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Multidisciplinary teams offer key to complex deliveries

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Medical practice has evolved, and will continue to do so, as we begin pushing for more personalized and better precision health care. Gone are the days of the general practitioner who attempted to treat all conditions in all patients. Health care is now so complex that not only specialists but also so-called superspecialists are needed to manage complicated cases successfully.

One of the biggest challenges, and greatest opportunities, in ob.gyn. is the need to establish a multidisciplinary health team to the address the needs of today’s patients. More than ever, we are working with patients with advanced maternal age having their first pregnancies. More than ever, we are managing patients who have preexisting diabetes and are concurrently overweight or obese. More than ever, our patients are having multiple cesarean deliveries. More than ever, our patients are hoping – perhaps even expecting – to retain their fertility after a complicated delivery. More than ever, a single patient may need the guidance and care of not just an ob.gyn. or maternal-fetal medicine subspecialist but also an endocrinologist, cardiologist, diabetologist, genetic counselor, nutritionist – the list could go on.

Dr. E. Albert Reece
Although it may seem like a simple idea in theory – integrating health care professionals across disciplines to manage complex cases – it can be challenging in practice. However, only by breaking through the medical science silos and by emphasizing the importance of having a variety of specialists actively participating in the care team can we hope to accelerate and improve the outcome of cases dramatically that may otherwise end poorly. As medicine advances so, too, do the complications that we and our patients expect modern ob.gyn. practice to manage and address successfully. We need to be prepared.

The emergence and continued growth of personalized and preventive medicine in the very near future will catalyze fundamental changes at many different levels in health care and health systems. The need to establish multidisciplinary care teams is already apparent in ob.gyn. but is especially necessary in helping patients who experience complicated deliveries that could jeopardize their immediate and long-term health and fertility.

This month, we have invited M. Ozhan Turan, MD, PhD, the director of fetal therapy and complex obstetric surgery at the University of Maryland, Baltimore, to discuss the use of a multidisciplinary team in the management of patients with placenta accreta and other forms of morbidly adherent placenta.
 

Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column.

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Medical practice has evolved, and will continue to do so, as we begin pushing for more personalized and better precision health care. Gone are the days of the general practitioner who attempted to treat all conditions in all patients. Health care is now so complex that not only specialists but also so-called superspecialists are needed to manage complicated cases successfully.

One of the biggest challenges, and greatest opportunities, in ob.gyn. is the need to establish a multidisciplinary health team to the address the needs of today’s patients. More than ever, we are working with patients with advanced maternal age having their first pregnancies. More than ever, we are managing patients who have preexisting diabetes and are concurrently overweight or obese. More than ever, our patients are having multiple cesarean deliveries. More than ever, our patients are hoping – perhaps even expecting – to retain their fertility after a complicated delivery. More than ever, a single patient may need the guidance and care of not just an ob.gyn. or maternal-fetal medicine subspecialist but also an endocrinologist, cardiologist, diabetologist, genetic counselor, nutritionist – the list could go on.

Dr. E. Albert Reece
Although it may seem like a simple idea in theory – integrating health care professionals across disciplines to manage complex cases – it can be challenging in practice. However, only by breaking through the medical science silos and by emphasizing the importance of having a variety of specialists actively participating in the care team can we hope to accelerate and improve the outcome of cases dramatically that may otherwise end poorly. As medicine advances so, too, do the complications that we and our patients expect modern ob.gyn. practice to manage and address successfully. We need to be prepared.

The emergence and continued growth of personalized and preventive medicine in the very near future will catalyze fundamental changes at many different levels in health care and health systems. The need to establish multidisciplinary care teams is already apparent in ob.gyn. but is especially necessary in helping patients who experience complicated deliveries that could jeopardize their immediate and long-term health and fertility.

This month, we have invited M. Ozhan Turan, MD, PhD, the director of fetal therapy and complex obstetric surgery at the University of Maryland, Baltimore, to discuss the use of a multidisciplinary team in the management of patients with placenta accreta and other forms of morbidly adherent placenta.
 

Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column.

 

Medical practice has evolved, and will continue to do so, as we begin pushing for more personalized and better precision health care. Gone are the days of the general practitioner who attempted to treat all conditions in all patients. Health care is now so complex that not only specialists but also so-called superspecialists are needed to manage complicated cases successfully.

One of the biggest challenges, and greatest opportunities, in ob.gyn. is the need to establish a multidisciplinary health team to the address the needs of today’s patients. More than ever, we are working with patients with advanced maternal age having their first pregnancies. More than ever, we are managing patients who have preexisting diabetes and are concurrently overweight or obese. More than ever, our patients are having multiple cesarean deliveries. More than ever, our patients are hoping – perhaps even expecting – to retain their fertility after a complicated delivery. More than ever, a single patient may need the guidance and care of not just an ob.gyn. or maternal-fetal medicine subspecialist but also an endocrinologist, cardiologist, diabetologist, genetic counselor, nutritionist – the list could go on.

Dr. E. Albert Reece
Although it may seem like a simple idea in theory – integrating health care professionals across disciplines to manage complex cases – it can be challenging in practice. However, only by breaking through the medical science silos and by emphasizing the importance of having a variety of specialists actively participating in the care team can we hope to accelerate and improve the outcome of cases dramatically that may otherwise end poorly. As medicine advances so, too, do the complications that we and our patients expect modern ob.gyn. practice to manage and address successfully. We need to be prepared.

The emergence and continued growth of personalized and preventive medicine in the very near future will catalyze fundamental changes at many different levels in health care and health systems. The need to establish multidisciplinary care teams is already apparent in ob.gyn. but is especially necessary in helping patients who experience complicated deliveries that could jeopardize their immediate and long-term health and fertility.

This month, we have invited M. Ozhan Turan, MD, PhD, the director of fetal therapy and complex obstetric surgery at the University of Maryland, Baltimore, to discuss the use of a multidisciplinary team in the management of patients with placenta accreta and other forms of morbidly adherent placenta.
 

Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column.

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One-step GDM diagnosis: Research moves closer

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Data are accumulating that lend more support to a one-step approach for diagnosing gestational diabetes mellitus in the United States.

The American College of Obstetricians and Gynecologists now acknowledges this approach as an option, yet “tremendous controversy persists,” according to Mark Landon, MD.

“In the U.S., we continue to be the principal purveyors of a two-step method with a 100-g [oral glucose tolerance test] diagnostic approach, which is in contrast to much of the rest of the world,” he said the biennial meeting of the Diabetes in Pregnancy Study Group of North America.

“At this time, if we’re going to [turn nationally] to the one-step approach, we have to lower the cost of diagnosis and treatment, and we may need some upwards adjustments in the [International Association of Diabetes and Pregnancy Study Groups] criteria in order to achieve consensus,” said Dr. Landon, professor and chair of the department of obstetrics and gynecology at Ohio State University, Columbus.

The International Association of Diabetes in Pregnancy Study Groups (IADPSG) created a stir in the American obstetrics community when it recommended in 2010 that a universal 75-g, 2-hour oral glucose tolerance test (OGTT) be performed during pregnancy and that gestational diabetes mellitus (GDM) be diagnosed when any single measurement threshold – a fasting value of 92 mg/dL, a 1-hour value of 180 mg/dL, or a 2-hour value of 153 mg/dL – is met or exceeded (Diabetes Care 2010 Mar; 33[3]:676-82).

The consensus group made its recommendation based largely on published associations of maternal glycemia with perinatal and long-term outcomes in offspring. Chief among the studies was the landmark Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study, which found continuous linear relationships between maternal glucose levels – including levels that had been viewed as normal – and adverse fetal outcomes such as high fetal birth weight, cord-blood serum C-peptide level (an index of fetal beta-cell function and fetal hyperinsulinemia), and clinical neonatal hypoglycemia. Maternal glucose tolerance was measured in the study with the 75-g 2-hour OGTT.

The IADPSG chose its cut-off points to convey an odds ratio for adverse outcomes of 1.75. But use of the criteria meant that 16%-18% of pregnant women in the United States would be identified as having GDM – a doubling, at least.

Courtesy Ohio State University
Dr. Mark B. Landon

In 2013, a National Institute of Child Health and Human Development Consensus Development Conference recommended against adoption of the new criteria, citing uncertainties regarding the benefits of treating so many additional cases of GDM, as well as the costs and additional burden on patients, providers, and the health care system.

In an updated Practice Bulletin on GDM, ACOG recommends that the suggested changes be studied “before they are proposed at a national level.” But ACOG noted that “individual practices and institutions may choose to use the IADPSG’s recommendation, if appropriate, for the population they serve” (Obstet Gynecol. 2017;130[1]:e17-37).

Since the IADPSG proposal came out, Dr. Landon said, at least a half-dozen published studies have attempted to clarify the additional benefit of their proposed criteria, analyzing the risk of adverse maternal and fetal outcomes in women who are diagnosed using IADPSG criteria and not treated, versus those with a normal glucose tolerance test. In these analyses, researchers have excluded women who would also meet usual diagnostic criteria, such as the Carpenter-Coustan criteria, in order to hone in on those with the mildest levels of GDM – the new diagnoses.

Research published “in the last 5-6 years has almost exclusively shown that, in using the IADPSG criteria, and excluding other usual criteria, you see graded, increased frequencies in large babies, preeclampsia, [neonatal] hypoglycemia” and other adverse outcomes, Dr. Landon said. “I know of only one study that refutes these associations.”

A secondary analysis of HAPO study data, for instance, grouped women into three categories: those with no GDM, GDM based on traditional Carpenter-Coustan criteria, and GDM based on IADPSG criteria but not the Carpenter-Coustan thresholds. A 3-hour OGTT result was not used in this analysis since the HAPO study did not collect this.

Compared with cases with no GDM, those with GDM based on IADPSG criteria (but not the Carpenter-Coustan criteria) were nearly twice as likely to have birth weights above the 90th percentile, newborn percentage fat over the 90th percentile, and preeclampsia, for instance (Diabetes Care 2016;39[12];2204-10).

Other researchers are trying to tease apart risk levels according to thresholds that differ slightly from traditional criteria. A retrospective cohort study from Kaiser Permanente Southern California, for instance, chose two strata of women whose GDM was in the lower levels of the IADPSG-defined spectrum for glucose intolerance and found that, in those with the lesser degree of hyperglycemia, only birth weight and large-for-gestational-age was significantly greater than in women with no GDM (Obstet Gynecol. 2015;126[1]:67-73).

“This study is interesting because it raises the question of whether there might be differential treatment effects based on the level of hyperglycemia within the IADPSG category,” Dr. Landon said.

Dr. Landon served as the principal investigator of a large national, randomized controlled trial that showed a reduction in the risk of fetal overgrowth, shoulder dystocia, cesarean delivery, and hypertensive disorders in women who were treated for mild gestational diabetes (N Engl J Med. 2009;361:1339-48). But this study defined mild gestational diabetes according to the Carpenter-Coustan criteria.

“What about the women who meet the [even lower thresholds] of the IADPSG criteria? One would expect that the treatment benefit would not be as great, but will they still benefit from treatment? To date, this is simply unknown,” he said in an interview.

Research in the last 5 years has also begun to look at the financial implications of the IADPSG criteria and strategies for reducing the cost of implementation. Dr. Landon noted that investigators in Brazil, for instance, have determined that an alternative strategy of using a fasting plasma glucose value of 92 mg/gL or greater to rule in GDM, and a fasting value of 80 mg/dL or less to rule out GDM, eliminates the need for 61% of oral glucose challenges and has 96.9% sensitivity for diagnosing GDM (Diabetes Res Clin Pract. 2015 May;108[2]:288-95).

Dr. Landon reported having no relevant financial disclosures.

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Data are accumulating that lend more support to a one-step approach for diagnosing gestational diabetes mellitus in the United States.

The American College of Obstetricians and Gynecologists now acknowledges this approach as an option, yet “tremendous controversy persists,” according to Mark Landon, MD.

“In the U.S., we continue to be the principal purveyors of a two-step method with a 100-g [oral glucose tolerance test] diagnostic approach, which is in contrast to much of the rest of the world,” he said the biennial meeting of the Diabetes in Pregnancy Study Group of North America.

“At this time, if we’re going to [turn nationally] to the one-step approach, we have to lower the cost of diagnosis and treatment, and we may need some upwards adjustments in the [International Association of Diabetes and Pregnancy Study Groups] criteria in order to achieve consensus,” said Dr. Landon, professor and chair of the department of obstetrics and gynecology at Ohio State University, Columbus.

The International Association of Diabetes in Pregnancy Study Groups (IADPSG) created a stir in the American obstetrics community when it recommended in 2010 that a universal 75-g, 2-hour oral glucose tolerance test (OGTT) be performed during pregnancy and that gestational diabetes mellitus (GDM) be diagnosed when any single measurement threshold – a fasting value of 92 mg/dL, a 1-hour value of 180 mg/dL, or a 2-hour value of 153 mg/dL – is met or exceeded (Diabetes Care 2010 Mar; 33[3]:676-82).

The consensus group made its recommendation based largely on published associations of maternal glycemia with perinatal and long-term outcomes in offspring. Chief among the studies was the landmark Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study, which found continuous linear relationships between maternal glucose levels – including levels that had been viewed as normal – and adverse fetal outcomes such as high fetal birth weight, cord-blood serum C-peptide level (an index of fetal beta-cell function and fetal hyperinsulinemia), and clinical neonatal hypoglycemia. Maternal glucose tolerance was measured in the study with the 75-g 2-hour OGTT.

The IADPSG chose its cut-off points to convey an odds ratio for adverse outcomes of 1.75. But use of the criteria meant that 16%-18% of pregnant women in the United States would be identified as having GDM – a doubling, at least.

Courtesy Ohio State University
Dr. Mark B. Landon

In 2013, a National Institute of Child Health and Human Development Consensus Development Conference recommended against adoption of the new criteria, citing uncertainties regarding the benefits of treating so many additional cases of GDM, as well as the costs and additional burden on patients, providers, and the health care system.

In an updated Practice Bulletin on GDM, ACOG recommends that the suggested changes be studied “before they are proposed at a national level.” But ACOG noted that “individual practices and institutions may choose to use the IADPSG’s recommendation, if appropriate, for the population they serve” (Obstet Gynecol. 2017;130[1]:e17-37).

Since the IADPSG proposal came out, Dr. Landon said, at least a half-dozen published studies have attempted to clarify the additional benefit of their proposed criteria, analyzing the risk of adverse maternal and fetal outcomes in women who are diagnosed using IADPSG criteria and not treated, versus those with a normal glucose tolerance test. In these analyses, researchers have excluded women who would also meet usual diagnostic criteria, such as the Carpenter-Coustan criteria, in order to hone in on those with the mildest levels of GDM – the new diagnoses.

Research published “in the last 5-6 years has almost exclusively shown that, in using the IADPSG criteria, and excluding other usual criteria, you see graded, increased frequencies in large babies, preeclampsia, [neonatal] hypoglycemia” and other adverse outcomes, Dr. Landon said. “I know of only one study that refutes these associations.”

A secondary analysis of HAPO study data, for instance, grouped women into three categories: those with no GDM, GDM based on traditional Carpenter-Coustan criteria, and GDM based on IADPSG criteria but not the Carpenter-Coustan thresholds. A 3-hour OGTT result was not used in this analysis since the HAPO study did not collect this.

Compared with cases with no GDM, those with GDM based on IADPSG criteria (but not the Carpenter-Coustan criteria) were nearly twice as likely to have birth weights above the 90th percentile, newborn percentage fat over the 90th percentile, and preeclampsia, for instance (Diabetes Care 2016;39[12];2204-10).

Other researchers are trying to tease apart risk levels according to thresholds that differ slightly from traditional criteria. A retrospective cohort study from Kaiser Permanente Southern California, for instance, chose two strata of women whose GDM was in the lower levels of the IADPSG-defined spectrum for glucose intolerance and found that, in those with the lesser degree of hyperglycemia, only birth weight and large-for-gestational-age was significantly greater than in women with no GDM (Obstet Gynecol. 2015;126[1]:67-73).

“This study is interesting because it raises the question of whether there might be differential treatment effects based on the level of hyperglycemia within the IADPSG category,” Dr. Landon said.

Dr. Landon served as the principal investigator of a large national, randomized controlled trial that showed a reduction in the risk of fetal overgrowth, shoulder dystocia, cesarean delivery, and hypertensive disorders in women who were treated for mild gestational diabetes (N Engl J Med. 2009;361:1339-48). But this study defined mild gestational diabetes according to the Carpenter-Coustan criteria.

“What about the women who meet the [even lower thresholds] of the IADPSG criteria? One would expect that the treatment benefit would not be as great, but will they still benefit from treatment? To date, this is simply unknown,” he said in an interview.

Research in the last 5 years has also begun to look at the financial implications of the IADPSG criteria and strategies for reducing the cost of implementation. Dr. Landon noted that investigators in Brazil, for instance, have determined that an alternative strategy of using a fasting plasma glucose value of 92 mg/gL or greater to rule in GDM, and a fasting value of 80 mg/dL or less to rule out GDM, eliminates the need for 61% of oral glucose challenges and has 96.9% sensitivity for diagnosing GDM (Diabetes Res Clin Pract. 2015 May;108[2]:288-95).

Dr. Landon reported having no relevant financial disclosures.

 

Data are accumulating that lend more support to a one-step approach for diagnosing gestational diabetes mellitus in the United States.

The American College of Obstetricians and Gynecologists now acknowledges this approach as an option, yet “tremendous controversy persists,” according to Mark Landon, MD.

“In the U.S., we continue to be the principal purveyors of a two-step method with a 100-g [oral glucose tolerance test] diagnostic approach, which is in contrast to much of the rest of the world,” he said the biennial meeting of the Diabetes in Pregnancy Study Group of North America.

“At this time, if we’re going to [turn nationally] to the one-step approach, we have to lower the cost of diagnosis and treatment, and we may need some upwards adjustments in the [International Association of Diabetes and Pregnancy Study Groups] criteria in order to achieve consensus,” said Dr. Landon, professor and chair of the department of obstetrics and gynecology at Ohio State University, Columbus.

The International Association of Diabetes in Pregnancy Study Groups (IADPSG) created a stir in the American obstetrics community when it recommended in 2010 that a universal 75-g, 2-hour oral glucose tolerance test (OGTT) be performed during pregnancy and that gestational diabetes mellitus (GDM) be diagnosed when any single measurement threshold – a fasting value of 92 mg/dL, a 1-hour value of 180 mg/dL, or a 2-hour value of 153 mg/dL – is met or exceeded (Diabetes Care 2010 Mar; 33[3]:676-82).

The consensus group made its recommendation based largely on published associations of maternal glycemia with perinatal and long-term outcomes in offspring. Chief among the studies was the landmark Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study, which found continuous linear relationships between maternal glucose levels – including levels that had been viewed as normal – and adverse fetal outcomes such as high fetal birth weight, cord-blood serum C-peptide level (an index of fetal beta-cell function and fetal hyperinsulinemia), and clinical neonatal hypoglycemia. Maternal glucose tolerance was measured in the study with the 75-g 2-hour OGTT.

The IADPSG chose its cut-off points to convey an odds ratio for adverse outcomes of 1.75. But use of the criteria meant that 16%-18% of pregnant women in the United States would be identified as having GDM – a doubling, at least.

Courtesy Ohio State University
Dr. Mark B. Landon

In 2013, a National Institute of Child Health and Human Development Consensus Development Conference recommended against adoption of the new criteria, citing uncertainties regarding the benefits of treating so many additional cases of GDM, as well as the costs and additional burden on patients, providers, and the health care system.

In an updated Practice Bulletin on GDM, ACOG recommends that the suggested changes be studied “before they are proposed at a national level.” But ACOG noted that “individual practices and institutions may choose to use the IADPSG’s recommendation, if appropriate, for the population they serve” (Obstet Gynecol. 2017;130[1]:e17-37).

Since the IADPSG proposal came out, Dr. Landon said, at least a half-dozen published studies have attempted to clarify the additional benefit of their proposed criteria, analyzing the risk of adverse maternal and fetal outcomes in women who are diagnosed using IADPSG criteria and not treated, versus those with a normal glucose tolerance test. In these analyses, researchers have excluded women who would also meet usual diagnostic criteria, such as the Carpenter-Coustan criteria, in order to hone in on those with the mildest levels of GDM – the new diagnoses.

Research published “in the last 5-6 years has almost exclusively shown that, in using the IADPSG criteria, and excluding other usual criteria, you see graded, increased frequencies in large babies, preeclampsia, [neonatal] hypoglycemia” and other adverse outcomes, Dr. Landon said. “I know of only one study that refutes these associations.”

A secondary analysis of HAPO study data, for instance, grouped women into three categories: those with no GDM, GDM based on traditional Carpenter-Coustan criteria, and GDM based on IADPSG criteria but not the Carpenter-Coustan thresholds. A 3-hour OGTT result was not used in this analysis since the HAPO study did not collect this.

Compared with cases with no GDM, those with GDM based on IADPSG criteria (but not the Carpenter-Coustan criteria) were nearly twice as likely to have birth weights above the 90th percentile, newborn percentage fat over the 90th percentile, and preeclampsia, for instance (Diabetes Care 2016;39[12];2204-10).

Other researchers are trying to tease apart risk levels according to thresholds that differ slightly from traditional criteria. A retrospective cohort study from Kaiser Permanente Southern California, for instance, chose two strata of women whose GDM was in the lower levels of the IADPSG-defined spectrum for glucose intolerance and found that, in those with the lesser degree of hyperglycemia, only birth weight and large-for-gestational-age was significantly greater than in women with no GDM (Obstet Gynecol. 2015;126[1]:67-73).

“This study is interesting because it raises the question of whether there might be differential treatment effects based on the level of hyperglycemia within the IADPSG category,” Dr. Landon said.

Dr. Landon served as the principal investigator of a large national, randomized controlled trial that showed a reduction in the risk of fetal overgrowth, shoulder dystocia, cesarean delivery, and hypertensive disorders in women who were treated for mild gestational diabetes (N Engl J Med. 2009;361:1339-48). But this study defined mild gestational diabetes according to the Carpenter-Coustan criteria.

“What about the women who meet the [even lower thresholds] of the IADPSG criteria? One would expect that the treatment benefit would not be as great, but will they still benefit from treatment? To date, this is simply unknown,” he said in an interview.

Research in the last 5 years has also begun to look at the financial implications of the IADPSG criteria and strategies for reducing the cost of implementation. Dr. Landon noted that investigators in Brazil, for instance, have determined that an alternative strategy of using a fasting plasma glucose value of 92 mg/gL or greater to rule in GDM, and a fasting value of 80 mg/dL or less to rule out GDM, eliminates the need for 61% of oral glucose challenges and has 96.9% sensitivity for diagnosing GDM (Diabetes Res Clin Pract. 2015 May;108[2]:288-95).

Dr. Landon reported having no relevant financial disclosures.

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The race is on for a Zika vaccine

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– A DNA vaccine developed at the National Institute of Allergy and Infectious Diseases Vaccine Research Center – one of five National Institutes of Health Zika vaccine candidates – has entered phase 2 testing in a trial underway in Brazil, Peru, Ecuador, Mexico, and Texas.

“The DNA vaccine is a simple 21st century way of developing vaccines that I think will become one of the major [methods of the future] for emerging infections, as opposed to growing a virus and inactivating or attenuating it,” Anthony S. Fauci, MD, said at the biennial meeting of the Diabetes in Pregnancy Study Group of North America. With Zika “this is the vaccine that is ahead of all the others.”

Dr. Anthony S. Fauci
The method involves the insertion into a plasmid of a gene that encodes the virus’s surface protein(s) against which an immune response is sought. When the DNA containing the virus’s gene is injected into an individual, the body’s cells produce viruslike particles and a subsequent immune response. Since the method was employed during the SARS epidemic of 2003, the time from sequence selection to a phase 1 trial has gone from 20 months to 3.25 months (for the Zika DNA vaccine).

Will it be possible to test efficacy, given the declining prevalence of Zika across the Americas, and will it be too late to prevent more disease? Dr. Fauci, director of NIAID, said that’s a concern, and that an accelerated approval based on a bridging of animal efficacy data with human safety and immunogenicity data might be possible.

The Southern hemisphere is “entering their summer, so it’s conceivable there will be an uptick in Zika. … We’ll just need to wait and see,” he said.
 

Sexual transmission

The Zika virus is part of a “long line of arboviruses that have threatened us in the Americas,” but infection with the organism is “the first – and may be the only – arthropod-borne or mosquito-borne infection that is also sexually transmitted,” Dr. Fauci said.

Sexual contact as an important mode of viral transmission “has been documented very clearly through a number of studies in which individuals clearly had no exposure to mosquitoes but were in fact a sexual partner of someone who got infected,” he said. And recent research suggests that the “female reproductive tract is a preferentially permissive site for Zika replication, which adds to the concern about sexual transmission.”

He cited a study published in July 2017 in PLOS Pathogens in which the Zika virus was found to preferentially replicate in the reproductive tract of female rhesus macaques who received vaginal inoculations of the virus.

Zika virus was “detected in the reproductive tract before it was detected in plasma, and replication levels in the reproductive tract did not reflect viral levels in other parts of the body,” according to the author summary. The kinetics of virus replication and dissemination after intravaginal inoculation were markedly different from what was previously seen in macaques infected with the Zika virus by subcutaneous infection, the report noted (PLOS Pathogens 13[7]:e1006537).

Dr. Fauci briefly described this and several other studies and findings that he said exemplify growing knowledge of the infection. He pointed to a prospective observational study that documents episodes of oligospermia in 15 men who presented with infection in 2016 in the French Caribbean (Lancet Infect Dis. 2017;17:1200-08).

Sperm counts fell in some of the study participants by about 50% between days 7 and 60 post infection, and the counts “recovered somewhat” by day 120. “We’re still following patients in prospective studies to determine if there’s a long-term effect in men,” he said.

In the meantime, he said, research in mice has shown that “without a doubt, Zika infection damages the testes,” Dr. Fauci said, noting that the mouse model is proving to be a good model for studying Zika’s effects. “They become oligospermic and have testicular atrophy.”
 

Maternal-fetal transmission

Regarding maternal-fetal transmission, there’s evidence that placental trophoblasts “are exquisitely permissive for Zika virus replication,” he said.

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– A DNA vaccine developed at the National Institute of Allergy and Infectious Diseases Vaccine Research Center – one of five National Institutes of Health Zika vaccine candidates – has entered phase 2 testing in a trial underway in Brazil, Peru, Ecuador, Mexico, and Texas.

“The DNA vaccine is a simple 21st century way of developing vaccines that I think will become one of the major [methods of the future] for emerging infections, as opposed to growing a virus and inactivating or attenuating it,” Anthony S. Fauci, MD, said at the biennial meeting of the Diabetes in Pregnancy Study Group of North America. With Zika “this is the vaccine that is ahead of all the others.”

Dr. Anthony S. Fauci
The method involves the insertion into a plasmid of a gene that encodes the virus’s surface protein(s) against which an immune response is sought. When the DNA containing the virus’s gene is injected into an individual, the body’s cells produce viruslike particles and a subsequent immune response. Since the method was employed during the SARS epidemic of 2003, the time from sequence selection to a phase 1 trial has gone from 20 months to 3.25 months (for the Zika DNA vaccine).

Will it be possible to test efficacy, given the declining prevalence of Zika across the Americas, and will it be too late to prevent more disease? Dr. Fauci, director of NIAID, said that’s a concern, and that an accelerated approval based on a bridging of animal efficacy data with human safety and immunogenicity data might be possible.

The Southern hemisphere is “entering their summer, so it’s conceivable there will be an uptick in Zika. … We’ll just need to wait and see,” he said.
 

Sexual transmission

The Zika virus is part of a “long line of arboviruses that have threatened us in the Americas,” but infection with the organism is “the first – and may be the only – arthropod-borne or mosquito-borne infection that is also sexually transmitted,” Dr. Fauci said.

Sexual contact as an important mode of viral transmission “has been documented very clearly through a number of studies in which individuals clearly had no exposure to mosquitoes but were in fact a sexual partner of someone who got infected,” he said. And recent research suggests that the “female reproductive tract is a preferentially permissive site for Zika replication, which adds to the concern about sexual transmission.”

He cited a study published in July 2017 in PLOS Pathogens in which the Zika virus was found to preferentially replicate in the reproductive tract of female rhesus macaques who received vaginal inoculations of the virus.

Zika virus was “detected in the reproductive tract before it was detected in plasma, and replication levels in the reproductive tract did not reflect viral levels in other parts of the body,” according to the author summary. The kinetics of virus replication and dissemination after intravaginal inoculation were markedly different from what was previously seen in macaques infected with the Zika virus by subcutaneous infection, the report noted (PLOS Pathogens 13[7]:e1006537).

Dr. Fauci briefly described this and several other studies and findings that he said exemplify growing knowledge of the infection. He pointed to a prospective observational study that documents episodes of oligospermia in 15 men who presented with infection in 2016 in the French Caribbean (Lancet Infect Dis. 2017;17:1200-08).

Sperm counts fell in some of the study participants by about 50% between days 7 and 60 post infection, and the counts “recovered somewhat” by day 120. “We’re still following patients in prospective studies to determine if there’s a long-term effect in men,” he said.

In the meantime, he said, research in mice has shown that “without a doubt, Zika infection damages the testes,” Dr. Fauci said, noting that the mouse model is proving to be a good model for studying Zika’s effects. “They become oligospermic and have testicular atrophy.”
 

Maternal-fetal transmission

Regarding maternal-fetal transmission, there’s evidence that placental trophoblasts “are exquisitely permissive for Zika virus replication,” he said.

 

– A DNA vaccine developed at the National Institute of Allergy and Infectious Diseases Vaccine Research Center – one of five National Institutes of Health Zika vaccine candidates – has entered phase 2 testing in a trial underway in Brazil, Peru, Ecuador, Mexico, and Texas.

“The DNA vaccine is a simple 21st century way of developing vaccines that I think will become one of the major [methods of the future] for emerging infections, as opposed to growing a virus and inactivating or attenuating it,” Anthony S. Fauci, MD, said at the biennial meeting of the Diabetes in Pregnancy Study Group of North America. With Zika “this is the vaccine that is ahead of all the others.”

Dr. Anthony S. Fauci
The method involves the insertion into a plasmid of a gene that encodes the virus’s surface protein(s) against which an immune response is sought. When the DNA containing the virus’s gene is injected into an individual, the body’s cells produce viruslike particles and a subsequent immune response. Since the method was employed during the SARS epidemic of 2003, the time from sequence selection to a phase 1 trial has gone from 20 months to 3.25 months (for the Zika DNA vaccine).

Will it be possible to test efficacy, given the declining prevalence of Zika across the Americas, and will it be too late to prevent more disease? Dr. Fauci, director of NIAID, said that’s a concern, and that an accelerated approval based on a bridging of animal efficacy data with human safety and immunogenicity data might be possible.

The Southern hemisphere is “entering their summer, so it’s conceivable there will be an uptick in Zika. … We’ll just need to wait and see,” he said.
 

Sexual transmission

The Zika virus is part of a “long line of arboviruses that have threatened us in the Americas,” but infection with the organism is “the first – and may be the only – arthropod-borne or mosquito-borne infection that is also sexually transmitted,” Dr. Fauci said.

Sexual contact as an important mode of viral transmission “has been documented very clearly through a number of studies in which individuals clearly had no exposure to mosquitoes but were in fact a sexual partner of someone who got infected,” he said. And recent research suggests that the “female reproductive tract is a preferentially permissive site for Zika replication, which adds to the concern about sexual transmission.”

He cited a study published in July 2017 in PLOS Pathogens in which the Zika virus was found to preferentially replicate in the reproductive tract of female rhesus macaques who received vaginal inoculations of the virus.

Zika virus was “detected in the reproductive tract before it was detected in plasma, and replication levels in the reproductive tract did not reflect viral levels in other parts of the body,” according to the author summary. The kinetics of virus replication and dissemination after intravaginal inoculation were markedly different from what was previously seen in macaques infected with the Zika virus by subcutaneous infection, the report noted (PLOS Pathogens 13[7]:e1006537).

Dr. Fauci briefly described this and several other studies and findings that he said exemplify growing knowledge of the infection. He pointed to a prospective observational study that documents episodes of oligospermia in 15 men who presented with infection in 2016 in the French Caribbean (Lancet Infect Dis. 2017;17:1200-08).

Sperm counts fell in some of the study participants by about 50% between days 7 and 60 post infection, and the counts “recovered somewhat” by day 120. “We’re still following patients in prospective studies to determine if there’s a long-term effect in men,” he said.

In the meantime, he said, research in mice has shown that “without a doubt, Zika infection damages the testes,” Dr. Fauci said, noting that the mouse model is proving to be a good model for studying Zika’s effects. “They become oligospermic and have testicular atrophy.”
 

Maternal-fetal transmission

Regarding maternal-fetal transmission, there’s evidence that placental trophoblasts “are exquisitely permissive for Zika virus replication,” he said.

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Reduce maternal morbidity by the expeditious and decisive treatment of severe hypertension in pregnancy

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Reduce maternal morbidity by the expeditious and decisive treatment of severe hypertension in pregnancy

Obstetrician-gynecologists are deeply committed to reducing maternal mortality and severe morbidity. Hypertensive diseases of pregnancy, including preeclampsia and eclampsia, are important contributors to both maternal mortality and severe morbidity. Among US live births from 2011–2013 there were 1,078 pregnancy-related maternal deaths, and 10% were attributed to preeclampsia or eclampsia.1 Hypertensive disease of pregnancy is also a major cause of severe maternal morbidity, with an increased risk of acute renal failure, respiratory failure, and cerebrovascular events.2 Preeclampsia is associated with a 4-fold increased risk of thrombocytopenia and coagulopathy and a 2-fold increased risk of postpartum hemorrhage.3

Severe hypertension is defined as a systolic blood pressure (BP) ≥160 mm Hg or a diastolic BP ≥110 mm Hg on 2 measurements within 15 minutes.4,5 Severe hypertensive disease of pregnancy is a common clinical problem in obstetrics, requiring clinicians to respond expeditiously and decisively to minimize adverse maternal outcomes. Following the identification of severe hypertension, a diagnosis and management plan should be initiated within 30 to 60 minutes.4 Some experts recommend that treatment be initiated within 15 minutes of identifying severe hypertension in a pregnant woman.6

The American College of Obstetricians and Gynecologists recommends that obstetric programs adopt standardized guidelines for the management of women with preeclampsia or eclampsia.4 The National Partnership for Maternal Safety recommends that all obstetric programs develop care bundles to respond to severe hypertension.5 Key points in managing severe hypertension are summarized below.

 

Related article:
2017 Update on obstetrics: Preeclampsia prevention

1. Expeditiously initiate treatment of severe hypertension…

…with intravenous (IV) labetalol (administered as 20 mg/40 mg/80 mg sequential doses as needed) or hydralazine (administered as 10 mg/10 mg/20 mg/40 mg sequential doses as needed). Our preferred agent is labetalol, administered as a 20-mg IV infusion over 2 minutes. If the patient’s BP remains elevated 10 min after the initial dose, administer labetalol 40 mg as an IV infusion over 2 min. If her BP remains elevated 10 min after this dose, administer 80 mg of labetalol. If the BP continues to be elevated, hydralazine treatment can be initiated as described below.

Occasionally there are national shortages of labetalol or a patient has a low heart rate or contraindication such as heart disease or asthma prohibiting its use. If labetalol is not available, we use hydralazine administered as a 10-mg IV bolus over 2 min. If the BP remains elevated, every 20 min, an escalating dose of hydralazine is administered, first by repeating the 10-mg dose, then administering 20 mg, and finally 40 mg.

For women without IV access, we use oral nifedipine 10 mg to control hypertension only while awaiting the placement of an IV. If BP remains elevated after 30 min, a second dose of oral nifedipine 20 mg can be given with a plan to transition to IV agents as soon as possible. The risks of maternal tachycardia or overshoot hypotension with immediate release oral nifedipine limit its use in our clinical practice to this circumstance.

Once the BP is controlled, start maintenance oral hypertension therapy. Our first-line agent is labetalol 200 mg twice per day with a maximum dose of 800 mg 3 times daily (2,400 mg maximal daily dose).

2. Initiate treatment with magnesium sulfate

If the patient’s BP is ≥160/110 mm Hg or if her BP is ≥140/90 mm Hg with coexisting symptoms of severe preeclampsia (for example a severe headache), initiate magnesium sulfate treatment. A standard regimen is magnesium sulfate 4 to 6 g administered as an IV bolus over 20 min followed by the IV infusion of 2 g per hour. In our clinical opinion, if you plan on initiating IV antihypertensive treatment for severe hypertension you also should strongly consider starting magnesium sulfate to reduce the risk of an eclamptic seizure.

We also start magnesium sulfate therapy for women with severe hypertension and clinical symptoms or laboratory signs of preeclampsia even in the absence of proteinuria. Approximately 2% of women with preeclampsia will develop an eclamptic seizure and magnesium sulfate treatment significantly reduces the risk of seizure and may also reduce maternal mortality.7,8

Magnesium sulfate is contra-indicated in women with myasthenia gravis. In women with renal dysfunction, the loading dose can be given, but the continuous magnesium sulfate infusion should not be initiated until serum magnesium levels are assessed.

3. Consider administering maternal betamethasone

Treatment with betamethasone advances fetal maturation if the pregnancy is preterm (for example, <34 weeks of gestation). A major cause of neonatal morbidity and mortality for pregnancy complicated by severe hypertensive disease is premature delivery. Maternal glucocorticoid treatment reduces the risk of neonatal morbidity and mortality if preterm delivery is anticipated. However, do not delay delivery for antenatal corticosteroids for women with severe and persistent hypertension or symptoms of preeclampsia that do not resolve following treatment.

We also consider women with eclampsia, placental abruption, pulmonary edema, or severe laboratory derangements too unstable to delay delivery for 48 hours to achieve the maximum benefit of steroid treatment. If antenatal corticosteroids are administered in the late preterm period between 34 0/7 weeks and 36 6/7 weeks of gestation, obstetric management should not be altered and delivery should not be delayed.9

 

Related article:
Start offering antenatal corticosteroids to women delivering between 34 0/7 and 36 6/7 weeks of gestation to improve newborn outcomes

4. Preeclampsia plus a severe headache is a toxic combination

For patients with this constellation either have a plan for delivery or keep them under close surveillance. Occasionally a woman >20 weeks pregnant with new onset hypertension and a headache is seen in an emergency department and is not assessed for proteinuria or other preeclampsia laboratory abnormalities. If the woman is diagnosed as having a migraine or tension headache and discharged home with a headache medicine they are at high risk for serious morbidity, including stroke.

 

Read about preeclampsia and thrombocytopenia, HELLP syndrome, more.

 

 

5. Preeclampsia plus thrombocytopenia complicates anesthesia options

If the platelet count falls too low (for instance, <70,000 platelets per µL), many anesthesiologists will not provide a regional anesthetic for delivery because of the risk of peridural bleeding. In addition, a low platelet count (<50,000 platelets per µL) significantly increases the risk of obstetric hemorrhage. Transfer of the patient to an obstetrics unit with a full-service blood bank capable of supporting multiple platelet transfusions may be warranted.

6. Preeclampsia plus dyspnea or chest pain increases the risk of severe maternal morbidity

Authors of a prospective study of 2,023 women with preeclampsia reported an increase in adverse maternal outcomes when the following factors were present: early gestational age, dyspnea, chest pain, oxygen saturation of SpO2 <93%, thrombocytopenia, elevated creatinine, or elevated aspartate transaminase concentration.10 If dyspnea is present, the patient may have pulmonary edema, pulmonary embolism, heart failure, acute asthma, or pneumonia. If the patient has chest pain the differential diagnosis includes pulmonary embolism, cardiac ischemia, cardiomyopathy, or another cardiac disease.

Consider obtaining a chest radiograph for pregnant women with dyspnea and a computed tomography pulmonary angiogram or lung scintigraphy (ventilation perfusion scan) if the chest radiograph is normal for women with chest pain.6,11 We obtain a transthoracic echocardiogram in cases of pulmonary edema to evaluate for the possibility of peripartum cardiomyopathy.

7. HELLP syndrome

The triad of hemolysis, elevated liver enzymes, and low platelet count (HELLP) is associated with an increased risk of maternal mortality and severe morbidity.12 In a study of 171 women with HELLP, factors that increased the risk for adverse maternal outcomes included12:

  • aspartate aminotransferase (AST) levels >316 U/L
  • alanine aminotransferase (ALT) levels >217 U/L
  • total bilirubin levels >2.0 mg/dL
  • lactate dehydrogenase (LDH) levels >1,290 U/L
  • blood urea nitrogen test results >44 mg/dL
  • platelet count <50,000 platelets per µL.

The clinical course of HELLP syndrome is characterized by progression and the potential for sudden and catastrophic deterioration. For example, some women with HELLP will suddenly develop a ruptured liver, pulmonary edema, or a stroke. The Society for Maternal-Fetal Medicine recommends against expectant management of women with HELLP syndrome.13

 

Related article:
Optimal obstetric care for women aged 40 and older

8. Delivery or expectant management?

Currently the only cure for preeclampsia is delivery. The Society for Maternal-Fetal Medicine recommends against expectant management of severe preeclampsia if certain problems occur (BOX).13 For women with preeclampsia who are less than 34 weeks’ gestation and do not have a contraindication to expectant management, consider transferring the patient to a tertiary maternal care center. In our practice, pregnant women with a hypertensive disorder are scheduled for an induction of labor and delivery at 37 weeks’ gestation.
 

The Society for Maternal-Fetal Medicine recommends delivery (not expectant management) in the presence of severe preeclampsia if any of the following are present13:


  • eclampsia
  • pulmonary edema
  • disseminated intravascular coagulation
  • renal insufficiency
  • abruptio placentae
  • abnormal fetal testing
  • HELLP syndrome or persistent symptoms of severe preeclampsia.


In the United States, major obstetric causes of pregnancy-related death include sepsis, venous thromboembolism-pulmonary embolism, hemorrhage, and hypertensive disease of pregnancy. Other important causes of pregnancy-related death include cardiac disease, stroke, and pre-existing major medical disease including advanced cancer. In the United States there are approximately 17 pregnancy-related maternal deaths per 100,000 live births.1 Obstetricians are dedicated to reducing this excessively high rate of maternal death.

Given the US maternal death rate of 1 maternity death per 5,880 live births, over the course of a 40-year career, most obstetrician-gynecologists will have 1 or 2 of their pregnant patients die. From the perspective of an individual clinician, maternal death is an extremely rare event, with 1 death during every 20 years of practice. However, from a population perspective, maternal death in the United States is all too common compared to other developed countries. We can only reduce the rate of maternal death by working in interdisciplinary teams to ensure our obstetrics units are prepared to expeditiously diagnose and treat the most common obstetric causes of death and severe morbidity.

 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References
  1. Creanga AA, Syverson C, Seed K, Callaghan WM. Pregnancy-related mortality in the United States, 2011-2013. Obstet Gynecol. 2017;130(2):366–373.
  2. Kuklina EV, Ayala C, Callaghan WM. Hyper-tensive disorders and severe obstetric morbidity in the United States. Obstet Gynecol. 2009;113(6):1299–1306.
  3. Stevens  S, Shih T, Incerti D, et al. Short-term costs of preeclampsia to the United States health care system. Am J Obstet Gynecol. 2017;217(3):237–248.e16.
  4. Committee on Obstetric Practice. Committee Opinion No. 692: Emergent therapy for acute-onset, severe hypertension during pregnancy and the postpartum period. Obstet Gynecol. 2017;129(4):e90–e95.
  5. Bernstein PS, Martin JN Jr, Barton JR, et al. National Partnership for Maternal Safety: Consensus bundle on severe hypertension during pregnancy and the postpartum period. Obstet Gynecol. 2017;130(2):347–357.
  6. Clark SL, Hankins GD. Preventing maternal death: 10 clinical diamonds. Obstet Gynecol. 2012;119(2 pt 1):360–364.
  7. Thornton C, Dahlen H, Korda A, Hennessy A. The incidence of preeclampsia and eclampsia and associated maternal mortality in Australia from population-linked datasets: 2000-2008. Am J Obstet Gynecol. 2013;208(6):476.e1–e5.
  8. Altman D, Carroli G, Duley L, et al; Magpie Trial Collaboration Group. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet. 2002;359(9321):1877–1890.
  9. Gyamfi-Bannerman C, Thom EA, Blackwell SC, et al; NICHD Maternal-Fetal Medicine Units Network. Antenatal betamethasone for women at risk for late preterm delivery. N Engl J Med. 2016;374(14):1311–1320.
  10. von Dadelszen P, Payne B, Li J, et al; PIERS Study Group. Prediction of adverse maternal outcomes in pre-eclampsia: development and validation of the full PIERS model. Lancet. 2011;377(9761):219–227.
  11. Shahir  K, Goodman LR, Tali A, Thorsen KM, Hellman RS. Pulmonary embolism in pregnancy: CT pulmonary angiography versus perfusion scanning. AJR Am J Roentgenol. 2010;195(3):W214–W220.
  12. Erkilinç S, Eyi EG. Factors contributing to adverse maternal outcomes in patients with HELLP syndrome. J Matern Fetal Neonatal Med. 2017:1–7. doi:10.1080/14767058.2017.1359528.
  13. Publications Committee, Society for Maternal-Fetal Medicine, Sibai BM. Evaluation and management of severe preeclampsia before 34 weeks’ gestation. Am J Obstet Gynecol. 2011;205(3):191–198
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Dr. Easter is Clinical Fellow, Maternal-Fetal Medicine Department of Obstetrics and Gynecology Brigham and Women's Hospital, Boston, Massachusetts; Havard Medical School, Boston.

Dr. Barbieri is Editor in Chief, OBG Management; Chair, Obstetrics and Gynecology, Brigham and Women’s Hospital; and Kate Macy Ladd Professor of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, Massachusetts.

The authors report no financial relationships relevant to this article.

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Dr. Easter is Clinical Fellow, Maternal-Fetal Medicine Department of Obstetrics and Gynecology Brigham and Women's Hospital, Boston, Massachusetts; Havard Medical School, Boston.

Dr. Barbieri is Editor in Chief, OBG Management; Chair, Obstetrics and Gynecology, Brigham and Women’s Hospital; and Kate Macy Ladd Professor of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, Massachusetts.

The authors report no financial relationships relevant to this article.

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Dr. Easter is Clinical Fellow, Maternal-Fetal Medicine Department of Obstetrics and Gynecology Brigham and Women's Hospital, Boston, Massachusetts; Havard Medical School, Boston.

Dr. Barbieri is Editor in Chief, OBG Management; Chair, Obstetrics and Gynecology, Brigham and Women’s Hospital; and Kate Macy Ladd Professor of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, Massachusetts.

The authors report no financial relationships relevant to this article.

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Obstetrician-gynecologists are deeply committed to reducing maternal mortality and severe morbidity. Hypertensive diseases of pregnancy, including preeclampsia and eclampsia, are important contributors to both maternal mortality and severe morbidity. Among US live births from 2011–2013 there were 1,078 pregnancy-related maternal deaths, and 10% were attributed to preeclampsia or eclampsia.1 Hypertensive disease of pregnancy is also a major cause of severe maternal morbidity, with an increased risk of acute renal failure, respiratory failure, and cerebrovascular events.2 Preeclampsia is associated with a 4-fold increased risk of thrombocytopenia and coagulopathy and a 2-fold increased risk of postpartum hemorrhage.3

Severe hypertension is defined as a systolic blood pressure (BP) ≥160 mm Hg or a diastolic BP ≥110 mm Hg on 2 measurements within 15 minutes.4,5 Severe hypertensive disease of pregnancy is a common clinical problem in obstetrics, requiring clinicians to respond expeditiously and decisively to minimize adverse maternal outcomes. Following the identification of severe hypertension, a diagnosis and management plan should be initiated within 30 to 60 minutes.4 Some experts recommend that treatment be initiated within 15 minutes of identifying severe hypertension in a pregnant woman.6

The American College of Obstetricians and Gynecologists recommends that obstetric programs adopt standardized guidelines for the management of women with preeclampsia or eclampsia.4 The National Partnership for Maternal Safety recommends that all obstetric programs develop care bundles to respond to severe hypertension.5 Key points in managing severe hypertension are summarized below.

 

Related article:
2017 Update on obstetrics: Preeclampsia prevention

1. Expeditiously initiate treatment of severe hypertension…

…with intravenous (IV) labetalol (administered as 20 mg/40 mg/80 mg sequential doses as needed) or hydralazine (administered as 10 mg/10 mg/20 mg/40 mg sequential doses as needed). Our preferred agent is labetalol, administered as a 20-mg IV infusion over 2 minutes. If the patient’s BP remains elevated 10 min after the initial dose, administer labetalol 40 mg as an IV infusion over 2 min. If her BP remains elevated 10 min after this dose, administer 80 mg of labetalol. If the BP continues to be elevated, hydralazine treatment can be initiated as described below.

Occasionally there are national shortages of labetalol or a patient has a low heart rate or contraindication such as heart disease or asthma prohibiting its use. If labetalol is not available, we use hydralazine administered as a 10-mg IV bolus over 2 min. If the BP remains elevated, every 20 min, an escalating dose of hydralazine is administered, first by repeating the 10-mg dose, then administering 20 mg, and finally 40 mg.

For women without IV access, we use oral nifedipine 10 mg to control hypertension only while awaiting the placement of an IV. If BP remains elevated after 30 min, a second dose of oral nifedipine 20 mg can be given with a plan to transition to IV agents as soon as possible. The risks of maternal tachycardia or overshoot hypotension with immediate release oral nifedipine limit its use in our clinical practice to this circumstance.

Once the BP is controlled, start maintenance oral hypertension therapy. Our first-line agent is labetalol 200 mg twice per day with a maximum dose of 800 mg 3 times daily (2,400 mg maximal daily dose).

2. Initiate treatment with magnesium sulfate

If the patient’s BP is ≥160/110 mm Hg or if her BP is ≥140/90 mm Hg with coexisting symptoms of severe preeclampsia (for example a severe headache), initiate magnesium sulfate treatment. A standard regimen is magnesium sulfate 4 to 6 g administered as an IV bolus over 20 min followed by the IV infusion of 2 g per hour. In our clinical opinion, if you plan on initiating IV antihypertensive treatment for severe hypertension you also should strongly consider starting magnesium sulfate to reduce the risk of an eclamptic seizure.

We also start magnesium sulfate therapy for women with severe hypertension and clinical symptoms or laboratory signs of preeclampsia even in the absence of proteinuria. Approximately 2% of women with preeclampsia will develop an eclamptic seizure and magnesium sulfate treatment significantly reduces the risk of seizure and may also reduce maternal mortality.7,8

Magnesium sulfate is contra-indicated in women with myasthenia gravis. In women with renal dysfunction, the loading dose can be given, but the continuous magnesium sulfate infusion should not be initiated until serum magnesium levels are assessed.

3. Consider administering maternal betamethasone

Treatment with betamethasone advances fetal maturation if the pregnancy is preterm (for example, <34 weeks of gestation). A major cause of neonatal morbidity and mortality for pregnancy complicated by severe hypertensive disease is premature delivery. Maternal glucocorticoid treatment reduces the risk of neonatal morbidity and mortality if preterm delivery is anticipated. However, do not delay delivery for antenatal corticosteroids for women with severe and persistent hypertension or symptoms of preeclampsia that do not resolve following treatment.

We also consider women with eclampsia, placental abruption, pulmonary edema, or severe laboratory derangements too unstable to delay delivery for 48 hours to achieve the maximum benefit of steroid treatment. If antenatal corticosteroids are administered in the late preterm period between 34 0/7 weeks and 36 6/7 weeks of gestation, obstetric management should not be altered and delivery should not be delayed.9

 

Related article:
Start offering antenatal corticosteroids to women delivering between 34 0/7 and 36 6/7 weeks of gestation to improve newborn outcomes

4. Preeclampsia plus a severe headache is a toxic combination

For patients with this constellation either have a plan for delivery or keep them under close surveillance. Occasionally a woman >20 weeks pregnant with new onset hypertension and a headache is seen in an emergency department and is not assessed for proteinuria or other preeclampsia laboratory abnormalities. If the woman is diagnosed as having a migraine or tension headache and discharged home with a headache medicine they are at high risk for serious morbidity, including stroke.

 

Read about preeclampsia and thrombocytopenia, HELLP syndrome, more.

 

 

5. Preeclampsia plus thrombocytopenia complicates anesthesia options

If the platelet count falls too low (for instance, <70,000 platelets per µL), many anesthesiologists will not provide a regional anesthetic for delivery because of the risk of peridural bleeding. In addition, a low platelet count (<50,000 platelets per µL) significantly increases the risk of obstetric hemorrhage. Transfer of the patient to an obstetrics unit with a full-service blood bank capable of supporting multiple platelet transfusions may be warranted.

6. Preeclampsia plus dyspnea or chest pain increases the risk of severe maternal morbidity

Authors of a prospective study of 2,023 women with preeclampsia reported an increase in adverse maternal outcomes when the following factors were present: early gestational age, dyspnea, chest pain, oxygen saturation of SpO2 <93%, thrombocytopenia, elevated creatinine, or elevated aspartate transaminase concentration.10 If dyspnea is present, the patient may have pulmonary edema, pulmonary embolism, heart failure, acute asthma, or pneumonia. If the patient has chest pain the differential diagnosis includes pulmonary embolism, cardiac ischemia, cardiomyopathy, or another cardiac disease.

Consider obtaining a chest radiograph for pregnant women with dyspnea and a computed tomography pulmonary angiogram or lung scintigraphy (ventilation perfusion scan) if the chest radiograph is normal for women with chest pain.6,11 We obtain a transthoracic echocardiogram in cases of pulmonary edema to evaluate for the possibility of peripartum cardiomyopathy.

7. HELLP syndrome

The triad of hemolysis, elevated liver enzymes, and low platelet count (HELLP) is associated with an increased risk of maternal mortality and severe morbidity.12 In a study of 171 women with HELLP, factors that increased the risk for adverse maternal outcomes included12:

  • aspartate aminotransferase (AST) levels >316 U/L
  • alanine aminotransferase (ALT) levels >217 U/L
  • total bilirubin levels >2.0 mg/dL
  • lactate dehydrogenase (LDH) levels >1,290 U/L
  • blood urea nitrogen test results >44 mg/dL
  • platelet count <50,000 platelets per µL.

The clinical course of HELLP syndrome is characterized by progression and the potential for sudden and catastrophic deterioration. For example, some women with HELLP will suddenly develop a ruptured liver, pulmonary edema, or a stroke. The Society for Maternal-Fetal Medicine recommends against expectant management of women with HELLP syndrome.13

 

Related article:
Optimal obstetric care for women aged 40 and older

8. Delivery or expectant management?

Currently the only cure for preeclampsia is delivery. The Society for Maternal-Fetal Medicine recommends against expectant management of severe preeclampsia if certain problems occur (BOX).13 For women with preeclampsia who are less than 34 weeks’ gestation and do not have a contraindication to expectant management, consider transferring the patient to a tertiary maternal care center. In our practice, pregnant women with a hypertensive disorder are scheduled for an induction of labor and delivery at 37 weeks’ gestation.
 

The Society for Maternal-Fetal Medicine recommends delivery (not expectant management) in the presence of severe preeclampsia if any of the following are present13:


  • eclampsia
  • pulmonary edema
  • disseminated intravascular coagulation
  • renal insufficiency
  • abruptio placentae
  • abnormal fetal testing
  • HELLP syndrome or persistent symptoms of severe preeclampsia.


In the United States, major obstetric causes of pregnancy-related death include sepsis, venous thromboembolism-pulmonary embolism, hemorrhage, and hypertensive disease of pregnancy. Other important causes of pregnancy-related death include cardiac disease, stroke, and pre-existing major medical disease including advanced cancer. In the United States there are approximately 17 pregnancy-related maternal deaths per 100,000 live births.1 Obstetricians are dedicated to reducing this excessively high rate of maternal death.

Given the US maternal death rate of 1 maternity death per 5,880 live births, over the course of a 40-year career, most obstetrician-gynecologists will have 1 or 2 of their pregnant patients die. From the perspective of an individual clinician, maternal death is an extremely rare event, with 1 death during every 20 years of practice. However, from a population perspective, maternal death in the United States is all too common compared to other developed countries. We can only reduce the rate of maternal death by working in interdisciplinary teams to ensure our obstetrics units are prepared to expeditiously diagnose and treat the most common obstetric causes of death and severe morbidity.

 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Obstetrician-gynecologists are deeply committed to reducing maternal mortality and severe morbidity. Hypertensive diseases of pregnancy, including preeclampsia and eclampsia, are important contributors to both maternal mortality and severe morbidity. Among US live births from 2011–2013 there were 1,078 pregnancy-related maternal deaths, and 10% were attributed to preeclampsia or eclampsia.1 Hypertensive disease of pregnancy is also a major cause of severe maternal morbidity, with an increased risk of acute renal failure, respiratory failure, and cerebrovascular events.2 Preeclampsia is associated with a 4-fold increased risk of thrombocytopenia and coagulopathy and a 2-fold increased risk of postpartum hemorrhage.3

Severe hypertension is defined as a systolic blood pressure (BP) ≥160 mm Hg or a diastolic BP ≥110 mm Hg on 2 measurements within 15 minutes.4,5 Severe hypertensive disease of pregnancy is a common clinical problem in obstetrics, requiring clinicians to respond expeditiously and decisively to minimize adverse maternal outcomes. Following the identification of severe hypertension, a diagnosis and management plan should be initiated within 30 to 60 minutes.4 Some experts recommend that treatment be initiated within 15 minutes of identifying severe hypertension in a pregnant woman.6

The American College of Obstetricians and Gynecologists recommends that obstetric programs adopt standardized guidelines for the management of women with preeclampsia or eclampsia.4 The National Partnership for Maternal Safety recommends that all obstetric programs develop care bundles to respond to severe hypertension.5 Key points in managing severe hypertension are summarized below.

 

Related article:
2017 Update on obstetrics: Preeclampsia prevention

1. Expeditiously initiate treatment of severe hypertension…

…with intravenous (IV) labetalol (administered as 20 mg/40 mg/80 mg sequential doses as needed) or hydralazine (administered as 10 mg/10 mg/20 mg/40 mg sequential doses as needed). Our preferred agent is labetalol, administered as a 20-mg IV infusion over 2 minutes. If the patient’s BP remains elevated 10 min after the initial dose, administer labetalol 40 mg as an IV infusion over 2 min. If her BP remains elevated 10 min after this dose, administer 80 mg of labetalol. If the BP continues to be elevated, hydralazine treatment can be initiated as described below.

Occasionally there are national shortages of labetalol or a patient has a low heart rate or contraindication such as heart disease or asthma prohibiting its use. If labetalol is not available, we use hydralazine administered as a 10-mg IV bolus over 2 min. If the BP remains elevated, every 20 min, an escalating dose of hydralazine is administered, first by repeating the 10-mg dose, then administering 20 mg, and finally 40 mg.

For women without IV access, we use oral nifedipine 10 mg to control hypertension only while awaiting the placement of an IV. If BP remains elevated after 30 min, a second dose of oral nifedipine 20 mg can be given with a plan to transition to IV agents as soon as possible. The risks of maternal tachycardia or overshoot hypotension with immediate release oral nifedipine limit its use in our clinical practice to this circumstance.

Once the BP is controlled, start maintenance oral hypertension therapy. Our first-line agent is labetalol 200 mg twice per day with a maximum dose of 800 mg 3 times daily (2,400 mg maximal daily dose).

2. Initiate treatment with magnesium sulfate

If the patient’s BP is ≥160/110 mm Hg or if her BP is ≥140/90 mm Hg with coexisting symptoms of severe preeclampsia (for example a severe headache), initiate magnesium sulfate treatment. A standard regimen is magnesium sulfate 4 to 6 g administered as an IV bolus over 20 min followed by the IV infusion of 2 g per hour. In our clinical opinion, if you plan on initiating IV antihypertensive treatment for severe hypertension you also should strongly consider starting magnesium sulfate to reduce the risk of an eclamptic seizure.

We also start magnesium sulfate therapy for women with severe hypertension and clinical symptoms or laboratory signs of preeclampsia even in the absence of proteinuria. Approximately 2% of women with preeclampsia will develop an eclamptic seizure and magnesium sulfate treatment significantly reduces the risk of seizure and may also reduce maternal mortality.7,8

Magnesium sulfate is contra-indicated in women with myasthenia gravis. In women with renal dysfunction, the loading dose can be given, but the continuous magnesium sulfate infusion should not be initiated until serum magnesium levels are assessed.

3. Consider administering maternal betamethasone

Treatment with betamethasone advances fetal maturation if the pregnancy is preterm (for example, <34 weeks of gestation). A major cause of neonatal morbidity and mortality for pregnancy complicated by severe hypertensive disease is premature delivery. Maternal glucocorticoid treatment reduces the risk of neonatal morbidity and mortality if preterm delivery is anticipated. However, do not delay delivery for antenatal corticosteroids for women with severe and persistent hypertension or symptoms of preeclampsia that do not resolve following treatment.

We also consider women with eclampsia, placental abruption, pulmonary edema, or severe laboratory derangements too unstable to delay delivery for 48 hours to achieve the maximum benefit of steroid treatment. If antenatal corticosteroids are administered in the late preterm period between 34 0/7 weeks and 36 6/7 weeks of gestation, obstetric management should not be altered and delivery should not be delayed.9

 

Related article:
Start offering antenatal corticosteroids to women delivering between 34 0/7 and 36 6/7 weeks of gestation to improve newborn outcomes

4. Preeclampsia plus a severe headache is a toxic combination

For patients with this constellation either have a plan for delivery or keep them under close surveillance. Occasionally a woman >20 weeks pregnant with new onset hypertension and a headache is seen in an emergency department and is not assessed for proteinuria or other preeclampsia laboratory abnormalities. If the woman is diagnosed as having a migraine or tension headache and discharged home with a headache medicine they are at high risk for serious morbidity, including stroke.

 

Read about preeclampsia and thrombocytopenia, HELLP syndrome, more.

 

 

5. Preeclampsia plus thrombocytopenia complicates anesthesia options

If the platelet count falls too low (for instance, <70,000 platelets per µL), many anesthesiologists will not provide a regional anesthetic for delivery because of the risk of peridural bleeding. In addition, a low platelet count (<50,000 platelets per µL) significantly increases the risk of obstetric hemorrhage. Transfer of the patient to an obstetrics unit with a full-service blood bank capable of supporting multiple platelet transfusions may be warranted.

6. Preeclampsia plus dyspnea or chest pain increases the risk of severe maternal morbidity

Authors of a prospective study of 2,023 women with preeclampsia reported an increase in adverse maternal outcomes when the following factors were present: early gestational age, dyspnea, chest pain, oxygen saturation of SpO2 <93%, thrombocytopenia, elevated creatinine, or elevated aspartate transaminase concentration.10 If dyspnea is present, the patient may have pulmonary edema, pulmonary embolism, heart failure, acute asthma, or pneumonia. If the patient has chest pain the differential diagnosis includes pulmonary embolism, cardiac ischemia, cardiomyopathy, or another cardiac disease.

Consider obtaining a chest radiograph for pregnant women with dyspnea and a computed tomography pulmonary angiogram or lung scintigraphy (ventilation perfusion scan) if the chest radiograph is normal for women with chest pain.6,11 We obtain a transthoracic echocardiogram in cases of pulmonary edema to evaluate for the possibility of peripartum cardiomyopathy.

7. HELLP syndrome

The triad of hemolysis, elevated liver enzymes, and low platelet count (HELLP) is associated with an increased risk of maternal mortality and severe morbidity.12 In a study of 171 women with HELLP, factors that increased the risk for adverse maternal outcomes included12:

  • aspartate aminotransferase (AST) levels >316 U/L
  • alanine aminotransferase (ALT) levels >217 U/L
  • total bilirubin levels >2.0 mg/dL
  • lactate dehydrogenase (LDH) levels >1,290 U/L
  • blood urea nitrogen test results >44 mg/dL
  • platelet count <50,000 platelets per µL.

The clinical course of HELLP syndrome is characterized by progression and the potential for sudden and catastrophic deterioration. For example, some women with HELLP will suddenly develop a ruptured liver, pulmonary edema, or a stroke. The Society for Maternal-Fetal Medicine recommends against expectant management of women with HELLP syndrome.13

 

Related article:
Optimal obstetric care for women aged 40 and older

8. Delivery or expectant management?

Currently the only cure for preeclampsia is delivery. The Society for Maternal-Fetal Medicine recommends against expectant management of severe preeclampsia if certain problems occur (BOX).13 For women with preeclampsia who are less than 34 weeks’ gestation and do not have a contraindication to expectant management, consider transferring the patient to a tertiary maternal care center. In our practice, pregnant women with a hypertensive disorder are scheduled for an induction of labor and delivery at 37 weeks’ gestation.
 

The Society for Maternal-Fetal Medicine recommends delivery (not expectant management) in the presence of severe preeclampsia if any of the following are present13:


  • eclampsia
  • pulmonary edema
  • disseminated intravascular coagulation
  • renal insufficiency
  • abruptio placentae
  • abnormal fetal testing
  • HELLP syndrome or persistent symptoms of severe preeclampsia.


In the United States, major obstetric causes of pregnancy-related death include sepsis, venous thromboembolism-pulmonary embolism, hemorrhage, and hypertensive disease of pregnancy. Other important causes of pregnancy-related death include cardiac disease, stroke, and pre-existing major medical disease including advanced cancer. In the United States there are approximately 17 pregnancy-related maternal deaths per 100,000 live births.1 Obstetricians are dedicated to reducing this excessively high rate of maternal death.

Given the US maternal death rate of 1 maternity death per 5,880 live births, over the course of a 40-year career, most obstetrician-gynecologists will have 1 or 2 of their pregnant patients die. From the perspective of an individual clinician, maternal death is an extremely rare event, with 1 death during every 20 years of practice. However, from a population perspective, maternal death in the United States is all too common compared to other developed countries. We can only reduce the rate of maternal death by working in interdisciplinary teams to ensure our obstetrics units are prepared to expeditiously diagnose and treat the most common obstetric causes of death and severe morbidity.

 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References
  1. Creanga AA, Syverson C, Seed K, Callaghan WM. Pregnancy-related mortality in the United States, 2011-2013. Obstet Gynecol. 2017;130(2):366–373.
  2. Kuklina EV, Ayala C, Callaghan WM. Hyper-tensive disorders and severe obstetric morbidity in the United States. Obstet Gynecol. 2009;113(6):1299–1306.
  3. Stevens  S, Shih T, Incerti D, et al. Short-term costs of preeclampsia to the United States health care system. Am J Obstet Gynecol. 2017;217(3):237–248.e16.
  4. Committee on Obstetric Practice. Committee Opinion No. 692: Emergent therapy for acute-onset, severe hypertension during pregnancy and the postpartum period. Obstet Gynecol. 2017;129(4):e90–e95.
  5. Bernstein PS, Martin JN Jr, Barton JR, et al. National Partnership for Maternal Safety: Consensus bundle on severe hypertension during pregnancy and the postpartum period. Obstet Gynecol. 2017;130(2):347–357.
  6. Clark SL, Hankins GD. Preventing maternal death: 10 clinical diamonds. Obstet Gynecol. 2012;119(2 pt 1):360–364.
  7. Thornton C, Dahlen H, Korda A, Hennessy A. The incidence of preeclampsia and eclampsia and associated maternal mortality in Australia from population-linked datasets: 2000-2008. Am J Obstet Gynecol. 2013;208(6):476.e1–e5.
  8. Altman D, Carroli G, Duley L, et al; Magpie Trial Collaboration Group. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet. 2002;359(9321):1877–1890.
  9. Gyamfi-Bannerman C, Thom EA, Blackwell SC, et al; NICHD Maternal-Fetal Medicine Units Network. Antenatal betamethasone for women at risk for late preterm delivery. N Engl J Med. 2016;374(14):1311–1320.
  10. von Dadelszen P, Payne B, Li J, et al; PIERS Study Group. Prediction of adverse maternal outcomes in pre-eclampsia: development and validation of the full PIERS model. Lancet. 2011;377(9761):219–227.
  11. Shahir  K, Goodman LR, Tali A, Thorsen KM, Hellman RS. Pulmonary embolism in pregnancy: CT pulmonary angiography versus perfusion scanning. AJR Am J Roentgenol. 2010;195(3):W214–W220.
  12. Erkilinç S, Eyi EG. Factors contributing to adverse maternal outcomes in patients with HELLP syndrome. J Matern Fetal Neonatal Med. 2017:1–7. doi:10.1080/14767058.2017.1359528.
  13. Publications Committee, Society for Maternal-Fetal Medicine, Sibai BM. Evaluation and management of severe preeclampsia before 34 weeks’ gestation. Am J Obstet Gynecol. 2011;205(3):191–198
References
  1. Creanga AA, Syverson C, Seed K, Callaghan WM. Pregnancy-related mortality in the United States, 2011-2013. Obstet Gynecol. 2017;130(2):366–373.
  2. Kuklina EV, Ayala C, Callaghan WM. Hyper-tensive disorders and severe obstetric morbidity in the United States. Obstet Gynecol. 2009;113(6):1299–1306.
  3. Stevens  S, Shih T, Incerti D, et al. Short-term costs of preeclampsia to the United States health care system. Am J Obstet Gynecol. 2017;217(3):237–248.e16.
  4. Committee on Obstetric Practice. Committee Opinion No. 692: Emergent therapy for acute-onset, severe hypertension during pregnancy and the postpartum period. Obstet Gynecol. 2017;129(4):e90–e95.
  5. Bernstein PS, Martin JN Jr, Barton JR, et al. National Partnership for Maternal Safety: Consensus bundle on severe hypertension during pregnancy and the postpartum period. Obstet Gynecol. 2017;130(2):347–357.
  6. Clark SL, Hankins GD. Preventing maternal death: 10 clinical diamonds. Obstet Gynecol. 2012;119(2 pt 1):360–364.
  7. Thornton C, Dahlen H, Korda A, Hennessy A. The incidence of preeclampsia and eclampsia and associated maternal mortality in Australia from population-linked datasets: 2000-2008. Am J Obstet Gynecol. 2013;208(6):476.e1–e5.
  8. Altman D, Carroli G, Duley L, et al; Magpie Trial Collaboration Group. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet. 2002;359(9321):1877–1890.
  9. Gyamfi-Bannerman C, Thom EA, Blackwell SC, et al; NICHD Maternal-Fetal Medicine Units Network. Antenatal betamethasone for women at risk for late preterm delivery. N Engl J Med. 2016;374(14):1311–1320.
  10. von Dadelszen P, Payne B, Li J, et al; PIERS Study Group. Prediction of adverse maternal outcomes in pre-eclampsia: development and validation of the full PIERS model. Lancet. 2011;377(9761):219–227.
  11. Shahir  K, Goodman LR, Tali A, Thorsen KM, Hellman RS. Pulmonary embolism in pregnancy: CT pulmonary angiography versus perfusion scanning. AJR Am J Roentgenol. 2010;195(3):W214–W220.
  12. Erkilinç S, Eyi EG. Factors contributing to adverse maternal outcomes in patients with HELLP syndrome. J Matern Fetal Neonatal Med. 2017:1–7. doi:10.1080/14767058.2017.1359528.
  13. Publications Committee, Society for Maternal-Fetal Medicine, Sibai BM. Evaluation and management of severe preeclampsia before 34 weeks’ gestation. Am J Obstet Gynecol. 2011;205(3):191–198
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Product Update: Natera’s Panorama NIPT; Solosec from Symbiomix Therapeutics

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Product Update: Natera’s Panorama NIPT; Solosec from Symbiomix Therapeutics

NIPT SCREENING FOR TWIN ZYGOSITY AND GENETIC RISK FACTORS

The Natera® Panorama® non-invasive prenatal test (NIPT) now screens twin pregnancies for zygosity and chromosomal abnormalities. Natera says that Panorama is the first NIPT that can determine whether twins are monozygotic (identical) or dizygotic (non-identical/fraternal) as early as 9 weeks’ gestation.

Building on its history as the only NIPT that can differentiate between the mother’s and the baby’s DNA, Panorama is now also the only NIPT to distinguish between each twin’s DNA, says Natera. Panorama’s unique technology enables it to determine zygosity and each twin’s gender while also allowing it to identify risk for more genetic conditions in twin pregnancies than other NIPTs, including monosomy X, sex chromosome trisomies, and 22q11.2 deletion syndrome.

FOR MORE INFORMATION, VISIT: http://www.panoramatest.com/panorama-test/



NEW DRUG FOR TREATING BACTERIAL VAGINOSIS

Solosec™ (secnidazole), a 5-nitroimidazole antibiotic, has been given FDA approval for treatment of bacterial vaginosis (BV) in adult women, according to manufacturer Symbiomix Therapeutics. The drug, consisting of oral granules, can be given as a single 2-g dose, and taken with or without a meal. Symbiomix Therapeutics says that Solosec is clinically proven to normalize BV symptoms of odor and discharge.

Symbiomix Therapeutics reported that FDA approval was supported by comprehensive studies that found the single-dose secnidazole 2g was efficacious. All treatment-emergent adverse effects were mild or moderate in intensity; no serious adverse events were reported. Solosec will be available to patients in the first quarter of 2018.

FOR MORE INFORMATION, VISIT: https://symbiomix.com/sym-1219/

 

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NIPT SCREENING FOR TWIN ZYGOSITY AND GENETIC RISK FACTORS

The Natera® Panorama® non-invasive prenatal test (NIPT) now screens twin pregnancies for zygosity and chromosomal abnormalities. Natera says that Panorama is the first NIPT that can determine whether twins are monozygotic (identical) or dizygotic (non-identical/fraternal) as early as 9 weeks’ gestation.

Building on its history as the only NIPT that can differentiate between the mother’s and the baby’s DNA, Panorama is now also the only NIPT to distinguish between each twin’s DNA, says Natera. Panorama’s unique technology enables it to determine zygosity and each twin’s gender while also allowing it to identify risk for more genetic conditions in twin pregnancies than other NIPTs, including monosomy X, sex chromosome trisomies, and 22q11.2 deletion syndrome.

FOR MORE INFORMATION, VISIT: http://www.panoramatest.com/panorama-test/



NEW DRUG FOR TREATING BACTERIAL VAGINOSIS

Solosec™ (secnidazole), a 5-nitroimidazole antibiotic, has been given FDA approval for treatment of bacterial vaginosis (BV) in adult women, according to manufacturer Symbiomix Therapeutics. The drug, consisting of oral granules, can be given as a single 2-g dose, and taken with or without a meal. Symbiomix Therapeutics says that Solosec is clinically proven to normalize BV symptoms of odor and discharge.

Symbiomix Therapeutics reported that FDA approval was supported by comprehensive studies that found the single-dose secnidazole 2g was efficacious. All treatment-emergent adverse effects were mild or moderate in intensity; no serious adverse events were reported. Solosec will be available to patients in the first quarter of 2018.

FOR MORE INFORMATION, VISIT: https://symbiomix.com/sym-1219/

 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

NIPT SCREENING FOR TWIN ZYGOSITY AND GENETIC RISK FACTORS

The Natera® Panorama® non-invasive prenatal test (NIPT) now screens twin pregnancies for zygosity and chromosomal abnormalities. Natera says that Panorama is the first NIPT that can determine whether twins are monozygotic (identical) or dizygotic (non-identical/fraternal) as early as 9 weeks’ gestation.

Building on its history as the only NIPT that can differentiate between the mother’s and the baby’s DNA, Panorama is now also the only NIPT to distinguish between each twin’s DNA, says Natera. Panorama’s unique technology enables it to determine zygosity and each twin’s gender while also allowing it to identify risk for more genetic conditions in twin pregnancies than other NIPTs, including monosomy X, sex chromosome trisomies, and 22q11.2 deletion syndrome.

FOR MORE INFORMATION, VISIT: http://www.panoramatest.com/panorama-test/



NEW DRUG FOR TREATING BACTERIAL VAGINOSIS

Solosec™ (secnidazole), a 5-nitroimidazole antibiotic, has been given FDA approval for treatment of bacterial vaginosis (BV) in adult women, according to manufacturer Symbiomix Therapeutics. The drug, consisting of oral granules, can be given as a single 2-g dose, and taken with or without a meal. Symbiomix Therapeutics says that Solosec is clinically proven to normalize BV symptoms of odor and discharge.

Symbiomix Therapeutics reported that FDA approval was supported by comprehensive studies that found the single-dose secnidazole 2g was efficacious. All treatment-emergent adverse effects were mild or moderate in intensity; no serious adverse events were reported. Solosec will be available to patients in the first quarter of 2018.

FOR MORE INFORMATION, VISIT: https://symbiomix.com/sym-1219/

 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

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ACOG advises against vaginal seeding

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The practice of vaginal seeding should not be performed outside of an approved research protocol until adequate data on safety and potential benefits are available, according to a new policy statement from the American College of Obstetricians and Gynecologists.

Vaginal seeding is “the practice of inoculating a cotton gauze or a cotton swab with vaginal fluids to transfer the vaginal flora to the mouth, nose, or skin of a newborn infant,” according to ACOG.

AngelIce/Thinkstock
This practice has been gaining attention, and some patients have begun requesting the procedure following cesarean deliveries.

Data from several studies have suggested babies delivered by cesarean may lack the immunologic and metabolic benefits of vaginally delivered babies because of the unique properties of vaginal fluid, and a proof-of-concept study showed changes in newborns’ microbiome profiles when they received transfers of vaginal fluid soon after a cesarean delivery. However, the impact of the fluid transfer (vaginal seeding) remains unknown, according to the ACOG committee opinion (Obstet Gynecol. 2017;130:e274-8).

Additional safety concerns include the potential transfer of pathogens from mother to neonate from undiagnosed maternal conditions such as gonorrhea, human papillomavirus, group A streptococci, and others, the committee noted.

Women who wish to perform neonatal seeding themselves should be educated about the risks and tested for infectious diseases and pathogenic bacteria, the committee emphasized. Additionally, ACOG urged ob.gyns. to document the discussion in the medical record. The infant’s physician should also be made aware of the procedure because of the potential for neonatal infection.

The research on vaginal seeding currently consists of one pilot study, with an outcome measure of neonatal microbiota. No studies of other clinical outcomes have been completed.

“The paucity of data on this subject supports the need for additional research on the safety and benefit of vaginal seeding,” the ACOG Committee on Obstetric Practice wrote.

In the meantime, ACOG recommends exclusive breastfeeding in the first 6 months, noting that there are mixed data on associations between breastfeeding and the development of asthma and atopic disease in childhood.

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The practice of vaginal seeding should not be performed outside of an approved research protocol until adequate data on safety and potential benefits are available, according to a new policy statement from the American College of Obstetricians and Gynecologists.

Vaginal seeding is “the practice of inoculating a cotton gauze or a cotton swab with vaginal fluids to transfer the vaginal flora to the mouth, nose, or skin of a newborn infant,” according to ACOG.

AngelIce/Thinkstock
This practice has been gaining attention, and some patients have begun requesting the procedure following cesarean deliveries.

Data from several studies have suggested babies delivered by cesarean may lack the immunologic and metabolic benefits of vaginally delivered babies because of the unique properties of vaginal fluid, and a proof-of-concept study showed changes in newborns’ microbiome profiles when they received transfers of vaginal fluid soon after a cesarean delivery. However, the impact of the fluid transfer (vaginal seeding) remains unknown, according to the ACOG committee opinion (Obstet Gynecol. 2017;130:e274-8).

Additional safety concerns include the potential transfer of pathogens from mother to neonate from undiagnosed maternal conditions such as gonorrhea, human papillomavirus, group A streptococci, and others, the committee noted.

Women who wish to perform neonatal seeding themselves should be educated about the risks and tested for infectious diseases and pathogenic bacteria, the committee emphasized. Additionally, ACOG urged ob.gyns. to document the discussion in the medical record. The infant’s physician should also be made aware of the procedure because of the potential for neonatal infection.

The research on vaginal seeding currently consists of one pilot study, with an outcome measure of neonatal microbiota. No studies of other clinical outcomes have been completed.

“The paucity of data on this subject supports the need for additional research on the safety and benefit of vaginal seeding,” the ACOG Committee on Obstetric Practice wrote.

In the meantime, ACOG recommends exclusive breastfeeding in the first 6 months, noting that there are mixed data on associations between breastfeeding and the development of asthma and atopic disease in childhood.

 

The practice of vaginal seeding should not be performed outside of an approved research protocol until adequate data on safety and potential benefits are available, according to a new policy statement from the American College of Obstetricians and Gynecologists.

Vaginal seeding is “the practice of inoculating a cotton gauze or a cotton swab with vaginal fluids to transfer the vaginal flora to the mouth, nose, or skin of a newborn infant,” according to ACOG.

AngelIce/Thinkstock
This practice has been gaining attention, and some patients have begun requesting the procedure following cesarean deliveries.

Data from several studies have suggested babies delivered by cesarean may lack the immunologic and metabolic benefits of vaginally delivered babies because of the unique properties of vaginal fluid, and a proof-of-concept study showed changes in newborns’ microbiome profiles when they received transfers of vaginal fluid soon after a cesarean delivery. However, the impact of the fluid transfer (vaginal seeding) remains unknown, according to the ACOG committee opinion (Obstet Gynecol. 2017;130:e274-8).

Additional safety concerns include the potential transfer of pathogens from mother to neonate from undiagnosed maternal conditions such as gonorrhea, human papillomavirus, group A streptococci, and others, the committee noted.

Women who wish to perform neonatal seeding themselves should be educated about the risks and tested for infectious diseases and pathogenic bacteria, the committee emphasized. Additionally, ACOG urged ob.gyns. to document the discussion in the medical record. The infant’s physician should also be made aware of the procedure because of the potential for neonatal infection.

The research on vaginal seeding currently consists of one pilot study, with an outcome measure of neonatal microbiota. No studies of other clinical outcomes have been completed.

“The paucity of data on this subject supports the need for additional research on the safety and benefit of vaginal seeding,” the ACOG Committee on Obstetric Practice wrote.

In the meantime, ACOG recommends exclusive breastfeeding in the first 6 months, noting that there are mixed data on associations between breastfeeding and the development of asthma and atopic disease in childhood.

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Questions value of ACOG/SMFM guidelines

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“FOR THE MANAGEMENT OF LABOR, PATIENCE IS A VIRTUE”
ROBERT L. BARBIERI, MD (EDITORIAL; AUGUST 2017)

 

Questions value of ACOG/SMFM guidelines

The labor management guidelines recommended by the American College of Obstetricians and Gynecologists (ACOG) and the Society of Maternal-Fetal Medicine (SMFM) are terrible. Now retired, I trained in 1959–1963. In my career as an obstetrician, my primary cesarean delivery rate was 10% or less, and part of that was external pressure from people who did not know how to deliver a baby. Persistent occiput posterior position is a problem of inadequate flexion of the head, often due to ineffective contractions earlier. In such a situation, “pit” early! Rotate the head if you must, and teach residents how, please. The guidelines do not discuss the exhausted mother who goes home after a long labor or hours of pushing. I have interviewed new obstetricians in my community as early as 1980 who did not know what deep transverse arrest was. There, I am done voicing my disgust with obstetrics as it is practiced today.

James Honig, MD
Merritt Island, Florida

 

Managing difficult labor scenarios

I concur with Dr. Barbieri’s views on labor management that watchful waiting and giving the patient adequate time to progress naturally is the key to increase the chances of vaginal delivery. After all, labor is a physiologic process and should progress naturally. Having said that, I would like to know Dr. Barbieri’s views on handling certain circumstances in which patients these days land in the labor room, including 1) postdated pregnancy with reduced fetal movements and not in labor; 2) full-term/post-term pregnancy with free-floating head and poor Bishop score; 3) full-term pregnancy with niggling pains for more than 1 week; and many such conditions that place you in the dilemma of whether to induce, knowing that chances of failure are high.

Manju Hotchandani, MD
New Delhi, India

 

Midwives always use patience to guide labor

As a Certified Nurse-Midwife since 1985 (now retired), “patience” in managing labor has always been my guide, as it has been for my midwifery colleagues. This is another example of ACOG finally acknowledging the truths we women have always known, without crediting the wisdom of midwives over the centuries. Lamaze International’s 6 Healthy Birth Practices also must have been their guide. “Evolving concepts of normal labor progress,” as though this was new information, would be humorous if it were not so frustrating!

Marsha Kelly, CNM
Charlotte, North Carolina

 

Dr. Barbieri responds

The readers of OBG Management have vast clinical experience, and we can all learn from their insights and guidance. On behalf of all our readers, I thank Drs. Honig and Hotchandani and Ms. Kelly for taking the time to share their expert advice.

Every clinician involved in the birth process is deeply committed to a safe delivery for both mother and baby. Clinicians guide the birth process based on the unique characteristics and needs of each woman. Dr. Honig advocates for the active management of the labor process, while Ms. Kelly advocates for less intervention. Both approaches to labor management may be optimal depending on the unique clinical needs of each woman. Dr. Hotchandani inquires about managing common obstetrical presentations. In my practice, induction is recommended for all women post-term who report consistently reduced fetal movement with the goal of reducing the risk of sudden intrauterine fetal demise. For healthy women at term with painful contractions and reassuring fetal status, but no cervical change, we support and counsel the patient and offer therapeutic rest with morphine. For women at term with a floating head and poor Bishop score, we would not intervene, until 41 weeks’ gestation when we would initiate gentle cervical ripening with mechanical or pharmacologic treatment.

 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

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“FOR THE MANAGEMENT OF LABOR, PATIENCE IS A VIRTUE”
ROBERT L. BARBIERI, MD (EDITORIAL; AUGUST 2017)

 

Questions value of ACOG/SMFM guidelines

The labor management guidelines recommended by the American College of Obstetricians and Gynecologists (ACOG) and the Society of Maternal-Fetal Medicine (SMFM) are terrible. Now retired, I trained in 1959–1963. In my career as an obstetrician, my primary cesarean delivery rate was 10% or less, and part of that was external pressure from people who did not know how to deliver a baby. Persistent occiput posterior position is a problem of inadequate flexion of the head, often due to ineffective contractions earlier. In such a situation, “pit” early! Rotate the head if you must, and teach residents how, please. The guidelines do not discuss the exhausted mother who goes home after a long labor or hours of pushing. I have interviewed new obstetricians in my community as early as 1980 who did not know what deep transverse arrest was. There, I am done voicing my disgust with obstetrics as it is practiced today.

James Honig, MD
Merritt Island, Florida

 

Managing difficult labor scenarios

I concur with Dr. Barbieri’s views on labor management that watchful waiting and giving the patient adequate time to progress naturally is the key to increase the chances of vaginal delivery. After all, labor is a physiologic process and should progress naturally. Having said that, I would like to know Dr. Barbieri’s views on handling certain circumstances in which patients these days land in the labor room, including 1) postdated pregnancy with reduced fetal movements and not in labor; 2) full-term/post-term pregnancy with free-floating head and poor Bishop score; 3) full-term pregnancy with niggling pains for more than 1 week; and many such conditions that place you in the dilemma of whether to induce, knowing that chances of failure are high.

Manju Hotchandani, MD
New Delhi, India

 

Midwives always use patience to guide labor

As a Certified Nurse-Midwife since 1985 (now retired), “patience” in managing labor has always been my guide, as it has been for my midwifery colleagues. This is another example of ACOG finally acknowledging the truths we women have always known, without crediting the wisdom of midwives over the centuries. Lamaze International’s 6 Healthy Birth Practices also must have been their guide. “Evolving concepts of normal labor progress,” as though this was new information, would be humorous if it were not so frustrating!

Marsha Kelly, CNM
Charlotte, North Carolina

 

Dr. Barbieri responds

The readers of OBG Management have vast clinical experience, and we can all learn from their insights and guidance. On behalf of all our readers, I thank Drs. Honig and Hotchandani and Ms. Kelly for taking the time to share their expert advice.

Every clinician involved in the birth process is deeply committed to a safe delivery for both mother and baby. Clinicians guide the birth process based on the unique characteristics and needs of each woman. Dr. Honig advocates for the active management of the labor process, while Ms. Kelly advocates for less intervention. Both approaches to labor management may be optimal depending on the unique clinical needs of each woman. Dr. Hotchandani inquires about managing common obstetrical presentations. In my practice, induction is recommended for all women post-term who report consistently reduced fetal movement with the goal of reducing the risk of sudden intrauterine fetal demise. For healthy women at term with painful contractions and reassuring fetal status, but no cervical change, we support and counsel the patient and offer therapeutic rest with morphine. For women at term with a floating head and poor Bishop score, we would not intervene, until 41 weeks’ gestation when we would initiate gentle cervical ripening with mechanical or pharmacologic treatment.

 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

“FOR THE MANAGEMENT OF LABOR, PATIENCE IS A VIRTUE”
ROBERT L. BARBIERI, MD (EDITORIAL; AUGUST 2017)

 

Questions value of ACOG/SMFM guidelines

The labor management guidelines recommended by the American College of Obstetricians and Gynecologists (ACOG) and the Society of Maternal-Fetal Medicine (SMFM) are terrible. Now retired, I trained in 1959–1963. In my career as an obstetrician, my primary cesarean delivery rate was 10% or less, and part of that was external pressure from people who did not know how to deliver a baby. Persistent occiput posterior position is a problem of inadequate flexion of the head, often due to ineffective contractions earlier. In such a situation, “pit” early! Rotate the head if you must, and teach residents how, please. The guidelines do not discuss the exhausted mother who goes home after a long labor or hours of pushing. I have interviewed new obstetricians in my community as early as 1980 who did not know what deep transverse arrest was. There, I am done voicing my disgust with obstetrics as it is practiced today.

James Honig, MD
Merritt Island, Florida

 

Managing difficult labor scenarios

I concur with Dr. Barbieri’s views on labor management that watchful waiting and giving the patient adequate time to progress naturally is the key to increase the chances of vaginal delivery. After all, labor is a physiologic process and should progress naturally. Having said that, I would like to know Dr. Barbieri’s views on handling certain circumstances in which patients these days land in the labor room, including 1) postdated pregnancy with reduced fetal movements and not in labor; 2) full-term/post-term pregnancy with free-floating head and poor Bishop score; 3) full-term pregnancy with niggling pains for more than 1 week; and many such conditions that place you in the dilemma of whether to induce, knowing that chances of failure are high.

Manju Hotchandani, MD
New Delhi, India

 

Midwives always use patience to guide labor

As a Certified Nurse-Midwife since 1985 (now retired), “patience” in managing labor has always been my guide, as it has been for my midwifery colleagues. This is another example of ACOG finally acknowledging the truths we women have always known, without crediting the wisdom of midwives over the centuries. Lamaze International’s 6 Healthy Birth Practices also must have been their guide. “Evolving concepts of normal labor progress,” as though this was new information, would be humorous if it were not so frustrating!

Marsha Kelly, CNM
Charlotte, North Carolina

 

Dr. Barbieri responds

The readers of OBG Management have vast clinical experience, and we can all learn from their insights and guidance. On behalf of all our readers, I thank Drs. Honig and Hotchandani and Ms. Kelly for taking the time to share their expert advice.

Every clinician involved in the birth process is deeply committed to a safe delivery for both mother and baby. Clinicians guide the birth process based on the unique characteristics and needs of each woman. Dr. Honig advocates for the active management of the labor process, while Ms. Kelly advocates for less intervention. Both approaches to labor management may be optimal depending on the unique clinical needs of each woman. Dr. Hotchandani inquires about managing common obstetrical presentations. In my practice, induction is recommended for all women post-term who report consistently reduced fetal movement with the goal of reducing the risk of sudden intrauterine fetal demise. For healthy women at term with painful contractions and reassuring fetal status, but no cervical change, we support and counsel the patient and offer therapeutic rest with morphine. For women at term with a floating head and poor Bishop score, we would not intervene, until 41 weeks’ gestation when we would initiate gentle cervical ripening with mechanical or pharmacologic treatment.

 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

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Late delivery of macrosomic baby

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Late delivery of macrosomic baby: $5.5M settlement

After a woman was admitted to the hospital, her labor was complicated by very slow progress, maternal fever, and multiple fetal heart-rate (FHR) monitor strip abnormalities. A baby boy was born by cesarean delivery 26 hours after the mother's admission, weighing almost 11 lb. At birth, the baby was asphyxiated, with an arterial cord blood pH of 7.01 and a base excess of -14.4. He was resuscitated and sent to the neonatal intensive care unit (NICU). Nine days after birth, he began to have seizures. The placental pathology report revealed infection; placental cultures grew Group B strep. The infant was diagnosed 6 days later with hypoxic ischemic encephalopathy after magnetic resonance imaging.

PARENTS' CLAIM:
The ObGyn and hospital failed to recognize that the baby was macrosomic. The ObGyn should have delivered the baby when the FHR monitor first showed fetal distress.

DEFENDANTS' DEFENSE:
The case was settled during the trial.

VERDICT:
A $5.5 million Washington settlement was reached.

 

Size of perineal tear and its consequences disputed: $1.8M verdict

A 34-year-old woman gave birth vaginally. During forceps delivery, she suffered a 4th-degree perineal tear, running from her vagina to her rectum, which was misidentified by the ObGyn as a 2nd-degree tear. The perineal tear lead to complications including infection and a persistent rectovaginal fistula. She underwent several operations over the next  5 years.

PARENTS' CLAIM:
The ObGyn did not appropriately address the wound. Had a cesarean delivery been performed, the wound would not have occurred.

DEFENDANTS' DEFENSE:
The decisions to allow labor to continue and to use forceps were reasonable. The ObGyn contended that the patient sustained only a 2nd-degree tear in the delivery room, with the 4th-degree tear occurring the next day due to attenuated tissue.

VERDICT:
A $1.8 million Illinois verdict was returned.

 

Related article:
Develop and use a checklist for 3rd- and 4th-degree perineal lacerations

 

Macrosomic baby,  cerebral palsy: $5.5M settlement

At 42 weeks' gestation, a mother was sent to the hospital in labor. During delivery, thick meconium was encountered. At birth, the baby weighed more than 9 lb. At age 16 years, the child has cerebral palsy, a seizure disorder, and developmental and cognitive deficits. She functions at the level of an 8-year-old child.

PARENTS' CLAIM:
The ObGyn and nurses did not deliver the baby in a timely manner by cesarean delivery. The estimated weight and a deteriorating in utero environment, as evidenced by the thick meconium, caused the child's brain injury.

DEFENDANTS' DEFENSE:
The case settled during trial.

VERDICT:
A $5.5 million Illinois settlement was reached.

 

Did baby get Group B strep from her mother?

During prenatal care by an ObGyn, a woman underwent a routine test for Group B strep, the results of which were negative. The child, with APGAR scores of 9 at 1 and 5 minutes after birth, was admitted to the well-baby nursery. Four hours after birth, the baby appeared to be in distress and was moved to the NICU. She was found to have respiratory distress, metabolic acidosis, and sepsis, allegedly caused by Group B strep, and was placed on a ventilator and prescribed medications. When the baby's condition worsened, she was transferred to a children's hospital. She was discharged 3 months later with bronchopulmonary dysplasia and a chronic lung disease that requires continuous treatment.

PARENTS' CLAIM:
The baby's injuries were attributable to Group B strep. The ObGyn's prenatal treatment did not meet the standard of care.

PHYSICIAN'S DEFENSE:
There was no negligence on the part of the ObGyn. The standard of care was met.

VERDICT:
An Alabama defense verdict was returned.

 

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

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Late delivery of macrosomic baby: $5.5M settlement

After a woman was admitted to the hospital, her labor was complicated by very slow progress, maternal fever, and multiple fetal heart-rate (FHR) monitor strip abnormalities. A baby boy was born by cesarean delivery 26 hours after the mother's admission, weighing almost 11 lb. At birth, the baby was asphyxiated, with an arterial cord blood pH of 7.01 and a base excess of -14.4. He was resuscitated and sent to the neonatal intensive care unit (NICU). Nine days after birth, he began to have seizures. The placental pathology report revealed infection; placental cultures grew Group B strep. The infant was diagnosed 6 days later with hypoxic ischemic encephalopathy after magnetic resonance imaging.

PARENTS' CLAIM:
The ObGyn and hospital failed to recognize that the baby was macrosomic. The ObGyn should have delivered the baby when the FHR monitor first showed fetal distress.

DEFENDANTS' DEFENSE:
The case was settled during the trial.

VERDICT:
A $5.5 million Washington settlement was reached.

 

Size of perineal tear and its consequences disputed: $1.8M verdict

A 34-year-old woman gave birth vaginally. During forceps delivery, she suffered a 4th-degree perineal tear, running from her vagina to her rectum, which was misidentified by the ObGyn as a 2nd-degree tear. The perineal tear lead to complications including infection and a persistent rectovaginal fistula. She underwent several operations over the next  5 years.

PARENTS' CLAIM:
The ObGyn did not appropriately address the wound. Had a cesarean delivery been performed, the wound would not have occurred.

DEFENDANTS' DEFENSE:
The decisions to allow labor to continue and to use forceps were reasonable. The ObGyn contended that the patient sustained only a 2nd-degree tear in the delivery room, with the 4th-degree tear occurring the next day due to attenuated tissue.

VERDICT:
A $1.8 million Illinois verdict was returned.

 

Related article:
Develop and use a checklist for 3rd- and 4th-degree perineal lacerations

 

Macrosomic baby,  cerebral palsy: $5.5M settlement

At 42 weeks' gestation, a mother was sent to the hospital in labor. During delivery, thick meconium was encountered. At birth, the baby weighed more than 9 lb. At age 16 years, the child has cerebral palsy, a seizure disorder, and developmental and cognitive deficits. She functions at the level of an 8-year-old child.

PARENTS' CLAIM:
The ObGyn and nurses did not deliver the baby in a timely manner by cesarean delivery. The estimated weight and a deteriorating in utero environment, as evidenced by the thick meconium, caused the child's brain injury.

DEFENDANTS' DEFENSE:
The case settled during trial.

VERDICT:
A $5.5 million Illinois settlement was reached.

 

Did baby get Group B strep from her mother?

During prenatal care by an ObGyn, a woman underwent a routine test for Group B strep, the results of which were negative. The child, with APGAR scores of 9 at 1 and 5 minutes after birth, was admitted to the well-baby nursery. Four hours after birth, the baby appeared to be in distress and was moved to the NICU. She was found to have respiratory distress, metabolic acidosis, and sepsis, allegedly caused by Group B strep, and was placed on a ventilator and prescribed medications. When the baby's condition worsened, she was transferred to a children's hospital. She was discharged 3 months later with bronchopulmonary dysplasia and a chronic lung disease that requires continuous treatment.

PARENTS' CLAIM:
The baby's injuries were attributable to Group B strep. The ObGyn's prenatal treatment did not meet the standard of care.

PHYSICIAN'S DEFENSE:
There was no negligence on the part of the ObGyn. The standard of care was met.

VERDICT:
An Alabama defense verdict was returned.

 

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Late delivery of macrosomic baby: $5.5M settlement

After a woman was admitted to the hospital, her labor was complicated by very slow progress, maternal fever, and multiple fetal heart-rate (FHR) monitor strip abnormalities. A baby boy was born by cesarean delivery 26 hours after the mother's admission, weighing almost 11 lb. At birth, the baby was asphyxiated, with an arterial cord blood pH of 7.01 and a base excess of -14.4. He was resuscitated and sent to the neonatal intensive care unit (NICU). Nine days after birth, he began to have seizures. The placental pathology report revealed infection; placental cultures grew Group B strep. The infant was diagnosed 6 days later with hypoxic ischemic encephalopathy after magnetic resonance imaging.

PARENTS' CLAIM:
The ObGyn and hospital failed to recognize that the baby was macrosomic. The ObGyn should have delivered the baby when the FHR monitor first showed fetal distress.

DEFENDANTS' DEFENSE:
The case was settled during the trial.

VERDICT:
A $5.5 million Washington settlement was reached.

 

Size of perineal tear and its consequences disputed: $1.8M verdict

A 34-year-old woman gave birth vaginally. During forceps delivery, she suffered a 4th-degree perineal tear, running from her vagina to her rectum, which was misidentified by the ObGyn as a 2nd-degree tear. The perineal tear lead to complications including infection and a persistent rectovaginal fistula. She underwent several operations over the next  5 years.

PARENTS' CLAIM:
The ObGyn did not appropriately address the wound. Had a cesarean delivery been performed, the wound would not have occurred.

DEFENDANTS' DEFENSE:
The decisions to allow labor to continue and to use forceps were reasonable. The ObGyn contended that the patient sustained only a 2nd-degree tear in the delivery room, with the 4th-degree tear occurring the next day due to attenuated tissue.

VERDICT:
A $1.8 million Illinois verdict was returned.

 

Related article:
Develop and use a checklist for 3rd- and 4th-degree perineal lacerations

 

Macrosomic baby,  cerebral palsy: $5.5M settlement

At 42 weeks' gestation, a mother was sent to the hospital in labor. During delivery, thick meconium was encountered. At birth, the baby weighed more than 9 lb. At age 16 years, the child has cerebral palsy, a seizure disorder, and developmental and cognitive deficits. She functions at the level of an 8-year-old child.

PARENTS' CLAIM:
The ObGyn and nurses did not deliver the baby in a timely manner by cesarean delivery. The estimated weight and a deteriorating in utero environment, as evidenced by the thick meconium, caused the child's brain injury.

DEFENDANTS' DEFENSE:
The case settled during trial.

VERDICT:
A $5.5 million Illinois settlement was reached.

 

Did baby get Group B strep from her mother?

During prenatal care by an ObGyn, a woman underwent a routine test for Group B strep, the results of which were negative. The child, with APGAR scores of 9 at 1 and 5 minutes after birth, was admitted to the well-baby nursery. Four hours after birth, the baby appeared to be in distress and was moved to the NICU. She was found to have respiratory distress, metabolic acidosis, and sepsis, allegedly caused by Group B strep, and was placed on a ventilator and prescribed medications. When the baby's condition worsened, she was transferred to a children's hospital. She was discharged 3 months later with bronchopulmonary dysplasia and a chronic lung disease that requires continuous treatment.

PARENTS' CLAIM:
The baby's injuries were attributable to Group B strep. The ObGyn's prenatal treatment did not meet the standard of care.

PHYSICIAN'S DEFENSE:
There was no negligence on the part of the ObGyn. The standard of care was met.

VERDICT:
An Alabama defense verdict was returned.

 

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

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Fetal fibronectin may be underused in preterm birth detection

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Only a small percentage of pregnant women with symptoms of preterm labor who are admitted to emergency departments or labor and delivery units receive fetal fibronectin testing, suggesting the test may not be fully utilized, according to results from a retrospective study.

Using data collected from the Medical Outcomes Research for Effectiveness and Economics Registry, 23,062 patients were included in the study, of whom just 12% received fetal fibronectin (fFN) testing, according to Sean C. Blackwell, MD, of the department of obstetrics, gynecology and reproductive sciences at the University of Texas, Houston, and his associates (Clinicoecon Outcomes Res. 2017 Oct 3;9:585-94. doi: 10.2147/CEOR.S141061).

The rate of fFN testing was even lower – 4.2% – among women who were discharged home but gave birth within 3 days, compared with the testing rate of 16.7% in women who were discharged and did not give birth within 3 days, which suggests “that there may be opportunities to improve the care management of these patients with the use of such screening tools as fFN testing,” the researchers wrote.



Patients who resided in the Northeast were less likely to receive fFN testing, while patients in the West were slightly more likely to receive testing. Patients with more all-cause physician visits and who had received transvaginal ultrasound also were more likely to receive fFN testing, they reported.

“Additional research is needed to determine how to use quantitative fFN testing tools currently under development as part of screening for risk of [preterm labor] allowing physicians the opportunity to better understand patient risk factors and tailor interventions to optimize pre- and perinatal care for the woman and her neonate,” Dr. Blackwell and his associates wrote.

Three of the study authors are employees of Avalere Health, which received funding from Hologic Inc., to support the study. Another author is an employee of Hologic, which produces fFN tests. The authors had no other disclosures.

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Only a small percentage of pregnant women with symptoms of preterm labor who are admitted to emergency departments or labor and delivery units receive fetal fibronectin testing, suggesting the test may not be fully utilized, according to results from a retrospective study.

Using data collected from the Medical Outcomes Research for Effectiveness and Economics Registry, 23,062 patients were included in the study, of whom just 12% received fetal fibronectin (fFN) testing, according to Sean C. Blackwell, MD, of the department of obstetrics, gynecology and reproductive sciences at the University of Texas, Houston, and his associates (Clinicoecon Outcomes Res. 2017 Oct 3;9:585-94. doi: 10.2147/CEOR.S141061).

The rate of fFN testing was even lower – 4.2% – among women who were discharged home but gave birth within 3 days, compared with the testing rate of 16.7% in women who were discharged and did not give birth within 3 days, which suggests “that there may be opportunities to improve the care management of these patients with the use of such screening tools as fFN testing,” the researchers wrote.



Patients who resided in the Northeast were less likely to receive fFN testing, while patients in the West were slightly more likely to receive testing. Patients with more all-cause physician visits and who had received transvaginal ultrasound also were more likely to receive fFN testing, they reported.

“Additional research is needed to determine how to use quantitative fFN testing tools currently under development as part of screening for risk of [preterm labor] allowing physicians the opportunity to better understand patient risk factors and tailor interventions to optimize pre- and perinatal care for the woman and her neonate,” Dr. Blackwell and his associates wrote.

Three of the study authors are employees of Avalere Health, which received funding from Hologic Inc., to support the study. Another author is an employee of Hologic, which produces fFN tests. The authors had no other disclosures.

 

Only a small percentage of pregnant women with symptoms of preterm labor who are admitted to emergency departments or labor and delivery units receive fetal fibronectin testing, suggesting the test may not be fully utilized, according to results from a retrospective study.

Using data collected from the Medical Outcomes Research for Effectiveness and Economics Registry, 23,062 patients were included in the study, of whom just 12% received fetal fibronectin (fFN) testing, according to Sean C. Blackwell, MD, of the department of obstetrics, gynecology and reproductive sciences at the University of Texas, Houston, and his associates (Clinicoecon Outcomes Res. 2017 Oct 3;9:585-94. doi: 10.2147/CEOR.S141061).

The rate of fFN testing was even lower – 4.2% – among women who were discharged home but gave birth within 3 days, compared with the testing rate of 16.7% in women who were discharged and did not give birth within 3 days, which suggests “that there may be opportunities to improve the care management of these patients with the use of such screening tools as fFN testing,” the researchers wrote.



Patients who resided in the Northeast were less likely to receive fFN testing, while patients in the West were slightly more likely to receive testing. Patients with more all-cause physician visits and who had received transvaginal ultrasound also were more likely to receive fFN testing, they reported.

“Additional research is needed to determine how to use quantitative fFN testing tools currently under development as part of screening for risk of [preterm labor] allowing physicians the opportunity to better understand patient risk factors and tailor interventions to optimize pre- and perinatal care for the woman and her neonate,” Dr. Blackwell and his associates wrote.

Three of the study authors are employees of Avalere Health, which received funding from Hologic Inc., to support the study. Another author is an employee of Hologic, which produces fFN tests. The authors had no other disclosures.

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Key clinical point: The rate of fetal fibronectin (fFN) testing is low, especially in women who give birth within 3 days of emergency department discharge.

Major finding: Pregnant women with symptoms of preterm labor received fFN testing at an overall rate of 12%.

Data source: A total of 23,062 patients from the Medical Outcomes Research for Effectiveness and Economics Registry.

Disclosures: Three of the study authors are employees of Avalere Health, which received funding from Hologic Inc., to support the study. Another author is an employee of Hologic, which produces fFN tests. The authors had no other disclosures.

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Hep C screening falling short in neonatal abstinence syndrome infants

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SAN DIEGO – A review of care for neonates born with neonatal abstinence syndrome (NAS) found that screening for hepatitis C virus (HCV) infection is low, based on Medicaid data from the state of Kentucky.

“These children are at high risk for HCV, and the screening rate should really be 100%. We think that it is important to get the message out there,” said Michael Smith, MD, of the department of pediatrics at the Duke University, Durham, N.C.

Jarun011/Thinkstock
As a result of the opioid epidemic, rates of NAS have been increasing nationwide, but Kentucky is an epicenter, according to Dr. Smith, who collaborated on this study with John Myers, PhD, a researcher in Kentucky’s University of Louisville School of Public Health and Information Services. In Kentucky, the rate of NAS in 2015 was 30 cases per 1,000 live births, which is more than four times the national average of 7 cases per 1,000 live births, according to Dr. Smith, who was a pediatric infectious disease specialist at the University of Louisville before recently moving to Duke.

According to the Kentucky Medicaid data, the rates of NAS are not evenly distributed in the state. Stratifying the incidence rates by eight regions, Dr. Smith reported that 33% of the NAS births in 2016 were in region 8. Although region 8 is a rural Appalachian section on the eastern border of the state, the proportion in this region was more than 50% greater than any other region, including the more populated regions containing Louisville, the largest city, and Lexington, the capital.

Statewide, approximately one in three newborns with NAS were screened for HCV, but the rate was as low as 5% in some areas, and low rates were more common in those counties with the highest rates of opioid use and NAS, Dr. Smith said at an annual scientific meeting on infectious diseases. Although he acknowledged that rates of HCV screening in newborns with NAS appeared to be increasing when 2015 and 2012 data were compared, “there is still a long way to go.”

“Why is this important? There are a couple of reasons. One is that, if you get children into care early, you are more likely to have follow-up,” Dr. Smith said. Follow-up will be important if, as Dr. Smith predicted, HCV therapies become available for children. When providers know which children are infected, treatment can be initiated more efficiently, and this has implications for risk of transmission and, potentially, for outcomes.

At the University of Louisville, children with NAS are typically screened for HCV, HIV, and other transmissible infections that “travel together,” such as syphilis. The evaluation of the Medicaid data suggested that there were no differences in likelihood of HCV testing for sex and race, but Dr. Smith noted that children placed in foster care were significantly more likely to be tested, likely a reflection of processing regulations.

Overall, there are striking differences in the rates of opioid use, rates of NAS, and likelihood of HCV testing in NAS neonates in eastern Appalachian regions of Kentucky and those in regions in the center of the state closer to academic medical centers. The three regions near the University of Louisville, University of Kentucky in Lexington, and the Ohio River border with Cincinnati are known as “the Golden Triangle,” according to Dr. Smith; these regions are where HCV testing rates in neonates with NAS are higher, but testing still is not uniform.

Currently, HCV testing is mandated for adults in several states, but Dr. Smith emphasized that children with NAS are particularly “vulnerable.” He called for policy changes that would require testing in these children and urged HCV screening regardless of whether official policies are established.

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SAN DIEGO – A review of care for neonates born with neonatal abstinence syndrome (NAS) found that screening for hepatitis C virus (HCV) infection is low, based on Medicaid data from the state of Kentucky.

“These children are at high risk for HCV, and the screening rate should really be 100%. We think that it is important to get the message out there,” said Michael Smith, MD, of the department of pediatrics at the Duke University, Durham, N.C.

Jarun011/Thinkstock
As a result of the opioid epidemic, rates of NAS have been increasing nationwide, but Kentucky is an epicenter, according to Dr. Smith, who collaborated on this study with John Myers, PhD, a researcher in Kentucky’s University of Louisville School of Public Health and Information Services. In Kentucky, the rate of NAS in 2015 was 30 cases per 1,000 live births, which is more than four times the national average of 7 cases per 1,000 live births, according to Dr. Smith, who was a pediatric infectious disease specialist at the University of Louisville before recently moving to Duke.

According to the Kentucky Medicaid data, the rates of NAS are not evenly distributed in the state. Stratifying the incidence rates by eight regions, Dr. Smith reported that 33% of the NAS births in 2016 were in region 8. Although region 8 is a rural Appalachian section on the eastern border of the state, the proportion in this region was more than 50% greater than any other region, including the more populated regions containing Louisville, the largest city, and Lexington, the capital.

Statewide, approximately one in three newborns with NAS were screened for HCV, but the rate was as low as 5% in some areas, and low rates were more common in those counties with the highest rates of opioid use and NAS, Dr. Smith said at an annual scientific meeting on infectious diseases. Although he acknowledged that rates of HCV screening in newborns with NAS appeared to be increasing when 2015 and 2012 data were compared, “there is still a long way to go.”

“Why is this important? There are a couple of reasons. One is that, if you get children into care early, you are more likely to have follow-up,” Dr. Smith said. Follow-up will be important if, as Dr. Smith predicted, HCV therapies become available for children. When providers know which children are infected, treatment can be initiated more efficiently, and this has implications for risk of transmission and, potentially, for outcomes.

At the University of Louisville, children with NAS are typically screened for HCV, HIV, and other transmissible infections that “travel together,” such as syphilis. The evaluation of the Medicaid data suggested that there were no differences in likelihood of HCV testing for sex and race, but Dr. Smith noted that children placed in foster care were significantly more likely to be tested, likely a reflection of processing regulations.

Overall, there are striking differences in the rates of opioid use, rates of NAS, and likelihood of HCV testing in NAS neonates in eastern Appalachian regions of Kentucky and those in regions in the center of the state closer to academic medical centers. The three regions near the University of Louisville, University of Kentucky in Lexington, and the Ohio River border with Cincinnati are known as “the Golden Triangle,” according to Dr. Smith; these regions are where HCV testing rates in neonates with NAS are higher, but testing still is not uniform.

Currently, HCV testing is mandated for adults in several states, but Dr. Smith emphasized that children with NAS are particularly “vulnerable.” He called for policy changes that would require testing in these children and urged HCV screening regardless of whether official policies are established.

 

SAN DIEGO – A review of care for neonates born with neonatal abstinence syndrome (NAS) found that screening for hepatitis C virus (HCV) infection is low, based on Medicaid data from the state of Kentucky.

“These children are at high risk for HCV, and the screening rate should really be 100%. We think that it is important to get the message out there,” said Michael Smith, MD, of the department of pediatrics at the Duke University, Durham, N.C.

Jarun011/Thinkstock
As a result of the opioid epidemic, rates of NAS have been increasing nationwide, but Kentucky is an epicenter, according to Dr. Smith, who collaborated on this study with John Myers, PhD, a researcher in Kentucky’s University of Louisville School of Public Health and Information Services. In Kentucky, the rate of NAS in 2015 was 30 cases per 1,000 live births, which is more than four times the national average of 7 cases per 1,000 live births, according to Dr. Smith, who was a pediatric infectious disease specialist at the University of Louisville before recently moving to Duke.

According to the Kentucky Medicaid data, the rates of NAS are not evenly distributed in the state. Stratifying the incidence rates by eight regions, Dr. Smith reported that 33% of the NAS births in 2016 were in region 8. Although region 8 is a rural Appalachian section on the eastern border of the state, the proportion in this region was more than 50% greater than any other region, including the more populated regions containing Louisville, the largest city, and Lexington, the capital.

Statewide, approximately one in three newborns with NAS were screened for HCV, but the rate was as low as 5% in some areas, and low rates were more common in those counties with the highest rates of opioid use and NAS, Dr. Smith said at an annual scientific meeting on infectious diseases. Although he acknowledged that rates of HCV screening in newborns with NAS appeared to be increasing when 2015 and 2012 data were compared, “there is still a long way to go.”

“Why is this important? There are a couple of reasons. One is that, if you get children into care early, you are more likely to have follow-up,” Dr. Smith said. Follow-up will be important if, as Dr. Smith predicted, HCV therapies become available for children. When providers know which children are infected, treatment can be initiated more efficiently, and this has implications for risk of transmission and, potentially, for outcomes.

At the University of Louisville, children with NAS are typically screened for HCV, HIV, and other transmissible infections that “travel together,” such as syphilis. The evaluation of the Medicaid data suggested that there were no differences in likelihood of HCV testing for sex and race, but Dr. Smith noted that children placed in foster care were significantly more likely to be tested, likely a reflection of processing regulations.

Overall, there are striking differences in the rates of opioid use, rates of NAS, and likelihood of HCV testing in NAS neonates in eastern Appalachian regions of Kentucky and those in regions in the center of the state closer to academic medical centers. The three regions near the University of Louisville, University of Kentucky in Lexington, and the Ohio River border with Cincinnati are known as “the Golden Triangle,” according to Dr. Smith; these regions are where HCV testing rates in neonates with NAS are higher, but testing still is not uniform.

Currently, HCV testing is mandated for adults in several states, but Dr. Smith emphasized that children with NAS are particularly “vulnerable.” He called for policy changes that would require testing in these children and urged HCV screening regardless of whether official policies are established.

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Key clinical point: In Kentucky, which has one of the highest rates of neonates with NAS, screening rates for HCV remain low.

Major finding: Only one in three newborns with neonatal abstinence syndrome are screened for HCV, which leads to missed opportunities for early detection.

Data source: Retrospective data analysis of Kentucky Medicaid data.

Disclosures: Dr. Smith reported no financial relationships relevant to this study.

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