User login
Obstacles plague prenatal cell-free DNA testing use
A recent California study examining cell-free DNA (cfDNA) testing suggests that the test generally performs well as a second-line screen for fetal aneuploidy. However, while the test itself is reliable, some physicians say gaps in patient education, limited availability of genetic counseling, and a lack of coordinated research and data collection are all standing in the way of its optimal utilization.
In some of the most recent data presented on cfDNA test performance, researchers in California found that the test had few false positives and was best at predicting Down syndrome, with a positive predictive value of 98.6%.
California offers prenatal screening as a public health program, with a structured system of screening tests and follow-up services, according to Dr. Currier, who is chief of the evaluation section of the state’s Genetic Disease Screening Program. First trimester screening includes screens for trisomies 18 and 21. During the second trimester, the screening adds on checks for neural tube defects and Smith-Lemli-Opitz syndrome, also known as 7-dehydrocholesterol reductase deficiency.
Overall, 20,852 patients were offered cfDNA screening during this period, and 63% (n = 12,960) went on to have the screen. Dr. Currier and his colleagues found that about a third of patients with a first- or second-trimester positive cfDNA test opted for diagnostic testing with either chorionic villus sampling or amniocentesis. If patients had a known karyotype, most were in agreement with the trisomy or sex-chromosome aneuploidies that had been picked up by cfDNA testing.
There were a small number of false-positive cfDNA results seen in the California data, Dr. Currier noted. Performance was best for Down syndrome, where cfDNA had a positive predictive value of 98.6%. Here, 214 of the 611 cfDNA positive results received diagnostic confirmation. Of those, 197 were true positives and 3 were false positives, while a karyotype other than trisomy 21 was revealed in 14 cases. Positive predictive values were lower in the less-common aneuploidies, he said.
A small number of test failures also occurred. Of the 148 failures reported, just 40 were followed by successful repeat tests.
“Cell-free DNA is a good second-tier screening test, but it does have false-positive and false-negative results, so pre- and post-test counseling addressing these limitations are essential,” Dr. Currier said.
Nancy Rose, MD, agrees with that assessment of the limitations of the cfDNA test. She helped write the American College of Obstetricians and Gynecologists 2015 opinion on cell-free DNA screening for aneuploidy, which states that conventional screening methods “remain the most appropriate choice for first-line screening for most women in the general obstetric population.”
While it is “perfectly reasonable” for general ob.gyns. to offer cfDNA screening, in her practice, “genetic counselors call out all the results for general providers because patients don’t really understand what a screen negative result is,” Dr. Rose said in an interview. “Certainly, screen positive results should go to a genetic counselor for sure.”
However, that level of follow-up may be hard to implement. “One issue that we’re all facing right now is that genetic counselors are a scarce commodity because of the competition with them working for labs or insurance companies,” said Dr. Rose, a maternal-fetal medicine specialist in Salt Lake City.
If the lack of appropriate counseling is an issue, are patients sometimes jumping the gun? The immediate past president of the Society for Maternal-Fetal Medicine, Mary Norton, MD, said maybe so.
When asked whether she thinks pregnancies are being terminated on the basis of cfDNA results alone, Dr. Norton said, “I absolutely think that is happening. How many is hard to know. I do know that we have many patients that we see who say, ‘My result here says that the chance of Down syndrome is greater than 99%,’ but that is not what that number means, and people don’t understand that.”
She added, “In some cases there are also ultrasound abnormalities, but there is no question that there is misunderstanding leading to the loss of normal fetuses.”
Patient misunderstandings about what’s entailed in first- and second-line screening tests persist, said Dr. Norton, professor of obstetrics and gynecology and reproductive sciences at the University of California, San Francisco. One example is ongoing hesitancy about amniocentesis. “Amnio has become very, very safe,” she said. “It’s much safer than it used to be. The miscarriage rate is nearly nonexistent.”
The care team needs to work to find time to educate patients about both older technologies and noninvasive prenatal testing (NIPT), Dr. Rose and Dr. Norton stressed.
“Even though ‘NIPT’ is easy to say – it rolls off the tongue – we really shouldn’t call it that. It’s misleading, because all of the other screening tests are noninvasive too,” Dr. Norton said. “I’ve had many patients who declined diagnostic testing, even though they want as much information as possible about what they should do.”
Dr. Rose added, “It’s a screening test; it’s not perfect. But screening tests are really what obstetricians do. They do pap smears; they do breast exams. So I think that isn’t the issue so much as that there is no time in an obstetrician’s office to really educate women about what they are accepting.”
Additional ethical issues revolving around the mother may arise in rare cases. Only about 10% of the DNA sampled is fetal, meaning that the rest is maternal DNA, Dr. Norton explained. “And they’re not separated,” she said. “So, the issue that is coming up is that they are finding things in the mother that are unanticipated, and women aren’t told that ahead of time.”
Some of these thorny – and still evolving – legal and ethical questions were addressed during a workshop at the 2017 Pregnancy Meeting. A working group that met there is developing a summary of their discussion for future publication.
For Dr. Rose, the larger issue is the lack of coordinated data collection and quality initiatives. She pointed out that the California outcomes study may not be generalizable to most of the rest of the country because most states don’t have such a coordinated public health approach to prenatal testing and data collection.
This reality is hampering knowledge advancement in the field, she said. When she was asked about terminations on the basis of cfDNA alone, Dr. Rose said, “Because there’s no outcome data on these patients, because there are no unbiased studies that cross through these companies, we actually don’t really know that on a national level. There are no unbiased outcome data. There may be small studies, but I think there are no national data to answer that question at the moment.”
Overall, Dr. Rose said that cfDNA screening is fairly reliable. “This is no different than what has been done before with serum analyte screening, and it’s probably a little bit better,” she said. “My feeling is the tragedy is really in the lack of companies either being able to work together or to have some unbiased funding so you could really actually know what test performance means.”
Dr. Norton reported receiving research funding from Natera and Ultragenyx. Dr. Rose reported no relevant disclosures. Dr. Currier’s study was funded by the California Department of Public Health, where he is employed.
[email protected]
On Twitter @karioakes
A recent California study examining cell-free DNA (cfDNA) testing suggests that the test generally performs well as a second-line screen for fetal aneuploidy. However, while the test itself is reliable, some physicians say gaps in patient education, limited availability of genetic counseling, and a lack of coordinated research and data collection are all standing in the way of its optimal utilization.
In some of the most recent data presented on cfDNA test performance, researchers in California found that the test had few false positives and was best at predicting Down syndrome, with a positive predictive value of 98.6%.
California offers prenatal screening as a public health program, with a structured system of screening tests and follow-up services, according to Dr. Currier, who is chief of the evaluation section of the state’s Genetic Disease Screening Program. First trimester screening includes screens for trisomies 18 and 21. During the second trimester, the screening adds on checks for neural tube defects and Smith-Lemli-Opitz syndrome, also known as 7-dehydrocholesterol reductase deficiency.
Overall, 20,852 patients were offered cfDNA screening during this period, and 63% (n = 12,960) went on to have the screen. Dr. Currier and his colleagues found that about a third of patients with a first- or second-trimester positive cfDNA test opted for diagnostic testing with either chorionic villus sampling or amniocentesis. If patients had a known karyotype, most were in agreement with the trisomy or sex-chromosome aneuploidies that had been picked up by cfDNA testing.
There were a small number of false-positive cfDNA results seen in the California data, Dr. Currier noted. Performance was best for Down syndrome, where cfDNA had a positive predictive value of 98.6%. Here, 214 of the 611 cfDNA positive results received diagnostic confirmation. Of those, 197 were true positives and 3 were false positives, while a karyotype other than trisomy 21 was revealed in 14 cases. Positive predictive values were lower in the less-common aneuploidies, he said.
A small number of test failures also occurred. Of the 148 failures reported, just 40 were followed by successful repeat tests.
“Cell-free DNA is a good second-tier screening test, but it does have false-positive and false-negative results, so pre- and post-test counseling addressing these limitations are essential,” Dr. Currier said.
Nancy Rose, MD, agrees with that assessment of the limitations of the cfDNA test. She helped write the American College of Obstetricians and Gynecologists 2015 opinion on cell-free DNA screening for aneuploidy, which states that conventional screening methods “remain the most appropriate choice for first-line screening for most women in the general obstetric population.”
While it is “perfectly reasonable” for general ob.gyns. to offer cfDNA screening, in her practice, “genetic counselors call out all the results for general providers because patients don’t really understand what a screen negative result is,” Dr. Rose said in an interview. “Certainly, screen positive results should go to a genetic counselor for sure.”
However, that level of follow-up may be hard to implement. “One issue that we’re all facing right now is that genetic counselors are a scarce commodity because of the competition with them working for labs or insurance companies,” said Dr. Rose, a maternal-fetal medicine specialist in Salt Lake City.
If the lack of appropriate counseling is an issue, are patients sometimes jumping the gun? The immediate past president of the Society for Maternal-Fetal Medicine, Mary Norton, MD, said maybe so.
When asked whether she thinks pregnancies are being terminated on the basis of cfDNA results alone, Dr. Norton said, “I absolutely think that is happening. How many is hard to know. I do know that we have many patients that we see who say, ‘My result here says that the chance of Down syndrome is greater than 99%,’ but that is not what that number means, and people don’t understand that.”
She added, “In some cases there are also ultrasound abnormalities, but there is no question that there is misunderstanding leading to the loss of normal fetuses.”
Patient misunderstandings about what’s entailed in first- and second-line screening tests persist, said Dr. Norton, professor of obstetrics and gynecology and reproductive sciences at the University of California, San Francisco. One example is ongoing hesitancy about amniocentesis. “Amnio has become very, very safe,” she said. “It’s much safer than it used to be. The miscarriage rate is nearly nonexistent.”
The care team needs to work to find time to educate patients about both older technologies and noninvasive prenatal testing (NIPT), Dr. Rose and Dr. Norton stressed.
“Even though ‘NIPT’ is easy to say – it rolls off the tongue – we really shouldn’t call it that. It’s misleading, because all of the other screening tests are noninvasive too,” Dr. Norton said. “I’ve had many patients who declined diagnostic testing, even though they want as much information as possible about what they should do.”
Dr. Rose added, “It’s a screening test; it’s not perfect. But screening tests are really what obstetricians do. They do pap smears; they do breast exams. So I think that isn’t the issue so much as that there is no time in an obstetrician’s office to really educate women about what they are accepting.”
Additional ethical issues revolving around the mother may arise in rare cases. Only about 10% of the DNA sampled is fetal, meaning that the rest is maternal DNA, Dr. Norton explained. “And they’re not separated,” she said. “So, the issue that is coming up is that they are finding things in the mother that are unanticipated, and women aren’t told that ahead of time.”
Some of these thorny – and still evolving – legal and ethical questions were addressed during a workshop at the 2017 Pregnancy Meeting. A working group that met there is developing a summary of their discussion for future publication.
For Dr. Rose, the larger issue is the lack of coordinated data collection and quality initiatives. She pointed out that the California outcomes study may not be generalizable to most of the rest of the country because most states don’t have such a coordinated public health approach to prenatal testing and data collection.
This reality is hampering knowledge advancement in the field, she said. When she was asked about terminations on the basis of cfDNA alone, Dr. Rose said, “Because there’s no outcome data on these patients, because there are no unbiased studies that cross through these companies, we actually don’t really know that on a national level. There are no unbiased outcome data. There may be small studies, but I think there are no national data to answer that question at the moment.”
Overall, Dr. Rose said that cfDNA screening is fairly reliable. “This is no different than what has been done before with serum analyte screening, and it’s probably a little bit better,” she said. “My feeling is the tragedy is really in the lack of companies either being able to work together or to have some unbiased funding so you could really actually know what test performance means.”
Dr. Norton reported receiving research funding from Natera and Ultragenyx. Dr. Rose reported no relevant disclosures. Dr. Currier’s study was funded by the California Department of Public Health, where he is employed.
[email protected]
On Twitter @karioakes
A recent California study examining cell-free DNA (cfDNA) testing suggests that the test generally performs well as a second-line screen for fetal aneuploidy. However, while the test itself is reliable, some physicians say gaps in patient education, limited availability of genetic counseling, and a lack of coordinated research and data collection are all standing in the way of its optimal utilization.
In some of the most recent data presented on cfDNA test performance, researchers in California found that the test had few false positives and was best at predicting Down syndrome, with a positive predictive value of 98.6%.
California offers prenatal screening as a public health program, with a structured system of screening tests and follow-up services, according to Dr. Currier, who is chief of the evaluation section of the state’s Genetic Disease Screening Program. First trimester screening includes screens for trisomies 18 and 21. During the second trimester, the screening adds on checks for neural tube defects and Smith-Lemli-Opitz syndrome, also known as 7-dehydrocholesterol reductase deficiency.
Overall, 20,852 patients were offered cfDNA screening during this period, and 63% (n = 12,960) went on to have the screen. Dr. Currier and his colleagues found that about a third of patients with a first- or second-trimester positive cfDNA test opted for diagnostic testing with either chorionic villus sampling or amniocentesis. If patients had a known karyotype, most were in agreement with the trisomy or sex-chromosome aneuploidies that had been picked up by cfDNA testing.
There were a small number of false-positive cfDNA results seen in the California data, Dr. Currier noted. Performance was best for Down syndrome, where cfDNA had a positive predictive value of 98.6%. Here, 214 of the 611 cfDNA positive results received diagnostic confirmation. Of those, 197 were true positives and 3 were false positives, while a karyotype other than trisomy 21 was revealed in 14 cases. Positive predictive values were lower in the less-common aneuploidies, he said.
A small number of test failures also occurred. Of the 148 failures reported, just 40 were followed by successful repeat tests.
“Cell-free DNA is a good second-tier screening test, but it does have false-positive and false-negative results, so pre- and post-test counseling addressing these limitations are essential,” Dr. Currier said.
Nancy Rose, MD, agrees with that assessment of the limitations of the cfDNA test. She helped write the American College of Obstetricians and Gynecologists 2015 opinion on cell-free DNA screening for aneuploidy, which states that conventional screening methods “remain the most appropriate choice for first-line screening for most women in the general obstetric population.”
While it is “perfectly reasonable” for general ob.gyns. to offer cfDNA screening, in her practice, “genetic counselors call out all the results for general providers because patients don’t really understand what a screen negative result is,” Dr. Rose said in an interview. “Certainly, screen positive results should go to a genetic counselor for sure.”
However, that level of follow-up may be hard to implement. “One issue that we’re all facing right now is that genetic counselors are a scarce commodity because of the competition with them working for labs or insurance companies,” said Dr. Rose, a maternal-fetal medicine specialist in Salt Lake City.
If the lack of appropriate counseling is an issue, are patients sometimes jumping the gun? The immediate past president of the Society for Maternal-Fetal Medicine, Mary Norton, MD, said maybe so.
When asked whether she thinks pregnancies are being terminated on the basis of cfDNA results alone, Dr. Norton said, “I absolutely think that is happening. How many is hard to know. I do know that we have many patients that we see who say, ‘My result here says that the chance of Down syndrome is greater than 99%,’ but that is not what that number means, and people don’t understand that.”
She added, “In some cases there are also ultrasound abnormalities, but there is no question that there is misunderstanding leading to the loss of normal fetuses.”
Patient misunderstandings about what’s entailed in first- and second-line screening tests persist, said Dr. Norton, professor of obstetrics and gynecology and reproductive sciences at the University of California, San Francisco. One example is ongoing hesitancy about amniocentesis. “Amnio has become very, very safe,” she said. “It’s much safer than it used to be. The miscarriage rate is nearly nonexistent.”
The care team needs to work to find time to educate patients about both older technologies and noninvasive prenatal testing (NIPT), Dr. Rose and Dr. Norton stressed.
“Even though ‘NIPT’ is easy to say – it rolls off the tongue – we really shouldn’t call it that. It’s misleading, because all of the other screening tests are noninvasive too,” Dr. Norton said. “I’ve had many patients who declined diagnostic testing, even though they want as much information as possible about what they should do.”
Dr. Rose added, “It’s a screening test; it’s not perfect. But screening tests are really what obstetricians do. They do pap smears; they do breast exams. So I think that isn’t the issue so much as that there is no time in an obstetrician’s office to really educate women about what they are accepting.”
Additional ethical issues revolving around the mother may arise in rare cases. Only about 10% of the DNA sampled is fetal, meaning that the rest is maternal DNA, Dr. Norton explained. “And they’re not separated,” she said. “So, the issue that is coming up is that they are finding things in the mother that are unanticipated, and women aren’t told that ahead of time.”
Some of these thorny – and still evolving – legal and ethical questions were addressed during a workshop at the 2017 Pregnancy Meeting. A working group that met there is developing a summary of their discussion for future publication.
For Dr. Rose, the larger issue is the lack of coordinated data collection and quality initiatives. She pointed out that the California outcomes study may not be generalizable to most of the rest of the country because most states don’t have such a coordinated public health approach to prenatal testing and data collection.
This reality is hampering knowledge advancement in the field, she said. When she was asked about terminations on the basis of cfDNA alone, Dr. Rose said, “Because there’s no outcome data on these patients, because there are no unbiased studies that cross through these companies, we actually don’t really know that on a national level. There are no unbiased outcome data. There may be small studies, but I think there are no national data to answer that question at the moment.”
Overall, Dr. Rose said that cfDNA screening is fairly reliable. “This is no different than what has been done before with serum analyte screening, and it’s probably a little bit better,” she said. “My feeling is the tragedy is really in the lack of companies either being able to work together or to have some unbiased funding so you could really actually know what test performance means.”
Dr. Norton reported receiving research funding from Natera and Ultragenyx. Dr. Rose reported no relevant disclosures. Dr. Currier’s study was funded by the California Department of Public Health, where he is employed.
[email protected]
On Twitter @karioakes
FROM THE PREGNANCY MEETING
Cervicovaginal microbiota correlates with preterm birth rate
LAS VEGAS – Certain cervicovaginal microbiota predispose women to spontaneous preterm birth, according to a new study, while other microbiota were found to be protective against preterm delivery.
The findings stand in contrast to previous clinical trials that “targeted uterine activity and/or uterine infection,” said Michal Elovitz, MD, the first author of a study presented at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
To answer the question, Dr. Elovitz and her colleagues conducted a large prospective cohort and validation study, testing the hypothesis that cervicovaginal microbial communities in women “destined to have a preterm birth” would differ from those of control patients.
The Motherhood and the Microbiome study enrolled 1,500 women aged 13-50 years with singleton pregnancies to constitute the prospective cohort. Cervicovaginal swabs were obtained at three time points: at gestational weeks 16-20, 20-24, and 24-28. Dr. Elovitz, professor of ob.gyn. at the University of Pennsylvania, Philadelphia, was the study adjudicator for determining preterm births.
Within the prospective cohort, Dr. Elovitz and her collaborators identified 83 cases of spontaneous preterm birth (SPTB), and frequency matched them by race to 336 patients who had term deliveries in a 4:1 ratio. The cervicovaginal microbiota of these patients was characterized by performing 165 rRNA gene analyses. Once the bacterial composition and structure had been identified, the investigators then calculated the effect of cervicovaginal bacterial composition on the risk of SPTB by using the log ratio between the mean relative abundance of a given phylotype for the SPTB, compared with the term birth samples.
A second prospective cohort of 616 women was formed for validation; cervicovaginal specimens in this cohort were collected between 22 and 32 weeks of gestation.
Taking both cohorts together, a total of 127 phylotypes were found in all samples. A total of 13 bacterial species were positively associated with an increased risk of spontaneous preterm birth in the primary cohort; 37 species were significantly associated with a decreased risk of spontaneous preterm birth.
“Bifidobacterium species were noted to be significantly protective against SPTB at all gestational time points,” wrote Dr. Elovitz and her collaborators in the abstract accompanying the presentation. On the other hand, they wrote, “BVAB2, BVAB3, and Mobiluncus were associated with a dramatic increase[d] risk of SPTB (all q-values less than 0.0001).”
Abundant Mobiluncus mulieris, in particular, was associated with significantly increased risk of SPTB at all time points during the study. The odds ratio for SPTB with a positive mobiluncus swab at visit one was 9.21.
Since the study examined both relative and absolute abundance of individual bacterial species, the investigators were able to determine that when Bifidobacterium breve was present, the incidence of BVAB3-associated preterm birth dropped from more than 30% to less than 10% (P = .006).
The notion that specific cervicovaginal bacterial species can be associated with increased rate of SPTB represents a different finding than most previous work in this field, said Dr. Elovitz, adding that much of the research on the vaginal microbiome during the reproductive years has focused on groupings of predominant bacteria, termed community state types (CSTs). “Classification of communities into CST, as performed in the nonpregnant woman, is not revealing for PTB,” Dr. Elovitz said.
Future research into cervicovaginal microbial communities and spontaneous preterm birth are likely to produce new methods to risk-stratify women and potential new therapeutics to reduce the rate of spontaneous preterm birth, she added.
The presentation won the conference’s March of Dimes award for best abstract in prematurity.
Dr. Elovitz reported having no relevant financial disclosures.
[email protected]
On Twitter @karioakes
LAS VEGAS – Certain cervicovaginal microbiota predispose women to spontaneous preterm birth, according to a new study, while other microbiota were found to be protective against preterm delivery.
The findings stand in contrast to previous clinical trials that “targeted uterine activity and/or uterine infection,” said Michal Elovitz, MD, the first author of a study presented at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
To answer the question, Dr. Elovitz and her colleagues conducted a large prospective cohort and validation study, testing the hypothesis that cervicovaginal microbial communities in women “destined to have a preterm birth” would differ from those of control patients.
The Motherhood and the Microbiome study enrolled 1,500 women aged 13-50 years with singleton pregnancies to constitute the prospective cohort. Cervicovaginal swabs were obtained at three time points: at gestational weeks 16-20, 20-24, and 24-28. Dr. Elovitz, professor of ob.gyn. at the University of Pennsylvania, Philadelphia, was the study adjudicator for determining preterm births.
Within the prospective cohort, Dr. Elovitz and her collaborators identified 83 cases of spontaneous preterm birth (SPTB), and frequency matched them by race to 336 patients who had term deliveries in a 4:1 ratio. The cervicovaginal microbiota of these patients was characterized by performing 165 rRNA gene analyses. Once the bacterial composition and structure had been identified, the investigators then calculated the effect of cervicovaginal bacterial composition on the risk of SPTB by using the log ratio between the mean relative abundance of a given phylotype for the SPTB, compared with the term birth samples.
A second prospective cohort of 616 women was formed for validation; cervicovaginal specimens in this cohort were collected between 22 and 32 weeks of gestation.
Taking both cohorts together, a total of 127 phylotypes were found in all samples. A total of 13 bacterial species were positively associated with an increased risk of spontaneous preterm birth in the primary cohort; 37 species were significantly associated with a decreased risk of spontaneous preterm birth.
“Bifidobacterium species were noted to be significantly protective against SPTB at all gestational time points,” wrote Dr. Elovitz and her collaborators in the abstract accompanying the presentation. On the other hand, they wrote, “BVAB2, BVAB3, and Mobiluncus were associated with a dramatic increase[d] risk of SPTB (all q-values less than 0.0001).”
Abundant Mobiluncus mulieris, in particular, was associated with significantly increased risk of SPTB at all time points during the study. The odds ratio for SPTB with a positive mobiluncus swab at visit one was 9.21.
Since the study examined both relative and absolute abundance of individual bacterial species, the investigators were able to determine that when Bifidobacterium breve was present, the incidence of BVAB3-associated preterm birth dropped from more than 30% to less than 10% (P = .006).
The notion that specific cervicovaginal bacterial species can be associated with increased rate of SPTB represents a different finding than most previous work in this field, said Dr. Elovitz, adding that much of the research on the vaginal microbiome during the reproductive years has focused on groupings of predominant bacteria, termed community state types (CSTs). “Classification of communities into CST, as performed in the nonpregnant woman, is not revealing for PTB,” Dr. Elovitz said.
Future research into cervicovaginal microbial communities and spontaneous preterm birth are likely to produce new methods to risk-stratify women and potential new therapeutics to reduce the rate of spontaneous preterm birth, she added.
The presentation won the conference’s March of Dimes award for best abstract in prematurity.
Dr. Elovitz reported having no relevant financial disclosures.
[email protected]
On Twitter @karioakes
LAS VEGAS – Certain cervicovaginal microbiota predispose women to spontaneous preterm birth, according to a new study, while other microbiota were found to be protective against preterm delivery.
The findings stand in contrast to previous clinical trials that “targeted uterine activity and/or uterine infection,” said Michal Elovitz, MD, the first author of a study presented at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
To answer the question, Dr. Elovitz and her colleagues conducted a large prospective cohort and validation study, testing the hypothesis that cervicovaginal microbial communities in women “destined to have a preterm birth” would differ from those of control patients.
The Motherhood and the Microbiome study enrolled 1,500 women aged 13-50 years with singleton pregnancies to constitute the prospective cohort. Cervicovaginal swabs were obtained at three time points: at gestational weeks 16-20, 20-24, and 24-28. Dr. Elovitz, professor of ob.gyn. at the University of Pennsylvania, Philadelphia, was the study adjudicator for determining preterm births.
Within the prospective cohort, Dr. Elovitz and her collaborators identified 83 cases of spontaneous preterm birth (SPTB), and frequency matched them by race to 336 patients who had term deliveries in a 4:1 ratio. The cervicovaginal microbiota of these patients was characterized by performing 165 rRNA gene analyses. Once the bacterial composition and structure had been identified, the investigators then calculated the effect of cervicovaginal bacterial composition on the risk of SPTB by using the log ratio between the mean relative abundance of a given phylotype for the SPTB, compared with the term birth samples.
A second prospective cohort of 616 women was formed for validation; cervicovaginal specimens in this cohort were collected between 22 and 32 weeks of gestation.
Taking both cohorts together, a total of 127 phylotypes were found in all samples. A total of 13 bacterial species were positively associated with an increased risk of spontaneous preterm birth in the primary cohort; 37 species were significantly associated with a decreased risk of spontaneous preterm birth.
“Bifidobacterium species were noted to be significantly protective against SPTB at all gestational time points,” wrote Dr. Elovitz and her collaborators in the abstract accompanying the presentation. On the other hand, they wrote, “BVAB2, BVAB3, and Mobiluncus were associated with a dramatic increase[d] risk of SPTB (all q-values less than 0.0001).”
Abundant Mobiluncus mulieris, in particular, was associated with significantly increased risk of SPTB at all time points during the study. The odds ratio for SPTB with a positive mobiluncus swab at visit one was 9.21.
Since the study examined both relative and absolute abundance of individual bacterial species, the investigators were able to determine that when Bifidobacterium breve was present, the incidence of BVAB3-associated preterm birth dropped from more than 30% to less than 10% (P = .006).
The notion that specific cervicovaginal bacterial species can be associated with increased rate of SPTB represents a different finding than most previous work in this field, said Dr. Elovitz, adding that much of the research on the vaginal microbiome during the reproductive years has focused on groupings of predominant bacteria, termed community state types (CSTs). “Classification of communities into CST, as performed in the nonpregnant woman, is not revealing for PTB,” Dr. Elovitz said.
Future research into cervicovaginal microbial communities and spontaneous preterm birth are likely to produce new methods to risk-stratify women and potential new therapeutics to reduce the rate of spontaneous preterm birth, she added.
The presentation won the conference’s March of Dimes award for best abstract in prematurity.
Dr. Elovitz reported having no relevant financial disclosures.
[email protected]
On Twitter @karioakes
AT THE PREGNANCY MEETING
Key clinical point:
Major finding: Mobiluncus mulieris in the cervicovaginal space was associated with an odds ratio of 9.21 for spontaneous preterm birth.
Data source: Nested case-control study of 83 cases of spontaneous preterm birth matched with 336 term deliveries, drawn from 1,500 patients participating in the National Institute of Nursing Research–sponsored Motherhood and Microbiome study.
Disclosures: Dr. Elovitz reported having no relevant financial disclosures.
Antihypertensive protocol cuts eclampsia rates
LAS VEGAS – A multisite trial that implemented a protocol for use of intravenous hydralazine or labetalol together with magnesium sulfate for critically high blood pressures in pregnancy saw maternal eclampsia rates fall by 46% and severe maternal morbidity fall by 17%, as the protocol compliance rate rose to almost 90% of deliveries by study’s end.
Hypertensive disorders of pregnancy (HDP) are seen in up to 10% of all births and are collectively a major cause of severe maternal morbidity, according to Laurence E. Shields, MD, a perinatologist at Marian Regional Medical Center, Santa Maria, Calif. Eclampsia, seen as a complication of HDP, can have a set of disastrous maternal neurologic, cognitive, and cardiac sequelae, he added.
Recently, both state and national guidelines have called for more attention to and aggressive treatment of critically elevated blood pressure in pregnant women, Dr. Shields said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
As part of a global pregnancy complications assessment and treatment algorithm termed the Maternal Early Warning Tool (MEWT), Dignity Health, which owns Dr. Shields’ home institution, put in place a protocol to manage hypertension in pregnancy.
For pregnant women with sustained blood pressures greater than 160 mm Hg systolic and/or 110 mm Hg diastolic, the protocol calls for intravenous hydralazine or labetalol together with magnesium sulfate. The protocol also calls for “appropriate labs” to be ordered, and permits oral medication if the patient does not have intravenous access.
These steps were taken regardless of the type of hypertension the patient had, Dr. Shields said. Patients with HDP who were treated with antihypertensives were also scheduled for postpartum follow-up within 7 days of delivery.
Originally, the MEWT trial had included a total of 29 perinatal centers, 6 of which instituted the blood pressure management protocol (“trial hospitals”). Dr. Shields said that for the present study, “we wanted to determine if we could replicate the reduction in the rate of eclampsia that we noted in the 6 MEWT trial sites after initiating similar hypertension treatment recommendations in the 23 non-MEWT sites.” He and his colleagues also wanted to determine whether using the hypertension protocol would reduce severe maternal morbidity.
Compliance with the three metrics of antihypertensive administration and magnesium sulfate administration for critical blood pressure elevations and early follow-up was assessed with an “all or none” judgment.
The study was broken into three broad phases. First, recommendations were distributed to all hospitals without monitoring compliance. Eight months later, the researchers conducted a retrospective assessment of institutional compliance with the protocol. They also monitored eclampsia rates and the incidence of severe maternal mortality, using Centers for Disease Control and Prevention (CDC) criteria. Finally, after 6 months of retrospective monitoring, a prospective assessment of compliance, rates of eclampsia, and incidence of severe maternal mortality was conducted, and the results were compared with the preintervention figures.
For data analysis, protocol compliance was assessed as a primary outcome measure, but also broken down so investigators could track rates of appropriate blood pressure medication administration and appropriate treatment with magnesium sulfate. Eclampsia and severe maternal morbidity rates were the other two outcome measures.
Delivery volume at the hospitals ranged from 150 to 5,000 per year. Hispanic patients made up 42% of the study population; white and Asian patients each made up 23%; 7% were African American, and the remainder identified as “other.”
Over the study period, compliance with all three metrics rose from a baseline of 50.5%, to a midpoint rate of 73.4%, to a final rate of 88.5%. The number of deliveries was approximately the same in all time periods.
There was an overall 10.5% increase in magnesium sulfate use, with the proportion of patients being appropriately treated with magnesium sulfate rising from 85.4% at baseline to 96.2% by the end of the trial (P less than .01).
Significantly more patients were appropriately treated with blood pressure medications by the trial’s end as well; just 56.9% of patients received appropriate hypertensive medication at baseline, but that grew to 90.1% by study’s end (P less than .01). This represented a 33.2% increase in the appropriate use of antihypertensives, Dr. Shields said.
Labetalol use increased from 44% of patients treated at baseline to 64% by the end of the study (P less than .01). Hydralazine use decreased from 39% to 26% (P less than .01), and fewer oral agents were used by the end of the study (17% compared with 10%; P less than .02).
This shift was accompanied by a decrease in eclampsia rates, with overall rates per 1,000 births decreasing from 1.15 to 0.62 by the end of the study (–46%; P = .02). Severe maternal morbidity also fell from 2.4 per 100 births to 2.0 per 1,000 patients (–16.8%; P less than .01).
About 40% of the reduction in eclampsia rates could be attributed to the improved magnesium sulfate administration rates, Dr. Shields said. “This finding would suggest that the combination of blood pressure treatment and magnesium sulfate produced a synergistic effect on the reduction of eclampsia.”
“Compliance with state and national recommendations for treatment of critically elevated blood pressures is poor without monitoring,” Dr. Shields said. But with education and monitoring, physician and nurse behavior can be modified in a relatively short time period, he said.
Dr. Shields did not report financial disclosure information.
[email protected]
On Twitter @karioakes
LAS VEGAS – A multisite trial that implemented a protocol for use of intravenous hydralazine or labetalol together with magnesium sulfate for critically high blood pressures in pregnancy saw maternal eclampsia rates fall by 46% and severe maternal morbidity fall by 17%, as the protocol compliance rate rose to almost 90% of deliveries by study’s end.
Hypertensive disorders of pregnancy (HDP) are seen in up to 10% of all births and are collectively a major cause of severe maternal morbidity, according to Laurence E. Shields, MD, a perinatologist at Marian Regional Medical Center, Santa Maria, Calif. Eclampsia, seen as a complication of HDP, can have a set of disastrous maternal neurologic, cognitive, and cardiac sequelae, he added.
Recently, both state and national guidelines have called for more attention to and aggressive treatment of critically elevated blood pressure in pregnant women, Dr. Shields said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
As part of a global pregnancy complications assessment and treatment algorithm termed the Maternal Early Warning Tool (MEWT), Dignity Health, which owns Dr. Shields’ home institution, put in place a protocol to manage hypertension in pregnancy.
For pregnant women with sustained blood pressures greater than 160 mm Hg systolic and/or 110 mm Hg diastolic, the protocol calls for intravenous hydralazine or labetalol together with magnesium sulfate. The protocol also calls for “appropriate labs” to be ordered, and permits oral medication if the patient does not have intravenous access.
These steps were taken regardless of the type of hypertension the patient had, Dr. Shields said. Patients with HDP who were treated with antihypertensives were also scheduled for postpartum follow-up within 7 days of delivery.
Originally, the MEWT trial had included a total of 29 perinatal centers, 6 of which instituted the blood pressure management protocol (“trial hospitals”). Dr. Shields said that for the present study, “we wanted to determine if we could replicate the reduction in the rate of eclampsia that we noted in the 6 MEWT trial sites after initiating similar hypertension treatment recommendations in the 23 non-MEWT sites.” He and his colleagues also wanted to determine whether using the hypertension protocol would reduce severe maternal morbidity.
Compliance with the three metrics of antihypertensive administration and magnesium sulfate administration for critical blood pressure elevations and early follow-up was assessed with an “all or none” judgment.
The study was broken into three broad phases. First, recommendations were distributed to all hospitals without monitoring compliance. Eight months later, the researchers conducted a retrospective assessment of institutional compliance with the protocol. They also monitored eclampsia rates and the incidence of severe maternal mortality, using Centers for Disease Control and Prevention (CDC) criteria. Finally, after 6 months of retrospective monitoring, a prospective assessment of compliance, rates of eclampsia, and incidence of severe maternal mortality was conducted, and the results were compared with the preintervention figures.
For data analysis, protocol compliance was assessed as a primary outcome measure, but also broken down so investigators could track rates of appropriate blood pressure medication administration and appropriate treatment with magnesium sulfate. Eclampsia and severe maternal morbidity rates were the other two outcome measures.
Delivery volume at the hospitals ranged from 150 to 5,000 per year. Hispanic patients made up 42% of the study population; white and Asian patients each made up 23%; 7% were African American, and the remainder identified as “other.”
Over the study period, compliance with all three metrics rose from a baseline of 50.5%, to a midpoint rate of 73.4%, to a final rate of 88.5%. The number of deliveries was approximately the same in all time periods.
There was an overall 10.5% increase in magnesium sulfate use, with the proportion of patients being appropriately treated with magnesium sulfate rising from 85.4% at baseline to 96.2% by the end of the trial (P less than .01).
Significantly more patients were appropriately treated with blood pressure medications by the trial’s end as well; just 56.9% of patients received appropriate hypertensive medication at baseline, but that grew to 90.1% by study’s end (P less than .01). This represented a 33.2% increase in the appropriate use of antihypertensives, Dr. Shields said.
Labetalol use increased from 44% of patients treated at baseline to 64% by the end of the study (P less than .01). Hydralazine use decreased from 39% to 26% (P less than .01), and fewer oral agents were used by the end of the study (17% compared with 10%; P less than .02).
This shift was accompanied by a decrease in eclampsia rates, with overall rates per 1,000 births decreasing from 1.15 to 0.62 by the end of the study (–46%; P = .02). Severe maternal morbidity also fell from 2.4 per 100 births to 2.0 per 1,000 patients (–16.8%; P less than .01).
About 40% of the reduction in eclampsia rates could be attributed to the improved magnesium sulfate administration rates, Dr. Shields said. “This finding would suggest that the combination of blood pressure treatment and magnesium sulfate produced a synergistic effect on the reduction of eclampsia.”
“Compliance with state and national recommendations for treatment of critically elevated blood pressures is poor without monitoring,” Dr. Shields said. But with education and monitoring, physician and nurse behavior can be modified in a relatively short time period, he said.
Dr. Shields did not report financial disclosure information.
[email protected]
On Twitter @karioakes
LAS VEGAS – A multisite trial that implemented a protocol for use of intravenous hydralazine or labetalol together with magnesium sulfate for critically high blood pressures in pregnancy saw maternal eclampsia rates fall by 46% and severe maternal morbidity fall by 17%, as the protocol compliance rate rose to almost 90% of deliveries by study’s end.
Hypertensive disorders of pregnancy (HDP) are seen in up to 10% of all births and are collectively a major cause of severe maternal morbidity, according to Laurence E. Shields, MD, a perinatologist at Marian Regional Medical Center, Santa Maria, Calif. Eclampsia, seen as a complication of HDP, can have a set of disastrous maternal neurologic, cognitive, and cardiac sequelae, he added.
Recently, both state and national guidelines have called for more attention to and aggressive treatment of critically elevated blood pressure in pregnant women, Dr. Shields said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
As part of a global pregnancy complications assessment and treatment algorithm termed the Maternal Early Warning Tool (MEWT), Dignity Health, which owns Dr. Shields’ home institution, put in place a protocol to manage hypertension in pregnancy.
For pregnant women with sustained blood pressures greater than 160 mm Hg systolic and/or 110 mm Hg diastolic, the protocol calls for intravenous hydralazine or labetalol together with magnesium sulfate. The protocol also calls for “appropriate labs” to be ordered, and permits oral medication if the patient does not have intravenous access.
These steps were taken regardless of the type of hypertension the patient had, Dr. Shields said. Patients with HDP who were treated with antihypertensives were also scheduled for postpartum follow-up within 7 days of delivery.
Originally, the MEWT trial had included a total of 29 perinatal centers, 6 of which instituted the blood pressure management protocol (“trial hospitals”). Dr. Shields said that for the present study, “we wanted to determine if we could replicate the reduction in the rate of eclampsia that we noted in the 6 MEWT trial sites after initiating similar hypertension treatment recommendations in the 23 non-MEWT sites.” He and his colleagues also wanted to determine whether using the hypertension protocol would reduce severe maternal morbidity.
Compliance with the three metrics of antihypertensive administration and magnesium sulfate administration for critical blood pressure elevations and early follow-up was assessed with an “all or none” judgment.
The study was broken into three broad phases. First, recommendations were distributed to all hospitals without monitoring compliance. Eight months later, the researchers conducted a retrospective assessment of institutional compliance with the protocol. They also monitored eclampsia rates and the incidence of severe maternal mortality, using Centers for Disease Control and Prevention (CDC) criteria. Finally, after 6 months of retrospective monitoring, a prospective assessment of compliance, rates of eclampsia, and incidence of severe maternal mortality was conducted, and the results were compared with the preintervention figures.
For data analysis, protocol compliance was assessed as a primary outcome measure, but also broken down so investigators could track rates of appropriate blood pressure medication administration and appropriate treatment with magnesium sulfate. Eclampsia and severe maternal morbidity rates were the other two outcome measures.
Delivery volume at the hospitals ranged from 150 to 5,000 per year. Hispanic patients made up 42% of the study population; white and Asian patients each made up 23%; 7% were African American, and the remainder identified as “other.”
Over the study period, compliance with all three metrics rose from a baseline of 50.5%, to a midpoint rate of 73.4%, to a final rate of 88.5%. The number of deliveries was approximately the same in all time periods.
There was an overall 10.5% increase in magnesium sulfate use, with the proportion of patients being appropriately treated with magnesium sulfate rising from 85.4% at baseline to 96.2% by the end of the trial (P less than .01).
Significantly more patients were appropriately treated with blood pressure medications by the trial’s end as well; just 56.9% of patients received appropriate hypertensive medication at baseline, but that grew to 90.1% by study’s end (P less than .01). This represented a 33.2% increase in the appropriate use of antihypertensives, Dr. Shields said.
Labetalol use increased from 44% of patients treated at baseline to 64% by the end of the study (P less than .01). Hydralazine use decreased from 39% to 26% (P less than .01), and fewer oral agents were used by the end of the study (17% compared with 10%; P less than .02).
This shift was accompanied by a decrease in eclampsia rates, with overall rates per 1,000 births decreasing from 1.15 to 0.62 by the end of the study (–46%; P = .02). Severe maternal morbidity also fell from 2.4 per 100 births to 2.0 per 1,000 patients (–16.8%; P less than .01).
About 40% of the reduction in eclampsia rates could be attributed to the improved magnesium sulfate administration rates, Dr. Shields said. “This finding would suggest that the combination of blood pressure treatment and magnesium sulfate produced a synergistic effect on the reduction of eclampsia.”
“Compliance with state and national recommendations for treatment of critically elevated blood pressures is poor without monitoring,” Dr. Shields said. But with education and monitoring, physician and nurse behavior can be modified in a relatively short time period, he said.
Dr. Shields did not report financial disclosure information.
[email protected]
On Twitter @karioakes
Key clinical point:
Major finding: Maternal eclampsia rates fell by 46% after the protocol was instituted (P = .02).
Data source: Prospective study of 29 perinatal centers in a single health care system.
Disclosures: Dr. Shields did not report financial disclosure information.
Monofilament suture works best for cesarean closure
LAS VEGAS – A monofilament suture led to substantially fewer wound complications than a braided suture for closing nonemergency cesarean incisions in a head-to-head trial with 520 evaluable women.
Cesarean incision closure with a braided, polyglactin 910 suture (Vicryl) led to 65% more wound complications than the monofilament poliglecaprone 25 suture (Monocryl), Arin M. Buresch, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
This is the first randomized, controlled trial to compare these two suture types, according to Dr. Buresch, and she highlighted the need for caution about changing practice based on results from a single study. But based in large part on these results, which were gathered at Montefiore Medical Center in New York, the obstetrical staff at Montefiore is now primarily using the monofilament, poliglecaprone 25 suture, she said.
The study enrolled 550 pregnant women at 37 weeks’ gestation or greater during May 2015 to July 2016. Participants were either scheduled for an elective cesarean delivery or underwent a nonemergency, indicated cesarean after labor began but without significant maternal or fetal distress. The study excluded emergency cesareans as well as women with a recent urogenital infection, chronic or injected steroid use, or a vertical skin incision. The enrolled women averaged 31 years old, and their average body mass index was 34 kg/m2. The demographic and clinical profile of the two randomized groups closely matched.
The study’s primary endpoint was the incidence of a wound complication during 30 days following delivery. A complication could be a surgical site infection, hematoma, seroma, or wound separation. Of the 550 women randomized, 520 were available for complete 30-day follow-up.
The results showed that wound complications occurred in 9% of the 263 women treated with the poliglecaprone 25 monofilament suture and in 14% of the 257 treated with the polyglactin 910 braided suture, a statistically significant difference, Dr. Buresch reported. The relative risk for a complication increased by 65% with the braided suture, compared with patients treated with monofilament sutures. Treating 18 patients with the monofilament suture prevented one wound complication, on average.
A subgroup analysis showed that the poliglecaprone 25 suture was effective at reducing wound complications in women who underwent elective cesarean deliveries, but among the 17% of participants who had begun labor at the time of their cesarean delivery the monofilament suture conferred no significant advantage, compared with the braided suture. Benefit from the poliglecaprone 25 monofilament occurred about equally across the entire range of body mass index among the women in the study, Dr. Buresch said.
Dr. Buresch had no disclosures.
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – A monofilament suture led to substantially fewer wound complications than a braided suture for closing nonemergency cesarean incisions in a head-to-head trial with 520 evaluable women.
Cesarean incision closure with a braided, polyglactin 910 suture (Vicryl) led to 65% more wound complications than the monofilament poliglecaprone 25 suture (Monocryl), Arin M. Buresch, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
This is the first randomized, controlled trial to compare these two suture types, according to Dr. Buresch, and she highlighted the need for caution about changing practice based on results from a single study. But based in large part on these results, which were gathered at Montefiore Medical Center in New York, the obstetrical staff at Montefiore is now primarily using the monofilament, poliglecaprone 25 suture, she said.
The study enrolled 550 pregnant women at 37 weeks’ gestation or greater during May 2015 to July 2016. Participants were either scheduled for an elective cesarean delivery or underwent a nonemergency, indicated cesarean after labor began but without significant maternal or fetal distress. The study excluded emergency cesareans as well as women with a recent urogenital infection, chronic or injected steroid use, or a vertical skin incision. The enrolled women averaged 31 years old, and their average body mass index was 34 kg/m2. The demographic and clinical profile of the two randomized groups closely matched.
The study’s primary endpoint was the incidence of a wound complication during 30 days following delivery. A complication could be a surgical site infection, hematoma, seroma, or wound separation. Of the 550 women randomized, 520 were available for complete 30-day follow-up.
The results showed that wound complications occurred in 9% of the 263 women treated with the poliglecaprone 25 monofilament suture and in 14% of the 257 treated with the polyglactin 910 braided suture, a statistically significant difference, Dr. Buresch reported. The relative risk for a complication increased by 65% with the braided suture, compared with patients treated with monofilament sutures. Treating 18 patients with the monofilament suture prevented one wound complication, on average.
A subgroup analysis showed that the poliglecaprone 25 suture was effective at reducing wound complications in women who underwent elective cesarean deliveries, but among the 17% of participants who had begun labor at the time of their cesarean delivery the monofilament suture conferred no significant advantage, compared with the braided suture. Benefit from the poliglecaprone 25 monofilament occurred about equally across the entire range of body mass index among the women in the study, Dr. Buresch said.
Dr. Buresch had no disclosures.
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – A monofilament suture led to substantially fewer wound complications than a braided suture for closing nonemergency cesarean incisions in a head-to-head trial with 520 evaluable women.
Cesarean incision closure with a braided, polyglactin 910 suture (Vicryl) led to 65% more wound complications than the monofilament poliglecaprone 25 suture (Monocryl), Arin M. Buresch, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
This is the first randomized, controlled trial to compare these two suture types, according to Dr. Buresch, and she highlighted the need for caution about changing practice based on results from a single study. But based in large part on these results, which were gathered at Montefiore Medical Center in New York, the obstetrical staff at Montefiore is now primarily using the monofilament, poliglecaprone 25 suture, she said.
The study enrolled 550 pregnant women at 37 weeks’ gestation or greater during May 2015 to July 2016. Participants were either scheduled for an elective cesarean delivery or underwent a nonemergency, indicated cesarean after labor began but without significant maternal or fetal distress. The study excluded emergency cesareans as well as women with a recent urogenital infection, chronic or injected steroid use, or a vertical skin incision. The enrolled women averaged 31 years old, and their average body mass index was 34 kg/m2. The demographic and clinical profile of the two randomized groups closely matched.
The study’s primary endpoint was the incidence of a wound complication during 30 days following delivery. A complication could be a surgical site infection, hematoma, seroma, or wound separation. Of the 550 women randomized, 520 were available for complete 30-day follow-up.
The results showed that wound complications occurred in 9% of the 263 women treated with the poliglecaprone 25 monofilament suture and in 14% of the 257 treated with the polyglactin 910 braided suture, a statistically significant difference, Dr. Buresch reported. The relative risk for a complication increased by 65% with the braided suture, compared with patients treated with monofilament sutures. Treating 18 patients with the monofilament suture prevented one wound complication, on average.
A subgroup analysis showed that the poliglecaprone 25 suture was effective at reducing wound complications in women who underwent elective cesarean deliveries, but among the 17% of participants who had begun labor at the time of their cesarean delivery the monofilament suture conferred no significant advantage, compared with the braided suture. Benefit from the poliglecaprone 25 monofilament occurred about equally across the entire range of body mass index among the women in the study, Dr. Buresch said.
Dr. Buresch had no disclosures.
[email protected]
On Twitter @mitchelzoler
Early delivery by morbidly obese moms improves outcomes
LAS VEGAS – Delivery at 38 weeks’ gestation is linked with improved perinatal survival among singleton infants born to morbidly obese mothers in a retrospective review of more than 2 million U.S. births.
“If reasonable, consider delivery at 38 weeks in morbidly obese mothers” delivering singleton pregnancies, Ruofan Yao, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
When mothers have diabetes, hypertension, or cholestasis, they receive frequent prenatal testing and fetal growth measurements, and delivery is typically at 37, 38, or 39 weeks. “This is what we also need to think about for morbidly obese mothers,” Dr. Yao said.
“Because of increased fetal growth in morbidly obese mothers there is probably earlier placental insufficiency,” he said in an interview.
The upshot is that, once a morbidly obese mother reaches 38 weeks’ gestation, induced labor should be considered, according to Dr. Yao. Induction could start immediately if the mother’s cervix is ripe, or clinicians could first take steps to hasten cervical ripening.
Induction can be especially slow in morbidly obese women, who are generally less sensitive to oxytocin and can require multiple induction strategies.
While Dr. Yao considered the evidence he reported persuasive enough to recommend this strategy, he cautioned that, ideally, the benefits of an early-delivery approach should be confirmed in a prospective, randomized trial.
The study used delivery records maintained by the state of Texas for 2006-2011. Of the more than 2.4 million births recorded during the period, Dr. Yao excluded multiple deliveries, births at less than 34 weeks’ or more than 42 weeks’ gestation, deliveries from underweight mothers (less than 18.5 kg/m2), and fetal anomalies. This left 2,181,530 births, of which 52% were by normal weight mothers (18.5-24 kg/m2), 26% by overweight mothers (25-29 kg/m2), 18% by obese mothers (30-39 kg/m2), and 4% by morbidly obese mothers (40 kg/m2 or greater). The women averaged 27 years old, 4% had preeclampsia, and 4% had pregestational diabetes.
The researchers then calculated perinatal mortality rates relative to gestational age at birth for women in each body mass index stratum. The calculations showed no significant impact of gestational age among late-term deliveries by normal weight, overweight, and obese mothers, but, among morbidly obese mothers, early deliveries made a difference and were significantly linked with reduced perinatal mortality.
Every 400 deliveries, approximately, induced at 38 weeks among morbidly obese mothers resulted in one less perinatal death, Dr. Yao reported. This relationship held even when the researchers excluded mothers with preeclampsia or pregestational diabetes (about 8% of the study group).
Dr. Yao had no disclosures.
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – Delivery at 38 weeks’ gestation is linked with improved perinatal survival among singleton infants born to morbidly obese mothers in a retrospective review of more than 2 million U.S. births.
“If reasonable, consider delivery at 38 weeks in morbidly obese mothers” delivering singleton pregnancies, Ruofan Yao, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
When mothers have diabetes, hypertension, or cholestasis, they receive frequent prenatal testing and fetal growth measurements, and delivery is typically at 37, 38, or 39 weeks. “This is what we also need to think about for morbidly obese mothers,” Dr. Yao said.
“Because of increased fetal growth in morbidly obese mothers there is probably earlier placental insufficiency,” he said in an interview.
The upshot is that, once a morbidly obese mother reaches 38 weeks’ gestation, induced labor should be considered, according to Dr. Yao. Induction could start immediately if the mother’s cervix is ripe, or clinicians could first take steps to hasten cervical ripening.
Induction can be especially slow in morbidly obese women, who are generally less sensitive to oxytocin and can require multiple induction strategies.
While Dr. Yao considered the evidence he reported persuasive enough to recommend this strategy, he cautioned that, ideally, the benefits of an early-delivery approach should be confirmed in a prospective, randomized trial.
The study used delivery records maintained by the state of Texas for 2006-2011. Of the more than 2.4 million births recorded during the period, Dr. Yao excluded multiple deliveries, births at less than 34 weeks’ or more than 42 weeks’ gestation, deliveries from underweight mothers (less than 18.5 kg/m2), and fetal anomalies. This left 2,181,530 births, of which 52% were by normal weight mothers (18.5-24 kg/m2), 26% by overweight mothers (25-29 kg/m2), 18% by obese mothers (30-39 kg/m2), and 4% by morbidly obese mothers (40 kg/m2 or greater). The women averaged 27 years old, 4% had preeclampsia, and 4% had pregestational diabetes.
The researchers then calculated perinatal mortality rates relative to gestational age at birth for women in each body mass index stratum. The calculations showed no significant impact of gestational age among late-term deliveries by normal weight, overweight, and obese mothers, but, among morbidly obese mothers, early deliveries made a difference and were significantly linked with reduced perinatal mortality.
Every 400 deliveries, approximately, induced at 38 weeks among morbidly obese mothers resulted in one less perinatal death, Dr. Yao reported. This relationship held even when the researchers excluded mothers with preeclampsia or pregestational diabetes (about 8% of the study group).
Dr. Yao had no disclosures.
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – Delivery at 38 weeks’ gestation is linked with improved perinatal survival among singleton infants born to morbidly obese mothers in a retrospective review of more than 2 million U.S. births.
“If reasonable, consider delivery at 38 weeks in morbidly obese mothers” delivering singleton pregnancies, Ruofan Yao, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
When mothers have diabetes, hypertension, or cholestasis, they receive frequent prenatal testing and fetal growth measurements, and delivery is typically at 37, 38, or 39 weeks. “This is what we also need to think about for morbidly obese mothers,” Dr. Yao said.
“Because of increased fetal growth in morbidly obese mothers there is probably earlier placental insufficiency,” he said in an interview.
The upshot is that, once a morbidly obese mother reaches 38 weeks’ gestation, induced labor should be considered, according to Dr. Yao. Induction could start immediately if the mother’s cervix is ripe, or clinicians could first take steps to hasten cervical ripening.
Induction can be especially slow in morbidly obese women, who are generally less sensitive to oxytocin and can require multiple induction strategies.
While Dr. Yao considered the evidence he reported persuasive enough to recommend this strategy, he cautioned that, ideally, the benefits of an early-delivery approach should be confirmed in a prospective, randomized trial.
The study used delivery records maintained by the state of Texas for 2006-2011. Of the more than 2.4 million births recorded during the period, Dr. Yao excluded multiple deliveries, births at less than 34 weeks’ or more than 42 weeks’ gestation, deliveries from underweight mothers (less than 18.5 kg/m2), and fetal anomalies. This left 2,181,530 births, of which 52% were by normal weight mothers (18.5-24 kg/m2), 26% by overweight mothers (25-29 kg/m2), 18% by obese mothers (30-39 kg/m2), and 4% by morbidly obese mothers (40 kg/m2 or greater). The women averaged 27 years old, 4% had preeclampsia, and 4% had pregestational diabetes.
The researchers then calculated perinatal mortality rates relative to gestational age at birth for women in each body mass index stratum. The calculations showed no significant impact of gestational age among late-term deliveries by normal weight, overweight, and obese mothers, but, among morbidly obese mothers, early deliveries made a difference and were significantly linked with reduced perinatal mortality.
Every 400 deliveries, approximately, induced at 38 weeks among morbidly obese mothers resulted in one less perinatal death, Dr. Yao reported. This relationship held even when the researchers excluded mothers with preeclampsia or pregestational diabetes (about 8% of the study group).
Dr. Yao had no disclosures.
[email protected]
On Twitter @mitchelzoler
AT THE PREGNANCY MEETING
Key clinical point:
Major finding: Every 400 deliveries at 38 weeks is linked with one fewer perinatal death, compared with full-term deliveries.
Data source: Review of 2,181,530 Texas births during 2006-2011.
Disclosures: Dr. Yao had no disclosures.
Term ultrasound shown unreliable for diagnosing macrosomia
LAS VEGAS – Fetal macrosomia can be challenging to detect by ultrasound performed just before delivery, which had 41% sensitivity and 58% positive predictive value in a prospective study of more than 2,300 pregnancies.
The results also showed that fetal macrosomia (defined as birth weight of more than 4,000 grams) is significantly linked with increased rates of prolonged labor, delivery by either operative vaginal or cesarean approaches, and postpartum hemorrhage, Daniel M. Galvin, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Because all clinicians involved with these deliveries were blinded to the prenatal ultrasound results, the findings suggest that prolonged labor, postpartum hemorrhage, and need for either operative vaginal delivery or cesarean delivery are all outcomes driven by macrosomia itself rather than by clinical actions taken because of an expectation of macrosomia, said Dr. Galvin, an ob.gyn. with Perinatal Ireland, a Dublin-based consortium of eight Irish fetal medicine centers that is examining ways to improve delivery outcomes.
The study used “a pure population of pregnancies with unsuspected fetal macrosomia,” he explained.
Dr. Galvin and his colleagues used data collected in GENESIS, a prospective study run by the Perinatal Ireland multicenter consortium with the primary goal of determining whether late-pregnancy fetal head circumference can predict labor dystocia and intrapartum cesarean delivery. They examined two secondary outcomes: the reliability of ultrasound to estimate fetal size, and the consequences of fetal macrosomia when it is not recognized until delivery is already underway.
The study enrolled 2,336 nulliparous women with singleton pregnancies that ranged from the start of 39 weeks’ gestational age through the end of 40 weeks. The women underwent a standard ultrasound examination to assess fetal biometrics. The study excluded pregnancies with an estimated fetal size greater than 5,000 g. Mothers carrying a fetus estimated to be less than 4,000 g constituted 88% of the study group, with 12% carrying pregnancies with an estimated fetal weight greater than 4,000 g.
The ultrasound examination worked reasonably well for ruling out macrosomia, with an 89% rate of correctly identifying fetuses with a birth weight of less than 4,000 g. Near-term ultrasound was less useful for a positive identification of macrosomia; it flagged 58% of the fetuses born heavier than 4,000 g.
Analysis of delivery mode showed that infants born weighing more than 4,000 g had a statistically significant 56% reduced rate of spontaneous vaginal deliveries compared with smaller neonates, a 63% greater rate of cesarean deliveries, and a 49% greater rate of operative vaginal deliveries, compared with small babies, Dr. Galvin reported. All three between-group differences were statistically significant.
The analysis also showed that compared with the smaller babies, the larger neonates were twice as likely to be born during prolonged labor of more than 12 hours. Delivery of larger neonates was also twice as likely to trigger postpartum hemorrhage. But deliveries of larger babies had no significant link with increased rates of neonatal intensive care admissions, anal sphincter injuries, shoulder dystocias or birth injuries, compared with deliveries of smaller babies.
Dr. Galvin reported having no financial disclosures.
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – Fetal macrosomia can be challenging to detect by ultrasound performed just before delivery, which had 41% sensitivity and 58% positive predictive value in a prospective study of more than 2,300 pregnancies.
The results also showed that fetal macrosomia (defined as birth weight of more than 4,000 grams) is significantly linked with increased rates of prolonged labor, delivery by either operative vaginal or cesarean approaches, and postpartum hemorrhage, Daniel M. Galvin, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Because all clinicians involved with these deliveries were blinded to the prenatal ultrasound results, the findings suggest that prolonged labor, postpartum hemorrhage, and need for either operative vaginal delivery or cesarean delivery are all outcomes driven by macrosomia itself rather than by clinical actions taken because of an expectation of macrosomia, said Dr. Galvin, an ob.gyn. with Perinatal Ireland, a Dublin-based consortium of eight Irish fetal medicine centers that is examining ways to improve delivery outcomes.
The study used “a pure population of pregnancies with unsuspected fetal macrosomia,” he explained.
Dr. Galvin and his colleagues used data collected in GENESIS, a prospective study run by the Perinatal Ireland multicenter consortium with the primary goal of determining whether late-pregnancy fetal head circumference can predict labor dystocia and intrapartum cesarean delivery. They examined two secondary outcomes: the reliability of ultrasound to estimate fetal size, and the consequences of fetal macrosomia when it is not recognized until delivery is already underway.
The study enrolled 2,336 nulliparous women with singleton pregnancies that ranged from the start of 39 weeks’ gestational age through the end of 40 weeks. The women underwent a standard ultrasound examination to assess fetal biometrics. The study excluded pregnancies with an estimated fetal size greater than 5,000 g. Mothers carrying a fetus estimated to be less than 4,000 g constituted 88% of the study group, with 12% carrying pregnancies with an estimated fetal weight greater than 4,000 g.
The ultrasound examination worked reasonably well for ruling out macrosomia, with an 89% rate of correctly identifying fetuses with a birth weight of less than 4,000 g. Near-term ultrasound was less useful for a positive identification of macrosomia; it flagged 58% of the fetuses born heavier than 4,000 g.
Analysis of delivery mode showed that infants born weighing more than 4,000 g had a statistically significant 56% reduced rate of spontaneous vaginal deliveries compared with smaller neonates, a 63% greater rate of cesarean deliveries, and a 49% greater rate of operative vaginal deliveries, compared with small babies, Dr. Galvin reported. All three between-group differences were statistically significant.
The analysis also showed that compared with the smaller babies, the larger neonates were twice as likely to be born during prolonged labor of more than 12 hours. Delivery of larger neonates was also twice as likely to trigger postpartum hemorrhage. But deliveries of larger babies had no significant link with increased rates of neonatal intensive care admissions, anal sphincter injuries, shoulder dystocias or birth injuries, compared with deliveries of smaller babies.
Dr. Galvin reported having no financial disclosures.
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – Fetal macrosomia can be challenging to detect by ultrasound performed just before delivery, which had 41% sensitivity and 58% positive predictive value in a prospective study of more than 2,300 pregnancies.
The results also showed that fetal macrosomia (defined as birth weight of more than 4,000 grams) is significantly linked with increased rates of prolonged labor, delivery by either operative vaginal or cesarean approaches, and postpartum hemorrhage, Daniel M. Galvin, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Because all clinicians involved with these deliveries were blinded to the prenatal ultrasound results, the findings suggest that prolonged labor, postpartum hemorrhage, and need for either operative vaginal delivery or cesarean delivery are all outcomes driven by macrosomia itself rather than by clinical actions taken because of an expectation of macrosomia, said Dr. Galvin, an ob.gyn. with Perinatal Ireland, a Dublin-based consortium of eight Irish fetal medicine centers that is examining ways to improve delivery outcomes.
The study used “a pure population of pregnancies with unsuspected fetal macrosomia,” he explained.
Dr. Galvin and his colleagues used data collected in GENESIS, a prospective study run by the Perinatal Ireland multicenter consortium with the primary goal of determining whether late-pregnancy fetal head circumference can predict labor dystocia and intrapartum cesarean delivery. They examined two secondary outcomes: the reliability of ultrasound to estimate fetal size, and the consequences of fetal macrosomia when it is not recognized until delivery is already underway.
The study enrolled 2,336 nulliparous women with singleton pregnancies that ranged from the start of 39 weeks’ gestational age through the end of 40 weeks. The women underwent a standard ultrasound examination to assess fetal biometrics. The study excluded pregnancies with an estimated fetal size greater than 5,000 g. Mothers carrying a fetus estimated to be less than 4,000 g constituted 88% of the study group, with 12% carrying pregnancies with an estimated fetal weight greater than 4,000 g.
The ultrasound examination worked reasonably well for ruling out macrosomia, with an 89% rate of correctly identifying fetuses with a birth weight of less than 4,000 g. Near-term ultrasound was less useful for a positive identification of macrosomia; it flagged 58% of the fetuses born heavier than 4,000 g.
Analysis of delivery mode showed that infants born weighing more than 4,000 g had a statistically significant 56% reduced rate of spontaneous vaginal deliveries compared with smaller neonates, a 63% greater rate of cesarean deliveries, and a 49% greater rate of operative vaginal deliveries, compared with small babies, Dr. Galvin reported. All three between-group differences were statistically significant.
The analysis also showed that compared with the smaller babies, the larger neonates were twice as likely to be born during prolonged labor of more than 12 hours. Delivery of larger neonates was also twice as likely to trigger postpartum hemorrhage. But deliveries of larger babies had no significant link with increased rates of neonatal intensive care admissions, anal sphincter injuries, shoulder dystocias or birth injuries, compared with deliveries of smaller babies.
Dr. Galvin reported having no financial disclosures.
[email protected]
On Twitter @mitchelzoler
AT THE PREGNANCY MEETING
Key clinical point:
Major finding: Near-term ultrasound identified 58% of fetuses born weighing more than 4,000 g.
Data source: Prospective, multicenter study of 2,336 singleton pregnancies.
Disclosures: Dr. Galvin reported having no financial disclosures.
Pregnancy medical home reduces hospital visits, overall costs
LAS VEGAS – Women and their newborns who received care through a pregnancy medical home model used the emergency department less and had fewer inpatient stays, resulting in significant cost savings to a state health insurance plan.
In the single-center, retrospective cohort study, women who had at least one medical home visit had 897 emergency department visits per 1,000 member months, compared with 1,969/1,000 member months for patients who had no medical home visits (P less than .01). Newborns in the medical home group had fewer inpatient days per 1,000 member months as well, compared with non–medical home infants (698 vs. 1,799 days/member month, P less than .01). Inpatient stays for pregnant women receiving medical home care were also reduced (4,279 vs. 2,939 inpatient days, P less than .01).
The pregnancy medical home project was conducted jointly by the Texas Children’s Health Plan and Baylor College of Medicine. The care delivery model, offered from the Baylor Center for Children and Women, gave pregnant women enhanced access, used evidence-based protocols for treatment, and emphasized both quality care and the patient experience, said Dr. Suhag, professor of ob.gyn. at Baylor College of Medicine, Houston.
The pregnancy medical home includes extended hours, walk-in appointments, 24-hour nurse availability for triage, and a laborist model for hospital coverage.
From a payment perspective, the medical home is a fully capitated, full-risk model. “Our center is paid on a monthly basis to provide care to members of our panel,” Dr. Suhag said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
The primary outcomes measured by the study were the number of inpatient days and the rate of emergency department usage among pregnancy medical home participants, compared with nonparticipating pregnant women and newborns seen at the Center for Children and Women. Annualized cost savings for the pregnancy medical home model was a secondary outcome measure.
Over a 1-year period, the study examined claims data for pregnant women and newborns who were enrolled in the Texas Children’s Health Plan and were assigned to the pregnancy medical home panel. In total, 27,912 member months (including care for both women and newborns) were examined; of these, about 37% (10,402) were for women and newborns who had at least one medical home visit, and 63% (17,510) of the member months accrued to patients who had no medical home visits. Women and their infants were excluded from the cohort if they received care billed to another health plan.
Participation in the medical home group resulted in lower costs, with annualized estimated emergency department cost savings of $330,161 and $30,739 for pregnant women and newborns, respectively. The reduced number of inpatient days in the medical home group resulted in a total savings of $494,313 for pregnant women and $1,606,392 for newborns in this cohort.
The integrated care model, which used a care coordinator and provided care from multiple specialties at a single site, was likely the key to success, Dr. Suhag said. “With this access, 40% of our pregnant moms were able to access prenatal care in the first trimester, which likely improved outcomes and contributed to the cost savings,” she said.
The control group in the study was made up of individuals who had been randomized to the medical home, but who had chosen care from another provider instead. Because the researchers were relying on health claims data, they were not able to perform a detailed comparison between the two groups, leaving open the possibility that patient characteristics may have accounted for part of the differences in outcomes. Women “could self-select to receive care at the Center for Children and Women,” Dr. Suhag said in an interview. “It is possible that they are different than the women who did not choose care in our clinic.”
A strength of the study, Dr. Suhag said, is that it evaluated outcomes from the medical home model by comparing it to several other medical practices caring for a similar demographic in the same geographic area.
The study was conducted by the Texas Children’s Health Plan and Baylor College of Medicine. Dr. Suhag reported having no other outside sources of funding or conflicts of interest.
Dr. Suhag reported having no outside sources of funding beyond the study’s two sponsoring organizations and no conflicts of interest.
[email protected]
On Twitter @karioakes
LAS VEGAS – Women and their newborns who received care through a pregnancy medical home model used the emergency department less and had fewer inpatient stays, resulting in significant cost savings to a state health insurance plan.
In the single-center, retrospective cohort study, women who had at least one medical home visit had 897 emergency department visits per 1,000 member months, compared with 1,969/1,000 member months for patients who had no medical home visits (P less than .01). Newborns in the medical home group had fewer inpatient days per 1,000 member months as well, compared with non–medical home infants (698 vs. 1,799 days/member month, P less than .01). Inpatient stays for pregnant women receiving medical home care were also reduced (4,279 vs. 2,939 inpatient days, P less than .01).
The pregnancy medical home project was conducted jointly by the Texas Children’s Health Plan and Baylor College of Medicine. The care delivery model, offered from the Baylor Center for Children and Women, gave pregnant women enhanced access, used evidence-based protocols for treatment, and emphasized both quality care and the patient experience, said Dr. Suhag, professor of ob.gyn. at Baylor College of Medicine, Houston.
The pregnancy medical home includes extended hours, walk-in appointments, 24-hour nurse availability for triage, and a laborist model for hospital coverage.
From a payment perspective, the medical home is a fully capitated, full-risk model. “Our center is paid on a monthly basis to provide care to members of our panel,” Dr. Suhag said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
The primary outcomes measured by the study were the number of inpatient days and the rate of emergency department usage among pregnancy medical home participants, compared with nonparticipating pregnant women and newborns seen at the Center for Children and Women. Annualized cost savings for the pregnancy medical home model was a secondary outcome measure.
Over a 1-year period, the study examined claims data for pregnant women and newborns who were enrolled in the Texas Children’s Health Plan and were assigned to the pregnancy medical home panel. In total, 27,912 member months (including care for both women and newborns) were examined; of these, about 37% (10,402) were for women and newborns who had at least one medical home visit, and 63% (17,510) of the member months accrued to patients who had no medical home visits. Women and their infants were excluded from the cohort if they received care billed to another health plan.
Participation in the medical home group resulted in lower costs, with annualized estimated emergency department cost savings of $330,161 and $30,739 for pregnant women and newborns, respectively. The reduced number of inpatient days in the medical home group resulted in a total savings of $494,313 for pregnant women and $1,606,392 for newborns in this cohort.
The integrated care model, which used a care coordinator and provided care from multiple specialties at a single site, was likely the key to success, Dr. Suhag said. “With this access, 40% of our pregnant moms were able to access prenatal care in the first trimester, which likely improved outcomes and contributed to the cost savings,” she said.
The control group in the study was made up of individuals who had been randomized to the medical home, but who had chosen care from another provider instead. Because the researchers were relying on health claims data, they were not able to perform a detailed comparison between the two groups, leaving open the possibility that patient characteristics may have accounted for part of the differences in outcomes. Women “could self-select to receive care at the Center for Children and Women,” Dr. Suhag said in an interview. “It is possible that they are different than the women who did not choose care in our clinic.”
A strength of the study, Dr. Suhag said, is that it evaluated outcomes from the medical home model by comparing it to several other medical practices caring for a similar demographic in the same geographic area.
The study was conducted by the Texas Children’s Health Plan and Baylor College of Medicine. Dr. Suhag reported having no other outside sources of funding or conflicts of interest.
Dr. Suhag reported having no outside sources of funding beyond the study’s two sponsoring organizations and no conflicts of interest.
[email protected]
On Twitter @karioakes
LAS VEGAS – Women and their newborns who received care through a pregnancy medical home model used the emergency department less and had fewer inpatient stays, resulting in significant cost savings to a state health insurance plan.
In the single-center, retrospective cohort study, women who had at least one medical home visit had 897 emergency department visits per 1,000 member months, compared with 1,969/1,000 member months for patients who had no medical home visits (P less than .01). Newborns in the medical home group had fewer inpatient days per 1,000 member months as well, compared with non–medical home infants (698 vs. 1,799 days/member month, P less than .01). Inpatient stays for pregnant women receiving medical home care were also reduced (4,279 vs. 2,939 inpatient days, P less than .01).
The pregnancy medical home project was conducted jointly by the Texas Children’s Health Plan and Baylor College of Medicine. The care delivery model, offered from the Baylor Center for Children and Women, gave pregnant women enhanced access, used evidence-based protocols for treatment, and emphasized both quality care and the patient experience, said Dr. Suhag, professor of ob.gyn. at Baylor College of Medicine, Houston.
The pregnancy medical home includes extended hours, walk-in appointments, 24-hour nurse availability for triage, and a laborist model for hospital coverage.
From a payment perspective, the medical home is a fully capitated, full-risk model. “Our center is paid on a monthly basis to provide care to members of our panel,” Dr. Suhag said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
The primary outcomes measured by the study were the number of inpatient days and the rate of emergency department usage among pregnancy medical home participants, compared with nonparticipating pregnant women and newborns seen at the Center for Children and Women. Annualized cost savings for the pregnancy medical home model was a secondary outcome measure.
Over a 1-year period, the study examined claims data for pregnant women and newborns who were enrolled in the Texas Children’s Health Plan and were assigned to the pregnancy medical home panel. In total, 27,912 member months (including care for both women and newborns) were examined; of these, about 37% (10,402) were for women and newborns who had at least one medical home visit, and 63% (17,510) of the member months accrued to patients who had no medical home visits. Women and their infants were excluded from the cohort if they received care billed to another health plan.
Participation in the medical home group resulted in lower costs, with annualized estimated emergency department cost savings of $330,161 and $30,739 for pregnant women and newborns, respectively. The reduced number of inpatient days in the medical home group resulted in a total savings of $494,313 for pregnant women and $1,606,392 for newborns in this cohort.
The integrated care model, which used a care coordinator and provided care from multiple specialties at a single site, was likely the key to success, Dr. Suhag said. “With this access, 40% of our pregnant moms were able to access prenatal care in the first trimester, which likely improved outcomes and contributed to the cost savings,” she said.
The control group in the study was made up of individuals who had been randomized to the medical home, but who had chosen care from another provider instead. Because the researchers were relying on health claims data, they were not able to perform a detailed comparison between the two groups, leaving open the possibility that patient characteristics may have accounted for part of the differences in outcomes. Women “could self-select to receive care at the Center for Children and Women,” Dr. Suhag said in an interview. “It is possible that they are different than the women who did not choose care in our clinic.”
A strength of the study, Dr. Suhag said, is that it evaluated outcomes from the medical home model by comparing it to several other medical practices caring for a similar demographic in the same geographic area.
The study was conducted by the Texas Children’s Health Plan and Baylor College of Medicine. Dr. Suhag reported having no other outside sources of funding or conflicts of interest.
Dr. Suhag reported having no outside sources of funding beyond the study’s two sponsoring organizations and no conflicts of interest.
[email protected]
On Twitter @karioakes
AT THE PREGNANCY MEETING
Key clinical point:
Major finding: Medical home patients had 897 emergency department visits, compared with 1,969 per 1,000 member months for non–medical home patients (P less than .01).
Data source: A retrospective cohort study of 27,912 patient member months comparing pregnancy medical home patients with non–medical home patients.
Disclosures: The study was conducted by the Texas Children’s Health Plan and Baylor College of Medicine. Dr. Suhag reported having no other outside sources of funding or conflicts of interest.
Weekend births linked to higher maternal-fetal mortality
LAS VEGAS – Weekend deliveries were associated with a significantly increased risk of maternal-fetal morbidity and death, according to a review of all U.S. deliveries over the past decade.
“Maternal morbidity and mortality were increased on weekends, compared to weekdays, and stillbirth and neonatal morbidity were also increased in infants delivered on weekends. Both of these findings occur against a background of lower intrinsic risk among weekend deliveries,” Amirhossein Moaddab, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Study objectives included measuring both maternal and fetal mortality ratios by the day and month of death or delivery; the study also tracked maternal and neonatal morbidities according to the day of the week the delivery occurred.
Using publicly available data sets (the National Vital Statistics System and the Centers for Disease Control and Prevention WONDER online database), Dr. Moaddab and his colleagues examined all live births and all maternal and fetal deaths in all 50 states and the District of Columbia for the period from 2004 to 2014.
In total, there were 45,036,622 live births, 7,551 maternal deaths, and 275,914 stillbirths during this period.
On weekdays, the maternal mortality rate was 15.3/100,000 live births; the rate rose to 22.8 maternal deaths per 100,000 live births on the weekends (P less than .001). Fetal mortality followed a similar pattern: The weekday fetal mortality rate was 5.85/1,000 live births, compared with 7.21/1,000 live births on the weekends (P less than .001).
A wide range of maternal and fetal morbidities were also more common when deliveries happened on the weekend. For mothers, the adjusted relative risk (aRR) ranged from 1.41 for maternal transfusion to 1.166 for perineal lacerations with Saturday or Sunday deliveries. Unplanned hysterectomy, however, was less likely on the weekend (aRR, 0.810).
Neonatal morbidities with a higher adjusted relative risk included gestational age less than 28 weeks (aRR, 1.481), a 5-minute Apgar score less than 7 (aRR, 1.251), and being placed on a ventilator or admitted to the neonatal intensive care unit (aRRs, 1.219 and 1.199, respectively). The odds of having a chromosomal abnormality were lower for infants delivered on weekends (aRR, 0.864), a result consistent with the increased likelihood of planned delivery for fetuses whose chromosomal status was known, said Dr. Moaddab, a postdoctoral fellow in obstetrics and gynecology at the Baylor College of Medicine, Houston .
Examining maternal characteristics, Dr. Moaddab and his colleagues did find some significant differences between those delivering on weekdays and weekends. However, because the weekend group was healthier overall than the weekday group, these differences were not likely to account for the worse weekend outcomes.
“We were able to control for pregnancy complications, and found that most women with pregnancy complications known to lead to death actually deliver on weekdays, suggesting that the total problem with weekend deliveries is even greater,” said Dr. Clark, professor of ob.gyn. at Baylor College of Medicine.
For example, women delivering on weekends were less likely to be smokers, have diabetes or gestational diabetes, or have chronic or gestational hypertension; they were also less likely to have had a previous cesarean delivery (all P equal to or less than .0001). They were, however, more likely to be nulliparous and to have eclampsia (P equal to or less than .0001).
Dr. Moaddab said that his group’s examination of monthly variations in maternal and fetal morbidity and mortality showed no sign of the “July phenomenon,” the worsening in outcomes seen in some specialties when new interns take to the wards and clinics.
The “weekend effect,” said Dr. Moaddab, has been documented elsewhere as well. In the United Kingdom, a recent observational study of obstetric outcomes found “increases in the rates of death and other complications for both women and babies born at weekends,” he said (BMJ. 2015;351:h5774).
Though Dr. Moaddab’s descriptive study couldn’t get at underlying causes, he said that there are many possible culprits. These can include the divided physician attention and reduced provider availability that can come with weekend staffing, as well as the possibility that the experience level of both physician and nurse staff drops on weekends. Long work hours that come with call may also contribute, he said.
The study authors reported no outside sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
LAS VEGAS – Weekend deliveries were associated with a significantly increased risk of maternal-fetal morbidity and death, according to a review of all U.S. deliveries over the past decade.
“Maternal morbidity and mortality were increased on weekends, compared to weekdays, and stillbirth and neonatal morbidity were also increased in infants delivered on weekends. Both of these findings occur against a background of lower intrinsic risk among weekend deliveries,” Amirhossein Moaddab, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Study objectives included measuring both maternal and fetal mortality ratios by the day and month of death or delivery; the study also tracked maternal and neonatal morbidities according to the day of the week the delivery occurred.
Using publicly available data sets (the National Vital Statistics System and the Centers for Disease Control and Prevention WONDER online database), Dr. Moaddab and his colleagues examined all live births and all maternal and fetal deaths in all 50 states and the District of Columbia for the period from 2004 to 2014.
In total, there were 45,036,622 live births, 7,551 maternal deaths, and 275,914 stillbirths during this period.
On weekdays, the maternal mortality rate was 15.3/100,000 live births; the rate rose to 22.8 maternal deaths per 100,000 live births on the weekends (P less than .001). Fetal mortality followed a similar pattern: The weekday fetal mortality rate was 5.85/1,000 live births, compared with 7.21/1,000 live births on the weekends (P less than .001).
A wide range of maternal and fetal morbidities were also more common when deliveries happened on the weekend. For mothers, the adjusted relative risk (aRR) ranged from 1.41 for maternal transfusion to 1.166 for perineal lacerations with Saturday or Sunday deliveries. Unplanned hysterectomy, however, was less likely on the weekend (aRR, 0.810).
Neonatal morbidities with a higher adjusted relative risk included gestational age less than 28 weeks (aRR, 1.481), a 5-minute Apgar score less than 7 (aRR, 1.251), and being placed on a ventilator or admitted to the neonatal intensive care unit (aRRs, 1.219 and 1.199, respectively). The odds of having a chromosomal abnormality were lower for infants delivered on weekends (aRR, 0.864), a result consistent with the increased likelihood of planned delivery for fetuses whose chromosomal status was known, said Dr. Moaddab, a postdoctoral fellow in obstetrics and gynecology at the Baylor College of Medicine, Houston .
Examining maternal characteristics, Dr. Moaddab and his colleagues did find some significant differences between those delivering on weekdays and weekends. However, because the weekend group was healthier overall than the weekday group, these differences were not likely to account for the worse weekend outcomes.
“We were able to control for pregnancy complications, and found that most women with pregnancy complications known to lead to death actually deliver on weekdays, suggesting that the total problem with weekend deliveries is even greater,” said Dr. Clark, professor of ob.gyn. at Baylor College of Medicine.
For example, women delivering on weekends were less likely to be smokers, have diabetes or gestational diabetes, or have chronic or gestational hypertension; they were also less likely to have had a previous cesarean delivery (all P equal to or less than .0001). They were, however, more likely to be nulliparous and to have eclampsia (P equal to or less than .0001).
Dr. Moaddab said that his group’s examination of monthly variations in maternal and fetal morbidity and mortality showed no sign of the “July phenomenon,” the worsening in outcomes seen in some specialties when new interns take to the wards and clinics.
The “weekend effect,” said Dr. Moaddab, has been documented elsewhere as well. In the United Kingdom, a recent observational study of obstetric outcomes found “increases in the rates of death and other complications for both women and babies born at weekends,” he said (BMJ. 2015;351:h5774).
Though Dr. Moaddab’s descriptive study couldn’t get at underlying causes, he said that there are many possible culprits. These can include the divided physician attention and reduced provider availability that can come with weekend staffing, as well as the possibility that the experience level of both physician and nurse staff drops on weekends. Long work hours that come with call may also contribute, he said.
The study authors reported no outside sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
LAS VEGAS – Weekend deliveries were associated with a significantly increased risk of maternal-fetal morbidity and death, according to a review of all U.S. deliveries over the past decade.
“Maternal morbidity and mortality were increased on weekends, compared to weekdays, and stillbirth and neonatal morbidity were also increased in infants delivered on weekends. Both of these findings occur against a background of lower intrinsic risk among weekend deliveries,” Amirhossein Moaddab, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Study objectives included measuring both maternal and fetal mortality ratios by the day and month of death or delivery; the study also tracked maternal and neonatal morbidities according to the day of the week the delivery occurred.
Using publicly available data sets (the National Vital Statistics System and the Centers for Disease Control and Prevention WONDER online database), Dr. Moaddab and his colleagues examined all live births and all maternal and fetal deaths in all 50 states and the District of Columbia for the period from 2004 to 2014.
In total, there were 45,036,622 live births, 7,551 maternal deaths, and 275,914 stillbirths during this period.
On weekdays, the maternal mortality rate was 15.3/100,000 live births; the rate rose to 22.8 maternal deaths per 100,000 live births on the weekends (P less than .001). Fetal mortality followed a similar pattern: The weekday fetal mortality rate was 5.85/1,000 live births, compared with 7.21/1,000 live births on the weekends (P less than .001).
A wide range of maternal and fetal morbidities were also more common when deliveries happened on the weekend. For mothers, the adjusted relative risk (aRR) ranged from 1.41 for maternal transfusion to 1.166 for perineal lacerations with Saturday or Sunday deliveries. Unplanned hysterectomy, however, was less likely on the weekend (aRR, 0.810).
Neonatal morbidities with a higher adjusted relative risk included gestational age less than 28 weeks (aRR, 1.481), a 5-minute Apgar score less than 7 (aRR, 1.251), and being placed on a ventilator or admitted to the neonatal intensive care unit (aRRs, 1.219 and 1.199, respectively). The odds of having a chromosomal abnormality were lower for infants delivered on weekends (aRR, 0.864), a result consistent with the increased likelihood of planned delivery for fetuses whose chromosomal status was known, said Dr. Moaddab, a postdoctoral fellow in obstetrics and gynecology at the Baylor College of Medicine, Houston .
Examining maternal characteristics, Dr. Moaddab and his colleagues did find some significant differences between those delivering on weekdays and weekends. However, because the weekend group was healthier overall than the weekday group, these differences were not likely to account for the worse weekend outcomes.
“We were able to control for pregnancy complications, and found that most women with pregnancy complications known to lead to death actually deliver on weekdays, suggesting that the total problem with weekend deliveries is even greater,” said Dr. Clark, professor of ob.gyn. at Baylor College of Medicine.
For example, women delivering on weekends were less likely to be smokers, have diabetes or gestational diabetes, or have chronic or gestational hypertension; they were also less likely to have had a previous cesarean delivery (all P equal to or less than .0001). They were, however, more likely to be nulliparous and to have eclampsia (P equal to or less than .0001).
Dr. Moaddab said that his group’s examination of monthly variations in maternal and fetal morbidity and mortality showed no sign of the “July phenomenon,” the worsening in outcomes seen in some specialties when new interns take to the wards and clinics.
The “weekend effect,” said Dr. Moaddab, has been documented elsewhere as well. In the United Kingdom, a recent observational study of obstetric outcomes found “increases in the rates of death and other complications for both women and babies born at weekends,” he said (BMJ. 2015;351:h5774).
Though Dr. Moaddab’s descriptive study couldn’t get at underlying causes, he said that there are many possible culprits. These can include the divided physician attention and reduced provider availability that can come with weekend staffing, as well as the possibility that the experience level of both physician and nurse staff drops on weekends. Long work hours that come with call may also contribute, he said.
The study authors reported no outside sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
AT THE PREGNANCY MEETING
Key clinical point:
Major finding: On weekends, the maternal death rate was 22.8/100,000 live births, compared with a weekday rate of 15.3/100,000 (P less than .001).
Data source: A retrospective study of U.S. publicly available maternal-fetal data, including 45,036,622 live births, 7,551 maternal deaths, and 275,914 stillbirths from 2004 to 2014.
Disclosures: The study authors reported no outside sources of funding and no conflicts of interest.
VIDEO: Dual antibiotic prophylaxis cuts cesarean SSIs
LAS VEGAS – Two days of prophylaxis with two oral antibiotics cut the surgical site infection rate by more than half in a randomized trial with more than 400 obese women who had cesarean deliveries.
The protective effect from combined treatment with cephalexin and metronidazole was especially powerful in the most at-risk patients, women with ruptured membranes before cesarean surgery. In this subgroup prophylaxis with the two antibiotics for 2 days cut surgical site infections (SSIs) during the 30 days after surgery, from a rate of 33% in control women who received placebo to a 10% rate, a 77% relative risk reduction that was statistically significant, Carri R. Warshak, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal and Fetal Medicine.
“I am very excited that we found a way to help the kinds of women in the study, very-high-risk women, with an effective way to reduce their risk of infection,” Dr. Warshak of the University of Cincinnati said in a video interview. The obese women enrolled in the study, especially those with ruptured membranes, “have a very high risk of morbidity, so it’s very exciting that we found a way to help prevent” SSIs.
“Our study is the first to target postpartum interventions to reduce SSIs specifically in this high-risk population” of obese mothers, said Amy M. Valent, DO, a maternal fetal medicine clinician at Oregon Health & Science University in Portland, who ran the trial with Dr. Warshak.
The trial randomized women with a body mass index of at least 30 kg/m2 who underwent a planned or unplanned cesarean delivery at the University of Cincinnati during 2010-2015. Following standard management during cesarean delivery, the women received either 500 mg oral cephalexin and 500 mg oral metronidazole or placebo every 8 hours for 48 hours following delivery. The primary outcome was the incidence of SSIs, and randomization was stratified so that similar numbers of women with ruptured membranes got into each treatment arm. The enrolled women averaged 28 years of age, and average BMI was about 40 kg/m2. Nearly a third of the women had ruptured membranes at the time of surgery, more than a quarter of the enrolled women used tobacco, and more than a fifth had preeclampsia.
Additional analyses reported at the meeting by Dr. Valent showed that other risk factors that significantly boosted the rate of SSIs were labor prior to delivery, use of internal monitoring, and operative time of more than 90 minutes. Antibiotic prophylaxis was able to significantly reduce SSI rates in women with any of these additional risk factors, compared with placebo. A cost effectiveness analysis she ran estimated that if the antibiotic prophylaxis tested in the study were used on the roughly 460,000 obese U.S. women having cesarean deliveries annually, it would be cost saving as long as the antibiotic regimen cost no more than $357 a person. Factoring in the SSIs and long-term morbidity that prophylaxis would prevent, and the quality-adjusted life-years it would add, showed that prophylaxis would be cost-effective up to a cost of $33,557 per woman.
The prophylaxis carries a “relatively low cost and is easy to use,” Dr. Valent said.
Safety of the antibiotic combination was a question raised by Laura E. Riley, MD, director of ob.gyn. infectious disease and labor and delivery at Massachusetts General Hospital in Boston. “My biggest concern is 48 hours of these antibiotics,” and whether prophylaxis could be achieved with fewer doses, she said in an interview. “I’d want to minimize the dosage, and also try other, nondrug approaches to minimizing SSI risk in obese women.”
“I wouldn’t say that universally, every obstetrical program should do this, but clinicians should look at the comorbidities their mothers have and their SSI rates. There are populations out there at lower risk, but there are also populations like ours, with a SSI rate of 10%-20%,” Dr. Warshak said.
She also acknowledged that even her own obstetrical group in Cincinnati needs to now reach a consensus on an appropriate strategy for expanded cesarean-delivery prophylaxis. That’s because a 2016 report from a large, randomized trial documented another successful strategy for limiting infections following cesarean delivery: a preoperative intravenous dose of azithromycin as a supplement to standard cefazolin. The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) trial, done in women with any BMI but specifically nonelective cesarean deliveries, showed a significant reduction in the combined rate of SSIs, endometritis, or any other infection during 6 weeks of follow-up among women who received azithromycin on top of standard prophylaxis (N Engl J Med. 2016 Sept 29;375[13]:1231-41).
“The bottom line is that, a couple of grams of cefazolin [administered before the incision] isn’t enough, especially for women with risk factors for infection. We see infection rates of more than 10% because cefazolin alone is simply inadequate. The results from both our study and the 2016 study show we can do better to reduce morbidity,” said Dr. Warshak.
“In high-risk women, such as those who are obese, we probably need to expand the spectrum and duration of prophylaxis,” agreed Dr. Main. “Obesity is one high-risk group, but there are others.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – Two days of prophylaxis with two oral antibiotics cut the surgical site infection rate by more than half in a randomized trial with more than 400 obese women who had cesarean deliveries.
The protective effect from combined treatment with cephalexin and metronidazole was especially powerful in the most at-risk patients, women with ruptured membranes before cesarean surgery. In this subgroup prophylaxis with the two antibiotics for 2 days cut surgical site infections (SSIs) during the 30 days after surgery, from a rate of 33% in control women who received placebo to a 10% rate, a 77% relative risk reduction that was statistically significant, Carri R. Warshak, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal and Fetal Medicine.
“I am very excited that we found a way to help the kinds of women in the study, very-high-risk women, with an effective way to reduce their risk of infection,” Dr. Warshak of the University of Cincinnati said in a video interview. The obese women enrolled in the study, especially those with ruptured membranes, “have a very high risk of morbidity, so it’s very exciting that we found a way to help prevent” SSIs.
“Our study is the first to target postpartum interventions to reduce SSIs specifically in this high-risk population” of obese mothers, said Amy M. Valent, DO, a maternal fetal medicine clinician at Oregon Health & Science University in Portland, who ran the trial with Dr. Warshak.
The trial randomized women with a body mass index of at least 30 kg/m2 who underwent a planned or unplanned cesarean delivery at the University of Cincinnati during 2010-2015. Following standard management during cesarean delivery, the women received either 500 mg oral cephalexin and 500 mg oral metronidazole or placebo every 8 hours for 48 hours following delivery. The primary outcome was the incidence of SSIs, and randomization was stratified so that similar numbers of women with ruptured membranes got into each treatment arm. The enrolled women averaged 28 years of age, and average BMI was about 40 kg/m2. Nearly a third of the women had ruptured membranes at the time of surgery, more than a quarter of the enrolled women used tobacco, and more than a fifth had preeclampsia.
Additional analyses reported at the meeting by Dr. Valent showed that other risk factors that significantly boosted the rate of SSIs were labor prior to delivery, use of internal monitoring, and operative time of more than 90 minutes. Antibiotic prophylaxis was able to significantly reduce SSI rates in women with any of these additional risk factors, compared with placebo. A cost effectiveness analysis she ran estimated that if the antibiotic prophylaxis tested in the study were used on the roughly 460,000 obese U.S. women having cesarean deliveries annually, it would be cost saving as long as the antibiotic regimen cost no more than $357 a person. Factoring in the SSIs and long-term morbidity that prophylaxis would prevent, and the quality-adjusted life-years it would add, showed that prophylaxis would be cost-effective up to a cost of $33,557 per woman.
The prophylaxis carries a “relatively low cost and is easy to use,” Dr. Valent said.
Safety of the antibiotic combination was a question raised by Laura E. Riley, MD, director of ob.gyn. infectious disease and labor and delivery at Massachusetts General Hospital in Boston. “My biggest concern is 48 hours of these antibiotics,” and whether prophylaxis could be achieved with fewer doses, she said in an interview. “I’d want to minimize the dosage, and also try other, nondrug approaches to minimizing SSI risk in obese women.”
“I wouldn’t say that universally, every obstetrical program should do this, but clinicians should look at the comorbidities their mothers have and their SSI rates. There are populations out there at lower risk, but there are also populations like ours, with a SSI rate of 10%-20%,” Dr. Warshak said.
She also acknowledged that even her own obstetrical group in Cincinnati needs to now reach a consensus on an appropriate strategy for expanded cesarean-delivery prophylaxis. That’s because a 2016 report from a large, randomized trial documented another successful strategy for limiting infections following cesarean delivery: a preoperative intravenous dose of azithromycin as a supplement to standard cefazolin. The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) trial, done in women with any BMI but specifically nonelective cesarean deliveries, showed a significant reduction in the combined rate of SSIs, endometritis, or any other infection during 6 weeks of follow-up among women who received azithromycin on top of standard prophylaxis (N Engl J Med. 2016 Sept 29;375[13]:1231-41).
“The bottom line is that, a couple of grams of cefazolin [administered before the incision] isn’t enough, especially for women with risk factors for infection. We see infection rates of more than 10% because cefazolin alone is simply inadequate. The results from both our study and the 2016 study show we can do better to reduce morbidity,” said Dr. Warshak.
“In high-risk women, such as those who are obese, we probably need to expand the spectrum and duration of prophylaxis,” agreed Dr. Main. “Obesity is one high-risk group, but there are others.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – Two days of prophylaxis with two oral antibiotics cut the surgical site infection rate by more than half in a randomized trial with more than 400 obese women who had cesarean deliveries.
The protective effect from combined treatment with cephalexin and metronidazole was especially powerful in the most at-risk patients, women with ruptured membranes before cesarean surgery. In this subgroup prophylaxis with the two antibiotics for 2 days cut surgical site infections (SSIs) during the 30 days after surgery, from a rate of 33% in control women who received placebo to a 10% rate, a 77% relative risk reduction that was statistically significant, Carri R. Warshak, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal and Fetal Medicine.
“I am very excited that we found a way to help the kinds of women in the study, very-high-risk women, with an effective way to reduce their risk of infection,” Dr. Warshak of the University of Cincinnati said in a video interview. The obese women enrolled in the study, especially those with ruptured membranes, “have a very high risk of morbidity, so it’s very exciting that we found a way to help prevent” SSIs.
“Our study is the first to target postpartum interventions to reduce SSIs specifically in this high-risk population” of obese mothers, said Amy M. Valent, DO, a maternal fetal medicine clinician at Oregon Health & Science University in Portland, who ran the trial with Dr. Warshak.
The trial randomized women with a body mass index of at least 30 kg/m2 who underwent a planned or unplanned cesarean delivery at the University of Cincinnati during 2010-2015. Following standard management during cesarean delivery, the women received either 500 mg oral cephalexin and 500 mg oral metronidazole or placebo every 8 hours for 48 hours following delivery. The primary outcome was the incidence of SSIs, and randomization was stratified so that similar numbers of women with ruptured membranes got into each treatment arm. The enrolled women averaged 28 years of age, and average BMI was about 40 kg/m2. Nearly a third of the women had ruptured membranes at the time of surgery, more than a quarter of the enrolled women used tobacco, and more than a fifth had preeclampsia.
Additional analyses reported at the meeting by Dr. Valent showed that other risk factors that significantly boosted the rate of SSIs were labor prior to delivery, use of internal monitoring, and operative time of more than 90 minutes. Antibiotic prophylaxis was able to significantly reduce SSI rates in women with any of these additional risk factors, compared with placebo. A cost effectiveness analysis she ran estimated that if the antibiotic prophylaxis tested in the study were used on the roughly 460,000 obese U.S. women having cesarean deliveries annually, it would be cost saving as long as the antibiotic regimen cost no more than $357 a person. Factoring in the SSIs and long-term morbidity that prophylaxis would prevent, and the quality-adjusted life-years it would add, showed that prophylaxis would be cost-effective up to a cost of $33,557 per woman.
The prophylaxis carries a “relatively low cost and is easy to use,” Dr. Valent said.
Safety of the antibiotic combination was a question raised by Laura E. Riley, MD, director of ob.gyn. infectious disease and labor and delivery at Massachusetts General Hospital in Boston. “My biggest concern is 48 hours of these antibiotics,” and whether prophylaxis could be achieved with fewer doses, she said in an interview. “I’d want to minimize the dosage, and also try other, nondrug approaches to minimizing SSI risk in obese women.”
“I wouldn’t say that universally, every obstetrical program should do this, but clinicians should look at the comorbidities their mothers have and their SSI rates. There are populations out there at lower risk, but there are also populations like ours, with a SSI rate of 10%-20%,” Dr. Warshak said.
She also acknowledged that even her own obstetrical group in Cincinnati needs to now reach a consensus on an appropriate strategy for expanded cesarean-delivery prophylaxis. That’s because a 2016 report from a large, randomized trial documented another successful strategy for limiting infections following cesarean delivery: a preoperative intravenous dose of azithromycin as a supplement to standard cefazolin. The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) trial, done in women with any BMI but specifically nonelective cesarean deliveries, showed a significant reduction in the combined rate of SSIs, endometritis, or any other infection during 6 weeks of follow-up among women who received azithromycin on top of standard prophylaxis (N Engl J Med. 2016 Sept 29;375[13]:1231-41).
“The bottom line is that, a couple of grams of cefazolin [administered before the incision] isn’t enough, especially for women with risk factors for infection. We see infection rates of more than 10% because cefazolin alone is simply inadequate. The results from both our study and the 2016 study show we can do better to reduce morbidity,” said Dr. Warshak.
“In high-risk women, such as those who are obese, we probably need to expand the spectrum and duration of prophylaxis,” agreed Dr. Main. “Obesity is one high-risk group, but there are others.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
AT THE PREGNANCY MEETING
Key clinical point:
Major finding: Surgical site infections occurred in 7% of women who received oral prophylaxis and 16% of controls during 30-day follow-up.
Data source: A single-center randomized trial with 382 evaluable women.
Disclosures: Dr. Warshak had no relevant disclosures.
Hypertensive disease of pregnancy linked to earlier mortality
LAS VEGAS – Women who develop any form of hypertensive disease during pregnancy have a significantly increased mortality rate until they reach age 50, compared with women without the condition.
The findings, presented at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, are based on a review of more than 2 million mothers who delivered babies in Utah during 1939-2012.
The relatively increased mortality rate linked with hypertensive disease of pregnancy (HDP) reached its peak during the first decade immediately following the index delivery and was dramatically higher in women for whom the index HDP was preceded by at least one earlier HDP. Increased mortality was especially elevated for certain types of deaths including stroke, diabetes, circulatory disease, and ischemic heart disease, said Lauren Theilen, MD, a maternal-fetal medicine researcher at the University of Utah in Salt Lake City.
She calculated that during the decade following an index case of HDP, life expectancy among mothers who had two or more HDP-affected pregnancies was about 49 years, life expectancy among women with a history of one HDP was 52 years, and postpartum women without HDP had a life expectancy of 55 years.
The data came from 2,083,331 singleton pregnancies delivered in Utah during 1939-2012 where the mother remained in Utah for at least 1 year following delivery. From this group, Dr. Theilen and her associates identified 67,384 women (3%) with HDP, including 49,598 women without a prior history of HDP and 7,786 with at least one prior HDP pregnancy. They included four different diagnoses as HDP: gestational hypertension, preeclampsia, HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), or eclampsia.
The analysis excluded women with chronic hypertension, antiphospholipid syndrome, pregestational diabetes, or chronic kidney disease. It also excluded women who died within a year of the index delivery. For each of the included 67,384 cases with HDP, the researchers selected two controls with a delivery unaffected by HDP and matched them to a case by age, year of childbirth, and parity.
The women in the study were 26 years old on average. Gestational age at delivery among the HDP cases averaged 1 week less than among the controls, 37.8 weeks compared with 38.9 weeks, a statistically significant difference. Average birth weight also differed by a significant amount, 3,079 grams in the HDP neonates and 3,319 grams in the control newborns. During follow-up, 8% of the HDP women died, compared with 6% of the control women.
Analysis showed that relative mortality rates in HDP women were especially elevated for certain types of death: endocrine and metabolic, circulatory, genitourinary, infectious disease, and digestive. In most types of death, the increased risk linked with HDP was markedly higher in the women with recurrent HDP.
Dr. Theilen reported the relative risks of death for certain specific mortality causes (Am J Obstet Gynecol. 2017 Jan;216[1][suppl]:S32-3). In women with a single index case of HDP, the mortality rate compared to women with no HDP was threefold higher for diabetes, twofold higher for ischemic heart disease, and 85% higher for stroke. In women with recurrent HDP, the relative mortality risks were fourfold higher for diabetes, threefold higher for ischemic heart disease, and fivefold higher for stroke.
For all causes of death except stroke, the increased relative risk from HDP existed only for women younger than 51 years. Once HDP women passed the age of 50, their excess mortality risk was substantially muted, even in women with recurrent HDP. But for stroke mortality, the added risk persisted among older women with a history of at least two HDPs. In this subgroup, stroke deaths were nearly fourfold higher than in the matched controls.
Dr. Theilen reported having no financial disclosures.
[email protected]
On Twitter @mitchelzoler
The findings Dr. Theilen and her associates made in this study confirm results reported several decades ago that first established a link between hypertensive disease of pregnancy (HDP) and significantly reduced life expectancy. We have known for some time that HDP identifies women with a long-term mortality risk. The real question is: Can we ameliorate the risk linked with HDP?
We know that HDP requires acute management, but we are not sure how to best manage these women once they have delivered. To address that, we need prospective studies.
Not all women who experience HDP receive appropriate follow-up after delivery. We need to ensure a better handoff of women who developed HDP from the physicians who cared for these women during pregnancy to the physicians who care for these women postpartum and during the balance of their life. Ideally, a primary care physician should closely follow and manage blood pressure and other risk factors of HDP women once they are no longer pregnant.
Mary E. D’Alton, MD , is professor and chair of ob.gyn. at Columbia University Medical Center in New York City. She is on the advisory board of Merck for Mothers. She made these comments in an interview.
The findings Dr. Theilen and her associates made in this study confirm results reported several decades ago that first established a link between hypertensive disease of pregnancy (HDP) and significantly reduced life expectancy. We have known for some time that HDP identifies women with a long-term mortality risk. The real question is: Can we ameliorate the risk linked with HDP?
We know that HDP requires acute management, but we are not sure how to best manage these women once they have delivered. To address that, we need prospective studies.
Not all women who experience HDP receive appropriate follow-up after delivery. We need to ensure a better handoff of women who developed HDP from the physicians who cared for these women during pregnancy to the physicians who care for these women postpartum and during the balance of their life. Ideally, a primary care physician should closely follow and manage blood pressure and other risk factors of HDP women once they are no longer pregnant.
Mary E. D’Alton, MD , is professor and chair of ob.gyn. at Columbia University Medical Center in New York City. She is on the advisory board of Merck for Mothers. She made these comments in an interview.
The findings Dr. Theilen and her associates made in this study confirm results reported several decades ago that first established a link between hypertensive disease of pregnancy (HDP) and significantly reduced life expectancy. We have known for some time that HDP identifies women with a long-term mortality risk. The real question is: Can we ameliorate the risk linked with HDP?
We know that HDP requires acute management, but we are not sure how to best manage these women once they have delivered. To address that, we need prospective studies.
Not all women who experience HDP receive appropriate follow-up after delivery. We need to ensure a better handoff of women who developed HDP from the physicians who cared for these women during pregnancy to the physicians who care for these women postpartum and during the balance of their life. Ideally, a primary care physician should closely follow and manage blood pressure and other risk factors of HDP women once they are no longer pregnant.
Mary E. D’Alton, MD , is professor and chair of ob.gyn. at Columbia University Medical Center in New York City. She is on the advisory board of Merck for Mothers. She made these comments in an interview.
LAS VEGAS – Women who develop any form of hypertensive disease during pregnancy have a significantly increased mortality rate until they reach age 50, compared with women without the condition.
The findings, presented at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, are based on a review of more than 2 million mothers who delivered babies in Utah during 1939-2012.
The relatively increased mortality rate linked with hypertensive disease of pregnancy (HDP) reached its peak during the first decade immediately following the index delivery and was dramatically higher in women for whom the index HDP was preceded by at least one earlier HDP. Increased mortality was especially elevated for certain types of deaths including stroke, diabetes, circulatory disease, and ischemic heart disease, said Lauren Theilen, MD, a maternal-fetal medicine researcher at the University of Utah in Salt Lake City.
She calculated that during the decade following an index case of HDP, life expectancy among mothers who had two or more HDP-affected pregnancies was about 49 years, life expectancy among women with a history of one HDP was 52 years, and postpartum women without HDP had a life expectancy of 55 years.
The data came from 2,083,331 singleton pregnancies delivered in Utah during 1939-2012 where the mother remained in Utah for at least 1 year following delivery. From this group, Dr. Theilen and her associates identified 67,384 women (3%) with HDP, including 49,598 women without a prior history of HDP and 7,786 with at least one prior HDP pregnancy. They included four different diagnoses as HDP: gestational hypertension, preeclampsia, HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), or eclampsia.
The analysis excluded women with chronic hypertension, antiphospholipid syndrome, pregestational diabetes, or chronic kidney disease. It also excluded women who died within a year of the index delivery. For each of the included 67,384 cases with HDP, the researchers selected two controls with a delivery unaffected by HDP and matched them to a case by age, year of childbirth, and parity.
The women in the study were 26 years old on average. Gestational age at delivery among the HDP cases averaged 1 week less than among the controls, 37.8 weeks compared with 38.9 weeks, a statistically significant difference. Average birth weight also differed by a significant amount, 3,079 grams in the HDP neonates and 3,319 grams in the control newborns. During follow-up, 8% of the HDP women died, compared with 6% of the control women.
Analysis showed that relative mortality rates in HDP women were especially elevated for certain types of death: endocrine and metabolic, circulatory, genitourinary, infectious disease, and digestive. In most types of death, the increased risk linked with HDP was markedly higher in the women with recurrent HDP.
Dr. Theilen reported the relative risks of death for certain specific mortality causes (Am J Obstet Gynecol. 2017 Jan;216[1][suppl]:S32-3). In women with a single index case of HDP, the mortality rate compared to women with no HDP was threefold higher for diabetes, twofold higher for ischemic heart disease, and 85% higher for stroke. In women with recurrent HDP, the relative mortality risks were fourfold higher for diabetes, threefold higher for ischemic heart disease, and fivefold higher for stroke.
For all causes of death except stroke, the increased relative risk from HDP existed only for women younger than 51 years. Once HDP women passed the age of 50, their excess mortality risk was substantially muted, even in women with recurrent HDP. But for stroke mortality, the added risk persisted among older women with a history of at least two HDPs. In this subgroup, stroke deaths were nearly fourfold higher than in the matched controls.
Dr. Theilen reported having no financial disclosures.
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – Women who develop any form of hypertensive disease during pregnancy have a significantly increased mortality rate until they reach age 50, compared with women without the condition.
The findings, presented at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, are based on a review of more than 2 million mothers who delivered babies in Utah during 1939-2012.
The relatively increased mortality rate linked with hypertensive disease of pregnancy (HDP) reached its peak during the first decade immediately following the index delivery and was dramatically higher in women for whom the index HDP was preceded by at least one earlier HDP. Increased mortality was especially elevated for certain types of deaths including stroke, diabetes, circulatory disease, and ischemic heart disease, said Lauren Theilen, MD, a maternal-fetal medicine researcher at the University of Utah in Salt Lake City.
She calculated that during the decade following an index case of HDP, life expectancy among mothers who had two or more HDP-affected pregnancies was about 49 years, life expectancy among women with a history of one HDP was 52 years, and postpartum women without HDP had a life expectancy of 55 years.
The data came from 2,083,331 singleton pregnancies delivered in Utah during 1939-2012 where the mother remained in Utah for at least 1 year following delivery. From this group, Dr. Theilen and her associates identified 67,384 women (3%) with HDP, including 49,598 women without a prior history of HDP and 7,786 with at least one prior HDP pregnancy. They included four different diagnoses as HDP: gestational hypertension, preeclampsia, HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), or eclampsia.
The analysis excluded women with chronic hypertension, antiphospholipid syndrome, pregestational diabetes, or chronic kidney disease. It also excluded women who died within a year of the index delivery. For each of the included 67,384 cases with HDP, the researchers selected two controls with a delivery unaffected by HDP and matched them to a case by age, year of childbirth, and parity.
The women in the study were 26 years old on average. Gestational age at delivery among the HDP cases averaged 1 week less than among the controls, 37.8 weeks compared with 38.9 weeks, a statistically significant difference. Average birth weight also differed by a significant amount, 3,079 grams in the HDP neonates and 3,319 grams in the control newborns. During follow-up, 8% of the HDP women died, compared with 6% of the control women.
Analysis showed that relative mortality rates in HDP women were especially elevated for certain types of death: endocrine and metabolic, circulatory, genitourinary, infectious disease, and digestive. In most types of death, the increased risk linked with HDP was markedly higher in the women with recurrent HDP.
Dr. Theilen reported the relative risks of death for certain specific mortality causes (Am J Obstet Gynecol. 2017 Jan;216[1][suppl]:S32-3). In women with a single index case of HDP, the mortality rate compared to women with no HDP was threefold higher for diabetes, twofold higher for ischemic heart disease, and 85% higher for stroke. In women with recurrent HDP, the relative mortality risks were fourfold higher for diabetes, threefold higher for ischemic heart disease, and fivefold higher for stroke.
For all causes of death except stroke, the increased relative risk from HDP existed only for women younger than 51 years. Once HDP women passed the age of 50, their excess mortality risk was substantially muted, even in women with recurrent HDP. But for stroke mortality, the added risk persisted among older women with a history of at least two HDPs. In this subgroup, stroke deaths were nearly fourfold higher than in the matched controls.
Dr. Theilen reported having no financial disclosures.
[email protected]
On Twitter @mitchelzoler
AT THE PREGNANCY MEETING
Key clinical point:
Major finding: Postpartum life expectancy was 49 years in women with two or more hypertensive pregnancies and 55 years in women without hypertension.
Data source: Retrospective, case-control study of 2,083,331 singleton pregnancies delivered in Utah during 1939-2012.
Disclosures: Dr. Theilen reported having no financial disclosures.