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HPV vaccine doesn’t provide herd immunity or cross-protection
WASHINGTON – The prevalence of human papillomavirus (HPV) types 16 and 18 has significantly decreased, but only among vaccinated women; national data show no evidence that the vaccine targeting them has conferred herd immunity or encouraged a shift toward lower-risk types.
From 2003, before the vaccine was introduced, to 2012, the prevalence of HPV 16 and 18 fell from 10% to about 4% in completely vaccinated women, Dr. Christopher Tarney said at the annual meeting of the American College of Obstetricians and Gynecologists. The prevalence among unvaccinated women, however, was virtually unchanged.
“Our study didn’t demonstrate cross-protection, type replacement, or herd immunity,” said Dr. Tarney of the Womack Army Medical Center, Ft. Bragg, N.C. “This is in contrast to some global data” that have recently shown such positive changes were linked to high HPV vaccine coverage in Scotland and Australia.
The lack of these findings in the United States probably has to do with the low rate of vaccine acceptance, Dr. Tarney said. Although 60% of eligible girls got at least one dose of the vaccine in 2014, only about 40% received the entire series.
Dr. Tarney compared data from the 2003 National Health and Nutrition Examination Survey (NHANES) for women 18-29 years old, with NHANES waves in 2007-2008, 2009-2010, and 2011-2012. He looked at the prevalence of high-risk HPV serotypes, and at the specific prevalence of HPV 16 and 18, which are specifically targeted in the vaccine. The study comprised 1,628 women who had submitted self-collected vaginal swabs for HPV analysis. The group was representative of more than 21 million U.S. women, Dr. Tarney said.
The prevalence of HPV 16 and 18 decreased significantly among vaccinated women, from 10% in 2003 to 4% in 2012. Even women who didn’t complete the series reaped some benefit from it. Among those who had at least one immunization, all high-risk HPV decreased from 67% in 2007-2008 to 41% in 2012.
Despite the vaccine’s effectiveness, it is not exerting cross-protection against other high-risk types, Dr. Tarney said, nor is there evidence of herd immunity. Among women who did not receive the vaccine, high-risk HPV prevalence was unchanged at about 49% in 2007-2008 and 51% in 2011-2012.
He expressed frustration that the vaccine has not been more widely adopted.
“During this postvaccine era, over 16 million eligible females didn’t get it. As women’s health care physicians, we must reduce missed clinical opportunities to administer this vaccine. We must strive to maximize access to it and increase support for it,” Dr. Tarney said. “We have a great opportunity to have a profound impact on the prevention of cervical cancer, but only when we can drastically increase the vaccination rates will we see these vaccines begin to contribute to the eradication of cervical cancer in the U.S.”
He reported having no relevant financial disclosures.
WASHINGTON – The prevalence of human papillomavirus (HPV) types 16 and 18 has significantly decreased, but only among vaccinated women; national data show no evidence that the vaccine targeting them has conferred herd immunity or encouraged a shift toward lower-risk types.
From 2003, before the vaccine was introduced, to 2012, the prevalence of HPV 16 and 18 fell from 10% to about 4% in completely vaccinated women, Dr. Christopher Tarney said at the annual meeting of the American College of Obstetricians and Gynecologists. The prevalence among unvaccinated women, however, was virtually unchanged.
“Our study didn’t demonstrate cross-protection, type replacement, or herd immunity,” said Dr. Tarney of the Womack Army Medical Center, Ft. Bragg, N.C. “This is in contrast to some global data” that have recently shown such positive changes were linked to high HPV vaccine coverage in Scotland and Australia.
The lack of these findings in the United States probably has to do with the low rate of vaccine acceptance, Dr. Tarney said. Although 60% of eligible girls got at least one dose of the vaccine in 2014, only about 40% received the entire series.
Dr. Tarney compared data from the 2003 National Health and Nutrition Examination Survey (NHANES) for women 18-29 years old, with NHANES waves in 2007-2008, 2009-2010, and 2011-2012. He looked at the prevalence of high-risk HPV serotypes, and at the specific prevalence of HPV 16 and 18, which are specifically targeted in the vaccine. The study comprised 1,628 women who had submitted self-collected vaginal swabs for HPV analysis. The group was representative of more than 21 million U.S. women, Dr. Tarney said.
The prevalence of HPV 16 and 18 decreased significantly among vaccinated women, from 10% in 2003 to 4% in 2012. Even women who didn’t complete the series reaped some benefit from it. Among those who had at least one immunization, all high-risk HPV decreased from 67% in 2007-2008 to 41% in 2012.
Despite the vaccine’s effectiveness, it is not exerting cross-protection against other high-risk types, Dr. Tarney said, nor is there evidence of herd immunity. Among women who did not receive the vaccine, high-risk HPV prevalence was unchanged at about 49% in 2007-2008 and 51% in 2011-2012.
He expressed frustration that the vaccine has not been more widely adopted.
“During this postvaccine era, over 16 million eligible females didn’t get it. As women’s health care physicians, we must reduce missed clinical opportunities to administer this vaccine. We must strive to maximize access to it and increase support for it,” Dr. Tarney said. “We have a great opportunity to have a profound impact on the prevention of cervical cancer, but only when we can drastically increase the vaccination rates will we see these vaccines begin to contribute to the eradication of cervical cancer in the U.S.”
He reported having no relevant financial disclosures.
WASHINGTON – The prevalence of human papillomavirus (HPV) types 16 and 18 has significantly decreased, but only among vaccinated women; national data show no evidence that the vaccine targeting them has conferred herd immunity or encouraged a shift toward lower-risk types.
From 2003, before the vaccine was introduced, to 2012, the prevalence of HPV 16 and 18 fell from 10% to about 4% in completely vaccinated women, Dr. Christopher Tarney said at the annual meeting of the American College of Obstetricians and Gynecologists. The prevalence among unvaccinated women, however, was virtually unchanged.
“Our study didn’t demonstrate cross-protection, type replacement, or herd immunity,” said Dr. Tarney of the Womack Army Medical Center, Ft. Bragg, N.C. “This is in contrast to some global data” that have recently shown such positive changes were linked to high HPV vaccine coverage in Scotland and Australia.
The lack of these findings in the United States probably has to do with the low rate of vaccine acceptance, Dr. Tarney said. Although 60% of eligible girls got at least one dose of the vaccine in 2014, only about 40% received the entire series.
Dr. Tarney compared data from the 2003 National Health and Nutrition Examination Survey (NHANES) for women 18-29 years old, with NHANES waves in 2007-2008, 2009-2010, and 2011-2012. He looked at the prevalence of high-risk HPV serotypes, and at the specific prevalence of HPV 16 and 18, which are specifically targeted in the vaccine. The study comprised 1,628 women who had submitted self-collected vaginal swabs for HPV analysis. The group was representative of more than 21 million U.S. women, Dr. Tarney said.
The prevalence of HPV 16 and 18 decreased significantly among vaccinated women, from 10% in 2003 to 4% in 2012. Even women who didn’t complete the series reaped some benefit from it. Among those who had at least one immunization, all high-risk HPV decreased from 67% in 2007-2008 to 41% in 2012.
Despite the vaccine’s effectiveness, it is not exerting cross-protection against other high-risk types, Dr. Tarney said, nor is there evidence of herd immunity. Among women who did not receive the vaccine, high-risk HPV prevalence was unchanged at about 49% in 2007-2008 and 51% in 2011-2012.
He expressed frustration that the vaccine has not been more widely adopted.
“During this postvaccine era, over 16 million eligible females didn’t get it. As women’s health care physicians, we must reduce missed clinical opportunities to administer this vaccine. We must strive to maximize access to it and increase support for it,” Dr. Tarney said. “We have a great opportunity to have a profound impact on the prevention of cervical cancer, but only when we can drastically increase the vaccination rates will we see these vaccines begin to contribute to the eradication of cervical cancer in the U.S.”
He reported having no relevant financial disclosures.
AT ACOG 2016
HPV vaccine doesn’t provide herd immunity or crossprotection
WASHINGTON – The prevalence of human papillomavirus (HPV) types 16 and 18 has significantly decreased, but only among vaccinated women; national data show no evidence that the vaccine targeting them has conferred herd immunity or encouraged a shift toward lower-risk types.
From 2003, before the vaccine was introduced, to 2012, the prevalence of HPV 16 and 18 fell from 10% to about 4% in completely vaccinated women, Dr. Christopher Tarney said at the annual meeting of the American College of Obstetricians and Gynecologists. The prevalence among unvaccinated women, however, was virtually unchanged.
“Our study didn’t demonstrate crossprotection, type replacement, or herd immunity,” said Dr. Tarney of the Womack Army Medical Center, Ft. Bragg, N.C. “This is in contrast to some global data” that have recently shown such positive changes were linked to high HPV vaccine coverage in Scotland and Australia.
The lack of these findings in the United States probably has to do with the low rate of vaccine acceptance, Dr. Tarney said. Although 60% of eligible girls got at least one dose of the vaccine in 2014, only about 40% received the entire series.
Dr. Tarney compared data from the 2003 National Health and Nutrition Examination Survey (NHANES) for women 18-29 years old, with NHANES waves in 2007-2008, 2009-2010, and 2011-2012. He looked at the prevalence of high-risk HPV serotypes, and at the specific prevalence of HPV 16 and 18, which are specifically targeted in the vaccine. The study comprised 1,628 women who had submitted self-collected vaginal swabs for HPV analysis. The group was representative of more than 21 million U.S. women, Dr. Tarney said.
The prevalence of HPV 16 and 18 decreased significantly among vaccinated women, from 10% in 2003 to 4% in 2012. Even women who didn’t complete the series reaped some benefit from it. Among those who had at least one immunization, all high-risk HPV decreased from 67% in 2007-2008 to 41% in 2012.
Despite the vaccine’s effectiveness, it is not exerting crossprotection against other high-risk types, Dr. Tarney said, nor is there evidence of herd immunity. Among women who did not receive the vaccine, high-risk HPV prevalence was unchanged at about 49% in 2007-2008 and 51% in 2011-2012.
He expressed frustration that the vaccine has not been more widely adopted.
“During this postvaccine era, over 16 million eligible females didn’t get it. As women’s health care physicians, we must reduce missed clinical opportunities to administer this vaccine. We must strive to maximize access to it and increase support for it,” Dr. Tarney said. “We have a great opportunity to have a profound impact on the prevention of cervical cancer, but only when we can drastically increase the vaccination rates will we see these vaccines begin to contribute to the eradication of cervical cancer in the U.S.”
He reported having no relevant financial disclosures.
WASHINGTON – The prevalence of human papillomavirus (HPV) types 16 and 18 has significantly decreased, but only among vaccinated women; national data show no evidence that the vaccine targeting them has conferred herd immunity or encouraged a shift toward lower-risk types.
From 2003, before the vaccine was introduced, to 2012, the prevalence of HPV 16 and 18 fell from 10% to about 4% in completely vaccinated women, Dr. Christopher Tarney said at the annual meeting of the American College of Obstetricians and Gynecologists. The prevalence among unvaccinated women, however, was virtually unchanged.
“Our study didn’t demonstrate crossprotection, type replacement, or herd immunity,” said Dr. Tarney of the Womack Army Medical Center, Ft. Bragg, N.C. “This is in contrast to some global data” that have recently shown such positive changes were linked to high HPV vaccine coverage in Scotland and Australia.
The lack of these findings in the United States probably has to do with the low rate of vaccine acceptance, Dr. Tarney said. Although 60% of eligible girls got at least one dose of the vaccine in 2014, only about 40% received the entire series.
Dr. Tarney compared data from the 2003 National Health and Nutrition Examination Survey (NHANES) for women 18-29 years old, with NHANES waves in 2007-2008, 2009-2010, and 2011-2012. He looked at the prevalence of high-risk HPV serotypes, and at the specific prevalence of HPV 16 and 18, which are specifically targeted in the vaccine. The study comprised 1,628 women who had submitted self-collected vaginal swabs for HPV analysis. The group was representative of more than 21 million U.S. women, Dr. Tarney said.
The prevalence of HPV 16 and 18 decreased significantly among vaccinated women, from 10% in 2003 to 4% in 2012. Even women who didn’t complete the series reaped some benefit from it. Among those who had at least one immunization, all high-risk HPV decreased from 67% in 2007-2008 to 41% in 2012.
Despite the vaccine’s effectiveness, it is not exerting crossprotection against other high-risk types, Dr. Tarney said, nor is there evidence of herd immunity. Among women who did not receive the vaccine, high-risk HPV prevalence was unchanged at about 49% in 2007-2008 and 51% in 2011-2012.
He expressed frustration that the vaccine has not been more widely adopted.
“During this postvaccine era, over 16 million eligible females didn’t get it. As women’s health care physicians, we must reduce missed clinical opportunities to administer this vaccine. We must strive to maximize access to it and increase support for it,” Dr. Tarney said. “We have a great opportunity to have a profound impact on the prevention of cervical cancer, but only when we can drastically increase the vaccination rates will we see these vaccines begin to contribute to the eradication of cervical cancer in the U.S.”
He reported having no relevant financial disclosures.
WASHINGTON – The prevalence of human papillomavirus (HPV) types 16 and 18 has significantly decreased, but only among vaccinated women; national data show no evidence that the vaccine targeting them has conferred herd immunity or encouraged a shift toward lower-risk types.
From 2003, before the vaccine was introduced, to 2012, the prevalence of HPV 16 and 18 fell from 10% to about 4% in completely vaccinated women, Dr. Christopher Tarney said at the annual meeting of the American College of Obstetricians and Gynecologists. The prevalence among unvaccinated women, however, was virtually unchanged.
“Our study didn’t demonstrate crossprotection, type replacement, or herd immunity,” said Dr. Tarney of the Womack Army Medical Center, Ft. Bragg, N.C. “This is in contrast to some global data” that have recently shown such positive changes were linked to high HPV vaccine coverage in Scotland and Australia.
The lack of these findings in the United States probably has to do with the low rate of vaccine acceptance, Dr. Tarney said. Although 60% of eligible girls got at least one dose of the vaccine in 2014, only about 40% received the entire series.
Dr. Tarney compared data from the 2003 National Health and Nutrition Examination Survey (NHANES) for women 18-29 years old, with NHANES waves in 2007-2008, 2009-2010, and 2011-2012. He looked at the prevalence of high-risk HPV serotypes, and at the specific prevalence of HPV 16 and 18, which are specifically targeted in the vaccine. The study comprised 1,628 women who had submitted self-collected vaginal swabs for HPV analysis. The group was representative of more than 21 million U.S. women, Dr. Tarney said.
The prevalence of HPV 16 and 18 decreased significantly among vaccinated women, from 10% in 2003 to 4% in 2012. Even women who didn’t complete the series reaped some benefit from it. Among those who had at least one immunization, all high-risk HPV decreased from 67% in 2007-2008 to 41% in 2012.
Despite the vaccine’s effectiveness, it is not exerting crossprotection against other high-risk types, Dr. Tarney said, nor is there evidence of herd immunity. Among women who did not receive the vaccine, high-risk HPV prevalence was unchanged at about 49% in 2007-2008 and 51% in 2011-2012.
He expressed frustration that the vaccine has not been more widely adopted.
“During this postvaccine era, over 16 million eligible females didn’t get it. As women’s health care physicians, we must reduce missed clinical opportunities to administer this vaccine. We must strive to maximize access to it and increase support for it,” Dr. Tarney said. “We have a great opportunity to have a profound impact on the prevention of cervical cancer, but only when we can drastically increase the vaccination rates will we see these vaccines begin to contribute to the eradication of cervical cancer in the U.S.”
He reported having no relevant financial disclosures.
AT ACOG 2016
Key clinical point: HPV types 16 and 18 have significantly decreased since the advent of the vaccine, but only among vaccinated women.
Major finding: HPV 16 and 18 prevalence dropped from 10% in 2003 to 4% in 2012 among vaccinated women.
Data source: A prospective study of 1,628 women.
Disclosures: Dr. Tarney reported having no relevant financial disclosures.
Vaginal delivery found safe for monoamniotic-monochorionic twins
WASHINGTON – Monoamniotic-monochorionic twins can be safely delivered vaginally, with low rates of adverse fetal or maternal outcomes.
Despite seeing cord entanglement in almost every case, a small retrospective study found no safety signals that support pre-emptive cesarean deliveries for this class of twins, Dr. Meena Khandelwal said at the annual meeting of the American College of Obstetricians and Gynecologists. In fact, vaginal delivery was associated with a significantly lower rate of intracranial hemorrhage, which occurred in 27% of the cesarean-delivered infants and none of the infants delivered vaginally.
Dr. Khandelwal and her colleagues won third prize for the study among the 2016 ACOG research awards.
In 2014, an ACOG technical bulletin advised cesarean delivery for all monoamniotic twins, a recommendation in line with those in Canada and France. But the ACOG advice was based on level C evidence, said Dr. Khandelwal of Cooper University Hospital, Camden, N.J.
“These recommendations are fear based, not fact based,” she said. “It is felt that the risk of entrapment is too great. But cord entanglement is seen in virtually all of these cases, and a large study recently found that it contributed nothing to morbidity or mortality in the fetuses.”
That study, published in 2013, reviewed 114 monoamniotic twin pregnancies (228 fetuses). There were 26 perinatal fetal deaths, only two of which were related to cord entanglement. The author found no significant difference in mortality between the fetuses with entanglement (82) and those without (Ultrasound Obstet Gynecol. 2013 Feb;41[2]:131-5).
Dr. Khandelwal conducted her own retrospective study of 29 sets of monoamniotic-monochorionic twins that were born vaginally or by cesarean delivery at two tertiary care centers in New Jersey, from 1997 to 2014. Her cohort comprised 10 pregnancies at Thomas Jefferson Hospital, Philadelphia, which only offers cesarean delivery for these cases, and 19 at Cooper University Hospital, which offers the option of vaginal delivery if the first twin is in cephalic position, the fetal heart rate is reactive at the onset of labor, and there are no contraindications to vaginal delivery.
Cooper also manages these pregnancies on an outpatient basis with vaginal delivery offered from 32 to 36 weeks. Thomas Jefferson admits them to the antepartum unit from 24 to 28 weeks and offers cesarean delivery from 32 to36 weeks.
The mean age of the women in the series was 29 years; median parity was one. Almost half of the women having a planned cesarean had a history of a prior cesarean; none of the women who planned a vaginal delivery had a prior cesarean delivery.
Of the 19 women offered vaginal delivery, 14 accepted. Of these, 10 (71%) delivered both twins vaginally. The mean time between the twin deliveries was 3 minutes. Cesarean delivery was necessary for four neonates in the planned vaginal delivery group: three due to concerning heart rate tracings and one because of a failed internal version of a transverse presentation of a second twin.
Three fetuses died before birth – one in the planned vaginal delivery group (7%) and two in the planned cesarean delivery group (13%). There was one post partum hemorrhage, which occurred in the planned cesarean group. There were no cases of chorioamnionitis. Birth weight was similar (about 1,800 grams). Cords were entangled in 100% of the vaginal delivery group and 93% of the cesarean group. Apgar at 5 minutes was 6.6 in the vaginal delivery group and 8.3 in the cesarean group.
Respiratory distress syndrome was significantly more common among the planned cesarean group (86% vs. 65%). There were eight cases of intracerebral hemorrhage in that group and none in the planned vaginal delivery group (28% vs. 0%). These were all grade 1 or 2 bleeds. There were no neonatal deaths.
The length of stay was shorter in the planned vaginal delivery group, but not significantly so (median 18 vs. 25 days).
“This is a small study but it does add valuable data on the safety of vaginal delivery in [monoamniotic-monochorionic] twins,” Dr. Khandelwal said. “Vaginal delivery can be considered a safe option in tertiary care centers.
She reported having no financial disclosures.
WASHINGTON – Monoamniotic-monochorionic twins can be safely delivered vaginally, with low rates of adverse fetal or maternal outcomes.
Despite seeing cord entanglement in almost every case, a small retrospective study found no safety signals that support pre-emptive cesarean deliveries for this class of twins, Dr. Meena Khandelwal said at the annual meeting of the American College of Obstetricians and Gynecologists. In fact, vaginal delivery was associated with a significantly lower rate of intracranial hemorrhage, which occurred in 27% of the cesarean-delivered infants and none of the infants delivered vaginally.
Dr. Khandelwal and her colleagues won third prize for the study among the 2016 ACOG research awards.
In 2014, an ACOG technical bulletin advised cesarean delivery for all monoamniotic twins, a recommendation in line with those in Canada and France. But the ACOG advice was based on level C evidence, said Dr. Khandelwal of Cooper University Hospital, Camden, N.J.
“These recommendations are fear based, not fact based,” she said. “It is felt that the risk of entrapment is too great. But cord entanglement is seen in virtually all of these cases, and a large study recently found that it contributed nothing to morbidity or mortality in the fetuses.”
That study, published in 2013, reviewed 114 monoamniotic twin pregnancies (228 fetuses). There were 26 perinatal fetal deaths, only two of which were related to cord entanglement. The author found no significant difference in mortality between the fetuses with entanglement (82) and those without (Ultrasound Obstet Gynecol. 2013 Feb;41[2]:131-5).
Dr. Khandelwal conducted her own retrospective study of 29 sets of monoamniotic-monochorionic twins that were born vaginally or by cesarean delivery at two tertiary care centers in New Jersey, from 1997 to 2014. Her cohort comprised 10 pregnancies at Thomas Jefferson Hospital, Philadelphia, which only offers cesarean delivery for these cases, and 19 at Cooper University Hospital, which offers the option of vaginal delivery if the first twin is in cephalic position, the fetal heart rate is reactive at the onset of labor, and there are no contraindications to vaginal delivery.
Cooper also manages these pregnancies on an outpatient basis with vaginal delivery offered from 32 to 36 weeks. Thomas Jefferson admits them to the antepartum unit from 24 to 28 weeks and offers cesarean delivery from 32 to36 weeks.
The mean age of the women in the series was 29 years; median parity was one. Almost half of the women having a planned cesarean had a history of a prior cesarean; none of the women who planned a vaginal delivery had a prior cesarean delivery.
Of the 19 women offered vaginal delivery, 14 accepted. Of these, 10 (71%) delivered both twins vaginally. The mean time between the twin deliveries was 3 minutes. Cesarean delivery was necessary for four neonates in the planned vaginal delivery group: three due to concerning heart rate tracings and one because of a failed internal version of a transverse presentation of a second twin.
Three fetuses died before birth – one in the planned vaginal delivery group (7%) and two in the planned cesarean delivery group (13%). There was one post partum hemorrhage, which occurred in the planned cesarean group. There were no cases of chorioamnionitis. Birth weight was similar (about 1,800 grams). Cords were entangled in 100% of the vaginal delivery group and 93% of the cesarean group. Apgar at 5 minutes was 6.6 in the vaginal delivery group and 8.3 in the cesarean group.
Respiratory distress syndrome was significantly more common among the planned cesarean group (86% vs. 65%). There were eight cases of intracerebral hemorrhage in that group and none in the planned vaginal delivery group (28% vs. 0%). These were all grade 1 or 2 bleeds. There were no neonatal deaths.
The length of stay was shorter in the planned vaginal delivery group, but not significantly so (median 18 vs. 25 days).
“This is a small study but it does add valuable data on the safety of vaginal delivery in [monoamniotic-monochorionic] twins,” Dr. Khandelwal said. “Vaginal delivery can be considered a safe option in tertiary care centers.
She reported having no financial disclosures.
WASHINGTON – Monoamniotic-monochorionic twins can be safely delivered vaginally, with low rates of adverse fetal or maternal outcomes.
Despite seeing cord entanglement in almost every case, a small retrospective study found no safety signals that support pre-emptive cesarean deliveries for this class of twins, Dr. Meena Khandelwal said at the annual meeting of the American College of Obstetricians and Gynecologists. In fact, vaginal delivery was associated with a significantly lower rate of intracranial hemorrhage, which occurred in 27% of the cesarean-delivered infants and none of the infants delivered vaginally.
Dr. Khandelwal and her colleagues won third prize for the study among the 2016 ACOG research awards.
In 2014, an ACOG technical bulletin advised cesarean delivery for all monoamniotic twins, a recommendation in line with those in Canada and France. But the ACOG advice was based on level C evidence, said Dr. Khandelwal of Cooper University Hospital, Camden, N.J.
“These recommendations are fear based, not fact based,” she said. “It is felt that the risk of entrapment is too great. But cord entanglement is seen in virtually all of these cases, and a large study recently found that it contributed nothing to morbidity or mortality in the fetuses.”
That study, published in 2013, reviewed 114 monoamniotic twin pregnancies (228 fetuses). There were 26 perinatal fetal deaths, only two of which were related to cord entanglement. The author found no significant difference in mortality between the fetuses with entanglement (82) and those without (Ultrasound Obstet Gynecol. 2013 Feb;41[2]:131-5).
Dr. Khandelwal conducted her own retrospective study of 29 sets of monoamniotic-monochorionic twins that were born vaginally or by cesarean delivery at two tertiary care centers in New Jersey, from 1997 to 2014. Her cohort comprised 10 pregnancies at Thomas Jefferson Hospital, Philadelphia, which only offers cesarean delivery for these cases, and 19 at Cooper University Hospital, which offers the option of vaginal delivery if the first twin is in cephalic position, the fetal heart rate is reactive at the onset of labor, and there are no contraindications to vaginal delivery.
Cooper also manages these pregnancies on an outpatient basis with vaginal delivery offered from 32 to 36 weeks. Thomas Jefferson admits them to the antepartum unit from 24 to 28 weeks and offers cesarean delivery from 32 to36 weeks.
The mean age of the women in the series was 29 years; median parity was one. Almost half of the women having a planned cesarean had a history of a prior cesarean; none of the women who planned a vaginal delivery had a prior cesarean delivery.
Of the 19 women offered vaginal delivery, 14 accepted. Of these, 10 (71%) delivered both twins vaginally. The mean time between the twin deliveries was 3 minutes. Cesarean delivery was necessary for four neonates in the planned vaginal delivery group: three due to concerning heart rate tracings and one because of a failed internal version of a transverse presentation of a second twin.
Three fetuses died before birth – one in the planned vaginal delivery group (7%) and two in the planned cesarean delivery group (13%). There was one post partum hemorrhage, which occurred in the planned cesarean group. There were no cases of chorioamnionitis. Birth weight was similar (about 1,800 grams). Cords were entangled in 100% of the vaginal delivery group and 93% of the cesarean group. Apgar at 5 minutes was 6.6 in the vaginal delivery group and 8.3 in the cesarean group.
Respiratory distress syndrome was significantly more common among the planned cesarean group (86% vs. 65%). There were eight cases of intracerebral hemorrhage in that group and none in the planned vaginal delivery group (28% vs. 0%). These were all grade 1 or 2 bleeds. There were no neonatal deaths.
The length of stay was shorter in the planned vaginal delivery group, but not significantly so (median 18 vs. 25 days).
“This is a small study but it does add valuable data on the safety of vaginal delivery in [monoamniotic-monochorionic] twins,” Dr. Khandelwal said. “Vaginal delivery can be considered a safe option in tertiary care centers.
She reported having no financial disclosures.
AT ACOG 2016
Key clinical point: Vaginal delivery is a safe option for monoamniotic-monochorionic twins.
Major finding: Successful vaginal delivery of both twins occurred in 71% of those who attempted it.
Data source: A retrospective study comprising 29 sets of monoamniotic-monochorionic twins.
Disclosures: Dr. Khandelwal reported having no financial disclosures.
Methadone programs allowed pregnancy outcomes similar to nonusers
Methadone users under professional programs have similar pregnancy outcomes as nonmethadone users, according to a study of more than 34,000 deliveries.
Dr. Conisha Holloman of Winnie Palmer Hospital Orlando, Fla., analyzed 34,482 deliveries from 2010 to 2013, comparing women enrolled in methadone programs, those with cocaine or heroine use but no treatment or self medication with methadone, and a large group of controls.
“What we found was a significant difference between preterm births in the groups,” Dr. Holloman said at the annual meeting of the American College of Obstetricians and Gynecologists.
The preterm birth rate was 15% among the 55 patients enrolled in methadone programs. The preterm birth rate rose to 36% among the 34,408 patients in the control group, who had no addiction issues. Comparatively, the preterm birth rate was 53% among the 19 patients who tested positive for cocaine, heroine, or methadone use and were either self treating or not enrolled in a treatment program.
The study also noted neonatal intensive care unit (NICU) admission rates were higher for infants of drug-using patients who were self treating or who were not enrolled in methadone programs. The NICU admission rate for infants of those patients was 26%, compared with 16% for the women in the methadone program and 7% for the control group.
The demographics in the groups were comparable, with no significant difference between age, primigravida, and class III obesity status.
“We encourage women to get into a methadone assisted program, because a lot of these women end up getting earlier prenatal care and better social situations as far as high-risk behavior and improved nutrition for maternal health,” said Dr. Holloman.
Dr. Holloman reported having no relevant financial disclosures.
Methadone users under professional programs have similar pregnancy outcomes as nonmethadone users, according to a study of more than 34,000 deliveries.
Dr. Conisha Holloman of Winnie Palmer Hospital Orlando, Fla., analyzed 34,482 deliveries from 2010 to 2013, comparing women enrolled in methadone programs, those with cocaine or heroine use but no treatment or self medication with methadone, and a large group of controls.
“What we found was a significant difference between preterm births in the groups,” Dr. Holloman said at the annual meeting of the American College of Obstetricians and Gynecologists.
The preterm birth rate was 15% among the 55 patients enrolled in methadone programs. The preterm birth rate rose to 36% among the 34,408 patients in the control group, who had no addiction issues. Comparatively, the preterm birth rate was 53% among the 19 patients who tested positive for cocaine, heroine, or methadone use and were either self treating or not enrolled in a treatment program.
The study also noted neonatal intensive care unit (NICU) admission rates were higher for infants of drug-using patients who were self treating or who were not enrolled in methadone programs. The NICU admission rate for infants of those patients was 26%, compared with 16% for the women in the methadone program and 7% for the control group.
The demographics in the groups were comparable, with no significant difference between age, primigravida, and class III obesity status.
“We encourage women to get into a methadone assisted program, because a lot of these women end up getting earlier prenatal care and better social situations as far as high-risk behavior and improved nutrition for maternal health,” said Dr. Holloman.
Dr. Holloman reported having no relevant financial disclosures.
Methadone users under professional programs have similar pregnancy outcomes as nonmethadone users, according to a study of more than 34,000 deliveries.
Dr. Conisha Holloman of Winnie Palmer Hospital Orlando, Fla., analyzed 34,482 deliveries from 2010 to 2013, comparing women enrolled in methadone programs, those with cocaine or heroine use but no treatment or self medication with methadone, and a large group of controls.
“What we found was a significant difference between preterm births in the groups,” Dr. Holloman said at the annual meeting of the American College of Obstetricians and Gynecologists.
The preterm birth rate was 15% among the 55 patients enrolled in methadone programs. The preterm birth rate rose to 36% among the 34,408 patients in the control group, who had no addiction issues. Comparatively, the preterm birth rate was 53% among the 19 patients who tested positive for cocaine, heroine, or methadone use and were either self treating or not enrolled in a treatment program.
The study also noted neonatal intensive care unit (NICU) admission rates were higher for infants of drug-using patients who were self treating or who were not enrolled in methadone programs. The NICU admission rate for infants of those patients was 26%, compared with 16% for the women in the methadone program and 7% for the control group.
The demographics in the groups were comparable, with no significant difference between age, primigravida, and class III obesity status.
“We encourage women to get into a methadone assisted program, because a lot of these women end up getting earlier prenatal care and better social situations as far as high-risk behavior and improved nutrition for maternal health,” said Dr. Holloman.
Dr. Holloman reported having no relevant financial disclosures.
At ACOG 2016
Key clinical point: Women enrolled in supervised methadone programs had similar preterm birth rates to healthy controls.
Major finding: Preterm birth rates were 15% among methadone users and 36% among controls.
Data source: A retrospective study of 34,482 deliveries from 2010 to 2013.
Disclosures: Dr. Holloman reported having no relevant financial disclosures.
Patients: Intraperitoneal chemotherapy ‘worth it’ for ovarian cancer
WASHINGTON – Intraperitoneal chemotherapy may be unpleasant and interfere with daily life, but the large majority of women who received it for ovarian cancer agreed that it was the right choice for them.
A small survey of women who completed up to six cycles of the treatment found that most women did experience side effects, including fatigue, pain, and gastrointestinal issues. Despite those problems, more than 80% said they felt the regimen was “worth it,” and more than 90% said they would recommend it to another woman.
“Outpatient administration of chemotherapy appears to be feasible with acceptable toxicities and high completion rates,” Dr. Kristin Gotimer said at the annual meeting of the American College of Obstetricians and Gynecologists. “Toxicities were troublesome, and they did definitely affect quality of life; but almost none of our patients regretted being treated – even the ones who experienced recurrent disease.”
Dr. Gotimer of the Winthrop University Hospital, Mineola, N.Y., discussed a retrospective study of 98 women who underwent intraperitoneal chemotherapy for a gynecologic cancer from 2006 to 2014. Mean age of the patients was 58 years. Most women (71%) had ovarian cancer, and most cancer (70%) was stage IIIC or higher. All patients underwent cytoreductive surgery before starting chemotherapy.
Almost all women were prescribed six cycles of the regimen, which consisted of IV paclitaxel on day 1, intraperitoneal cisplatin on day 2, and intraperitoneal paclitaxel on day 8. Overall, 73% of patients completed their prescribed treatment. Among those prescribed six cycles, 71% completed all of them. Of the 26 patients who discontinued, 12 did so because of port complications, and 14 did so because of toxicities.
The most commonly reported side effects were gastrointestinal effects, fatigue, and neuropathy. Grade 3/4 toxicities were most often fatigue, neuropathy, and pain; those occurred in about 6% of patients per cycle. There were four cases of neutropenic fever; two of those resulted in treatment delays.
Seven patients had to change treatment, Dr. Gotimer said. Six switched from intraperitoneal cisplatin to intraperitoneal carboplatin, and one patient switched from IV paclitaxel to IV Abraxane. Toxicities were more likely to appear in later cycles. “The probability of starting each cycle was lower if the patient had experienced a severe toxicity in the prior cycle,” Dr. Gotimer explained.
A subset of patients (48) completed a survey about the treatment at a mean of 31 months after treatment. Of those, 92% had completed all their prescribed cycles. Disease had recurred in 21%. The three-domain survey queried the mental, physical, and social impact of the treatment.
On the physical health domain, half the group reported fatigue associated with the treatment. Others complained of pain (40%), gastrointestinal effects (37%), “chemo brain” cognitive dysfunction (29%), and alopecia (25%). A few patients experienced infections and dermatologic problems (less than 10% each).
In the mental health domain, patients most often noted stress (25%), anxiety (21%), and depression (15%) during treatment. They also said the therapy interfered with their social health, affecting work attendance (27%), housework (29%), and social interactions (19%). It also imposed a substantial time commitment, 17% of patients noted.
Despite those issues, 83% of patients endorsed intraperitoneal chemotherapy as “worth it,” and almost 90% said they would recommend it to a friend or family member considering it. Only about 5% of patients said they regretted using the treatment, although Dr. Gotimer didn’t specify what those regrets were.
Despite its small size and retrospective nature, the survey offers some clinically useful information, Dr. Gotimer noted. “We can identify modifiable side effects and develop specific interventions aimed at increasing tolerability.”
The results could also be used to “improve physician and patient understanding of realistic short- and long-term expectations to improve patient counseling,” she added.
Dr. Gotimer had no financial declarations.
On Twitter @Alz_Gal
WASHINGTON – Intraperitoneal chemotherapy may be unpleasant and interfere with daily life, but the large majority of women who received it for ovarian cancer agreed that it was the right choice for them.
A small survey of women who completed up to six cycles of the treatment found that most women did experience side effects, including fatigue, pain, and gastrointestinal issues. Despite those problems, more than 80% said they felt the regimen was “worth it,” and more than 90% said they would recommend it to another woman.
“Outpatient administration of chemotherapy appears to be feasible with acceptable toxicities and high completion rates,” Dr. Kristin Gotimer said at the annual meeting of the American College of Obstetricians and Gynecologists. “Toxicities were troublesome, and they did definitely affect quality of life; but almost none of our patients regretted being treated – even the ones who experienced recurrent disease.”
Dr. Gotimer of the Winthrop University Hospital, Mineola, N.Y., discussed a retrospective study of 98 women who underwent intraperitoneal chemotherapy for a gynecologic cancer from 2006 to 2014. Mean age of the patients was 58 years. Most women (71%) had ovarian cancer, and most cancer (70%) was stage IIIC or higher. All patients underwent cytoreductive surgery before starting chemotherapy.
Almost all women were prescribed six cycles of the regimen, which consisted of IV paclitaxel on day 1, intraperitoneal cisplatin on day 2, and intraperitoneal paclitaxel on day 8. Overall, 73% of patients completed their prescribed treatment. Among those prescribed six cycles, 71% completed all of them. Of the 26 patients who discontinued, 12 did so because of port complications, and 14 did so because of toxicities.
The most commonly reported side effects were gastrointestinal effects, fatigue, and neuropathy. Grade 3/4 toxicities were most often fatigue, neuropathy, and pain; those occurred in about 6% of patients per cycle. There were four cases of neutropenic fever; two of those resulted in treatment delays.
Seven patients had to change treatment, Dr. Gotimer said. Six switched from intraperitoneal cisplatin to intraperitoneal carboplatin, and one patient switched from IV paclitaxel to IV Abraxane. Toxicities were more likely to appear in later cycles. “The probability of starting each cycle was lower if the patient had experienced a severe toxicity in the prior cycle,” Dr. Gotimer explained.
A subset of patients (48) completed a survey about the treatment at a mean of 31 months after treatment. Of those, 92% had completed all their prescribed cycles. Disease had recurred in 21%. The three-domain survey queried the mental, physical, and social impact of the treatment.
On the physical health domain, half the group reported fatigue associated with the treatment. Others complained of pain (40%), gastrointestinal effects (37%), “chemo brain” cognitive dysfunction (29%), and alopecia (25%). A few patients experienced infections and dermatologic problems (less than 10% each).
In the mental health domain, patients most often noted stress (25%), anxiety (21%), and depression (15%) during treatment. They also said the therapy interfered with their social health, affecting work attendance (27%), housework (29%), and social interactions (19%). It also imposed a substantial time commitment, 17% of patients noted.
Despite those issues, 83% of patients endorsed intraperitoneal chemotherapy as “worth it,” and almost 90% said they would recommend it to a friend or family member considering it. Only about 5% of patients said they regretted using the treatment, although Dr. Gotimer didn’t specify what those regrets were.
Despite its small size and retrospective nature, the survey offers some clinically useful information, Dr. Gotimer noted. “We can identify modifiable side effects and develop specific interventions aimed at increasing tolerability.”
The results could also be used to “improve physician and patient understanding of realistic short- and long-term expectations to improve patient counseling,” she added.
Dr. Gotimer had no financial declarations.
On Twitter @Alz_Gal
WASHINGTON – Intraperitoneal chemotherapy may be unpleasant and interfere with daily life, but the large majority of women who received it for ovarian cancer agreed that it was the right choice for them.
A small survey of women who completed up to six cycles of the treatment found that most women did experience side effects, including fatigue, pain, and gastrointestinal issues. Despite those problems, more than 80% said they felt the regimen was “worth it,” and more than 90% said they would recommend it to another woman.
“Outpatient administration of chemotherapy appears to be feasible with acceptable toxicities and high completion rates,” Dr. Kristin Gotimer said at the annual meeting of the American College of Obstetricians and Gynecologists. “Toxicities were troublesome, and they did definitely affect quality of life; but almost none of our patients regretted being treated – even the ones who experienced recurrent disease.”
Dr. Gotimer of the Winthrop University Hospital, Mineola, N.Y., discussed a retrospective study of 98 women who underwent intraperitoneal chemotherapy for a gynecologic cancer from 2006 to 2014. Mean age of the patients was 58 years. Most women (71%) had ovarian cancer, and most cancer (70%) was stage IIIC or higher. All patients underwent cytoreductive surgery before starting chemotherapy.
Almost all women were prescribed six cycles of the regimen, which consisted of IV paclitaxel on day 1, intraperitoneal cisplatin on day 2, and intraperitoneal paclitaxel on day 8. Overall, 73% of patients completed their prescribed treatment. Among those prescribed six cycles, 71% completed all of them. Of the 26 patients who discontinued, 12 did so because of port complications, and 14 did so because of toxicities.
The most commonly reported side effects were gastrointestinal effects, fatigue, and neuropathy. Grade 3/4 toxicities were most often fatigue, neuropathy, and pain; those occurred in about 6% of patients per cycle. There were four cases of neutropenic fever; two of those resulted in treatment delays.
Seven patients had to change treatment, Dr. Gotimer said. Six switched from intraperitoneal cisplatin to intraperitoneal carboplatin, and one patient switched from IV paclitaxel to IV Abraxane. Toxicities were more likely to appear in later cycles. “The probability of starting each cycle was lower if the patient had experienced a severe toxicity in the prior cycle,” Dr. Gotimer explained.
A subset of patients (48) completed a survey about the treatment at a mean of 31 months after treatment. Of those, 92% had completed all their prescribed cycles. Disease had recurred in 21%. The three-domain survey queried the mental, physical, and social impact of the treatment.
On the physical health domain, half the group reported fatigue associated with the treatment. Others complained of pain (40%), gastrointestinal effects (37%), “chemo brain” cognitive dysfunction (29%), and alopecia (25%). A few patients experienced infections and dermatologic problems (less than 10% each).
In the mental health domain, patients most often noted stress (25%), anxiety (21%), and depression (15%) during treatment. They also said the therapy interfered with their social health, affecting work attendance (27%), housework (29%), and social interactions (19%). It also imposed a substantial time commitment, 17% of patients noted.
Despite those issues, 83% of patients endorsed intraperitoneal chemotherapy as “worth it,” and almost 90% said they would recommend it to a friend or family member considering it. Only about 5% of patients said they regretted using the treatment, although Dr. Gotimer didn’t specify what those regrets were.
Despite its small size and retrospective nature, the survey offers some clinically useful information, Dr. Gotimer noted. “We can identify modifiable side effects and develop specific interventions aimed at increasing tolerability.”
The results could also be used to “improve physician and patient understanding of realistic short- and long-term expectations to improve patient counseling,” she added.
Dr. Gotimer had no financial declarations.
On Twitter @Alz_Gal
AT ACOG 2016
Key clinical point: Despite its challenges, most women who used intraperitoneal chemotherapy for ovarian cancer said it was a good option for them.
Major finding: More than 80% of women said the regimen was “worth it,” and more than 90% said they would recommend it to another woman.
Data source: The retrospective study comprised 98 women, 48 of whom completed a survey about their treatment.
Disclosures: Dr. Gotimer had no financial disclosures.
Care bundle reduces cesarean surgical site infections
WASHINGTON – The rate of cesarean delivery surgical site infections fell significantly at Yale New Haven (Conn.) Hospital after implementation of a multidisciplinary care bundle with protocols covering preoperative, intraoperative, and postoperative care.
An analysis of two 3-month sampling periods – one before implementation of the bundle of care and one after – showed a drop in the surgical site infection (SSI) rate among total cesarean sections from 3.4% to 2.2%.
At the annual meeting of the American College of Obstetricians and Gynecologists, Dr. Ashley Pritchard of the hospital described the care bundle and urged obstetricians to consider the impact of even small reductions in SSIs after a cesarean.
“Infection is the most common complication following cesarean delivery … 2.5%-16% of all cesarean deliveries will result in a surgical site infection, and there is significant underestimation as between 15% to 80% of infections are diagnosed after patients leave the hospital,” she said.
A cesarean delivery SSI task force created by the hospital’s obstetric patient safety program developed the care bundle after reviewing best practices, guidelines, and evidence-based reviews.
Preoperative protocols for planned cesareans focused on patient education and included a preoperative appointment and instructions for showering the night before surgery, not shaving for more than 24 hours prior to scheduled surgery, using 2% chlorhexidine wipes both the night prior to surgery and the day of surgery, and other hygiene processes.
“We know from numerous studies that chlorhexidine is superior to iodine, but we also have found that with these wipes you get a level of antibiosis on the skin surface that decreases surgical site infections at the time of incisions,” Dr. Pritchard said.
For the operative care part of the bundle, staff were reeducated about the scrubbing protocol, proper attire and limits on operating room traffic, and the correct and timely use of antibiotics (for example, a cephalosporin administered within 30 minutes of incision). Staff also watched a video and were quizzed on the proper technique and timing for preoperative skin preparation.
Increased attention was paid to normothermia and included preoperative use of warming blankets and proper temperature in the operating room and post–anesthesia care unit.
“We’ve learned from colorectal and trauma surgery that normothermia and patient warming lead to reduced SSI,” Dr. Pritchard said. “This hasn’t been proven with cesarean delivery, but we know there’s improved maternal and fetal well-being with preoperative warming.”
Postoperatively, the use of supplemental oxygen was discontinued unless clinically indicated “since it’s been shown to have no positive effect on SSI,” she said. Incision dressing application and removal were also standardized, with sterile dressings maintained for at least 24 hours – with a tag labeling the date and time of application – and no more than 48 hours. At discharge, patients were given clear discharge instructions and a postpartum appointment for an incision check.
During the 3-month sampling period prior to implementation of the care bundle, there were 382 cesarean deliveries, and 147 patients presented for a postpartum appointment (either the prescribed visit or a later “issue visit”) within 30 days (38%). Of these patients, 8.6% were diagnosed with an SSI.
In the postimplementation sampling period, which began 6 months after rollout, there were 361 cesarean deliveries at the hospital, and 297 patients (77%) presented for postpartum care. Of these patients, 2.9% were diagnosed with an SSI.
An analysis based on the total number of cesarean deliveries performed at the hospital (planned and unplanned) during the two 3-month periods showed a decline in the cesarean delivery SSI rate from 3.4% to 2.2%. “This is statistically significant. It shows a dramatic decline in the SSI rate in our patient population … a clear impact of the bundle of care,” Dr. Pritchard said.
The Yale team attributes the significant increase in postoperative visit attendance to the preoperative protocol for planned cesareans. “We think it had something to do with our creating better relationships by having [patients] present preoperatively and starting their care prior to incision,” she said.
The preoperative visit also provided an opportunity to identify and treat any active skin infections, upper respiratory infections, or chronic colonizations (without evidence of completion of treatment) before delivery. “If necessary and if possible, [we could] push back their cesarean section date to ensure adequate treatment had been achieved,” Dr. Pritchard said.
All aspects of the care bundle were rolled out simultaneously. Next steps for the New Haven team include further analysis of provider and patient views, a look at the sustainability of the bundle of care and its impact, and a cost analysis. “We reduced our SSIs, but we’ve also added a number of elements to our care spectrum, pre- and postoperatively,” Dr. Pritchard said.
For now, one thing seems clear: “We learned from cardiac and colorectal surgery that there really is strength in the bundle, that the sum of the parts is greater than the individual aspects,” she said.
Dr. Pritchard reported that she and her coinvestigators have no relevant financial disclosures.
WASHINGTON – The rate of cesarean delivery surgical site infections fell significantly at Yale New Haven (Conn.) Hospital after implementation of a multidisciplinary care bundle with protocols covering preoperative, intraoperative, and postoperative care.
An analysis of two 3-month sampling periods – one before implementation of the bundle of care and one after – showed a drop in the surgical site infection (SSI) rate among total cesarean sections from 3.4% to 2.2%.
At the annual meeting of the American College of Obstetricians and Gynecologists, Dr. Ashley Pritchard of the hospital described the care bundle and urged obstetricians to consider the impact of even small reductions in SSIs after a cesarean.
“Infection is the most common complication following cesarean delivery … 2.5%-16% of all cesarean deliveries will result in a surgical site infection, and there is significant underestimation as between 15% to 80% of infections are diagnosed after patients leave the hospital,” she said.
A cesarean delivery SSI task force created by the hospital’s obstetric patient safety program developed the care bundle after reviewing best practices, guidelines, and evidence-based reviews.
Preoperative protocols for planned cesareans focused on patient education and included a preoperative appointment and instructions for showering the night before surgery, not shaving for more than 24 hours prior to scheduled surgery, using 2% chlorhexidine wipes both the night prior to surgery and the day of surgery, and other hygiene processes.
“We know from numerous studies that chlorhexidine is superior to iodine, but we also have found that with these wipes you get a level of antibiosis on the skin surface that decreases surgical site infections at the time of incisions,” Dr. Pritchard said.
For the operative care part of the bundle, staff were reeducated about the scrubbing protocol, proper attire and limits on operating room traffic, and the correct and timely use of antibiotics (for example, a cephalosporin administered within 30 minutes of incision). Staff also watched a video and were quizzed on the proper technique and timing for preoperative skin preparation.
Increased attention was paid to normothermia and included preoperative use of warming blankets and proper temperature in the operating room and post–anesthesia care unit.
“We’ve learned from colorectal and trauma surgery that normothermia and patient warming lead to reduced SSI,” Dr. Pritchard said. “This hasn’t been proven with cesarean delivery, but we know there’s improved maternal and fetal well-being with preoperative warming.”
Postoperatively, the use of supplemental oxygen was discontinued unless clinically indicated “since it’s been shown to have no positive effect on SSI,” she said. Incision dressing application and removal were also standardized, with sterile dressings maintained for at least 24 hours – with a tag labeling the date and time of application – and no more than 48 hours. At discharge, patients were given clear discharge instructions and a postpartum appointment for an incision check.
During the 3-month sampling period prior to implementation of the care bundle, there were 382 cesarean deliveries, and 147 patients presented for a postpartum appointment (either the prescribed visit or a later “issue visit”) within 30 days (38%). Of these patients, 8.6% were diagnosed with an SSI.
In the postimplementation sampling period, which began 6 months after rollout, there were 361 cesarean deliveries at the hospital, and 297 patients (77%) presented for postpartum care. Of these patients, 2.9% were diagnosed with an SSI.
An analysis based on the total number of cesarean deliveries performed at the hospital (planned and unplanned) during the two 3-month periods showed a decline in the cesarean delivery SSI rate from 3.4% to 2.2%. “This is statistically significant. It shows a dramatic decline in the SSI rate in our patient population … a clear impact of the bundle of care,” Dr. Pritchard said.
The Yale team attributes the significant increase in postoperative visit attendance to the preoperative protocol for planned cesareans. “We think it had something to do with our creating better relationships by having [patients] present preoperatively and starting their care prior to incision,” she said.
The preoperative visit also provided an opportunity to identify and treat any active skin infections, upper respiratory infections, or chronic colonizations (without evidence of completion of treatment) before delivery. “If necessary and if possible, [we could] push back their cesarean section date to ensure adequate treatment had been achieved,” Dr. Pritchard said.
All aspects of the care bundle were rolled out simultaneously. Next steps for the New Haven team include further analysis of provider and patient views, a look at the sustainability of the bundle of care and its impact, and a cost analysis. “We reduced our SSIs, but we’ve also added a number of elements to our care spectrum, pre- and postoperatively,” Dr. Pritchard said.
For now, one thing seems clear: “We learned from cardiac and colorectal surgery that there really is strength in the bundle, that the sum of the parts is greater than the individual aspects,” she said.
Dr. Pritchard reported that she and her coinvestigators have no relevant financial disclosures.
WASHINGTON – The rate of cesarean delivery surgical site infections fell significantly at Yale New Haven (Conn.) Hospital after implementation of a multidisciplinary care bundle with protocols covering preoperative, intraoperative, and postoperative care.
An analysis of two 3-month sampling periods – one before implementation of the bundle of care and one after – showed a drop in the surgical site infection (SSI) rate among total cesarean sections from 3.4% to 2.2%.
At the annual meeting of the American College of Obstetricians and Gynecologists, Dr. Ashley Pritchard of the hospital described the care bundle and urged obstetricians to consider the impact of even small reductions in SSIs after a cesarean.
“Infection is the most common complication following cesarean delivery … 2.5%-16% of all cesarean deliveries will result in a surgical site infection, and there is significant underestimation as between 15% to 80% of infections are diagnosed after patients leave the hospital,” she said.
A cesarean delivery SSI task force created by the hospital’s obstetric patient safety program developed the care bundle after reviewing best practices, guidelines, and evidence-based reviews.
Preoperative protocols for planned cesareans focused on patient education and included a preoperative appointment and instructions for showering the night before surgery, not shaving for more than 24 hours prior to scheduled surgery, using 2% chlorhexidine wipes both the night prior to surgery and the day of surgery, and other hygiene processes.
“We know from numerous studies that chlorhexidine is superior to iodine, but we also have found that with these wipes you get a level of antibiosis on the skin surface that decreases surgical site infections at the time of incisions,” Dr. Pritchard said.
For the operative care part of the bundle, staff were reeducated about the scrubbing protocol, proper attire and limits on operating room traffic, and the correct and timely use of antibiotics (for example, a cephalosporin administered within 30 minutes of incision). Staff also watched a video and were quizzed on the proper technique and timing for preoperative skin preparation.
Increased attention was paid to normothermia and included preoperative use of warming blankets and proper temperature in the operating room and post–anesthesia care unit.
“We’ve learned from colorectal and trauma surgery that normothermia and patient warming lead to reduced SSI,” Dr. Pritchard said. “This hasn’t been proven with cesarean delivery, but we know there’s improved maternal and fetal well-being with preoperative warming.”
Postoperatively, the use of supplemental oxygen was discontinued unless clinically indicated “since it’s been shown to have no positive effect on SSI,” she said. Incision dressing application and removal were also standardized, with sterile dressings maintained for at least 24 hours – with a tag labeling the date and time of application – and no more than 48 hours. At discharge, patients were given clear discharge instructions and a postpartum appointment for an incision check.
During the 3-month sampling period prior to implementation of the care bundle, there were 382 cesarean deliveries, and 147 patients presented for a postpartum appointment (either the prescribed visit or a later “issue visit”) within 30 days (38%). Of these patients, 8.6% were diagnosed with an SSI.
In the postimplementation sampling period, which began 6 months after rollout, there were 361 cesarean deliveries at the hospital, and 297 patients (77%) presented for postpartum care. Of these patients, 2.9% were diagnosed with an SSI.
An analysis based on the total number of cesarean deliveries performed at the hospital (planned and unplanned) during the two 3-month periods showed a decline in the cesarean delivery SSI rate from 3.4% to 2.2%. “This is statistically significant. It shows a dramatic decline in the SSI rate in our patient population … a clear impact of the bundle of care,” Dr. Pritchard said.
The Yale team attributes the significant increase in postoperative visit attendance to the preoperative protocol for planned cesareans. “We think it had something to do with our creating better relationships by having [patients] present preoperatively and starting their care prior to incision,” she said.
The preoperative visit also provided an opportunity to identify and treat any active skin infections, upper respiratory infections, or chronic colonizations (without evidence of completion of treatment) before delivery. “If necessary and if possible, [we could] push back their cesarean section date to ensure adequate treatment had been achieved,” Dr. Pritchard said.
All aspects of the care bundle were rolled out simultaneously. Next steps for the New Haven team include further analysis of provider and patient views, a look at the sustainability of the bundle of care and its impact, and a cost analysis. “We reduced our SSIs, but we’ve also added a number of elements to our care spectrum, pre- and postoperatively,” Dr. Pritchard said.
For now, one thing seems clear: “We learned from cardiac and colorectal surgery that there really is strength in the bundle, that the sum of the parts is greater than the individual aspects,” she said.
Dr. Pritchard reported that she and her coinvestigators have no relevant financial disclosures.
AT ACOG 2016
Key clinical point: A multidisciplinary bundle of care was effective in reducing the rate of surgical site infections with cesarean delivery.
Major finding: The rate of cesarean delivery SSIs decreased from 3.4% to 2.2% after implementation of a care bundle.
Data source: An analysis of a quality improvement project at Yale New Haven Hospital.
Disclosures: Dr. Pritchard reported that she and her coinvestigators have no relevant financial disclosures.
Tamoxifen cuts bleeding associated with etonogestrel contraceptive implant
WASHINGTON – A 1-week course of tamoxifen significantly reduced unscheduled bleeding in women using an etonogestrel contraceptive implant, compared with placebo.
The selective estrogen reuptake modifier cut bleeding days by half, compared with placebo, and in some women induced at least 1 month of amenorrhea, Dr. Katharine Simmons said at the annual meeting of the American College of Obstetricians and Gynecologists.
There were no real downsides to using the drug, added Dr. Simmons, an ob.gyn. in Atlanta. There were no significant differences in adverse events between the two treatment groups.
The 6-month study randomized 56 women to 10 mg tamoxifen twice daily or placebo for 7 days. Women were instructed to begin treatment on the third day of any period of unscheduled bleeding. They could use the drug once each month, for up to three cycles during the study period. Every day, the women had to complete a short bleeding diary. This was administered by a daily text message, which asked them to rate the strength of any bleeding over the last 24 hours, and whether or not they had taken the study drug on that day.
The women were young (mean age 25 years), and most were white (about 80%). More than 60% were nulliparous. They had been using the implant for a mean of 275 days. Upon randomization, those in the tamoxifen group reported more unscheduled bleeding days than did those in the placebo group (mean 23 vs. 20 per 30 days). Ten women in the tamoxifen group reported bleeding almost every day of the prior month.
Thirty days after taking the study drug, bleeding days were significantly reduced in the tamoxifen group, compared with the placebo group. Four of 28 women taking the drug experienced complete amenorrhea; 9 reported 5 days of bleeding. The tamoxifen group reported a median of 6 bleeding days after treatment, compared with 12 days in the placebo group.
The effect was sustained, Dr. Simmons said, with a median of 30 days before bleeding resumed in the tamoxifen group, compared with 8 days in the placebo group. Women taking the drug reported significantly greater levels of satisfaction than did those taking placebo. They also were less likely to discontinue the treatment (18% vs. 36%).
There were no significant differences in side effects. Headache was the most common, with 12 women in each group reporting it. Mood changes occurred in 7 taking tamoxifen and in 12 women taking placebo. Hot flashes were slightly more common in the tamoxifen group (6 vs. 4). Reports of nausea, weight gain, and fluid retention were similar.
Dr. Simmons conducted the study during her time at Oregon Health & Science University in Portland. She had no financial disclosures.
On Twitter @Alz_Gal
WASHINGTON – A 1-week course of tamoxifen significantly reduced unscheduled bleeding in women using an etonogestrel contraceptive implant, compared with placebo.
The selective estrogen reuptake modifier cut bleeding days by half, compared with placebo, and in some women induced at least 1 month of amenorrhea, Dr. Katharine Simmons said at the annual meeting of the American College of Obstetricians and Gynecologists.
There were no real downsides to using the drug, added Dr. Simmons, an ob.gyn. in Atlanta. There were no significant differences in adverse events between the two treatment groups.
The 6-month study randomized 56 women to 10 mg tamoxifen twice daily or placebo for 7 days. Women were instructed to begin treatment on the third day of any period of unscheduled bleeding. They could use the drug once each month, for up to three cycles during the study period. Every day, the women had to complete a short bleeding diary. This was administered by a daily text message, which asked them to rate the strength of any bleeding over the last 24 hours, and whether or not they had taken the study drug on that day.
The women were young (mean age 25 years), and most were white (about 80%). More than 60% were nulliparous. They had been using the implant for a mean of 275 days. Upon randomization, those in the tamoxifen group reported more unscheduled bleeding days than did those in the placebo group (mean 23 vs. 20 per 30 days). Ten women in the tamoxifen group reported bleeding almost every day of the prior month.
Thirty days after taking the study drug, bleeding days were significantly reduced in the tamoxifen group, compared with the placebo group. Four of 28 women taking the drug experienced complete amenorrhea; 9 reported 5 days of bleeding. The tamoxifen group reported a median of 6 bleeding days after treatment, compared with 12 days in the placebo group.
The effect was sustained, Dr. Simmons said, with a median of 30 days before bleeding resumed in the tamoxifen group, compared with 8 days in the placebo group. Women taking the drug reported significantly greater levels of satisfaction than did those taking placebo. They also were less likely to discontinue the treatment (18% vs. 36%).
There were no significant differences in side effects. Headache was the most common, with 12 women in each group reporting it. Mood changes occurred in 7 taking tamoxifen and in 12 women taking placebo. Hot flashes were slightly more common in the tamoxifen group (6 vs. 4). Reports of nausea, weight gain, and fluid retention were similar.
Dr. Simmons conducted the study during her time at Oregon Health & Science University in Portland. She had no financial disclosures.
On Twitter @Alz_Gal
WASHINGTON – A 1-week course of tamoxifen significantly reduced unscheduled bleeding in women using an etonogestrel contraceptive implant, compared with placebo.
The selective estrogen reuptake modifier cut bleeding days by half, compared with placebo, and in some women induced at least 1 month of amenorrhea, Dr. Katharine Simmons said at the annual meeting of the American College of Obstetricians and Gynecologists.
There were no real downsides to using the drug, added Dr. Simmons, an ob.gyn. in Atlanta. There were no significant differences in adverse events between the two treatment groups.
The 6-month study randomized 56 women to 10 mg tamoxifen twice daily or placebo for 7 days. Women were instructed to begin treatment on the third day of any period of unscheduled bleeding. They could use the drug once each month, for up to three cycles during the study period. Every day, the women had to complete a short bleeding diary. This was administered by a daily text message, which asked them to rate the strength of any bleeding over the last 24 hours, and whether or not they had taken the study drug on that day.
The women were young (mean age 25 years), and most were white (about 80%). More than 60% were nulliparous. They had been using the implant for a mean of 275 days. Upon randomization, those in the tamoxifen group reported more unscheduled bleeding days than did those in the placebo group (mean 23 vs. 20 per 30 days). Ten women in the tamoxifen group reported bleeding almost every day of the prior month.
Thirty days after taking the study drug, bleeding days were significantly reduced in the tamoxifen group, compared with the placebo group. Four of 28 women taking the drug experienced complete amenorrhea; 9 reported 5 days of bleeding. The tamoxifen group reported a median of 6 bleeding days after treatment, compared with 12 days in the placebo group.
The effect was sustained, Dr. Simmons said, with a median of 30 days before bleeding resumed in the tamoxifen group, compared with 8 days in the placebo group. Women taking the drug reported significantly greater levels of satisfaction than did those taking placebo. They also were less likely to discontinue the treatment (18% vs. 36%).
There were no significant differences in side effects. Headache was the most common, with 12 women in each group reporting it. Mood changes occurred in 7 taking tamoxifen and in 12 women taking placebo. Hot flashes were slightly more common in the tamoxifen group (6 vs. 4). Reports of nausea, weight gain, and fluid retention were similar.
Dr. Simmons conducted the study during her time at Oregon Health & Science University in Portland. She had no financial disclosures.
On Twitter @Alz_Gal
AT ACOG 2016
Key clinical point: Tamoxifen reduced bleeding days in most and induced extended amenorrhea in some women.
Major finding: Those taking the drug reported a median of 6 bleeding days afterward, compared with 12 in those taking placebo.
Data source: A study randomizing 56 women to 10 mg tamoxifen twice daily for 7 days or a 7-day course of placebo.
Disclosures: Dr. Simmons had no financial disclosures.
Cervical length screening adopted in most academic programs
WASHINGTON – Universal cervical length screening to prevent preterm birth has been implemented by more two-thirds of institutions with maternal-fetal medicine fellowship programs, but less than half of these programs screen with transvaginal ultrasound, a national survey has found.
The survey of 78 accredited programs also revealed geographic variations in the use of routine screening and the ultrasound approach employed, Dr. Adeeb Khalifeh reported at the annual meeting of the American College of Obstetricians and Gynecologists.
All 78 programs responded to the survey. Fifty-three programs (68%) indicated they had implemented a universal screening program, defined as cervical length screening of women with singleton gestations who had not had a prior spontaneous preterm delivery. Of these, 28 use transabdominal ultrasound (TAU) and 25 use transvaginal ultrasound (TVU) for screening.
While the survey shows that a majority of academic institutions now perform universal cervical length screening, it also reveals that “almost one-third do not,” despite strong evidence of an inverse relationship between cervical length and risk of spontaneous preterm birth, said Dr. Khalifeh, a maternal-fetal medicine fellow at Thomas Jefferson University Hospital in Philadelphia who conducted the survey in 2015 with other physicians there.
Both ACOG and the Society for Maternal-Fetal Medicine recommend transvaginal measurements of cervical length for physicians who decide to implement universal cervical length screening.
ACOG’s 2012 Practice Bulletin on Prediction and Prevention of Preterm Birth, which does not mandate universal screening but supports its consideration, notes that, “if second trimester transabdominal scanning of the lower uterine segment suggests that the cervix may be short or have some other abnormality, it is recommended that a subsequent transvaginal ultrasound examination be performed to better visualize the cervix and establish its length” (Obstet Gynecol. 2012 Oct;120:964-73).
Cervical length assessment performed with TAU is unreliable, and it is less cost effective then assessment using TVU, Dr. Khalifeh said.
Vaginal progesterone as a treatment for short cervix in patients with singleton gestations was assessed and proven to be valuable in studies using TVU, not TAU, he noted.
Institutions in the Midwest had the highest rate of universal screening (94%) and the highest use of TVU (58% of programs with routine screening), while programs in the South had the lowest rate of university screening (58%) and the lowest use of TVU (12.5%).
In the Northeast, universal screening was reported by 60% of institutions, and the use of TVU by 40%. Among institutions in the West, 69% reported performing universal screening, with 40% of these programs using TVU.
Obstetrical volume did not impact the implementation of, or approach to, universal cervical length screening; there were no significant differences between institutions with a higher obstetrical volume (more than 3,000 deliveries annually) and a lower volume.
It’s “hard to extrapolate the practice of academic centers [to the community at large], so the findings might not be representative of what’s happening nationwide,” Dr. Khalifeh said.
He reported that he and his coinvestigators had no relevant financial disclosures.
WASHINGTON – Universal cervical length screening to prevent preterm birth has been implemented by more two-thirds of institutions with maternal-fetal medicine fellowship programs, but less than half of these programs screen with transvaginal ultrasound, a national survey has found.
The survey of 78 accredited programs also revealed geographic variations in the use of routine screening and the ultrasound approach employed, Dr. Adeeb Khalifeh reported at the annual meeting of the American College of Obstetricians and Gynecologists.
All 78 programs responded to the survey. Fifty-three programs (68%) indicated they had implemented a universal screening program, defined as cervical length screening of women with singleton gestations who had not had a prior spontaneous preterm delivery. Of these, 28 use transabdominal ultrasound (TAU) and 25 use transvaginal ultrasound (TVU) for screening.
While the survey shows that a majority of academic institutions now perform universal cervical length screening, it also reveals that “almost one-third do not,” despite strong evidence of an inverse relationship between cervical length and risk of spontaneous preterm birth, said Dr. Khalifeh, a maternal-fetal medicine fellow at Thomas Jefferson University Hospital in Philadelphia who conducted the survey in 2015 with other physicians there.
Both ACOG and the Society for Maternal-Fetal Medicine recommend transvaginal measurements of cervical length for physicians who decide to implement universal cervical length screening.
ACOG’s 2012 Practice Bulletin on Prediction and Prevention of Preterm Birth, which does not mandate universal screening but supports its consideration, notes that, “if second trimester transabdominal scanning of the lower uterine segment suggests that the cervix may be short or have some other abnormality, it is recommended that a subsequent transvaginal ultrasound examination be performed to better visualize the cervix and establish its length” (Obstet Gynecol. 2012 Oct;120:964-73).
Cervical length assessment performed with TAU is unreliable, and it is less cost effective then assessment using TVU, Dr. Khalifeh said.
Vaginal progesterone as a treatment for short cervix in patients with singleton gestations was assessed and proven to be valuable in studies using TVU, not TAU, he noted.
Institutions in the Midwest had the highest rate of universal screening (94%) and the highest use of TVU (58% of programs with routine screening), while programs in the South had the lowest rate of university screening (58%) and the lowest use of TVU (12.5%).
In the Northeast, universal screening was reported by 60% of institutions, and the use of TVU by 40%. Among institutions in the West, 69% reported performing universal screening, with 40% of these programs using TVU.
Obstetrical volume did not impact the implementation of, or approach to, universal cervical length screening; there were no significant differences between institutions with a higher obstetrical volume (more than 3,000 deliveries annually) and a lower volume.
It’s “hard to extrapolate the practice of academic centers [to the community at large], so the findings might not be representative of what’s happening nationwide,” Dr. Khalifeh said.
He reported that he and his coinvestigators had no relevant financial disclosures.
WASHINGTON – Universal cervical length screening to prevent preterm birth has been implemented by more two-thirds of institutions with maternal-fetal medicine fellowship programs, but less than half of these programs screen with transvaginal ultrasound, a national survey has found.
The survey of 78 accredited programs also revealed geographic variations in the use of routine screening and the ultrasound approach employed, Dr. Adeeb Khalifeh reported at the annual meeting of the American College of Obstetricians and Gynecologists.
All 78 programs responded to the survey. Fifty-three programs (68%) indicated they had implemented a universal screening program, defined as cervical length screening of women with singleton gestations who had not had a prior spontaneous preterm delivery. Of these, 28 use transabdominal ultrasound (TAU) and 25 use transvaginal ultrasound (TVU) for screening.
While the survey shows that a majority of academic institutions now perform universal cervical length screening, it also reveals that “almost one-third do not,” despite strong evidence of an inverse relationship between cervical length and risk of spontaneous preterm birth, said Dr. Khalifeh, a maternal-fetal medicine fellow at Thomas Jefferson University Hospital in Philadelphia who conducted the survey in 2015 with other physicians there.
Both ACOG and the Society for Maternal-Fetal Medicine recommend transvaginal measurements of cervical length for physicians who decide to implement universal cervical length screening.
ACOG’s 2012 Practice Bulletin on Prediction and Prevention of Preterm Birth, which does not mandate universal screening but supports its consideration, notes that, “if second trimester transabdominal scanning of the lower uterine segment suggests that the cervix may be short or have some other abnormality, it is recommended that a subsequent transvaginal ultrasound examination be performed to better visualize the cervix and establish its length” (Obstet Gynecol. 2012 Oct;120:964-73).
Cervical length assessment performed with TAU is unreliable, and it is less cost effective then assessment using TVU, Dr. Khalifeh said.
Vaginal progesterone as a treatment for short cervix in patients with singleton gestations was assessed and proven to be valuable in studies using TVU, not TAU, he noted.
Institutions in the Midwest had the highest rate of universal screening (94%) and the highest use of TVU (58% of programs with routine screening), while programs in the South had the lowest rate of university screening (58%) and the lowest use of TVU (12.5%).
In the Northeast, universal screening was reported by 60% of institutions, and the use of TVU by 40%. Among institutions in the West, 69% reported performing universal screening, with 40% of these programs using TVU.
Obstetrical volume did not impact the implementation of, or approach to, universal cervical length screening; there were no significant differences between institutions with a higher obstetrical volume (more than 3,000 deliveries annually) and a lower volume.
It’s “hard to extrapolate the practice of academic centers [to the community at large], so the findings might not be representative of what’s happening nationwide,” Dr. Khalifeh said.
He reported that he and his coinvestigators had no relevant financial disclosures.
AT ACOG 2016
Key clinical point: Universal cervical length screening is performed at a majority of academic institutions.
Major finding: More than two-thirds of institutions have adopted universal cervical length screening, but just under half use transvaginal ultrasound.
Data source: A national survey of 78 institutions with accredited maternal-fetal medicine fellowship programs.
Disclosures: Dr. Khalifeh and his coinvestigators reported having relevant financial disclosures.
VIDEO: SCOTUS decision sends contraception mandate to lower courts
WASHINGTON – It will be up to the lower courts to decide how to work out religious exemptions under the Affordable Care Act’s contraception mandate, following the Supreme Court’s decision to remand Zubik v. Burwell back to the U.S. Court of Appeals for the 3rd, 5th, 10th, and District of Columbia Circuits.
In an unusual move, on May 16 the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and has remanded the case back to the four appeals courts that had originally ruled on the issue.
At issue in the case is the implementation of the Affordable Care Act’s contraception mandate and specifically how nonprofit religious employers can opt out of directly paying for their employees’ contraception. The federal government had created a workaround that required employers to submit a form stating that they have religious objections, but the plaintiffs asserted that the process itself was a violation of their religious freedom.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
In March, the high court asked all parties in the case to submit additional briefs outlining how contraception could be provided without requiring notice on the part of the employers. After reviewing the briefs, the Supreme Court justices concluded that “such an option is feasible.”
“Given the gravity of the dispute and the substantial clarification and refinement in the positions of the parties, the parties on remand should be afforded an opportunity to arrive at an approach going forward that accommodates petitioners’ religious exercise while at the same time ensuring that women covered by petitioners’ health plans ‘receive full and equal health coverage, including contraceptive coverage,’ ” the justices wrote in the decision. “We anticipate that the Courts of Appeals will allow the parties sufficient time to resolve any outstanding issues between them.”
The Supreme Court made no decision about the merits of Zubik v. Burwell.
Dr. Sara Imershein, a clinical professor at George Washington University and an ob.gyn. at Planned Parenthood in Washington, said the decision was a disappointment because it requires the courts to sort out a workaround to the contraception mandate when the government has already put one in place. Dr. Imershein, who is a reproductive rights advocate, commented on the news in a video interview while attending the annual meeting of the American College of Obstetricians and Gynecologists.
Dr. Mark S. DeFrancesco, ACOG president, expressed the college’s disappointment in the Supreme Court’s decision.
“ACOG strongly believes that contraception is an essential part of women’s preventive care, and that any accommodation to employers’ beliefs must not impose barriers to women’s ability to access contraception,” Dr. DeFrancesco said in a statement. “We encourage the lower courts to adopt a solution that ensures that coverage is provided seamlessly ‘through petitioner’s insurance companies.’”
mschneider@frontlinemedcom.com
On Twitter @maryellenny
WASHINGTON – It will be up to the lower courts to decide how to work out religious exemptions under the Affordable Care Act’s contraception mandate, following the Supreme Court’s decision to remand Zubik v. Burwell back to the U.S. Court of Appeals for the 3rd, 5th, 10th, and District of Columbia Circuits.
In an unusual move, on May 16 the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and has remanded the case back to the four appeals courts that had originally ruled on the issue.
At issue in the case is the implementation of the Affordable Care Act’s contraception mandate and specifically how nonprofit religious employers can opt out of directly paying for their employees’ contraception. The federal government had created a workaround that required employers to submit a form stating that they have religious objections, but the plaintiffs asserted that the process itself was a violation of their religious freedom.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
In March, the high court asked all parties in the case to submit additional briefs outlining how contraception could be provided without requiring notice on the part of the employers. After reviewing the briefs, the Supreme Court justices concluded that “such an option is feasible.”
“Given the gravity of the dispute and the substantial clarification and refinement in the positions of the parties, the parties on remand should be afforded an opportunity to arrive at an approach going forward that accommodates petitioners’ religious exercise while at the same time ensuring that women covered by petitioners’ health plans ‘receive full and equal health coverage, including contraceptive coverage,’ ” the justices wrote in the decision. “We anticipate that the Courts of Appeals will allow the parties sufficient time to resolve any outstanding issues between them.”
The Supreme Court made no decision about the merits of Zubik v. Burwell.
Dr. Sara Imershein, a clinical professor at George Washington University and an ob.gyn. at Planned Parenthood in Washington, said the decision was a disappointment because it requires the courts to sort out a workaround to the contraception mandate when the government has already put one in place. Dr. Imershein, who is a reproductive rights advocate, commented on the news in a video interview while attending the annual meeting of the American College of Obstetricians and Gynecologists.
Dr. Mark S. DeFrancesco, ACOG president, expressed the college’s disappointment in the Supreme Court’s decision.
“ACOG strongly believes that contraception is an essential part of women’s preventive care, and that any accommodation to employers’ beliefs must not impose barriers to women’s ability to access contraception,” Dr. DeFrancesco said in a statement. “We encourage the lower courts to adopt a solution that ensures that coverage is provided seamlessly ‘through petitioner’s insurance companies.’”
mschneider@frontlinemedcom.com
On Twitter @maryellenny
WASHINGTON – It will be up to the lower courts to decide how to work out religious exemptions under the Affordable Care Act’s contraception mandate, following the Supreme Court’s decision to remand Zubik v. Burwell back to the U.S. Court of Appeals for the 3rd, 5th, 10th, and District of Columbia Circuits.
In an unusual move, on May 16 the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and has remanded the case back to the four appeals courts that had originally ruled on the issue.
At issue in the case is the implementation of the Affordable Care Act’s contraception mandate and specifically how nonprofit religious employers can opt out of directly paying for their employees’ contraception. The federal government had created a workaround that required employers to submit a form stating that they have religious objections, but the plaintiffs asserted that the process itself was a violation of their religious freedom.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
In March, the high court asked all parties in the case to submit additional briefs outlining how contraception could be provided without requiring notice on the part of the employers. After reviewing the briefs, the Supreme Court justices concluded that “such an option is feasible.”
“Given the gravity of the dispute and the substantial clarification and refinement in the positions of the parties, the parties on remand should be afforded an opportunity to arrive at an approach going forward that accommodates petitioners’ religious exercise while at the same time ensuring that women covered by petitioners’ health plans ‘receive full and equal health coverage, including contraceptive coverage,’ ” the justices wrote in the decision. “We anticipate that the Courts of Appeals will allow the parties sufficient time to resolve any outstanding issues between them.”
The Supreme Court made no decision about the merits of Zubik v. Burwell.
Dr. Sara Imershein, a clinical professor at George Washington University and an ob.gyn. at Planned Parenthood in Washington, said the decision was a disappointment because it requires the courts to sort out a workaround to the contraception mandate when the government has already put one in place. Dr. Imershein, who is a reproductive rights advocate, commented on the news in a video interview while attending the annual meeting of the American College of Obstetricians and Gynecologists.
Dr. Mark S. DeFrancesco, ACOG president, expressed the college’s disappointment in the Supreme Court’s decision.
“ACOG strongly believes that contraception is an essential part of women’s preventive care, and that any accommodation to employers’ beliefs must not impose barriers to women’s ability to access contraception,” Dr. DeFrancesco said in a statement. “We encourage the lower courts to adopt a solution that ensures that coverage is provided seamlessly ‘through petitioner’s insurance companies.’”
mschneider@frontlinemedcom.com
On Twitter @maryellenny
AT ACOG 2016
Delays in Receiving Zika Test Results Reported
WASHINGTON – The Centers for Disease Control and Prevention is recommending blood or urine testing for all pregnant women with possible Zika exposure through travel or because they live in an endemic area, regardless of whether they are symptomatic, Dr. Denise J. Jamieson said at the annual meeting of the American College of Obstetricians and Gynecologists.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Couples interested in conceiving who live in or have traveled to areas of active transmission should be alert for any signs of infection, no matter how slight; if they notice any, they should be tested for exposure before attempting conception, Dr. Jamieson, a medical officer with the CDC’s division of reproductive medicine, said in a video interview.
Unfortunately, she said at an update on the Zika situation, labs that process Zika blood and urine samples are backed up, and test results are being “unacceptably delayed.”
During a discussion period, some physicians in the audience complained of waiting up to 6 weeks for results. One said a local health department official told him that the CDC had a backlog of “a million tests.”
“We do not have a 1-million test backup,” Dr. Jamieson said. “But in some places there are still unacceptably long delays. This is not a test you can just check off on a form and send to a lab.”
Many of the tests are being funneled to the CDC’s Division of Vector-Borne Diseases in Ft. Collins, Colo.; that facility is experiencing a long turnaround time. Other samples are being handled in private labs with CDC contracts, but Dr. Jamieson said there’s an urgent need to expand the testing to many more commercial labs. There is no concrete plan for how or when this expansion will happen, however, she added.
Dr. Jamieson also discussed the CDC’s recommendation for managing pregnant women who have a positive serology or urine. These women should have serial ultrasounds every 3-4 weeks to track fetal brain development. Amniocentesis can positively confirm fetal exposure. A maternal-fetal medicine specialist should be on board if the fetus tests positive or if any concerning signs appear on imaging. Newborns can also be tested for exposure, as can placental and cord tissue.
On May 16, the World Health Organization released a comprehensive document describing a management algorithm for pregnant women who live in or travel to Zika-endemic areas.
Women who haven’t experienced signs and symptoms of an infection can proceed with routine care, and, if possible, an ultrasound before 18 weeks’ gestation and another at 28-30 weeks.
Women who have had signs of an infection should be tested for exposure. If negative, routine care with an early ultrasound and one at 28-30 weeks is indicated. If the results are positive, or if an early scan is concerning, patients should have a diagnostic ultrasound and amniocentesis, with referral to specialty care.
In the case of confirmed maternal exposure but normal early ultrasound, serial scans are indicated every month until delivery.
As a federal employee, Dr. Jamieson has no financial disclosures.
WASHINGTON – The Centers for Disease Control and Prevention is recommending blood or urine testing for all pregnant women with possible Zika exposure through travel or because they live in an endemic area, regardless of whether they are symptomatic, Dr. Denise J. Jamieson said at the annual meeting of the American College of Obstetricians and Gynecologists.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Couples interested in conceiving who live in or have traveled to areas of active transmission should be alert for any signs of infection, no matter how slight; if they notice any, they should be tested for exposure before attempting conception, Dr. Jamieson, a medical officer with the CDC’s division of reproductive medicine, said in a video interview.
Unfortunately, she said at an update on the Zika situation, labs that process Zika blood and urine samples are backed up, and test results are being “unacceptably delayed.”
During a discussion period, some physicians in the audience complained of waiting up to 6 weeks for results. One said a local health department official told him that the CDC had a backlog of “a million tests.”
“We do not have a 1-million test backup,” Dr. Jamieson said. “But in some places there are still unacceptably long delays. This is not a test you can just check off on a form and send to a lab.”
Many of the tests are being funneled to the CDC’s Division of Vector-Borne Diseases in Ft. Collins, Colo.; that facility is experiencing a long turnaround time. Other samples are being handled in private labs with CDC contracts, but Dr. Jamieson said there’s an urgent need to expand the testing to many more commercial labs. There is no concrete plan for how or when this expansion will happen, however, she added.
Dr. Jamieson also discussed the CDC’s recommendation for managing pregnant women who have a positive serology or urine. These women should have serial ultrasounds every 3-4 weeks to track fetal brain development. Amniocentesis can positively confirm fetal exposure. A maternal-fetal medicine specialist should be on board if the fetus tests positive or if any concerning signs appear on imaging. Newborns can also be tested for exposure, as can placental and cord tissue.
On May 16, the World Health Organization released a comprehensive document describing a management algorithm for pregnant women who live in or travel to Zika-endemic areas.
Women who haven’t experienced signs and symptoms of an infection can proceed with routine care, and, if possible, an ultrasound before 18 weeks’ gestation and another at 28-30 weeks.
Women who have had signs of an infection should be tested for exposure. If negative, routine care with an early ultrasound and one at 28-30 weeks is indicated. If the results are positive, or if an early scan is concerning, patients should have a diagnostic ultrasound and amniocentesis, with referral to specialty care.
In the case of confirmed maternal exposure but normal early ultrasound, serial scans are indicated every month until delivery.
As a federal employee, Dr. Jamieson has no financial disclosures.
WASHINGTON – The Centers for Disease Control and Prevention is recommending blood or urine testing for all pregnant women with possible Zika exposure through travel or because they live in an endemic area, regardless of whether they are symptomatic, Dr. Denise J. Jamieson said at the annual meeting of the American College of Obstetricians and Gynecologists.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Couples interested in conceiving who live in or have traveled to areas of active transmission should be alert for any signs of infection, no matter how slight; if they notice any, they should be tested for exposure before attempting conception, Dr. Jamieson, a medical officer with the CDC’s division of reproductive medicine, said in a video interview.
Unfortunately, she said at an update on the Zika situation, labs that process Zika blood and urine samples are backed up, and test results are being “unacceptably delayed.”
During a discussion period, some physicians in the audience complained of waiting up to 6 weeks for results. One said a local health department official told him that the CDC had a backlog of “a million tests.”
“We do not have a 1-million test backup,” Dr. Jamieson said. “But in some places there are still unacceptably long delays. This is not a test you can just check off on a form and send to a lab.”
Many of the tests are being funneled to the CDC’s Division of Vector-Borne Diseases in Ft. Collins, Colo.; that facility is experiencing a long turnaround time. Other samples are being handled in private labs with CDC contracts, but Dr. Jamieson said there’s an urgent need to expand the testing to many more commercial labs. There is no concrete plan for how or when this expansion will happen, however, she added.
Dr. Jamieson also discussed the CDC’s recommendation for managing pregnant women who have a positive serology or urine. These women should have serial ultrasounds every 3-4 weeks to track fetal brain development. Amniocentesis can positively confirm fetal exposure. A maternal-fetal medicine specialist should be on board if the fetus tests positive or if any concerning signs appear on imaging. Newborns can also be tested for exposure, as can placental and cord tissue.
On May 16, the World Health Organization released a comprehensive document describing a management algorithm for pregnant women who live in or travel to Zika-endemic areas.
Women who haven’t experienced signs and symptoms of an infection can proceed with routine care, and, if possible, an ultrasound before 18 weeks’ gestation and another at 28-30 weeks.
Women who have had signs of an infection should be tested for exposure. If negative, routine care with an early ultrasound and one at 28-30 weeks is indicated. If the results are positive, or if an early scan is concerning, patients should have a diagnostic ultrasound and amniocentesis, with referral to specialty care.
In the case of confirmed maternal exposure but normal early ultrasound, serial scans are indicated every month until delivery.
As a federal employee, Dr. Jamieson has no financial disclosures.
EXPERT ANALYSIS FROM ACOG 2016
