mortality Weekly Report, the Centers for Disease Control and Prevention recommended hepatitis C virus screening for all adults and all pregnant women – during each of their pregnancies – in areas where prevalence of the infection is 0.1% or greater.

That’s essentially the entire United States; there’s no state with a statewide adult prevalence below 0.1%, and “few settings are known to exist” otherwise, the CDC noted (MMWR Recomm Rep. 2020 Apr 10;69(2):1-17).

The agency encouraged providers to consult state or local health departments or the CDC directly to determine local HCV prevalence. “As a general guide ... approximately 59% of anti-HCV positive persons are HCV RNA positive,” indicating active infection, the agency noted.

The advice was an expansion from the CDC’s last universal screening recommendation in 2012, which was limited to people born from 1945 to 1965; the incidence of acute infections has climbed since then and is highest now among younger people, so the guideline needed to be revisited, explained authors led by Sarah Schillie, MD, of the CDC’s Division of Viral Hepatitis, Atlanta.

The U.S. Preventive Services Task Force also recently recommended universal adult screening after previously limiting it to baby boomers.

As for pregnancy, the CDC’s past advice was to screen pregnant women with known risk factors, but that needed to be revisited as well. For one thing, the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America have since recommended testing all pregnant women.

But also, the CDC said, it’s an opportune time for screening because “many women only have access to health care during pregnancy and the immediate postpartum period,” when treatment, if needed, can be started. Plus, HCV status is important for management decisions, such as using amniocentesis in positive women instead of chorionic villus sampling.

The rest of CDC’s 2012 recommendations stand, including screening all people with risk factors and repeating screening while they persist. Also, “any person who requests hepatitis C testing should receive it, regardless of disclosure of risk,” because people might be reluctant to report things like IV drug use, the authors said.

Screening in the guidelines means an HCV antibody test, followed by a nucleic acid test to check for active infection. The CDC encouraged automatic reflex testing, meaning immediately checking antibody positive samples for HCV RNA. RNA in the blood indicates active, replicating virus.

The new recommendations penciled out in modeling, with an incremental cost-effectiveness ratio (ICER) for universal adult screening of approximately $36,000 per quality-adjusted life year (QALY) gained, and an ICER of approximately $15,000 per QALY gained for pregnancy screening, where HCV prevalence is 0.1%; the 0.1% cost/benefit cutpoint was one of the reasons it was chosen as the prevalence threshold. An ICER under $50,000 is the conservative benchmark for cost-effectiveness, the authors noted.

There was no external funding, and the authors had no disclosures.

[email protected]

SOURCE: Schillie S et al. MMWR Recomm Rep. 2020 Apr 10;69[2]:1-17).

A large pooled analysis of almost 24,000 women showed women who breastfed had a 24% lower risk of invasive ovarian cancer.

Bonnie Becker/MDedge News

Multiple studies have reported a link between breastfeeding and a reduced risk of ovarian cancer, but other studies have found no such link, and the evidence that the protective effects differ by histologic types has been inconclusive.

“This large study with extensive information on breastfeeding provides epidemiological evidence that breastfeeding, a potentially modifiable factor, may confer significant reduction in ovarian cancer risk, including high-grade serous, the deadliest subtype,” Ana Babic, PhD, of Dana-Farber Cancer Institute and Harvard Medical School, both in Boston, and colleagues reported in JAMA Oncology.

Dr. Babic led the study of a pooled analysis of women from 13 case-control studies participating in the Ovarian Cancer Association Consortium. The study evaluated 9,973 women who had ovarian cancer and 13,843 controls, with a mean age of 57 and 56 years, respectively. The data were collected over 20 years through December 2009. Dr. Babic and colleagues claimed that this is the largest study of breastfeeding and ovarian cancer risk to date.

Besides calculating a lower risk of invasive cancer, the analysis also determined that any breastfeeding was associated with a 28% lower risk of borderline cancers, compared with women who never breastfed. “Among invasive tumors, the association was statistically significant for high-grade serous, endometrioid and clear-cell tumors,” Dr. Babic and colleagues wrote, with 25%, 27% and 22% reduced risk, respectively. The researchers also noted a similar, although not statistically significant, reduced risk for low-grade serous tumors, but no such association for mucinous tumors. For borderline tumors, breastfeeding correlated with a 32% lower risk for mucinous tumors and 23% reduction in risk for serous tumors.

The analysis included five studies with data on exclusive breastfeeding. Women who breastfed exclusively for at least 3 months had a 19% reduced risk of ovarian cancer, compared with women who never breastfed, while women who breastfed albeit not exclusively for 3 months had a 30% reduced risk. The analysis also found an association between longer duration of breastfeeding and reduced risk of invasive ovarian cancer: less than 3 months duration per child was associated with an 18% lower risk, while more than 12 months was associated with a 34% lower risk (P < .001). Other factors that seemed to mitigate risk were older age when breastfeeding and breastfeeding within the previous 10 years.

One of the strengths of the studies is that it separated low-grade and the more common and deadly high-grade serous tumors. While the analysis found similar trends with endometrioid ovarian cancers, it didn’t reach a conclusion about other invasive histotypes because there were fewer cases to evaluate. Because the study population was predominantly white, the researchers acknowledged they could not sufficiently evaluate patterns among blacks, Asian, and other ethnic groups. “The association between breastfeeding and ovarian cancer needs to be investigated in large populations of other races and ethnicities,” Dr. Babic and colleagues added.

Nonetheless, they noted that their results support the World Health Organization recommendations of at least 6 months of exclusive breastfeeding and continued breastfeeding with complementary foods for 2 years or more, even though breastfeeding for less than 3 months is associated with a significant reduction in ovarian cancer risk.

The study is significant because of its “thoughtful approach to addressing potential confounders (parity, age, etc.),” said David Barrington, MD, gynecologic oncology fellow at Ohio State University James Cancer Center in Columbus.

“For general obstetricians and gynecologists, this study provides an additional reason to advocate for breastfeeding,” Dr. Barrington added. “This data should be included in a thorough discussion of the multitudes of benefits breastfeeding provides to both the infant and the mother.”

He added that future studies should evaluate breastfeeding and ovarian cancer risks in a more ethnically diverse population. “Understanding the potential impact of modifiable risk factors for ovarian cancer is paramount to overcoming racial disparities in outcomes,” Dr. Barrington said.

The study was supported by the U.S. National Cancer Institute. Dr. Babic reported grants from the U.S. National Institutes of Health. Some coauthors reported grants from the NIH, the National Health and Medical Research Council of Australia, the Federal Ministry of Education and Research of Germany, the Danish Cancer Society, or the Mermaid I Project. Some coauthors had no disclosures to report. Dr. Barrington has no relevant relationships to disclose.

SOURCE: Babic A et al. JAMA Oncology. 2020. doi: 10.1001/jamaoncol.2020.0421.

A large pooled analysis of almost 24,000 women showed women who breastfed had a 24% lower risk of invasive ovarian cancer.

Bonnie Becker/MDedge News

Multiple studies have reported a link between breastfeeding and a reduced risk of ovarian cancer, but other studies have found no such link, and the evidence that the protective effects differ by histologic types has been inconclusive.

“This large study with extensive information on breastfeeding provides epidemiological evidence that breastfeeding, a potentially modifiable factor, may confer significant reduction in ovarian cancer risk, including high-grade serous, the deadliest subtype,” Ana Babic, PhD, of Dana-Farber Cancer Institute and Harvard Medical School, both in Boston, and colleagues reported in JAMA Oncology.

Dr. Babic led the study of a pooled analysis of women from 13 case-control studies participating in the Ovarian Cancer Association Consortium. The study evaluated 9,973 women who had ovarian cancer and 13,843 controls, with a mean age of 57 and 56 years, respectively. The data were collected over 20 years through December 2009. Dr. Babic and colleagues claimed that this is the largest study of breastfeeding and ovarian cancer risk to date.

Besides calculating a lower risk of invasive cancer, the analysis also determined that any breastfeeding was associated with a 28% lower risk of borderline cancers, compared with women who never breastfed. “Among invasive tumors, the association was statistically significant for high-grade serous, endometrioid and clear-cell tumors,” Dr. Babic and colleagues wrote, with 25%, 27% and 22% reduced risk, respectively. The researchers also noted a similar, although not statistically significant, reduced risk for low-grade serous tumors, but no such association for mucinous tumors. For borderline tumors, breastfeeding correlated with a 32% lower risk for mucinous tumors and 23% reduction in risk for serous tumors.

The analysis included five studies with data on exclusive breastfeeding. Women who breastfed exclusively for at least 3 months had a 19% reduced risk of ovarian cancer, compared with women who never breastfed, while women who breastfed albeit not exclusively for 3 months had a 30% reduced risk. The analysis also found an association between longer duration of breastfeeding and reduced risk of invasive ovarian cancer: less than 3 months duration per child was associated with an 18% lower risk, while more than 12 months was associated with a 34% lower risk (P < .001). Other factors that seemed to mitigate risk were older age when breastfeeding and breastfeeding within the previous 10 years.

One of the strengths of the studies is that it separated low-grade and the more common and deadly high-grade serous tumors. While the analysis found similar trends with endometrioid ovarian cancers, it didn’t reach a conclusion about other invasive histotypes because there were fewer cases to evaluate. Because the study population was predominantly white, the researchers acknowledged they could not sufficiently evaluate patterns among blacks, Asian, and other ethnic groups. “The association between breastfeeding and ovarian cancer needs to be investigated in large populations of other races and ethnicities,” Dr. Babic and colleagues added.

Nonetheless, they noted that their results support the World Health Organization recommendations of at least 6 months of exclusive breastfeeding and continued breastfeeding with complementary foods for 2 years or more, even though breastfeeding for less than 3 months is associated with a significant reduction in ovarian cancer risk.

The study is significant because of its “thoughtful approach to addressing potential confounders (parity, age, etc.),” said David Barrington, MD, gynecologic oncology fellow at Ohio State University James Cancer Center in Columbus.

“For general obstetricians and gynecologists, this study provides an additional reason to advocate for breastfeeding,” Dr. Barrington added. “This data should be included in a thorough discussion of the multitudes of benefits breastfeeding provides to both the infant and the mother.”

He added that future studies should evaluate breastfeeding and ovarian cancer risks in a more ethnically diverse population. “Understanding the potential impact of modifiable risk factors for ovarian cancer is paramount to overcoming racial disparities in outcomes,” Dr. Barrington said.

The study was supported by the U.S. National Cancer Institute. Dr. Babic reported grants from the U.S. National Institutes of Health. Some coauthors reported grants from the NIH, the National Health and Medical Research Council of Australia, the Federal Ministry of Education and Research of Germany, the Danish Cancer Society, or the Mermaid I Project. Some coauthors had no disclosures to report. Dr. Barrington has no relevant relationships to disclose.

SOURCE: Babic A et al. JAMA Oncology. 2020. doi: 10.1001/jamaoncol.2020.0421.

A large pooled analysis of almost 24,000 women showed women who breastfed had a 24% lower risk of invasive ovarian cancer.

Bonnie Becker/MDedge News

Multiple studies have reported a link between breastfeeding and a reduced risk of ovarian cancer, but other studies have found no such link, and the evidence that the protective effects differ by histologic types has been inconclusive.

“This large study with extensive information on breastfeeding provides epidemiological evidence that breastfeeding, a potentially modifiable factor, may confer significant reduction in ovarian cancer risk, including high-grade serous, the deadliest subtype,” Ana Babic, PhD, of Dana-Farber Cancer Institute and Harvard Medical School, both in Boston, and colleagues reported in JAMA Oncology.

Dr. Babic led the study of a pooled analysis of women from 13 case-control studies participating in the Ovarian Cancer Association Consortium. The study evaluated 9,973 women who had ovarian cancer and 13,843 controls, with a mean age of 57 and 56 years, respectively. The data were collected over 20 years through December 2009. Dr. Babic and colleagues claimed that this is the largest study of breastfeeding and ovarian cancer risk to date.

Besides calculating a lower risk of invasive cancer, the analysis also determined that any breastfeeding was associated with a 28% lower risk of borderline cancers, compared with women who never breastfed. “Among invasive tumors, the association was statistically significant for high-grade serous, endometrioid and clear-cell tumors,” Dr. Babic and colleagues wrote, with 25%, 27% and 22% reduced risk, respectively. The researchers also noted a similar, although not statistically significant, reduced risk for low-grade serous tumors, but no such association for mucinous tumors. For borderline tumors, breastfeeding correlated with a 32% lower risk for mucinous tumors and 23% reduction in risk for serous tumors.

The analysis included five studies with data on exclusive breastfeeding. Women who breastfed exclusively for at least 3 months had a 19% reduced risk of ovarian cancer, compared with women who never breastfed, while women who breastfed albeit not exclusively for 3 months had a 30% reduced risk. The analysis also found an association between longer duration of breastfeeding and reduced risk of invasive ovarian cancer: less than 3 months duration per child was associated with an 18% lower risk, while more than 12 months was associated with a 34% lower risk (P < .001). Other factors that seemed to mitigate risk were older age when breastfeeding and breastfeeding within the previous 10 years.

One of the strengths of the studies is that it separated low-grade and the more common and deadly high-grade serous tumors. While the analysis found similar trends with endometrioid ovarian cancers, it didn’t reach a conclusion about other invasive histotypes because there were fewer cases to evaluate. Because the study population was predominantly white, the researchers acknowledged they could not sufficiently evaluate patterns among blacks, Asian, and other ethnic groups. “The association between breastfeeding and ovarian cancer needs to be investigated in large populations of other races and ethnicities,” Dr. Babic and colleagues added.

Nonetheless, they noted that their results support the World Health Organization recommendations of at least 6 months of exclusive breastfeeding and continued breastfeeding with complementary foods for 2 years or more, even though breastfeeding for less than 3 months is associated with a significant reduction in ovarian cancer risk.

The study is significant because of its “thoughtful approach to addressing potential confounders (parity, age, etc.),” said David Barrington, MD, gynecologic oncology fellow at Ohio State University James Cancer Center in Columbus.

“For general obstetricians and gynecologists, this study provides an additional reason to advocate for breastfeeding,” Dr. Barrington added. “This data should be included in a thorough discussion of the multitudes of benefits breastfeeding provides to both the infant and the mother.”

He added that future studies should evaluate breastfeeding and ovarian cancer risks in a more ethnically diverse population. “Understanding the potential impact of modifiable risk factors for ovarian cancer is paramount to overcoming racial disparities in outcomes,” Dr. Barrington said.

The study was supported by the U.S. National Cancer Institute. Dr. Babic reported grants from the U.S. National Institutes of Health. Some coauthors reported grants from the NIH, the National Health and Medical Research Council of Australia, the Federal Ministry of Education and Research of Germany, the Danish Cancer Society, or the Mermaid I Project. Some coauthors had no disclosures to report. Dr. Barrington has no relevant relationships to disclose.

SOURCE: Babic A et al. JAMA Oncology. 2020. doi: 10.1001/jamaoncol.2020.0421.

Maternal preconception exposure to phthalates was associated with increased risk of preterm birth, according to a study of 420 births to subfertile couples over a 13-year period.

Previous studies have shown increased risk of preterm birth associated with prenatal exposure to phthalates, which are commonly found in a range of household and commercial products as well as medical equipment and some pharmaceuticals.

“Our results suggest that female exposure to [4 di(2-ethylhexyl) phthalate] DEHP before conception might be an unrecognized risk factor for adverse pregnancy outcomes, often overlooked in clinical practice,” wrote Yu Zhang of the department of environmental health at Harvard T.H. Chan School of Public Health, Boston, and colleagues.

The prospective cohort study evaluated preconception urinary levels of phthalates and phthalate substitutes in 419 women and 229 men participating in the Environment and Reproductive Health (EARTH) study, a cohort of couples seeking fertility care at the Massachusetts General Hospital Fertility Center. The study cohort gave birth during 2005-2018. The average gestational age of the 420 singleton children born to this cohort was 39 weeks, with 8% (n = 34) born preterm.

Adjusted models showed that maternal preconception urinary concentrations of phthalates and of cyclohexane-1, 2-dicarboxylic acid monohydroxy isononyl ester (MHiNCH), a metabolite of a nonphthalate plasticizer substitute, were associated with a 50% and 70% increased risk of preterm birth, respectively (P = .01, .11), according to results published in JAMA Network Open .

Sensitivity analysis showed that maternal preconception MHiNCH concentrations above the median were associated with a fourfold increased risk of preterm birth (risk ratio, 4.02; P = .08), Maternal preconception MHiNCH concentrations were associated with an average 2-day reduction in gestational age (P = .02).

Covariate-adjusted models found that paternal urinary phthalate metabolite concentrations were associated with an increased risk of preterm birth (RR, 1.41; P = .09), but this association was attenuated toward zero (RR, 1.06) in models that accounted for maternal preconception phthalate concentrations. Sensitivity analysis of 228 couples found the associations of maternal preconception phthalate metabolite concentrations and preterm birth remained robust in three different models: a twofold increased risk in covariate-adjusted models (P < .001); an almost fivefold increased risk in adjusting for prenatal levels (RR, 4.98; P < .001); and a twofold risk (P = .001) in adjusting for paternal levels. “Couple-based analyses confirmed the results for an association between maternal preconception DEHP concentrations and increased risk of preterm birth,” the investigators said.

“To our knowledge, this is the first study evaluating couples’ exposure to phthalate metabolites during the preconception window and its association with preterm birth,” the researchers wrote. “Our findings support a novel hypothesis: Maternal phthalate exposure during the critical period before conception may be associated with shorter gestation.”

“This study is consistent with several, but not all, prior studies supporting maternal prenatal exposure to phthalates increase preterm birth,” said Mark P. Trolice, MD, professor of obstetrics and gynecology at the University of Central Florida, Orlando. “The uniqueness of the current study was the assessment of couples’ exposures and the outcome, though paternal exposure to phthalates did not demonstrate a significant association.”

Dr. Trolice noted that about 25% of women in the study were smokers, but the study didn’t adjust for tobacco use and phthalate exposure, and 85% of the women were white. He urged caution in applying the study results in practice, adding that the study didn’t adjust for method of conception. “Assisted reproductive technology, multiple gestation, and advanced age are all known risk factors for preterm birth,”

The National Institute of Environmental Health Science funded the study. Two study coauthors received grants from the NIEHS, one coauthor received grants from the National Institutes of Health, and one received a grant from the Canadian Institutes of Health Research. No other disclosures were reported. Dr. Trolice has no financial relationships to disclose.

SOURCE: Zhang Y et al. JAMA Network Open. 2020; doi: 10.1001/jamanetworkopen.2020.2159.

Maternal preconception exposure to phthalates was associated with increased risk of preterm birth, according to a study of 420 births to subfertile couples over a 13-year period.

Previous studies have shown increased risk of preterm birth associated with prenatal exposure to phthalates, which are commonly found in a range of household and commercial products as well as medical equipment and some pharmaceuticals.

“Our results suggest that female exposure to [4 di(2-ethylhexyl) phthalate] DEHP before conception might be an unrecognized risk factor for adverse pregnancy outcomes, often overlooked in clinical practice,” wrote Yu Zhang of the department of environmental health at Harvard T.H. Chan School of Public Health, Boston, and colleagues.

The prospective cohort study evaluated preconception urinary levels of phthalates and phthalate substitutes in 419 women and 229 men participating in the Environment and Reproductive Health (EARTH) study, a cohort of couples seeking fertility care at the Massachusetts General Hospital Fertility Center. The study cohort gave birth during 2005-2018. The average gestational age of the 420 singleton children born to this cohort was 39 weeks, with 8% (n = 34) born preterm.

Adjusted models showed that maternal preconception urinary concentrations of phthalates and of cyclohexane-1, 2-dicarboxylic acid monohydroxy isononyl ester (MHiNCH), a metabolite of a nonphthalate plasticizer substitute, were associated with a 50% and 70% increased risk of preterm birth, respectively (P = .01, .11), according to results published in JAMA Network Open .

Sensitivity analysis showed that maternal preconception MHiNCH concentrations above the median were associated with a fourfold increased risk of preterm birth (risk ratio, 4.02; P = .08), Maternal preconception MHiNCH concentrations were associated with an average 2-day reduction in gestational age (P = .02).

Covariate-adjusted models found that paternal urinary phthalate metabolite concentrations were associated with an increased risk of preterm birth (RR, 1.41; P = .09), but this association was attenuated toward zero (RR, 1.06) in models that accounted for maternal preconception phthalate concentrations. Sensitivity analysis of 228 couples found the associations of maternal preconception phthalate metabolite concentrations and preterm birth remained robust in three different models: a twofold increased risk in covariate-adjusted models (P < .001); an almost fivefold increased risk in adjusting for prenatal levels (RR, 4.98; P < .001); and a twofold risk (P = .001) in adjusting for paternal levels. “Couple-based analyses confirmed the results for an association between maternal preconception DEHP concentrations and increased risk of preterm birth,” the investigators said.

“To our knowledge, this is the first study evaluating couples’ exposure to phthalate metabolites during the preconception window and its association with preterm birth,” the researchers wrote. “Our findings support a novel hypothesis: Maternal phthalate exposure during the critical period before conception may be associated with shorter gestation.”

“This study is consistent with several, but not all, prior studies supporting maternal prenatal exposure to phthalates increase preterm birth,” said Mark P. Trolice, MD, professor of obstetrics and gynecology at the University of Central Florida, Orlando. “The uniqueness of the current study was the assessment of couples’ exposures and the outcome, though paternal exposure to phthalates did not demonstrate a significant association.”

Dr. Trolice noted that about 25% of women in the study were smokers, but the study didn’t adjust for tobacco use and phthalate exposure, and 85% of the women were white. He urged caution in applying the study results in practice, adding that the study didn’t adjust for method of conception. “Assisted reproductive technology, multiple gestation, and advanced age are all known risk factors for preterm birth,”

The National Institute of Environmental Health Science funded the study. Two study coauthors received grants from the NIEHS, one coauthor received grants from the National Institutes of Health, and one received a grant from the Canadian Institutes of Health Research. No other disclosures were reported. Dr. Trolice has no financial relationships to disclose.

SOURCE: Zhang Y et al. JAMA Network Open. 2020; doi: 10.1001/jamanetworkopen.2020.2159.

Maternal preconception exposure to phthalates was associated with increased risk of preterm birth, according to a study of 420 births to subfertile couples over a 13-year period.

Previous studies have shown increased risk of preterm birth associated with prenatal exposure to phthalates, which are commonly found in a range of household and commercial products as well as medical equipment and some pharmaceuticals.

“Our results suggest that female exposure to [4 di(2-ethylhexyl) phthalate] DEHP before conception might be an unrecognized risk factor for adverse pregnancy outcomes, often overlooked in clinical practice,” wrote Yu Zhang of the department of environmental health at Harvard T.H. Chan School of Public Health, Boston, and colleagues.

The prospective cohort study evaluated preconception urinary levels of phthalates and phthalate substitutes in 419 women and 229 men participating in the Environment and Reproductive Health (EARTH) study, a cohort of couples seeking fertility care at the Massachusetts General Hospital Fertility Center. The study cohort gave birth during 2005-2018. The average gestational age of the 420 singleton children born to this cohort was 39 weeks, with 8% (n = 34) born preterm.

Adjusted models showed that maternal preconception urinary concentrations of phthalates and of cyclohexane-1, 2-dicarboxylic acid monohydroxy isononyl ester (MHiNCH), a metabolite of a nonphthalate plasticizer substitute, were associated with a 50% and 70% increased risk of preterm birth, respectively (P = .01, .11), according to results published in JAMA Network Open .

Sensitivity analysis showed that maternal preconception MHiNCH concentrations above the median were associated with a fourfold increased risk of preterm birth (risk ratio, 4.02; P = .08), Maternal preconception MHiNCH concentrations were associated with an average 2-day reduction in gestational age (P = .02).

Covariate-adjusted models found that paternal urinary phthalate metabolite concentrations were associated with an increased risk of preterm birth (RR, 1.41; P = .09), but this association was attenuated toward zero (RR, 1.06) in models that accounted for maternal preconception phthalate concentrations. Sensitivity analysis of 228 couples found the associations of maternal preconception phthalate metabolite concentrations and preterm birth remained robust in three different models: a twofold increased risk in covariate-adjusted models (P < .001); an almost fivefold increased risk in adjusting for prenatal levels (RR, 4.98; P < .001); and a twofold risk (P = .001) in adjusting for paternal levels. “Couple-based analyses confirmed the results for an association between maternal preconception DEHP concentrations and increased risk of preterm birth,” the investigators said.

“To our knowledge, this is the first study evaluating couples’ exposure to phthalate metabolites during the preconception window and its association with preterm birth,” the researchers wrote. “Our findings support a novel hypothesis: Maternal phthalate exposure during the critical period before conception may be associated with shorter gestation.”

“This study is consistent with several, but not all, prior studies supporting maternal prenatal exposure to phthalates increase preterm birth,” said Mark P. Trolice, MD, professor of obstetrics and gynecology at the University of Central Florida, Orlando. “The uniqueness of the current study was the assessment of couples’ exposures and the outcome, though paternal exposure to phthalates did not demonstrate a significant association.”

Dr. Trolice noted that about 25% of women in the study were smokers, but the study didn’t adjust for tobacco use and phthalate exposure, and 85% of the women were white. He urged caution in applying the study results in practice, adding that the study didn’t adjust for method of conception. “Assisted reproductive technology, multiple gestation, and advanced age are all known risk factors for preterm birth,”

The National Institute of Environmental Health Science funded the study. Two study coauthors received grants from the NIEHS, one coauthor received grants from the National Institutes of Health, and one received a grant from the Canadian Institutes of Health Research. No other disclosures were reported. Dr. Trolice has no financial relationships to disclose.

SOURCE: Zhang Y et al. JAMA Network Open. 2020; doi: 10.1001/jamanetworkopen.2020.2159.

Combination therapy with apatinib and camrelizumab shows promising antitumor activity in patients with advanced cervical cancer, regardless of programmed death–ligand 1 (PD-L1) expression, according to preliminary findings from a phase 2 study.

Dr. Chunyan Lan

Apatinib, an inhibitor of vascular endothelial growth factor receptor-2, and camrelizumab, an anti-PD-1 monoclonal antibody, produced an objective response rate of 60% in evaluable patients.

Chunyan Lan, MD, of Sun Yat-sen University Cancer Center in Guangzhou, China, and colleagues reported these results in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic. The following data differ somewhat from the abstract.

Dr. Lan and colleagues reported results in 45 patients who had progressed after at least one line of systemic chemotherapy for metastatic, recurrent, or persistent cervical cancer, and had measurable disease. Patients had a median age of 51 years and an Eastern Cooperative Oncology Group performance status of 0-1. They were enrolled at four centers in China between Jan. 21 and Aug. 1, 2019.

Treatment consisted of oral apatinib at a dose of 250 mg once daily and intravenous camrelizumab at a dose of 200 mg every 2 weeks until disease progression, unacceptable toxicity, or consent withdrawal.

As of Jan. 22, 2020, 25 of 42 efficacy-evaluable patients had achieved a response. Two patients had a complete response, 23 had a partial response, and 12 had stable disease.

“We saw responses in patients regardless of PD-L1 expression,” Dr. Lan said. “In our study, 34% were PD-L1 negative, and the response rate is 65% in PD-L1-positive and 50% in PD-L1-negative [patients].”

The median duration of response was not reached, she added.

The median follow-up was 9.2 months, with the last patient enrolled having 6 months of follow-up. At the data cutoff, 19 patients had disease progression, and 8 had died of their disease.

The median overall survival also was not reached, Dr. Lan said, but overall survival at 9 months was 80%. The median progression-free survival was 7.6 months, and the 6-month progression-free survival rate was 58%.

Grade 3 or greater treatment-related adverse events occurred in 68.9% of patients; adverse events occurring in at least 5% of patients included hypertension (22.2%), fatigue (15.6%), anemia (13.3%), and thrombocytopenia (6.7%).

“Nineteen patients were still on treatment at the data cutoff date, and 26 patients discontinued the study,” Dr. Lan said. “The most common reason to discontinue was disease progression, and three patients discontinued the study due to adverse events.”

“These preliminary results are very encouraging,” Dr. Lan said. “As we know, pembrolizumab is approved as the second-line therapy in recurrent cervical cancer [in] PD-L1-positive patients, and the objective response rate with pembrolizumab monotherapy for recurrent cervical cancer is only 17%, as reported in KEYNOTE-028 [J Clin Oncol. 2017 Dec 20;35(36):4035-41].”

Furthermore, apatinib monotherapy has been studied with only modest results.

“But in our study, this combination is really effective in recurrent cervical cancer, and we see a very durable response,” she said, again emphasizing that those responses occurred regardless of PD-L1 expression. “So this is important. ... We think our findings expand the opportunity of patients with recurrent cervical cancer to receive immune therapy.”

Study participants will be followed for 2 years, Dr. Lan noted.

She reported having no disclosures. The study is sponsored by Sun Yat-sen University.

[email protected]

SOURCE: Lan C et al. SGO 2020, Abstract 55.

Combination therapy with apatinib and camrelizumab shows promising antitumor activity in patients with advanced cervical cancer, regardless of programmed death–ligand 1 (PD-L1) expression, according to preliminary findings from a phase 2 study.

Dr. Chunyan Lan

Apatinib, an inhibitor of vascular endothelial growth factor receptor-2, and camrelizumab, an anti-PD-1 monoclonal antibody, produced an objective response rate of 60% in evaluable patients.

Chunyan Lan, MD, of Sun Yat-sen University Cancer Center in Guangzhou, China, and colleagues reported these results in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic. The following data differ somewhat from the abstract.

Dr. Lan and colleagues reported results in 45 patients who had progressed after at least one line of systemic chemotherapy for metastatic, recurrent, or persistent cervical cancer, and had measurable disease. Patients had a median age of 51 years and an Eastern Cooperative Oncology Group performance status of 0-1. They were enrolled at four centers in China between Jan. 21 and Aug. 1, 2019.

Treatment consisted of oral apatinib at a dose of 250 mg once daily and intravenous camrelizumab at a dose of 200 mg every 2 weeks until disease progression, unacceptable toxicity, or consent withdrawal.

As of Jan. 22, 2020, 25 of 42 efficacy-evaluable patients had achieved a response. Two patients had a complete response, 23 had a partial response, and 12 had stable disease.

“We saw responses in patients regardless of PD-L1 expression,” Dr. Lan said. “In our study, 34% were PD-L1 negative, and the response rate is 65% in PD-L1-positive and 50% in PD-L1-negative [patients].”

The median duration of response was not reached, she added.

The median follow-up was 9.2 months, with the last patient enrolled having 6 months of follow-up. At the data cutoff, 19 patients had disease progression, and 8 had died of their disease.

The median overall survival also was not reached, Dr. Lan said, but overall survival at 9 months was 80%. The median progression-free survival was 7.6 months, and the 6-month progression-free survival rate was 58%.

Grade 3 or greater treatment-related adverse events occurred in 68.9% of patients; adverse events occurring in at least 5% of patients included hypertension (22.2%), fatigue (15.6%), anemia (13.3%), and thrombocytopenia (6.7%).

“Nineteen patients were still on treatment at the data cutoff date, and 26 patients discontinued the study,” Dr. Lan said. “The most common reason to discontinue was disease progression, and three patients discontinued the study due to adverse events.”

“These preliminary results are very encouraging,” Dr. Lan said. “As we know, pembrolizumab is approved as the second-line therapy in recurrent cervical cancer [in] PD-L1-positive patients, and the objective response rate with pembrolizumab monotherapy for recurrent cervical cancer is only 17%, as reported in KEYNOTE-028 [J Clin Oncol. 2017 Dec 20;35(36):4035-41].”

Furthermore, apatinib monotherapy has been studied with only modest results.

“But in our study, this combination is really effective in recurrent cervical cancer, and we see a very durable response,” she said, again emphasizing that those responses occurred regardless of PD-L1 expression. “So this is important. ... We think our findings expand the opportunity of patients with recurrent cervical cancer to receive immune therapy.”

Study participants will be followed for 2 years, Dr. Lan noted.

She reported having no disclosures. The study is sponsored by Sun Yat-sen University.

[email protected]

SOURCE: Lan C et al. SGO 2020, Abstract 55.

Combination therapy with apatinib and camrelizumab shows promising antitumor activity in patients with advanced cervical cancer, regardless of programmed death–ligand 1 (PD-L1) expression, according to preliminary findings from a phase 2 study.

Dr. Chunyan Lan

Apatinib, an inhibitor of vascular endothelial growth factor receptor-2, and camrelizumab, an anti-PD-1 monoclonal antibody, produced an objective response rate of 60% in evaluable patients.

Chunyan Lan, MD, of Sun Yat-sen University Cancer Center in Guangzhou, China, and colleagues reported these results in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic. The following data differ somewhat from the abstract.

Dr. Lan and colleagues reported results in 45 patients who had progressed after at least one line of systemic chemotherapy for metastatic, recurrent, or persistent cervical cancer, and had measurable disease. Patients had a median age of 51 years and an Eastern Cooperative Oncology Group performance status of 0-1. They were enrolled at four centers in China between Jan. 21 and Aug. 1, 2019.

Treatment consisted of oral apatinib at a dose of 250 mg once daily and intravenous camrelizumab at a dose of 200 mg every 2 weeks until disease progression, unacceptable toxicity, or consent withdrawal.

As of Jan. 22, 2020, 25 of 42 efficacy-evaluable patients had achieved a response. Two patients had a complete response, 23 had a partial response, and 12 had stable disease.

“We saw responses in patients regardless of PD-L1 expression,” Dr. Lan said. “In our study, 34% were PD-L1 negative, and the response rate is 65% in PD-L1-positive and 50% in PD-L1-negative [patients].”

The median duration of response was not reached, she added.

The median follow-up was 9.2 months, with the last patient enrolled having 6 months of follow-up. At the data cutoff, 19 patients had disease progression, and 8 had died of their disease.

The median overall survival also was not reached, Dr. Lan said, but overall survival at 9 months was 80%. The median progression-free survival was 7.6 months, and the 6-month progression-free survival rate was 58%.

Grade 3 or greater treatment-related adverse events occurred in 68.9% of patients; adverse events occurring in at least 5% of patients included hypertension (22.2%), fatigue (15.6%), anemia (13.3%), and thrombocytopenia (6.7%).

“Nineteen patients were still on treatment at the data cutoff date, and 26 patients discontinued the study,” Dr. Lan said. “The most common reason to discontinue was disease progression, and three patients discontinued the study due to adverse events.”

“These preliminary results are very encouraging,” Dr. Lan said. “As we know, pembrolizumab is approved as the second-line therapy in recurrent cervical cancer [in] PD-L1-positive patients, and the objective response rate with pembrolizumab monotherapy for recurrent cervical cancer is only 17%, as reported in KEYNOTE-028 [J Clin Oncol. 2017 Dec 20;35(36):4035-41].”

Furthermore, apatinib monotherapy has been studied with only modest results.

“But in our study, this combination is really effective in recurrent cervical cancer, and we see a very durable response,” she said, again emphasizing that those responses occurred regardless of PD-L1 expression. “So this is important. ... We think our findings expand the opportunity of patients with recurrent cervical cancer to receive immune therapy.”

Study participants will be followed for 2 years, Dr. Lan noted.

She reported having no disclosures. The study is sponsored by Sun Yat-sen University.

[email protected]

SOURCE: Lan C et al. SGO 2020, Abstract 55.

The American College of Obstetricians and Gynecologists (ACOG) posted a useful resource on its website on March 30 for clinicians practicing ambulatory gynecology. The guidance, “COVID-19 FAQs for Obstetrician–Gynecologists, Gynecology” (https://www.acog.org/), is based on expert opinion and is intended to supplement guidance from the Centers for Disease Control and Prevention as well as previously issued ACOG guidance.¹

Which patients need to be seen, and when

The ACOG guidance provides examples of patients needing in-person appointments, video or telephone visits, or for whom deferral of a visit until after the COVID-19 outbreak would be appropriate. Highlights include:

In-person appointments

• suspected ectopic pregnancy
• profuse vaginal bleeding

Video or telephone visits

• contraceptive counseling and prescribing
• management of menopausal symptoms

Deferral of a visit until after the COVID-19 outbreak

• routine well-woman visits for average-risk patients.

Cervical screening

With respect to patients with abnormal cervical cancer screening results, ACOG recommends the ASCCP’s guidance that²:

• for patients with low-grade test results, colposcopy/cervical biopsies be deferred up to 6 to 12 months
• for patients with high-grade results, colposcopy/cervical biopsies be performed within 3 months.

Contraception

Regarding contraceptive services, the ACOG guidance suggests that placement of intrauterine devices (IUDs) and contraceptive implants should continue “where possible.” If initiation of long-acting reversible contraception (LARC) is not feasible, the guidance recommends that use of self-administered contraceptives (including subcutaneous injections, oral, transdermal patch, and vaginal ring contraception) be encouraged as a bridge to later initiation of LARC.

The guidance suggests that removal of IUDs and implants be postponed when possible.

Finally, the guidance suggests that patients with an existing IUD or implant who seek removal and replacement of their contraceptives be counseled regarding extended use of these devices.

Individualize your approach

ACOG emphasizes that no single solution applies to all situations and that each practice or clinic should evaluate the individual situation, including the availability of local and regional resources, staffing, and personal protective equipment; the prevalence of COVID-19 in the region; and the type of practice.

A roadmap for care

This guidance from ACOG should help clinicians caring for women during the COVID-19 outbreak to counsel and guide patients in a prudent manner.
 

The American College of Obstetricians and Gynecologists (ACOG) posted a useful resource on its website on March 30 for clinicians practicing ambulatory gynecology. The guidance, “COVID-19 FAQs for Obstetrician–Gynecologists, Gynecology” (https://www.acog.org/), is based on expert opinion and is intended to supplement guidance from the Centers for Disease Control and Prevention as well as previously issued ACOG guidance.¹

Which patients need to be seen, and when

The ACOG guidance provides examples of patients needing in-person appointments, video or telephone visits, or for whom deferral of a visit until after the COVID-19 outbreak would be appropriate. Highlights include:

In-person appointments

• suspected ectopic pregnancy
• profuse vaginal bleeding

Video or telephone visits

• contraceptive counseling and prescribing
• management of menopausal symptoms

Deferral of a visit until after the COVID-19 outbreak

• routine well-woman visits for average-risk patients.

Cervical screening

With respect to patients with abnormal cervical cancer screening results, ACOG recommends the ASCCP’s guidance that²:

• for patients with low-grade test results, colposcopy/cervical biopsies be deferred up to 6 to 12 months
• for patients with high-grade results, colposcopy/cervical biopsies be performed within 3 months.

Contraception

Regarding contraceptive services, the ACOG guidance suggests that placement of intrauterine devices (IUDs) and contraceptive implants should continue “where possible.” If initiation of long-acting reversible contraception (LARC) is not feasible, the guidance recommends that use of self-administered contraceptives (including subcutaneous injections, oral, transdermal patch, and vaginal ring contraception) be encouraged as a bridge to later initiation of LARC.

The guidance suggests that removal of IUDs and implants be postponed when possible.

Finally, the guidance suggests that patients with an existing IUD or implant who seek removal and replacement of their contraceptives be counseled regarding extended use of these devices.

Individualize your approach

ACOG emphasizes that no single solution applies to all situations and that each practice or clinic should evaluate the individual situation, including the availability of local and regional resources, staffing, and personal protective equipment; the prevalence of COVID-19 in the region; and the type of practice.

A roadmap for care

This guidance from ACOG should help clinicians caring for women during the COVID-19 outbreak to counsel and guide patients in a prudent manner.
 

The American College of Obstetricians and Gynecologists (ACOG) posted a useful resource on its website on March 30 for clinicians practicing ambulatory gynecology. The guidance, “COVID-19 FAQs for Obstetrician–Gynecologists, Gynecology” (https://www.acog.org/), is based on expert opinion and is intended to supplement guidance from the Centers for Disease Control and Prevention as well as previously issued ACOG guidance.¹

Which patients need to be seen, and when

The ACOG guidance provides examples of patients needing in-person appointments, video or telephone visits, or for whom deferral of a visit until after the COVID-19 outbreak would be appropriate. Highlights include:

In-person appointments

• suspected ectopic pregnancy
• profuse vaginal bleeding

Video or telephone visits

• contraceptive counseling and prescribing
• management of menopausal symptoms

Deferral of a visit until after the COVID-19 outbreak

• routine well-woman visits for average-risk patients.

Cervical screening

With respect to patients with abnormal cervical cancer screening results, ACOG recommends the ASCCP’s guidance that²:

• for patients with low-grade test results, colposcopy/cervical biopsies be deferred up to 6 to 12 months
• for patients with high-grade results, colposcopy/cervical biopsies be performed within 3 months.

Contraception

Regarding contraceptive services, the ACOG guidance suggests that placement of intrauterine devices (IUDs) and contraceptive implants should continue “where possible.” If initiation of long-acting reversible contraception (LARC) is not feasible, the guidance recommends that use of self-administered contraceptives (including subcutaneous injections, oral, transdermal patch, and vaginal ring contraception) be encouraged as a bridge to later initiation of LARC.

The guidance suggests that removal of IUDs and implants be postponed when possible.

Finally, the guidance suggests that patients with an existing IUD or implant who seek removal and replacement of their contraceptives be counseled regarding extended use of these devices.

Individualize your approach

ACOG emphasizes that no single solution applies to all situations and that each practice or clinic should evaluate the individual situation, including the availability of local and regional resources, staffing, and personal protective equipment; the prevalence of COVID-19 in the region; and the type of practice.

A roadmap for care

This guidance from ACOG should help clinicians caring for women during the COVID-19 outbreak to counsel and guide patients in a prudent manner.