User login
Meconium-stained amniotic fluid linked to postcesarean SSI
SAN DIEGO – Meconium-stained amniotic fluid may increased risk of surgical site infections following a cesarean delivery, results from a large analysis showed.
Surgical site infection (SSI) occurs in 3%-9% of patients who have a cesarean delivery, and many require hospitalization or further surgery, lead study author Andrea Snyder, MD, PhD, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. Risk factors for SSI included chorioamnionitis, obesity, preeclampsia, preterm premature rupture of membranes, nulliparity, or emergency cesarean. Current management for avoiding SSIs includes prophylactic antibiotics, antiseptic skin, and vaginal prep.
In an effort to test the hypothesis that meconium-stained fluid is an independent risk factor associated with an increased risk of postcesarean SSI, she and her associates evaluated a subset of 25,220 women from the Maternal-Fetal Medicine Units Network cesarean registry who were treated at 19 different institutions. Their mean age was 27 years, they were all attempting labor or induction of labor, were all singleton pregnancies, and all had cesarean deliveries.
Of the 25,220 patients studied, 5,883 (23%) had MSAF. The researchers found that the incidence of SSI was 11.9% among patients who had MSAF, compared with an incidence of 8.9% among patients who did not, a difference that reached statistical significance (P less than .001). After using a multivariable logistic regression model to control for confounders including chorioamnionitis, diabetes, intrauterine pressure catheter placement, tobacco use, length of labor, length of rupture, preeclampsia, and obesity, the association between MSAF and SSI persisted (odds ratio, 1.25; confidence interval, 1.12-1.39; P less than .001).
Advantages of the study, she said, include the fact that it was a large population of patients treated at multiple institutions, “so it should be very generalizable to most practices. We also controlled for many known factors associated with SSI.” Dr. Snyder acknowledged certain limitations of the study, including the fact that the data do not show causation and that there is no further information about the SSIs. “Were those associated with meconium less or more severe SSIs?” she asked. “Does the increase in risk confer an increased risk of severe infectious morbidity? Where do we go from here and what do we do with this information? At this point we don’t have any way of preventing meconium.”
A 2014 Cochrane review found that, while prophylactic antibiotics for patients with MSAF did not decrease the risk of postpartum endometriosis, it did decrease the risk of chorioamnionitis. “But would it help decrease the risk of SSIs? We have no idea,” Dr. Snyder asked. “Would continuing antibiotics after delivery help reduce wound infections? We don’t do that routinely in a C-section, but maybe that would make sense for patients that are higher risk.” She reported having no financial disclosures.
[email protected]
SAN DIEGO – Meconium-stained amniotic fluid may increased risk of surgical site infections following a cesarean delivery, results from a large analysis showed.
Surgical site infection (SSI) occurs in 3%-9% of patients who have a cesarean delivery, and many require hospitalization or further surgery, lead study author Andrea Snyder, MD, PhD, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. Risk factors for SSI included chorioamnionitis, obesity, preeclampsia, preterm premature rupture of membranes, nulliparity, or emergency cesarean. Current management for avoiding SSIs includes prophylactic antibiotics, antiseptic skin, and vaginal prep.
In an effort to test the hypothesis that meconium-stained fluid is an independent risk factor associated with an increased risk of postcesarean SSI, she and her associates evaluated a subset of 25,220 women from the Maternal-Fetal Medicine Units Network cesarean registry who were treated at 19 different institutions. Their mean age was 27 years, they were all attempting labor or induction of labor, were all singleton pregnancies, and all had cesarean deliveries.
Of the 25,220 patients studied, 5,883 (23%) had MSAF. The researchers found that the incidence of SSI was 11.9% among patients who had MSAF, compared with an incidence of 8.9% among patients who did not, a difference that reached statistical significance (P less than .001). After using a multivariable logistic regression model to control for confounders including chorioamnionitis, diabetes, intrauterine pressure catheter placement, tobacco use, length of labor, length of rupture, preeclampsia, and obesity, the association between MSAF and SSI persisted (odds ratio, 1.25; confidence interval, 1.12-1.39; P less than .001).
Advantages of the study, she said, include the fact that it was a large population of patients treated at multiple institutions, “so it should be very generalizable to most practices. We also controlled for many known factors associated with SSI.” Dr. Snyder acknowledged certain limitations of the study, including the fact that the data do not show causation and that there is no further information about the SSIs. “Were those associated with meconium less or more severe SSIs?” she asked. “Does the increase in risk confer an increased risk of severe infectious morbidity? Where do we go from here and what do we do with this information? At this point we don’t have any way of preventing meconium.”
A 2014 Cochrane review found that, while prophylactic antibiotics for patients with MSAF did not decrease the risk of postpartum endometriosis, it did decrease the risk of chorioamnionitis. “But would it help decrease the risk of SSIs? We have no idea,” Dr. Snyder asked. “Would continuing antibiotics after delivery help reduce wound infections? We don’t do that routinely in a C-section, but maybe that would make sense for patients that are higher risk.” She reported having no financial disclosures.
[email protected]
SAN DIEGO – Meconium-stained amniotic fluid may increased risk of surgical site infections following a cesarean delivery, results from a large analysis showed.
Surgical site infection (SSI) occurs in 3%-9% of patients who have a cesarean delivery, and many require hospitalization or further surgery, lead study author Andrea Snyder, MD, PhD, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. Risk factors for SSI included chorioamnionitis, obesity, preeclampsia, preterm premature rupture of membranes, nulliparity, or emergency cesarean. Current management for avoiding SSIs includes prophylactic antibiotics, antiseptic skin, and vaginal prep.
In an effort to test the hypothesis that meconium-stained fluid is an independent risk factor associated with an increased risk of postcesarean SSI, she and her associates evaluated a subset of 25,220 women from the Maternal-Fetal Medicine Units Network cesarean registry who were treated at 19 different institutions. Their mean age was 27 years, they were all attempting labor or induction of labor, were all singleton pregnancies, and all had cesarean deliveries.
Of the 25,220 patients studied, 5,883 (23%) had MSAF. The researchers found that the incidence of SSI was 11.9% among patients who had MSAF, compared with an incidence of 8.9% among patients who did not, a difference that reached statistical significance (P less than .001). After using a multivariable logistic regression model to control for confounders including chorioamnionitis, diabetes, intrauterine pressure catheter placement, tobacco use, length of labor, length of rupture, preeclampsia, and obesity, the association between MSAF and SSI persisted (odds ratio, 1.25; confidence interval, 1.12-1.39; P less than .001).
Advantages of the study, she said, include the fact that it was a large population of patients treated at multiple institutions, “so it should be very generalizable to most practices. We also controlled for many known factors associated with SSI.” Dr. Snyder acknowledged certain limitations of the study, including the fact that the data do not show causation and that there is no further information about the SSIs. “Were those associated with meconium less or more severe SSIs?” she asked. “Does the increase in risk confer an increased risk of severe infectious morbidity? Where do we go from here and what do we do with this information? At this point we don’t have any way of preventing meconium.”
A 2014 Cochrane review found that, while prophylactic antibiotics for patients with MSAF did not decrease the risk of postpartum endometriosis, it did decrease the risk of chorioamnionitis. “But would it help decrease the risk of SSIs? We have no idea,” Dr. Snyder asked. “Would continuing antibiotics after delivery help reduce wound infections? We don’t do that routinely in a C-section, but maybe that would make sense for patients that are higher risk.” She reported having no financial disclosures.
[email protected]
AT ACOG 2017
Key clinical point:
Major finding: The incidence of SSI was 11.9% in patients who had meconium-stained amniotic fluid, compared with an incidence of 8.9% in patients who did not, a difference that reached statistical significance (P less than .001).
Data source: A subset analysis of 25,220 women from the Maternal-Fetal Medicine Networks Cesarean Registry who were treated at 19 different institutions.
Disclosures: Dr. Snyder reported having no financial disclosures.
FDA: Some blood lead tests have reported falsely low levels since 2014
The Food and Drug Administration is recommending repeat lead testing of young children and at-risk women who were tested via a venous blood sample. The recommendation was issued May 17 after the agency discovered a probable 3-year history of inaccurate tests by the nation’s largest lead test distributor.
The tests should be repeated with a capillary sample in children younger than 6 years of age as of May 17, and all pregnant or breastfeeding women who had a lead level of 10 mcg/dL or lower in a venous blood draw tested with any system made by Magellan Diagnostics, FDA representatives said during at a press briefing.
“We do have evidence of a problem with falsely lower lead reading with venous blood,” said Dr. Shuren, director of the FDA Center for Devices and Radiological Health. “Based on the information we have now, we don’t know how often we see this inaccuracy in samples, or how much lower it is. There is a wide variation and a small amount of data. We need to do further testing to see how big the problem is and the root cause. However, we do have enough data to be confident that we don’t have the problem in capillary blood.”
The warning includes all tests run on four of Magellan Diagnostics’ lead testing systems: LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra. All LeadCare systems can be used with blood from a finger or heel stick, including the LeadCare II system – one found in many doctors’ offices and clinics. In addition, some laboratories offer other methods of lead testing, which are not now believed to be affected.
At this point, Magellan isn’t required to pay for any retesting. Tim Hill, acting director of the Center for Medicaid and CHIP Services, who was also on the call, confirmed that retesting will be covered for Medicaid and CHIP recipients. Patients with private insurance will have to contact their insurance companies to ascertain coverage, he said.
“Our first priority is to be sure folks get retested through our programs,” Mr. Hill said during the briefing. “We don’t want reimbursement to hold up the retesting. My understanding is that talks with Magellan with regard to their liability are ongoing.”
Regulators discovered the extent of the problem in March, after Magellan submitted a 510(k) premarket notification for a new iteration of its point-of-care test, FDA spokesperson Tara Goodin said in an interview. The new product was based on a kit approved in 2013, so all tests run on venous blood since then are in question.
During the data review, FDA discovered that customers began complaining to Magellan about inaccurate results on venous blood in 2014. Magellan issued three customer notifications letters (primarily to laboratories) alerting them to testing inaccuracies and recommending mitigations designed to address them. These customer notifications were issued on Nov. 24, 2014; Nov. 4, 2016; and April 28, 2017. In these, the company indicated that about 2.5% of patients whose tests were below the level of medical concern could actually have enough lead to warrant intervention. Magellan suggested that the problem could be solved by holding all samples for 24 hours before mixing them with the reagent – a step the company said would reduce risk of a misread to zero.
Regulators disagreed, Ms. Goodin said.
“Based on available information, the FDA believes that Magellan should have determined that the risk of an inaccurate test result and the number of people that could be adversely affected was much higher than they estimated and that their mitigation might not be adequate to address the increased risk. Instead, the company submitted a malfunction report in 2015 related to an observed increased frequency of falsely low test results in the LeadCare Ultra system that the firm indicated it first identified through the August 2014 complaint.”
In the malfunction report, the company characterized this issue as a Class III recall, which the FDA defines as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
The scope of the problem became apparent only after Magellan submitted its 510(k) paperwork in March, Ms. Goodin said.
“After reviewing initial data available from Magellan on these inaccuracies and their mitigations, the FDA was unable to identify the root cause of the inaccuracies, the frequency and extent of the inaccuracies, or to confirm that the mitigations are effective. While the FDA’s investigation is in its early stages, we did not want to delay warning health care professionals and laboratories about the risk of testing inaccuracies and encouraging parents and at-risk adults to follow the CDC’s recommendations.”
As soon as FDA identified the issue as a potential public health risk, it began working with the Centers for Medicare & Medicaid Services to issue recommendations for laboratories, health care professionals, and at-risk individuals.
“The FDA prioritized communicating to the public about this issue but is also aggressively investigating this issue to determine the cause of the inaccurate results and will provide updates as more is learned,” Ms. Goodin said. “This includes reviewing data provided by the company, requesting additional information from Magellan regarding the issue, and inspecting the company’s facility. The FDA has also requested an independent analysis of the test. We are aggressively investigating this issue and have already sent staff to inspect Magellan’s facility.”
Phone calls to Magellan for clarification on its mitigation procedures, the potential impact on customers, and the history of the LeadCare series’ approvals were not returned at press time, and the company had no prepared statement. A safety communication was posted to its website.
Since 2014, Magellan has run 8 million blood lead tests. Based on the company’s 2.5% estimate of misreads, 200,000 patients tested with the kit could have dangerously high blood lead levels. Currently, the FDA has no official estimate of how many tests were run on venous blood, how many of those returned inaccurate results, or even what caused the tests to read out with falsely low levels, Dr. Shuren said.
“We are investigating the cause, however when [Magellan’s prior test kits] came on the market, there was data supporting their accuracy. The root cause of this, we don’t know. It may not be specific to the test; it may have to do with the tubes, the reactions with chemicals, the way it’s processed. We are looking into all [of] these.”
On Twitter @Alz_gal
The Food and Drug Administration is recommending repeat lead testing of young children and at-risk women who were tested via a venous blood sample. The recommendation was issued May 17 after the agency discovered a probable 3-year history of inaccurate tests by the nation’s largest lead test distributor.
The tests should be repeated with a capillary sample in children younger than 6 years of age as of May 17, and all pregnant or breastfeeding women who had a lead level of 10 mcg/dL or lower in a venous blood draw tested with any system made by Magellan Diagnostics, FDA representatives said during at a press briefing.
“We do have evidence of a problem with falsely lower lead reading with venous blood,” said Dr. Shuren, director of the FDA Center for Devices and Radiological Health. “Based on the information we have now, we don’t know how often we see this inaccuracy in samples, or how much lower it is. There is a wide variation and a small amount of data. We need to do further testing to see how big the problem is and the root cause. However, we do have enough data to be confident that we don’t have the problem in capillary blood.”
The warning includes all tests run on four of Magellan Diagnostics’ lead testing systems: LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra. All LeadCare systems can be used with blood from a finger or heel stick, including the LeadCare II system – one found in many doctors’ offices and clinics. In addition, some laboratories offer other methods of lead testing, which are not now believed to be affected.
At this point, Magellan isn’t required to pay for any retesting. Tim Hill, acting director of the Center for Medicaid and CHIP Services, who was also on the call, confirmed that retesting will be covered for Medicaid and CHIP recipients. Patients with private insurance will have to contact their insurance companies to ascertain coverage, he said.
“Our first priority is to be sure folks get retested through our programs,” Mr. Hill said during the briefing. “We don’t want reimbursement to hold up the retesting. My understanding is that talks with Magellan with regard to their liability are ongoing.”
Regulators discovered the extent of the problem in March, after Magellan submitted a 510(k) premarket notification for a new iteration of its point-of-care test, FDA spokesperson Tara Goodin said in an interview. The new product was based on a kit approved in 2013, so all tests run on venous blood since then are in question.
During the data review, FDA discovered that customers began complaining to Magellan about inaccurate results on venous blood in 2014. Magellan issued three customer notifications letters (primarily to laboratories) alerting them to testing inaccuracies and recommending mitigations designed to address them. These customer notifications were issued on Nov. 24, 2014; Nov. 4, 2016; and April 28, 2017. In these, the company indicated that about 2.5% of patients whose tests were below the level of medical concern could actually have enough lead to warrant intervention. Magellan suggested that the problem could be solved by holding all samples for 24 hours before mixing them with the reagent – a step the company said would reduce risk of a misread to zero.
Regulators disagreed, Ms. Goodin said.
“Based on available information, the FDA believes that Magellan should have determined that the risk of an inaccurate test result and the number of people that could be adversely affected was much higher than they estimated and that their mitigation might not be adequate to address the increased risk. Instead, the company submitted a malfunction report in 2015 related to an observed increased frequency of falsely low test results in the LeadCare Ultra system that the firm indicated it first identified through the August 2014 complaint.”
In the malfunction report, the company characterized this issue as a Class III recall, which the FDA defines as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
The scope of the problem became apparent only after Magellan submitted its 510(k) paperwork in March, Ms. Goodin said.
“After reviewing initial data available from Magellan on these inaccuracies and their mitigations, the FDA was unable to identify the root cause of the inaccuracies, the frequency and extent of the inaccuracies, or to confirm that the mitigations are effective. While the FDA’s investigation is in its early stages, we did not want to delay warning health care professionals and laboratories about the risk of testing inaccuracies and encouraging parents and at-risk adults to follow the CDC’s recommendations.”
As soon as FDA identified the issue as a potential public health risk, it began working with the Centers for Medicare & Medicaid Services to issue recommendations for laboratories, health care professionals, and at-risk individuals.
“The FDA prioritized communicating to the public about this issue but is also aggressively investigating this issue to determine the cause of the inaccurate results and will provide updates as more is learned,” Ms. Goodin said. “This includes reviewing data provided by the company, requesting additional information from Magellan regarding the issue, and inspecting the company’s facility. The FDA has also requested an independent analysis of the test. We are aggressively investigating this issue and have already sent staff to inspect Magellan’s facility.”
Phone calls to Magellan for clarification on its mitigation procedures, the potential impact on customers, and the history of the LeadCare series’ approvals were not returned at press time, and the company had no prepared statement. A safety communication was posted to its website.
Since 2014, Magellan has run 8 million blood lead tests. Based on the company’s 2.5% estimate of misreads, 200,000 patients tested with the kit could have dangerously high blood lead levels. Currently, the FDA has no official estimate of how many tests were run on venous blood, how many of those returned inaccurate results, or even what caused the tests to read out with falsely low levels, Dr. Shuren said.
“We are investigating the cause, however when [Magellan’s prior test kits] came on the market, there was data supporting their accuracy. The root cause of this, we don’t know. It may not be specific to the test; it may have to do with the tubes, the reactions with chemicals, the way it’s processed. We are looking into all [of] these.”
On Twitter @Alz_gal
The Food and Drug Administration is recommending repeat lead testing of young children and at-risk women who were tested via a venous blood sample. The recommendation was issued May 17 after the agency discovered a probable 3-year history of inaccurate tests by the nation’s largest lead test distributor.
The tests should be repeated with a capillary sample in children younger than 6 years of age as of May 17, and all pregnant or breastfeeding women who had a lead level of 10 mcg/dL or lower in a venous blood draw tested with any system made by Magellan Diagnostics, FDA representatives said during at a press briefing.
“We do have evidence of a problem with falsely lower lead reading with venous blood,” said Dr. Shuren, director of the FDA Center for Devices and Radiological Health. “Based on the information we have now, we don’t know how often we see this inaccuracy in samples, or how much lower it is. There is a wide variation and a small amount of data. We need to do further testing to see how big the problem is and the root cause. However, we do have enough data to be confident that we don’t have the problem in capillary blood.”
The warning includes all tests run on four of Magellan Diagnostics’ lead testing systems: LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra. All LeadCare systems can be used with blood from a finger or heel stick, including the LeadCare II system – one found in many doctors’ offices and clinics. In addition, some laboratories offer other methods of lead testing, which are not now believed to be affected.
At this point, Magellan isn’t required to pay for any retesting. Tim Hill, acting director of the Center for Medicaid and CHIP Services, who was also on the call, confirmed that retesting will be covered for Medicaid and CHIP recipients. Patients with private insurance will have to contact their insurance companies to ascertain coverage, he said.
“Our first priority is to be sure folks get retested through our programs,” Mr. Hill said during the briefing. “We don’t want reimbursement to hold up the retesting. My understanding is that talks with Magellan with regard to their liability are ongoing.”
Regulators discovered the extent of the problem in March, after Magellan submitted a 510(k) premarket notification for a new iteration of its point-of-care test, FDA spokesperson Tara Goodin said in an interview. The new product was based on a kit approved in 2013, so all tests run on venous blood since then are in question.
During the data review, FDA discovered that customers began complaining to Magellan about inaccurate results on venous blood in 2014. Magellan issued three customer notifications letters (primarily to laboratories) alerting them to testing inaccuracies and recommending mitigations designed to address them. These customer notifications were issued on Nov. 24, 2014; Nov. 4, 2016; and April 28, 2017. In these, the company indicated that about 2.5% of patients whose tests were below the level of medical concern could actually have enough lead to warrant intervention. Magellan suggested that the problem could be solved by holding all samples for 24 hours before mixing them with the reagent – a step the company said would reduce risk of a misread to zero.
Regulators disagreed, Ms. Goodin said.
“Based on available information, the FDA believes that Magellan should have determined that the risk of an inaccurate test result and the number of people that could be adversely affected was much higher than they estimated and that their mitigation might not be adequate to address the increased risk. Instead, the company submitted a malfunction report in 2015 related to an observed increased frequency of falsely low test results in the LeadCare Ultra system that the firm indicated it first identified through the August 2014 complaint.”
In the malfunction report, the company characterized this issue as a Class III recall, which the FDA defines as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
The scope of the problem became apparent only after Magellan submitted its 510(k) paperwork in March, Ms. Goodin said.
“After reviewing initial data available from Magellan on these inaccuracies and their mitigations, the FDA was unable to identify the root cause of the inaccuracies, the frequency and extent of the inaccuracies, or to confirm that the mitigations are effective. While the FDA’s investigation is in its early stages, we did not want to delay warning health care professionals and laboratories about the risk of testing inaccuracies and encouraging parents and at-risk adults to follow the CDC’s recommendations.”
As soon as FDA identified the issue as a potential public health risk, it began working with the Centers for Medicare & Medicaid Services to issue recommendations for laboratories, health care professionals, and at-risk individuals.
“The FDA prioritized communicating to the public about this issue but is also aggressively investigating this issue to determine the cause of the inaccurate results and will provide updates as more is learned,” Ms. Goodin said. “This includes reviewing data provided by the company, requesting additional information from Magellan regarding the issue, and inspecting the company’s facility. The FDA has also requested an independent analysis of the test. We are aggressively investigating this issue and have already sent staff to inspect Magellan’s facility.”
Phone calls to Magellan for clarification on its mitigation procedures, the potential impact on customers, and the history of the LeadCare series’ approvals were not returned at press time, and the company had no prepared statement. A safety communication was posted to its website.
Since 2014, Magellan has run 8 million blood lead tests. Based on the company’s 2.5% estimate of misreads, 200,000 patients tested with the kit could have dangerously high blood lead levels. Currently, the FDA has no official estimate of how many tests were run on venous blood, how many of those returned inaccurate results, or even what caused the tests to read out with falsely low levels, Dr. Shuren said.
“We are investigating the cause, however when [Magellan’s prior test kits] came on the market, there was data supporting their accuracy. The root cause of this, we don’t know. It may not be specific to the test; it may have to do with the tubes, the reactions with chemicals, the way it’s processed. We are looking into all [of] these.”
On Twitter @Alz_gal
Group prenatal care offers benefits for young mothers
SAN DIEGO – Young women who received group prenatal visits under the CenteringPregnancy model were significantly more likely than were women receiving traditional prenatal care to elect long-acting reversible contraceptives postpartum, results from a small study show.
CenteringPregnancy (CP) – a group prenatal care model for women with due dates around the same time – has been touted as a way to decrease the incidence of preterm deliveries, but little is known about potential additional benefits for other birth-related outcomes, lead study author 
CP sessions “follow the regular prenatal visit structure but the care itself is in a group setting,” said Dr. Roussos-Ross, an ob.gyn. at the University of Florida, Gainesville. “Each session lasts an hour and a half to 2 hours. In that group session, patients receive routine prenatal care and increased knowledge of various topics in pregnancy.”
Dr. Roussos-Ross and her associates set out to compare pregnancy-related outcomes in 20 patients aged 18-21 years who received care through the CP model, with a random sample of 20 patients who received care via the traditional care model in women’s health clinics at the University of Florida Health from January to December of 2014. They found that a significantly higher proportion of women in the CP group were African American, compared with those in the control group (85% vs. 55%, respectively; P = .024). In addition, uptake of long-acting reversible contraceptives was significantly higher among the CP group, compared with the control group (32% vs. 0%; P = .0292).
“One of the centering sessions is revolved around the education of different contraceptive uses, so they get information on the different options that they have,” Dr. Roussos-Ross said.
Differences did not reach statistical significance in other birth-related outcomes, but trends favored the CP group in most of the variables studied, including higher rates of flu vaccination (50% vs. 30%; P = .196), Tdap vaccination (60% vs. 35%; P = .11), breastfeeding initiation (95% vs. 90%; P = .579), and breastfeeding at 6 weeks postpartum (42% vs. 20%; P = .2427). Some adverse outcomes were lower in the CP group, such as low birth weight (0% vs. 10%; P = .1468), and the proportion of patients who failed to appear for their postpartum visit (21% vs. 35%; P = .333).
“The CP program was not able to demonstrate an improved preterm delivery outcome in adolescent mothers,” Dr. Roussos-Ross said. “However, this small study was able to demonstrate complementary benefits of CP in adolescent mothers, including improved breastfeeding rates, immunization rates, and [long-acting reversible contraception] usage rates. Offering adolescent mothers group care allows for greater time with their provider, which in turn may lead to increased knowledge and understanding of health and pregnancy-related outcomes.”
The researchers received grant funding from the March of Dimes for start-up costs.
SAN DIEGO – Young women who received group prenatal visits under the CenteringPregnancy model were significantly more likely than were women receiving traditional prenatal care to elect long-acting reversible contraceptives postpartum, results from a small study show.
CenteringPregnancy (CP) – a group prenatal care model for women with due dates around the same time – has been touted as a way to decrease the incidence of preterm deliveries, but little is known about potential additional benefits for other birth-related outcomes, lead study author
CP sessions “follow the regular prenatal visit structure but the care itself is in a group setting,” said Dr. Roussos-Ross, an ob.gyn. at the University of Florida, Gainesville. “Each session lasts an hour and a half to 2 hours. In that group session, patients receive routine prenatal care and increased knowledge of various topics in pregnancy.”
Dr. Roussos-Ross and her associates set out to compare pregnancy-related outcomes in 20 patients aged 18-21 years who received care through the CP model, with a random sample of 20 patients who received care via the traditional care model in women’s health clinics at the University of Florida Health from January to December of 2014. They found that a significantly higher proportion of women in the CP group were African American, compared with those in the control group (85% vs. 55%, respectively; P = .024). In addition, uptake of long-acting reversible contraceptives was significantly higher among the CP group, compared with the control group (32% vs. 0%; P = .0292).
“One of the centering sessions is revolved around the education of different contraceptive uses, so they get information on the different options that they have,” Dr. Roussos-Ross said.
Differences did not reach statistical significance in other birth-related outcomes, but trends favored the CP group in most of the variables studied, including higher rates of flu vaccination (50% vs. 30%; P = .196), Tdap vaccination (60% vs. 35%; P = .11), breastfeeding initiation (95% vs. 90%; P = .579), and breastfeeding at 6 weeks postpartum (42% vs. 20%; P = .2427). Some adverse outcomes were lower in the CP group, such as low birth weight (0% vs. 10%; P = .1468), and the proportion of patients who failed to appear for their postpartum visit (21% vs. 35%; P = .333).
“The CP program was not able to demonstrate an improved preterm delivery outcome in adolescent mothers,” Dr. Roussos-Ross said. “However, this small study was able to demonstrate complementary benefits of CP in adolescent mothers, including improved breastfeeding rates, immunization rates, and [long-acting reversible contraception] usage rates. Offering adolescent mothers group care allows for greater time with their provider, which in turn may lead to increased knowledge and understanding of health and pregnancy-related outcomes.”
The researchers received grant funding from the March of Dimes for start-up costs.
SAN DIEGO – Young women who received group prenatal visits under the CenteringPregnancy model were significantly more likely than were women receiving traditional prenatal care to elect long-acting reversible contraceptives postpartum, results from a small study show.
CenteringPregnancy (CP) – a group prenatal care model for women with due dates around the same time – has been touted as a way to decrease the incidence of preterm deliveries, but little is known about potential additional benefits for other birth-related outcomes, lead study author
CP sessions “follow the regular prenatal visit structure but the care itself is in a group setting,” said Dr. Roussos-Ross, an ob.gyn. at the University of Florida, Gainesville. “Each session lasts an hour and a half to 2 hours. In that group session, patients receive routine prenatal care and increased knowledge of various topics in pregnancy.”
Dr. Roussos-Ross and her associates set out to compare pregnancy-related outcomes in 20 patients aged 18-21 years who received care through the CP model, with a random sample of 20 patients who received care via the traditional care model in women’s health clinics at the University of Florida Health from January to December of 2014. They found that a significantly higher proportion of women in the CP group were African American, compared with those in the control group (85% vs. 55%, respectively; P = .024). In addition, uptake of long-acting reversible contraceptives was significantly higher among the CP group, compared with the control group (32% vs. 0%; P = .0292).
“One of the centering sessions is revolved around the education of different contraceptive uses, so they get information on the different options that they have,” Dr. Roussos-Ross said.
Differences did not reach statistical significance in other birth-related outcomes, but trends favored the CP group in most of the variables studied, including higher rates of flu vaccination (50% vs. 30%; P = .196), Tdap vaccination (60% vs. 35%; P = .11), breastfeeding initiation (95% vs. 90%; P = .579), and breastfeeding at 6 weeks postpartum (42% vs. 20%; P = .2427). Some adverse outcomes were lower in the CP group, such as low birth weight (0% vs. 10%; P = .1468), and the proportion of patients who failed to appear for their postpartum visit (21% vs. 35%; P = .333).
“The CP program was not able to demonstrate an improved preterm delivery outcome in adolescent mothers,” Dr. Roussos-Ross said. “However, this small study was able to demonstrate complementary benefits of CP in adolescent mothers, including improved breastfeeding rates, immunization rates, and [long-acting reversible contraception] usage rates. Offering adolescent mothers group care allows for greater time with their provider, which in turn may lead to increased knowledge and understanding of health and pregnancy-related outcomes.”
The researchers received grant funding from the March of Dimes for start-up costs.
AT ACOG 2017
Key clinical point:
Major finding: Uptake of long-acting reversible contraceptives was significantly higher among the CenteringPregnancy group compared with the control group (32% vs. 0%; P = .0292).
Data source: A chart review of 20 patients aged 18-21 years who received prenatal care via the CenteringPregnancy model, compared with a random sample of 20 patients who received traditional prenatal care.
Disclosures: The researchers received grant funding from the March of Dimes for start-up costs.
Postcesarean outpatient opioid needs predicted by inpatient use
SAN DIEGO – The amount of pain medication a women requires in the hospital after a cesarean delivery was an accurate predictor of postdischarge needs, and could provide guidance to tailor home prescriptions, reducing the amount of unused opioids left after recovery, according to a new study.
Jenna Emerson, MD, and her colleagues also found that more than half of the opioid medications prescribed for home postcesarean use went untaken, and that one in five women used no opioid medication after leaving the hospital.
The prospective cohort study, one of two awarded the Donald F. Richardson Prize at the meeting, looked at how much opioid medication was used by women while they were inpatients, and also asked women to keep track of how much medication they used at home, to see if one could predict the other.
The pilot study enrolled 100 women who had a postdelivery inpatient stay of less than 8 days, who spoke English, and who had given birth to a live viable infant. The study’s statistical analysis looked for relationships not only between inpatient and outpatient use of opioids, but also between patient characteristics and level of opioid use in the hospital and at home.
A total of 76 women completed follow-up, said Dr. Emerson, who is a fourth-year ob.gyn. resident at Brown University, Providence, R.I. One patient was excluded because she was on high opioid doses for addiction treatment before delivery, and her postdelivery opioid requirements represented a clear outlier in the data.
The investigators used medical record data to determine opioid requirements as inpatients after cesarean delivery. For standardization of different strengths of opioids, use was expressed by using Mean Morphine Equivalents (MME). Baseline patient demographic characteristics and comorbidities were also obtained from medical record review.
Patients were asked to track their home opioid use for 2 weeks postdischarge, and also received a follow-up phone call at the end of their first 2 weeks at home.
Inpatient opioid use was divided into tertiles according to low (less than 40 MME), medium (41-70 MME), and high (greater than 70 MME) use. Overall, the group’s mean opioid use in the final 24 hours before discharge was 59 MME, an amount Dr. Emerson said was equivalent to about eight tablets of oxycodone/acetaminophen or 12 tablets of hydrocodone/acetaminophen.
Most patients (89%) went home with a prescription for oxycodone/acetaminophen, and the mean number of pills prescribed per patient was 35. For the original group of 100 patients, this meant that prescriptions were written for 3,150 oxycodone/acetaminophen tablets, 162 hydrocodone/acetaminophen tablets, and 139 oxycodone tablets.
Home use over the first 2 weeks postdischarge was a mean 126 MME, or the equivalent of about 17 oxycodone/acetaminophen tablets. A total of 39% of women reported they had used less than half of their opioid medication; 21% had used all or required more opioids, and 20% had used at least half of their opioids. One in five patients (20%) had not taken a single opioid tablet after discharge from the hospital, and only 2 of the 75 women were still using opioids at the time of the 2-week follow-up call, Dr. Emerson said.
This means there was a total of 1,538 tablets of unused prescription opioid medication left in the homes of the 75 women included in the final analysis, Dr. Emerson said.
When the investigators compared inpatient and outpatient opioid use, they found that 26 women (34.7%) had been in the lowest tertile of inpatient opioid use. These women also had the lowest mean MME at home, using 53 MME in the first 2 weeks post discharge. The middle tertile for inpatient use used a mean 111 MME at home, while the highest used 195 MME (analysis of variance P less than .001).
Higher outpatient opioid use was seen in patients with a history of psychiatric comorbidities (MME 172 vs. 103 for no psychiatric comorbidities; P = .046). Other factors associated with numerically higher use that did not reach statistical significance included breastfeeding status (MME 197 for no breastfeeding, 112 for breastfeeding; P = .068) and insurance status (MME 154 for public, 95 for private; P = .058).
Patients’ mean age was 30.3 years; 63% of participants were Caucasian, 5% were black, and 19% identified their ethnicity as Hispanic. Patients were about evenly divided between having public and private insurance, and most (72%) had some post-high school education. Just 5% had a prior history of drug use or abuse, and about half (49%) were having a repeat cesarean delivery. Three quarters were breastfeeding their infants.
Unused opioid prescriptions are a significant contributor to the pool of opioids available for diversion and recent work has shown that up to 23% of opioids prescribed are used for “nonmedical” purposes, Dr. Emerson said. Since cesarean deliveries are the most commonly performed major surgery in the United States, the opportunity to reduce the number of opioids available for diversion is significant, she said.
“Opioid prescription use after cesarean delivery should be tailored to patient needs,” she said, calling for larger studies to validate and expand on the findings.
Dr. Emerson reported having no outside sources of funding and no relevant financial disclosures.
[email protected]
On Twitter @karioakes
SAN DIEGO – The amount of pain medication a women requires in the hospital after a cesarean delivery was an accurate predictor of postdischarge needs, and could provide guidance to tailor home prescriptions, reducing the amount of unused opioids left after recovery, according to a new study.
Jenna Emerson, MD, and her colleagues also found that more than half of the opioid medications prescribed for home postcesarean use went untaken, and that one in five women used no opioid medication after leaving the hospital.
The prospective cohort study, one of two awarded the Donald F. Richardson Prize at the meeting, looked at how much opioid medication was used by women while they were inpatients, and also asked women to keep track of how much medication they used at home, to see if one could predict the other.
The pilot study enrolled 100 women who had a postdelivery inpatient stay of less than 8 days, who spoke English, and who had given birth to a live viable infant. The study’s statistical analysis looked for relationships not only between inpatient and outpatient use of opioids, but also between patient characteristics and level of opioid use in the hospital and at home.
A total of 76 women completed follow-up, said Dr. Emerson, who is a fourth-year ob.gyn. resident at Brown University, Providence, R.I. One patient was excluded because she was on high opioid doses for addiction treatment before delivery, and her postdelivery opioid requirements represented a clear outlier in the data.
The investigators used medical record data to determine opioid requirements as inpatients after cesarean delivery. For standardization of different strengths of opioids, use was expressed by using Mean Morphine Equivalents (MME). Baseline patient demographic characteristics and comorbidities were also obtained from medical record review.
Patients were asked to track their home opioid use for 2 weeks postdischarge, and also received a follow-up phone call at the end of their first 2 weeks at home.
Inpatient opioid use was divided into tertiles according to low (less than 40 MME), medium (41-70 MME), and high (greater than 70 MME) use. Overall, the group’s mean opioid use in the final 24 hours before discharge was 59 MME, an amount Dr. Emerson said was equivalent to about eight tablets of oxycodone/acetaminophen or 12 tablets of hydrocodone/acetaminophen.
Most patients (89%) went home with a prescription for oxycodone/acetaminophen, and the mean number of pills prescribed per patient was 35. For the original group of 100 patients, this meant that prescriptions were written for 3,150 oxycodone/acetaminophen tablets, 162 hydrocodone/acetaminophen tablets, and 139 oxycodone tablets.
Home use over the first 2 weeks postdischarge was a mean 126 MME, or the equivalent of about 17 oxycodone/acetaminophen tablets. A total of 39% of women reported they had used less than half of their opioid medication; 21% had used all or required more opioids, and 20% had used at least half of their opioids. One in five patients (20%) had not taken a single opioid tablet after discharge from the hospital, and only 2 of the 75 women were still using opioids at the time of the 2-week follow-up call, Dr. Emerson said.
This means there was a total of 1,538 tablets of unused prescription opioid medication left in the homes of the 75 women included in the final analysis, Dr. Emerson said.
When the investigators compared inpatient and outpatient opioid use, they found that 26 women (34.7%) had been in the lowest tertile of inpatient opioid use. These women also had the lowest mean MME at home, using 53 MME in the first 2 weeks post discharge. The middle tertile for inpatient use used a mean 111 MME at home, while the highest used 195 MME (analysis of variance P less than .001).
Higher outpatient opioid use was seen in patients with a history of psychiatric comorbidities (MME 172 vs. 103 for no psychiatric comorbidities; P = .046). Other factors associated with numerically higher use that did not reach statistical significance included breastfeeding status (MME 197 for no breastfeeding, 112 for breastfeeding; P = .068) and insurance status (MME 154 for public, 95 for private; P = .058).
Patients’ mean age was 30.3 years; 63% of participants were Caucasian, 5% were black, and 19% identified their ethnicity as Hispanic. Patients were about evenly divided between having public and private insurance, and most (72%) had some post-high school education. Just 5% had a prior history of drug use or abuse, and about half (49%) were having a repeat cesarean delivery. Three quarters were breastfeeding their infants.
Unused opioid prescriptions are a significant contributor to the pool of opioids available for diversion and recent work has shown that up to 23% of opioids prescribed are used for “nonmedical” purposes, Dr. Emerson said. Since cesarean deliveries are the most commonly performed major surgery in the United States, the opportunity to reduce the number of opioids available for diversion is significant, she said.
“Opioid prescription use after cesarean delivery should be tailored to patient needs,” she said, calling for larger studies to validate and expand on the findings.
Dr. Emerson reported having no outside sources of funding and no relevant financial disclosures.
[email protected]
On Twitter @karioakes
SAN DIEGO – The amount of pain medication a women requires in the hospital after a cesarean delivery was an accurate predictor of postdischarge needs, and could provide guidance to tailor home prescriptions, reducing the amount of unused opioids left after recovery, according to a new study.
Jenna Emerson, MD, and her colleagues also found that more than half of the opioid medications prescribed for home postcesarean use went untaken, and that one in five women used no opioid medication after leaving the hospital.
The prospective cohort study, one of two awarded the Donald F. Richardson Prize at the meeting, looked at how much opioid medication was used by women while they were inpatients, and also asked women to keep track of how much medication they used at home, to see if one could predict the other.
The pilot study enrolled 100 women who had a postdelivery inpatient stay of less than 8 days, who spoke English, and who had given birth to a live viable infant. The study’s statistical analysis looked for relationships not only between inpatient and outpatient use of opioids, but also between patient characteristics and level of opioid use in the hospital and at home.
A total of 76 women completed follow-up, said Dr. Emerson, who is a fourth-year ob.gyn. resident at Brown University, Providence, R.I. One patient was excluded because she was on high opioid doses for addiction treatment before delivery, and her postdelivery opioid requirements represented a clear outlier in the data.
The investigators used medical record data to determine opioid requirements as inpatients after cesarean delivery. For standardization of different strengths of opioids, use was expressed by using Mean Morphine Equivalents (MME). Baseline patient demographic characteristics and comorbidities were also obtained from medical record review.
Patients were asked to track their home opioid use for 2 weeks postdischarge, and also received a follow-up phone call at the end of their first 2 weeks at home.
Inpatient opioid use was divided into tertiles according to low (less than 40 MME), medium (41-70 MME), and high (greater than 70 MME) use. Overall, the group’s mean opioid use in the final 24 hours before discharge was 59 MME, an amount Dr. Emerson said was equivalent to about eight tablets of oxycodone/acetaminophen or 12 tablets of hydrocodone/acetaminophen.
Most patients (89%) went home with a prescription for oxycodone/acetaminophen, and the mean number of pills prescribed per patient was 35. For the original group of 100 patients, this meant that prescriptions were written for 3,150 oxycodone/acetaminophen tablets, 162 hydrocodone/acetaminophen tablets, and 139 oxycodone tablets.
Home use over the first 2 weeks postdischarge was a mean 126 MME, or the equivalent of about 17 oxycodone/acetaminophen tablets. A total of 39% of women reported they had used less than half of their opioid medication; 21% had used all or required more opioids, and 20% had used at least half of their opioids. One in five patients (20%) had not taken a single opioid tablet after discharge from the hospital, and only 2 of the 75 women were still using opioids at the time of the 2-week follow-up call, Dr. Emerson said.
This means there was a total of 1,538 tablets of unused prescription opioid medication left in the homes of the 75 women included in the final analysis, Dr. Emerson said.
When the investigators compared inpatient and outpatient opioid use, they found that 26 women (34.7%) had been in the lowest tertile of inpatient opioid use. These women also had the lowest mean MME at home, using 53 MME in the first 2 weeks post discharge. The middle tertile for inpatient use used a mean 111 MME at home, while the highest used 195 MME (analysis of variance P less than .001).
Higher outpatient opioid use was seen in patients with a history of psychiatric comorbidities (MME 172 vs. 103 for no psychiatric comorbidities; P = .046). Other factors associated with numerically higher use that did not reach statistical significance included breastfeeding status (MME 197 for no breastfeeding, 112 for breastfeeding; P = .068) and insurance status (MME 154 for public, 95 for private; P = .058).
Patients’ mean age was 30.3 years; 63% of participants were Caucasian, 5% were black, and 19% identified their ethnicity as Hispanic. Patients were about evenly divided between having public and private insurance, and most (72%) had some post-high school education. Just 5% had a prior history of drug use or abuse, and about half (49%) were having a repeat cesarean delivery. Three quarters were breastfeeding their infants.
Unused opioid prescriptions are a significant contributor to the pool of opioids available for diversion and recent work has shown that up to 23% of opioids prescribed are used for “nonmedical” purposes, Dr. Emerson said. Since cesarean deliveries are the most commonly performed major surgery in the United States, the opportunity to reduce the number of opioids available for diversion is significant, she said.
“Opioid prescription use after cesarean delivery should be tailored to patient needs,” she said, calling for larger studies to validate and expand on the findings.
Dr. Emerson reported having no outside sources of funding and no relevant financial disclosures.
[email protected]
On Twitter @karioakes
AT ACOG 2017
Key clinical point:
Major finding: Inpatient opioid use by tertile was highly associated with outpatient opioid use by tertile (P less than .001).
Data source: A prospective cohort study of 75 women with cesarean deliveries of live viable infants.
Disclosures: The study authors reported no outside sources of funding and no conflicts of interest.
Despite CVD risk, few internists screen for prior preeclampsia
SAN DIEGO – Women who have preeclampsia are at increased risk for later cardiovascular disease, yet internists performing well-woman exams were unlikely to have asked their patients about a history of preeclampsia, a small study showed.
Just 21 of 89 women were asked about preeclampsia during a well-woman exam, while 88 of 89 were asked about diabetes or smoking history, and all 89 were asked about hypertension (P = .0002 for comparing preeclampsia to each individual comorbidity).
“There is a screening gap leading to missed opportunities to identify women at risk for cardiovascular disease,” Irene Lewnard, MD, said at the annual meeting of the American College of Obstetricians and Gynecologists.
Dr. Lewnard and her colleagues at the Medical College of Wisconsin, Milwaukee, used a retrospective chart review to see whether internal medicine physicians were asking about preeclampsia as well as traditional CVD risk factors during well-woman exams.
The researchers looked at records from 89 women, aged 18-48 years, who had at least one prior delivery to see whether they were asked about preeclampsia. The review also assessed whether physicians had asked about traditional CVD risk factors: smoking, diabetes, and hypertension.
Of the 89 patients, 6 had a confirmed prior history of preeclampsia. The demographic characteristics and obstetric histories of these patients were not significantly different from those of the larger group. The mean patient age was about 35 years, and the average gravidity was three and parity was two.
Dr. Lewnard, an ob.gyn., and her colleagues looked at charts beginning Jan. 1, 2013, and ending May 31, 2016, after both the American Heart Association (AHA) and the American College of Obstetricians and Gynecologists (ACOG) had issued guidelines that recognized the elevated CVD risk for women with a history of preeclampsia.
In 2011, the AHA issued guidelines that preeclampsia should be listed along with gestational diabetes and gestational hypertension as risk factors for CVD. The AHA called for ob.gyns. to refer patients with these conditions to primary care physicians or cardiologists for follow-up, and recommended that providers include questions about pregnancy-related CVD risk factors when taking a history.
In 2013, ACOG recommended early screening for heart disease for women with a history of preterm or recurrent preeclampsia, to include a consideration for early assessment of blood pressure, body mass index, serum lipids, and fasting blood glucose. The group also recommended counseling on modifiable lifestyle factors for these patients.
Data from several large studies support preeclampsia’s status as an independent risk factor for CVD. A 2001 Norwegian study of more than 600,000 births found that, for women who had preeclampsia and were delivered at term, the relative risk for death from cardiovascular disease was 1.65. However, when women with preeclampsia gave birth before 37 weeks’ gestation, the relative risk for later death from CVD rose to 8.12 (BMJ. 2001;323[7323]:1213-7).
A 2007 systematic review and meta-analysis examined data from 3,488,160 women and found a relative risk of 2.16 for ischemic heart disease after an average 11.7 years of follow-up (BMJ 2007;335:974). Finally, a smaller 2010 California study of 14,403 women found a hazard ratio of 2.14 for CVD-related deaths for all women with a history of preeclampsia. For women whose preeclampsia began before 34 weeks’ gestation, that hazard ratio rose to 9.54 (Hypertension. 2010;56:166-71).
When Dr. Lewnard and her colleagues spoke with the internists who had participated in their study, several raised the point that there are not clear guidelines about how to incorporate a history of preeclampsia into risk calculators or treatment recommendations. This knowledge gap, she said, should be addressed, with an ultimate goal of establishing an interdisciplinary set of guidelines for counseling and management of women with prior preeclampsia.
The investigators are assessing whether adding prompts to the electronic medical record could increase the number of primary care physicians who include preeclampsia questions in their history taking.
Dr. Lewnard and her colleagues reported having no outside sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
SAN DIEGO – Women who have preeclampsia are at increased risk for later cardiovascular disease, yet internists performing well-woman exams were unlikely to have asked their patients about a history of preeclampsia, a small study showed.
Just 21 of 89 women were asked about preeclampsia during a well-woman exam, while 88 of 89 were asked about diabetes or smoking history, and all 89 were asked about hypertension (P = .0002 for comparing preeclampsia to each individual comorbidity).
“There is a screening gap leading to missed opportunities to identify women at risk for cardiovascular disease,” Irene Lewnard, MD, said at the annual meeting of the American College of Obstetricians and Gynecologists.
Dr. Lewnard and her colleagues at the Medical College of Wisconsin, Milwaukee, used a retrospective chart review to see whether internal medicine physicians were asking about preeclampsia as well as traditional CVD risk factors during well-woman exams.
The researchers looked at records from 89 women, aged 18-48 years, who had at least one prior delivery to see whether they were asked about preeclampsia. The review also assessed whether physicians had asked about traditional CVD risk factors: smoking, diabetes, and hypertension.
Of the 89 patients, 6 had a confirmed prior history of preeclampsia. The demographic characteristics and obstetric histories of these patients were not significantly different from those of the larger group. The mean patient age was about 35 years, and the average gravidity was three and parity was two.
Dr. Lewnard, an ob.gyn., and her colleagues looked at charts beginning Jan. 1, 2013, and ending May 31, 2016, after both the American Heart Association (AHA) and the American College of Obstetricians and Gynecologists (ACOG) had issued guidelines that recognized the elevated CVD risk for women with a history of preeclampsia.
In 2011, the AHA issued guidelines that preeclampsia should be listed along with gestational diabetes and gestational hypertension as risk factors for CVD. The AHA called for ob.gyns. to refer patients with these conditions to primary care physicians or cardiologists for follow-up, and recommended that providers include questions about pregnancy-related CVD risk factors when taking a history.
In 2013, ACOG recommended early screening for heart disease for women with a history of preterm or recurrent preeclampsia, to include a consideration for early assessment of blood pressure, body mass index, serum lipids, and fasting blood glucose. The group also recommended counseling on modifiable lifestyle factors for these patients.
Data from several large studies support preeclampsia’s status as an independent risk factor for CVD. A 2001 Norwegian study of more than 600,000 births found that, for women who had preeclampsia and were delivered at term, the relative risk for death from cardiovascular disease was 1.65. However, when women with preeclampsia gave birth before 37 weeks’ gestation, the relative risk for later death from CVD rose to 8.12 (BMJ. 2001;323[7323]:1213-7).
A 2007 systematic review and meta-analysis examined data from 3,488,160 women and found a relative risk of 2.16 for ischemic heart disease after an average 11.7 years of follow-up (BMJ 2007;335:974). Finally, a smaller 2010 California study of 14,403 women found a hazard ratio of 2.14 for CVD-related deaths for all women with a history of preeclampsia. For women whose preeclampsia began before 34 weeks’ gestation, that hazard ratio rose to 9.54 (Hypertension. 2010;56:166-71).
When Dr. Lewnard and her colleagues spoke with the internists who had participated in their study, several raised the point that there are not clear guidelines about how to incorporate a history of preeclampsia into risk calculators or treatment recommendations. This knowledge gap, she said, should be addressed, with an ultimate goal of establishing an interdisciplinary set of guidelines for counseling and management of women with prior preeclampsia.
The investigators are assessing whether adding prompts to the electronic medical record could increase the number of primary care physicians who include preeclampsia questions in their history taking.
Dr. Lewnard and her colleagues reported having no outside sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
SAN DIEGO – Women who have preeclampsia are at increased risk for later cardiovascular disease, yet internists performing well-woman exams were unlikely to have asked their patients about a history of preeclampsia, a small study showed.
Just 21 of 89 women were asked about preeclampsia during a well-woman exam, while 88 of 89 were asked about diabetes or smoking history, and all 89 were asked about hypertension (P = .0002 for comparing preeclampsia to each individual comorbidity).
“There is a screening gap leading to missed opportunities to identify women at risk for cardiovascular disease,” Irene Lewnard, MD, said at the annual meeting of the American College of Obstetricians and Gynecologists.
Dr. Lewnard and her colleagues at the Medical College of Wisconsin, Milwaukee, used a retrospective chart review to see whether internal medicine physicians were asking about preeclampsia as well as traditional CVD risk factors during well-woman exams.
The researchers looked at records from 89 women, aged 18-48 years, who had at least one prior delivery to see whether they were asked about preeclampsia. The review also assessed whether physicians had asked about traditional CVD risk factors: smoking, diabetes, and hypertension.
Of the 89 patients, 6 had a confirmed prior history of preeclampsia. The demographic characteristics and obstetric histories of these patients were not significantly different from those of the larger group. The mean patient age was about 35 years, and the average gravidity was three and parity was two.
Dr. Lewnard, an ob.gyn., and her colleagues looked at charts beginning Jan. 1, 2013, and ending May 31, 2016, after both the American Heart Association (AHA) and the American College of Obstetricians and Gynecologists (ACOG) had issued guidelines that recognized the elevated CVD risk for women with a history of preeclampsia.
In 2011, the AHA issued guidelines that preeclampsia should be listed along with gestational diabetes and gestational hypertension as risk factors for CVD. The AHA called for ob.gyns. to refer patients with these conditions to primary care physicians or cardiologists for follow-up, and recommended that providers include questions about pregnancy-related CVD risk factors when taking a history.
In 2013, ACOG recommended early screening for heart disease for women with a history of preterm or recurrent preeclampsia, to include a consideration for early assessment of blood pressure, body mass index, serum lipids, and fasting blood glucose. The group also recommended counseling on modifiable lifestyle factors for these patients.
Data from several large studies support preeclampsia’s status as an independent risk factor for CVD. A 2001 Norwegian study of more than 600,000 births found that, for women who had preeclampsia and were delivered at term, the relative risk for death from cardiovascular disease was 1.65. However, when women with preeclampsia gave birth before 37 weeks’ gestation, the relative risk for later death from CVD rose to 8.12 (BMJ. 2001;323[7323]:1213-7).
A 2007 systematic review and meta-analysis examined data from 3,488,160 women and found a relative risk of 2.16 for ischemic heart disease after an average 11.7 years of follow-up (BMJ 2007;335:974). Finally, a smaller 2010 California study of 14,403 women found a hazard ratio of 2.14 for CVD-related deaths for all women with a history of preeclampsia. For women whose preeclampsia began before 34 weeks’ gestation, that hazard ratio rose to 9.54 (Hypertension. 2010;56:166-71).
When Dr. Lewnard and her colleagues spoke with the internists who had participated in their study, several raised the point that there are not clear guidelines about how to incorporate a history of preeclampsia into risk calculators or treatment recommendations. This knowledge gap, she said, should be addressed, with an ultimate goal of establishing an interdisciplinary set of guidelines for counseling and management of women with prior preeclampsia.
The investigators are assessing whether adding prompts to the electronic medical record could increase the number of primary care physicians who include preeclampsia questions in their history taking.
Dr. Lewnard and her colleagues reported having no outside sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
AT ACOG 2017
Key clinical point:
Major finding: Of 89 women who received well-woman exams, 21 were asked about prior preeclampsia, while 88 were asked about diabetes and smoking, and 89, about hypertension (P = .0002).
Data source: A retrospective record review of 89 women receiving well-woman exams in the year after the American College of Obstetricians and Gynecologists issued CVD screening guidelines for prior preeclampsia.
Disclosures: The study authors reported having no outside sources of funding and no conflicts of interest.
Los Angeles County encourages LARC use to decrease Zika cases
Los Angeles County, California, has been identified as one of 7 areas in the nation with the highest risk of local Zika transmission by the Centers for Disease Control and Prevention (CDC), advise Adriana Ramos and colleagues from Los Angeles County Department of Public Health (DPH), Maternal, Child & Adolescent Health Programs.1 One factor for this classification is the county’s high birth rate. According to Ramos at el the CDC recommends that, before a Zika outbreak occurs, health departments in areas with Aedes species mosquitos increase access to and use of effective contraception.1 Long-acting reversible contraceptives (LARCs), including the intrauterine device (IUD) and the implant, are proven most effective methods.1
In a poster presented at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical Meeting in San Diego, California, Ramos and colleagues summarized contraceptive use within LA County using data from the Los Angeles Mommy and Baby (LAMB) project, conducted by the Maternal, Child, and Adolescent Health (MCAH) Programs of the LA County DPH, which surveyed mothers who recently delivered a live baby about their preconception and perinatal experiences. In 2012, 6,893 mothers participated. In 2014, MCAH re-interviewed the 2012 LAMB respondents, excluding those with a subsequent pregnancy after the 2012 survey or who had not originally answered questions about family planning, leaving 3,175 respondents. Findings, weighted to the 2012 live-birth cohort, estimated the weighted population at 115,284 live births.1
The study defined contraception use by efficacy, identifying no contraception use, condoms, withdrawal, and the rhythm method as less effective; oral contraceptive pills and vaginal ring as moderately effective; and LARCs and sterilization as highly effective. Unintended births account for 47% of births in LAC and more than 59% of women report using less effective contraceptive methods.1
Results of the study
As a result of their study, MCAH researchers Adriana Ramos, Shin Chao, MD, MPH, and Diana E. Ramos, MD, MPH, conclude that educating providers to place LARC contraceptives and educating the public on the most effective contraceptive methods can decrease the neonatal Zika complication rates by preventing unplanned pregnancy. LAC is undertaking these activities to decrease the number of neonatal Zika cases.1
- Ramos A, Chao S, Ramos DE. Zika: Preconception & perinatal opportunities in Los Angeles County. Poster presented at: American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting; May 6, 2017; San Diego, California.
Los Angeles County, California, has been identified as one of 7 areas in the nation with the highest risk of local Zika transmission by the Centers for Disease Control and Prevention (CDC), advise Adriana Ramos and colleagues from Los Angeles County Department of Public Health (DPH), Maternal, Child & Adolescent Health Programs.1 One factor for this classification is the county’s high birth rate. According to Ramos at el the CDC recommends that, before a Zika outbreak occurs, health departments in areas with Aedes species mosquitos increase access to and use of effective contraception.1 Long-acting reversible contraceptives (LARCs), including the intrauterine device (IUD) and the implant, are proven most effective methods.1
In a poster presented at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical Meeting in San Diego, California, Ramos and colleagues summarized contraceptive use within LA County using data from the Los Angeles Mommy and Baby (LAMB) project, conducted by the Maternal, Child, and Adolescent Health (MCAH) Programs of the LA County DPH, which surveyed mothers who recently delivered a live baby about their preconception and perinatal experiences. In 2012, 6,893 mothers participated. In 2014, MCAH re-interviewed the 2012 LAMB respondents, excluding those with a subsequent pregnancy after the 2012 survey or who had not originally answered questions about family planning, leaving 3,175 respondents. Findings, weighted to the 2012 live-birth cohort, estimated the weighted population at 115,284 live births.1
The study defined contraception use by efficacy, identifying no contraception use, condoms, withdrawal, and the rhythm method as less effective; oral contraceptive pills and vaginal ring as moderately effective; and LARCs and sterilization as highly effective. Unintended births account for 47% of births in LAC and more than 59% of women report using less effective contraceptive methods.1
Results of the study
As a result of their study, MCAH researchers Adriana Ramos, Shin Chao, MD, MPH, and Diana E. Ramos, MD, MPH, conclude that educating providers to place LARC contraceptives and educating the public on the most effective contraceptive methods can decrease the neonatal Zika complication rates by preventing unplanned pregnancy. LAC is undertaking these activities to decrease the number of neonatal Zika cases.1
Los Angeles County, California, has been identified as one of 7 areas in the nation with the highest risk of local Zika transmission by the Centers for Disease Control and Prevention (CDC), advise Adriana Ramos and colleagues from Los Angeles County Department of Public Health (DPH), Maternal, Child & Adolescent Health Programs.1 One factor for this classification is the county’s high birth rate. According to Ramos at el the CDC recommends that, before a Zika outbreak occurs, health departments in areas with Aedes species mosquitos increase access to and use of effective contraception.1 Long-acting reversible contraceptives (LARCs), including the intrauterine device (IUD) and the implant, are proven most effective methods.1
In a poster presented at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical Meeting in San Diego, California, Ramos and colleagues summarized contraceptive use within LA County using data from the Los Angeles Mommy and Baby (LAMB) project, conducted by the Maternal, Child, and Adolescent Health (MCAH) Programs of the LA County DPH, which surveyed mothers who recently delivered a live baby about their preconception and perinatal experiences. In 2012, 6,893 mothers participated. In 2014, MCAH re-interviewed the 2012 LAMB respondents, excluding those with a subsequent pregnancy after the 2012 survey or who had not originally answered questions about family planning, leaving 3,175 respondents. Findings, weighted to the 2012 live-birth cohort, estimated the weighted population at 115,284 live births.1
The study defined contraception use by efficacy, identifying no contraception use, condoms, withdrawal, and the rhythm method as less effective; oral contraceptive pills and vaginal ring as moderately effective; and LARCs and sterilization as highly effective. Unintended births account for 47% of births in LAC and more than 59% of women report using less effective contraceptive methods.1
Results of the study
As a result of their study, MCAH researchers Adriana Ramos, Shin Chao, MD, MPH, and Diana E. Ramos, MD, MPH, conclude that educating providers to place LARC contraceptives and educating the public on the most effective contraceptive methods can decrease the neonatal Zika complication rates by preventing unplanned pregnancy. LAC is undertaking these activities to decrease the number of neonatal Zika cases.1
- Ramos A, Chao S, Ramos DE. Zika: Preconception & perinatal opportunities in Los Angeles County. Poster presented at: American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting; May 6, 2017; San Diego, California.
- Ramos A, Chao S, Ramos DE. Zika: Preconception & perinatal opportunities in Los Angeles County. Poster presented at: American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting; May 6, 2017; San Diego, California.
Infants’ responses to multiple vaccines affected by maternal antibodies
Maternal antibody concentrations continue to affect children’s immune response to their first and later vaccine doses as late as age 2 years, according to study findings.
Greater spacing between doses did not eliminate the maternal antibody effects, the research published in JAMA Pediatrics showed.
“Our analysis comprehensively models the effects of maternal antibody inhibition and infant age at vaccination on the majority of vaccine antigens contained in current global infant immunization programs and reveals that, for almost all antigens, transplacental antibody inhibits the antibody response to priming vaccinations,” wrote Merryn Voysey of the University of Oxford (England), and her associates.
Booster doses do not diminish the effect, the authors add. “These analyses further reveal the benefit of infants being older when first immunized, an association that remains after adjusting for waning maternal antibody levels” (JAMA Pediatrics. 2017 May 15. doi: 10.1001/jamapediatrics.2017.0638).
Although the blunting from maternal antibodies has been long understood for the measles vaccine, this new study showed that even conjugate vaccines have this blunting in infancy, both due to “preexisting antibodies to the polysaccharide antigen [and] from antibodies associated with carrier proteins,” the authors wrote, referring to findings related to pneumococcal conjugate vaccines.
“Therefore, prenatal immunization programs containing multicomponent vaccines have the potential to interfere with the immunogenicity of current immunization programs,” Ms. Voysey and her colleagues wrote.
The authors requested and then analyzed deidentified participant data from GlaxoSmithKline vaccine immunogenicity clinical trials in which antibody concentration data were available before and after infants’ first vaccine dose. The analysis included 7,630 infants enrolled in 32 studies in 17 countries from Europe, Africa, Latin America, East Asia, Russia, and Australia. About half were boys, and infants’ mean age at baseline was 9 weeks.
The researchers found that infants’ antibody responses were blunted for 20 of 21 antigens due to maternal antibodies they still had. The inactivated polio vaccine was affected the most: a maternal antibody twice as high as other infants’ resulted in a 20% lower antibody geometric mean ratio for type 1 and a 28% lower antibody geometric mean ratio for type 2 after vaccination.
All three vaccines in the DTaP showed inhibited responses as well. Having twice as high a maternal antibody for acellular pertussis antigens resulted in an 11% reduction in infants’ antibody for both pertussis toxoid and filamentous hemagglutinin. Antibody for pertactin was 22% lower. Double the maternal antibody for tetanus translated to 13% lower response, and diphtheria antibody was similarly 24% lower.
Even at 12-24 months, children showed a blunted response due to maternal antibodies for the acellular pertussis, inactivated polio, and diphtheria vaccines. For each additional month of age children were when first immunized, their antibody response ranged from 10%-71% greater for 18 of 21 antigens, after accounting for the influence of maternal antibodies.
“In contrast to previous reports, the effects of maternal antibodies and the infant’s age when first immunized are not only seen in response to a priming series of vaccines, but continue to affect antibody responses to booster vaccinations at ages 12 to 24 months for many antigens,” the authors reported. “This finding suggests the importance of the quality of the immune response to the first dose of antigen, regardless of subsequent doses.”
For example, delaying administration of a first vaccine dose by 2-5 weeks resulted in offsetting a two- to fivefold greater concentration of maternal pertussis antibodies. To offset similarly higher maternal antibody concentrations for the other components of the DTaP would require a delay of 3-6 weeks for diphtheria and 2-4 weeks for tetanus.
The research funding came from the National Institute for Health Research via a fellowship of one author and salary support of another. Ms. Voysey had no relevant financial disclosures. Most of her colleagues received research grants or other assistance from pharmaceutical companies.
Maternal antibody concentrations continue to affect children’s immune response to their first and later vaccine doses as late as age 2 years, according to study findings.
Greater spacing between doses did not eliminate the maternal antibody effects, the research published in JAMA Pediatrics showed.
“Our analysis comprehensively models the effects of maternal antibody inhibition and infant age at vaccination on the majority of vaccine antigens contained in current global infant immunization programs and reveals that, for almost all antigens, transplacental antibody inhibits the antibody response to priming vaccinations,” wrote Merryn Voysey of the University of Oxford (England), and her associates.
Booster doses do not diminish the effect, the authors add. “These analyses further reveal the benefit of infants being older when first immunized, an association that remains after adjusting for waning maternal antibody levels” (JAMA Pediatrics. 2017 May 15. doi: 10.1001/jamapediatrics.2017.0638).
Although the blunting from maternal antibodies has been long understood for the measles vaccine, this new study showed that even conjugate vaccines have this blunting in infancy, both due to “preexisting antibodies to the polysaccharide antigen [and] from antibodies associated with carrier proteins,” the authors wrote, referring to findings related to pneumococcal conjugate vaccines.
“Therefore, prenatal immunization programs containing multicomponent vaccines have the potential to interfere with the immunogenicity of current immunization programs,” Ms. Voysey and her colleagues wrote.
The authors requested and then analyzed deidentified participant data from GlaxoSmithKline vaccine immunogenicity clinical trials in which antibody concentration data were available before and after infants’ first vaccine dose. The analysis included 7,630 infants enrolled in 32 studies in 17 countries from Europe, Africa, Latin America, East Asia, Russia, and Australia. About half were boys, and infants’ mean age at baseline was 9 weeks.
The researchers found that infants’ antibody responses were blunted for 20 of 21 antigens due to maternal antibodies they still had. The inactivated polio vaccine was affected the most: a maternal antibody twice as high as other infants’ resulted in a 20% lower antibody geometric mean ratio for type 1 and a 28% lower antibody geometric mean ratio for type 2 after vaccination.
All three vaccines in the DTaP showed inhibited responses as well. Having twice as high a maternal antibody for acellular pertussis antigens resulted in an 11% reduction in infants’ antibody for both pertussis toxoid and filamentous hemagglutinin. Antibody for pertactin was 22% lower. Double the maternal antibody for tetanus translated to 13% lower response, and diphtheria antibody was similarly 24% lower.
Even at 12-24 months, children showed a blunted response due to maternal antibodies for the acellular pertussis, inactivated polio, and diphtheria vaccines. For each additional month of age children were when first immunized, their antibody response ranged from 10%-71% greater for 18 of 21 antigens, after accounting for the influence of maternal antibodies.
“In contrast to previous reports, the effects of maternal antibodies and the infant’s age when first immunized are not only seen in response to a priming series of vaccines, but continue to affect antibody responses to booster vaccinations at ages 12 to 24 months for many antigens,” the authors reported. “This finding suggests the importance of the quality of the immune response to the first dose of antigen, regardless of subsequent doses.”
For example, delaying administration of a first vaccine dose by 2-5 weeks resulted in offsetting a two- to fivefold greater concentration of maternal pertussis antibodies. To offset similarly higher maternal antibody concentrations for the other components of the DTaP would require a delay of 3-6 weeks for diphtheria and 2-4 weeks for tetanus.
The research funding came from the National Institute for Health Research via a fellowship of one author and salary support of another. Ms. Voysey had no relevant financial disclosures. Most of her colleagues received research grants or other assistance from pharmaceutical companies.
Maternal antibody concentrations continue to affect children’s immune response to their first and later vaccine doses as late as age 2 years, according to study findings.
Greater spacing between doses did not eliminate the maternal antibody effects, the research published in JAMA Pediatrics showed.
“Our analysis comprehensively models the effects of maternal antibody inhibition and infant age at vaccination on the majority of vaccine antigens contained in current global infant immunization programs and reveals that, for almost all antigens, transplacental antibody inhibits the antibody response to priming vaccinations,” wrote Merryn Voysey of the University of Oxford (England), and her associates.
Booster doses do not diminish the effect, the authors add. “These analyses further reveal the benefit of infants being older when first immunized, an association that remains after adjusting for waning maternal antibody levels” (JAMA Pediatrics. 2017 May 15. doi: 10.1001/jamapediatrics.2017.0638).
Although the blunting from maternal antibodies has been long understood for the measles vaccine, this new study showed that even conjugate vaccines have this blunting in infancy, both due to “preexisting antibodies to the polysaccharide antigen [and] from antibodies associated with carrier proteins,” the authors wrote, referring to findings related to pneumococcal conjugate vaccines.
“Therefore, prenatal immunization programs containing multicomponent vaccines have the potential to interfere with the immunogenicity of current immunization programs,” Ms. Voysey and her colleagues wrote.
The authors requested and then analyzed deidentified participant data from GlaxoSmithKline vaccine immunogenicity clinical trials in which antibody concentration data were available before and after infants’ first vaccine dose. The analysis included 7,630 infants enrolled in 32 studies in 17 countries from Europe, Africa, Latin America, East Asia, Russia, and Australia. About half were boys, and infants’ mean age at baseline was 9 weeks.
The researchers found that infants’ antibody responses were blunted for 20 of 21 antigens due to maternal antibodies they still had. The inactivated polio vaccine was affected the most: a maternal antibody twice as high as other infants’ resulted in a 20% lower antibody geometric mean ratio for type 1 and a 28% lower antibody geometric mean ratio for type 2 after vaccination.
All three vaccines in the DTaP showed inhibited responses as well. Having twice as high a maternal antibody for acellular pertussis antigens resulted in an 11% reduction in infants’ antibody for both pertussis toxoid and filamentous hemagglutinin. Antibody for pertactin was 22% lower. Double the maternal antibody for tetanus translated to 13% lower response, and diphtheria antibody was similarly 24% lower.
Even at 12-24 months, children showed a blunted response due to maternal antibodies for the acellular pertussis, inactivated polio, and diphtheria vaccines. For each additional month of age children were when first immunized, their antibody response ranged from 10%-71% greater for 18 of 21 antigens, after accounting for the influence of maternal antibodies.
“In contrast to previous reports, the effects of maternal antibodies and the infant’s age when first immunized are not only seen in response to a priming series of vaccines, but continue to affect antibody responses to booster vaccinations at ages 12 to 24 months for many antigens,” the authors reported. “This finding suggests the importance of the quality of the immune response to the first dose of antigen, regardless of subsequent doses.”
For example, delaying administration of a first vaccine dose by 2-5 weeks resulted in offsetting a two- to fivefold greater concentration of maternal pertussis antibodies. To offset similarly higher maternal antibody concentrations for the other components of the DTaP would require a delay of 3-6 weeks for diphtheria and 2-4 weeks for tetanus.
The research funding came from the National Institute for Health Research via a fellowship of one author and salary support of another. Ms. Voysey had no relevant financial disclosures. Most of her colleagues received research grants or other assistance from pharmaceutical companies.
FROM JAMA PEDIATRICS
Key clinical point:
Major finding: Infants’ antibody concentrations after vaccination were inhibited for 20 of 21 antigens after a first dose and for 18 of 21 antigens up to 24 months later.
Data source: The findings are based on an analysis of pre- and postimmunization antibody concentrations to 21 vaccine antigens in 7,630 infants enrolled in 32 immunogenicity clinical studies in 17 countries.
Disclosures: The research funding came from the National Institute for Health Research via a fellowship of one author and salary support of another. Ms. Voysey had no relevant financial disclosures. Most of her colleagues received research grants or other assistance from pharmaceutical companies.
Corticosteroids effective just hours before preterm delivery
Antenatal corticosteroids may significantly decrease neonatal mortality and morbidity even when they are given just hours before preterm delivery, according to a report published online May 15 in JAMA Pediatrics.
In women at risk of preterm delivery, antenatal corticosteroids given between 1 and 7 days before birth reduce infant mortality by an estimated 31%, respiratory distress syndrome by 34%, intraventricular hemorrhage by 46%, and necrotizing enterocolitis by 54%. But until now their effect when given less than 24 hours before preterm birth has been described as “suboptimal,” “partial,” or “incomplete,” said Mikael Norman, MD, PhD, of Karolinska Institutet in Stockholm, Sweden, and his associates.
“Our findings challenge current thinking about the optimal timing” of antenatal corticosteroids and encourage “a more proactive management of women at risk for imminent preterm birth, which may help reduce infant mortality and severe neonatal brain injury,” the investigators said.
To further examine this issue, they assessed the effects of antenatal corticosteroids when given at different intervals before preterm birth, using data from a prospective cohort study of perinatal intensive care. That study involved 10,329 very preterm births throughout 11 countries in Europe during a 1-year period.
For their analysis, Dr. Norman and his associates focused on 4,594 singleton births at 24-31 weeks’ gestation. They classified the timing of antenatal corticosteroids into four categories: no injections (662 infants, or 14.4% of the study population), first injection at less than 24 hours before birth (1,111 infants, or 24.2%), first injection at the recommended 1-7 days before birth (1,871 infants, or 40.7%), and first injection more than 7 days before birth (950 infants, or 20.7%).
Receiving antenatal corticosteroids at any interval before preterm birth was associated with lower infant mortality, a lower rate of severe neonatal morbidity, and a lower rate of severe neonatal brain injury, compared with not receiving any antenatal corticosteroids. The largest reduction in risk (more than 50%) occurred at the recommended interval of 1-7 days before birth. However, receiving the treatment less than 24 hours before birth also significantly reduced these risks (JAMA Pediatr. 2017 May 15. doi: 10.1001/jamapediatrics.2017.0602).
Using their findings on treatment intervals and effectiveness, the investigators created a simulation model for the 661 infants in this cohort who did not receive any antenatal corticosteroids. Their model predicted that if these infants had received treatment at least 3 hours before delivery, overall mortality would have decreased by 26%. If they had received treatment 3-5 hours before delivery, mortality would have decreased by 37%, and if they had received treatment at 6-12 hours before delivery it would have decreased by 51%.
At the other end of the timing spectrum, infant mortality increased 40% when corticosteroids were given more than 7 days before delivery, compared with when they were given within the recommended 1-7 days. This represents a substantial number of infants – approximately 20% of the study cohort.
The study was supported by the European Union, the French Institute of Public Health, the Polish Ministry of Science and Higher Education, the Karolinska Institutet, and other nonindustry sources. Dr. Norman and his associates reported having no relevant financial disclosures.
Antenatal corticosteroids may significantly decrease neonatal mortality and morbidity even when they are given just hours before preterm delivery, according to a report published online May 15 in JAMA Pediatrics.
In women at risk of preterm delivery, antenatal corticosteroids given between 1 and 7 days before birth reduce infant mortality by an estimated 31%, respiratory distress syndrome by 34%, intraventricular hemorrhage by 46%, and necrotizing enterocolitis by 54%. But until now their effect when given less than 24 hours before preterm birth has been described as “suboptimal,” “partial,” or “incomplete,” said Mikael Norman, MD, PhD, of Karolinska Institutet in Stockholm, Sweden, and his associates.
“Our findings challenge current thinking about the optimal timing” of antenatal corticosteroids and encourage “a more proactive management of women at risk for imminent preterm birth, which may help reduce infant mortality and severe neonatal brain injury,” the investigators said.
To further examine this issue, they assessed the effects of antenatal corticosteroids when given at different intervals before preterm birth, using data from a prospective cohort study of perinatal intensive care. That study involved 10,329 very preterm births throughout 11 countries in Europe during a 1-year period.
For their analysis, Dr. Norman and his associates focused on 4,594 singleton births at 24-31 weeks’ gestation. They classified the timing of antenatal corticosteroids into four categories: no injections (662 infants, or 14.4% of the study population), first injection at less than 24 hours before birth (1,111 infants, or 24.2%), first injection at the recommended 1-7 days before birth (1,871 infants, or 40.7%), and first injection more than 7 days before birth (950 infants, or 20.7%).
Receiving antenatal corticosteroids at any interval before preterm birth was associated with lower infant mortality, a lower rate of severe neonatal morbidity, and a lower rate of severe neonatal brain injury, compared with not receiving any antenatal corticosteroids. The largest reduction in risk (more than 50%) occurred at the recommended interval of 1-7 days before birth. However, receiving the treatment less than 24 hours before birth also significantly reduced these risks (JAMA Pediatr. 2017 May 15. doi: 10.1001/jamapediatrics.2017.0602).
Using their findings on treatment intervals and effectiveness, the investigators created a simulation model for the 661 infants in this cohort who did not receive any antenatal corticosteroids. Their model predicted that if these infants had received treatment at least 3 hours before delivery, overall mortality would have decreased by 26%. If they had received treatment 3-5 hours before delivery, mortality would have decreased by 37%, and if they had received treatment at 6-12 hours before delivery it would have decreased by 51%.
At the other end of the timing spectrum, infant mortality increased 40% when corticosteroids were given more than 7 days before delivery, compared with when they were given within the recommended 1-7 days. This represents a substantial number of infants – approximately 20% of the study cohort.
The study was supported by the European Union, the French Institute of Public Health, the Polish Ministry of Science and Higher Education, the Karolinska Institutet, and other nonindustry sources. Dr. Norman and his associates reported having no relevant financial disclosures.
Antenatal corticosteroids may significantly decrease neonatal mortality and morbidity even when they are given just hours before preterm delivery, according to a report published online May 15 in JAMA Pediatrics.
In women at risk of preterm delivery, antenatal corticosteroids given between 1 and 7 days before birth reduce infant mortality by an estimated 31%, respiratory distress syndrome by 34%, intraventricular hemorrhage by 46%, and necrotizing enterocolitis by 54%. But until now their effect when given less than 24 hours before preterm birth has been described as “suboptimal,” “partial,” or “incomplete,” said Mikael Norman, MD, PhD, of Karolinska Institutet in Stockholm, Sweden, and his associates.
“Our findings challenge current thinking about the optimal timing” of antenatal corticosteroids and encourage “a more proactive management of women at risk for imminent preterm birth, which may help reduce infant mortality and severe neonatal brain injury,” the investigators said.
To further examine this issue, they assessed the effects of antenatal corticosteroids when given at different intervals before preterm birth, using data from a prospective cohort study of perinatal intensive care. That study involved 10,329 very preterm births throughout 11 countries in Europe during a 1-year period.
For their analysis, Dr. Norman and his associates focused on 4,594 singleton births at 24-31 weeks’ gestation. They classified the timing of antenatal corticosteroids into four categories: no injections (662 infants, or 14.4% of the study population), first injection at less than 24 hours before birth (1,111 infants, or 24.2%), first injection at the recommended 1-7 days before birth (1,871 infants, or 40.7%), and first injection more than 7 days before birth (950 infants, or 20.7%).
Receiving antenatal corticosteroids at any interval before preterm birth was associated with lower infant mortality, a lower rate of severe neonatal morbidity, and a lower rate of severe neonatal brain injury, compared with not receiving any antenatal corticosteroids. The largest reduction in risk (more than 50%) occurred at the recommended interval of 1-7 days before birth. However, receiving the treatment less than 24 hours before birth also significantly reduced these risks (JAMA Pediatr. 2017 May 15. doi: 10.1001/jamapediatrics.2017.0602).
Using their findings on treatment intervals and effectiveness, the investigators created a simulation model for the 661 infants in this cohort who did not receive any antenatal corticosteroids. Their model predicted that if these infants had received treatment at least 3 hours before delivery, overall mortality would have decreased by 26%. If they had received treatment 3-5 hours before delivery, mortality would have decreased by 37%, and if they had received treatment at 6-12 hours before delivery it would have decreased by 51%.
At the other end of the timing spectrum, infant mortality increased 40% when corticosteroids were given more than 7 days before delivery, compared with when they were given within the recommended 1-7 days. This represents a substantial number of infants – approximately 20% of the study cohort.
The study was supported by the European Union, the French Institute of Public Health, the Polish Ministry of Science and Higher Education, the Karolinska Institutet, and other nonindustry sources. Dr. Norman and his associates reported having no relevant financial disclosures.
Key clinical point:
Major finding: A simulation model predicted that if untreated infants had received antenatal corticosteroids 6-12 hours before delivery, overall mortality would have decreased by 51%.
Data source: A secondary analysis of data from a population-based cohort study of perinatal intensive care across Europe, involving 4,594 preterm singleton births.
Disclosures: The study was supported by the European Union, the French Institute of Public Health, the Polish Ministry of Science and Higher Education, the Karolinska Institutet, and other nonindustry sources. Dr. Norman and his associates reported having no relevant financial disclosures.
Children’s asthma risk reduced with prenatal vitamin D supplementation
SAN FRANCISCO – Vitamin D supplementation during pregnancy may reduce the incidence of asthma or allergies in children at high risk for atopic disease, a study showed.
At age 3 years, asthma or recurrent wheeze occurred in 24% of children born to mothers with substantial vitamin D3 supplementation in pregnancy, compared with 30% of children whose mothers took a placebo during pregnancy.
However, observational study findings on vitamin D deficiency in pregnancy and asthma risk have been mixed, with no effect seen in research using measurements of 25OHD levels, despite protective effects seen in studies estimating vitamin D intake based on diet. Dr. Litonjua, therefore, led a randomized, controlled trial at three clinical centers to test whether vitamin D supplementation in pregnancy could prevent children at high risk of asthma from developing the condition. High-risk status was based on the presence of maternal and/or paternal asthma, allergic rhinitis, or eczema.
The 881 initial participants, enrolled between October 2009 and January 2015, were randomized to receive either 4,000 IU daily of vitamin D3 (440 women) or a placebo daily (436 women). Both groups took a multivitamin that contained 400 IU of vitamin D3. The participants included 43% black women, 26% white women, 14% Hispanic women, and 17% of other races/ethnicities.
The researchers collected maternal blood at the start of the study, between 32 and 38 weeks’ post partum, and at 1-year post partum. They collected cord blood at birth and then children’s blood at 1, 3, and 6 years old. At the third trimester, 87% of the women in the intervention group and 72% of the control group women had at least 50 nmol/L of 25OHD. Levels of at least 75 nmol/L were present in 75% of the intervention group and 35% of the control group in the third trimester.
Primary follow-up occurred at 3 years old with continuing follow-up through 6 years old, but data also were collected every 3 months regarding asthma and allergy symptoms and environmental exposures and diet. Stool was collected for microbiome analysis at 6 months, 1 year, and 3 years, and then annually after age 3 years. Children’s lung function was assessed with impulse oscillometry annually starting at age 4 years, with spirometry annually starting at age 5 years, and with bronchodilator response at age 6 years, Dr. Litonjua reported at the Pediatric Academic Societies meeting.
Just over one-quarter (27%) of the 806 children included in the final analysis had parental report of either an asthma diagnosis or recurrent wheeze, defined using any of five criteria involving multiple wheeze reports and/or use of an asthma controller. Rates of asthma or wheeze were significantly lower in children of women supplemented with 4,400 IU of vitamin D than in those born to women in the control group.
At age 1 year, the rate of asthma or wheeze among children from the intervention group was 9 percentage points lower than that of children from the control group, a 36% reduction. By age 2 years, the rate difference was 7%, a 25% reduced risk for intervention children, compared with control children. Children from the intervention group had a 20% lower risk of asthma or wheeze at age 3 years than those from the control group, with a rate difference of 6% (P = .051).
“Both maternal baseline 25OHD levels and third-trimester 25OHD levels were inversely associated with asthma/recurrent wheeze by age 3 years,” Dr. Litonjua reported, and relative risk at age 3 years was identical in black and white children. Maternal levels of 25OHD in the first trimester, however, “modified the effects of supplementation such that children born to women with higher levels and [who] were in the treatment arm had lowest risks for asthma/recurrent wheeze,” he said.
The greater reduction among women with higher baseline levels and supplementation suggests that higher levels than 30 ng/mL may be necessary for the prevention of asthma or allergies, Dr. Litonjua said. Personalized dosing or earlier supplementation may, therefore, be needed, he said.
“One of the main findings from our trial was that there were no serious adverse effects,” he said. Other trials, however, have found concerns with vitamin D toxicity. One challenge in the study was very low adherence: Only about half the women regularly took their vitamin D supplements at first, Dr. Litonjua said, although they were eventually able to raise adherence to around 80%.
The research was funded by the National Heart, Lung, and Blood Institute. Dr. Litonjua reported royalties from UpToDate and Springer Humana Press and consultation fees from AstraZeneca.
SAN FRANCISCO – Vitamin D supplementation during pregnancy may reduce the incidence of asthma or allergies in children at high risk for atopic disease, a study showed.
At age 3 years, asthma or recurrent wheeze occurred in 24% of children born to mothers with substantial vitamin D3 supplementation in pregnancy, compared with 30% of children whose mothers took a placebo during pregnancy.
However, observational study findings on vitamin D deficiency in pregnancy and asthma risk have been mixed, with no effect seen in research using measurements of 25OHD levels, despite protective effects seen in studies estimating vitamin D intake based on diet. Dr. Litonjua, therefore, led a randomized, controlled trial at three clinical centers to test whether vitamin D supplementation in pregnancy could prevent children at high risk of asthma from developing the condition. High-risk status was based on the presence of maternal and/or paternal asthma, allergic rhinitis, or eczema.
The 881 initial participants, enrolled between October 2009 and January 2015, were randomized to receive either 4,000 IU daily of vitamin D3 (440 women) or a placebo daily (436 women). Both groups took a multivitamin that contained 400 IU of vitamin D3. The participants included 43% black women, 26% white women, 14% Hispanic women, and 17% of other races/ethnicities.
The researchers collected maternal blood at the start of the study, between 32 and 38 weeks’ post partum, and at 1-year post partum. They collected cord blood at birth and then children’s blood at 1, 3, and 6 years old. At the third trimester, 87% of the women in the intervention group and 72% of the control group women had at least 50 nmol/L of 25OHD. Levels of at least 75 nmol/L were present in 75% of the intervention group and 35% of the control group in the third trimester.
Primary follow-up occurred at 3 years old with continuing follow-up through 6 years old, but data also were collected every 3 months regarding asthma and allergy symptoms and environmental exposures and diet. Stool was collected for microbiome analysis at 6 months, 1 year, and 3 years, and then annually after age 3 years. Children’s lung function was assessed with impulse oscillometry annually starting at age 4 years, with spirometry annually starting at age 5 years, and with bronchodilator response at age 6 years, Dr. Litonjua reported at the Pediatric Academic Societies meeting.
Just over one-quarter (27%) of the 806 children included in the final analysis had parental report of either an asthma diagnosis or recurrent wheeze, defined using any of five criteria involving multiple wheeze reports and/or use of an asthma controller. Rates of asthma or wheeze were significantly lower in children of women supplemented with 4,400 IU of vitamin D than in those born to women in the control group.
At age 1 year, the rate of asthma or wheeze among children from the intervention group was 9 percentage points lower than that of children from the control group, a 36% reduction. By age 2 years, the rate difference was 7%, a 25% reduced risk for intervention children, compared with control children. Children from the intervention group had a 20% lower risk of asthma or wheeze at age 3 years than those from the control group, with a rate difference of 6% (P = .051).
“Both maternal baseline 25OHD levels and third-trimester 25OHD levels were inversely associated with asthma/recurrent wheeze by age 3 years,” Dr. Litonjua reported, and relative risk at age 3 years was identical in black and white children. Maternal levels of 25OHD in the first trimester, however, “modified the effects of supplementation such that children born to women with higher levels and [who] were in the treatment arm had lowest risks for asthma/recurrent wheeze,” he said.
The greater reduction among women with higher baseline levels and supplementation suggests that higher levels than 30 ng/mL may be necessary for the prevention of asthma or allergies, Dr. Litonjua said. Personalized dosing or earlier supplementation may, therefore, be needed, he said.
“One of the main findings from our trial was that there were no serious adverse effects,” he said. Other trials, however, have found concerns with vitamin D toxicity. One challenge in the study was very low adherence: Only about half the women regularly took their vitamin D supplements at first, Dr. Litonjua said, although they were eventually able to raise adherence to around 80%.
The research was funded by the National Heart, Lung, and Blood Institute. Dr. Litonjua reported royalties from UpToDate and Springer Humana Press and consultation fees from AstraZeneca.
SAN FRANCISCO – Vitamin D supplementation during pregnancy may reduce the incidence of asthma or allergies in children at high risk for atopic disease, a study showed.
At age 3 years, asthma or recurrent wheeze occurred in 24% of children born to mothers with substantial vitamin D3 supplementation in pregnancy, compared with 30% of children whose mothers took a placebo during pregnancy.
However, observational study findings on vitamin D deficiency in pregnancy and asthma risk have been mixed, with no effect seen in research using measurements of 25OHD levels, despite protective effects seen in studies estimating vitamin D intake based on diet. Dr. Litonjua, therefore, led a randomized, controlled trial at three clinical centers to test whether vitamin D supplementation in pregnancy could prevent children at high risk of asthma from developing the condition. High-risk status was based on the presence of maternal and/or paternal asthma, allergic rhinitis, or eczema.
The 881 initial participants, enrolled between October 2009 and January 2015, were randomized to receive either 4,000 IU daily of vitamin D3 (440 women) or a placebo daily (436 women). Both groups took a multivitamin that contained 400 IU of vitamin D3. The participants included 43% black women, 26% white women, 14% Hispanic women, and 17% of other races/ethnicities.
The researchers collected maternal blood at the start of the study, between 32 and 38 weeks’ post partum, and at 1-year post partum. They collected cord blood at birth and then children’s blood at 1, 3, and 6 years old. At the third trimester, 87% of the women in the intervention group and 72% of the control group women had at least 50 nmol/L of 25OHD. Levels of at least 75 nmol/L were present in 75% of the intervention group and 35% of the control group in the third trimester.
Primary follow-up occurred at 3 years old with continuing follow-up through 6 years old, but data also were collected every 3 months regarding asthma and allergy symptoms and environmental exposures and diet. Stool was collected for microbiome analysis at 6 months, 1 year, and 3 years, and then annually after age 3 years. Children’s lung function was assessed with impulse oscillometry annually starting at age 4 years, with spirometry annually starting at age 5 years, and with bronchodilator response at age 6 years, Dr. Litonjua reported at the Pediatric Academic Societies meeting.
Just over one-quarter (27%) of the 806 children included in the final analysis had parental report of either an asthma diagnosis or recurrent wheeze, defined using any of five criteria involving multiple wheeze reports and/or use of an asthma controller. Rates of asthma or wheeze were significantly lower in children of women supplemented with 4,400 IU of vitamin D than in those born to women in the control group.
At age 1 year, the rate of asthma or wheeze among children from the intervention group was 9 percentage points lower than that of children from the control group, a 36% reduction. By age 2 years, the rate difference was 7%, a 25% reduced risk for intervention children, compared with control children. Children from the intervention group had a 20% lower risk of asthma or wheeze at age 3 years than those from the control group, with a rate difference of 6% (P = .051).
“Both maternal baseline 25OHD levels and third-trimester 25OHD levels were inversely associated with asthma/recurrent wheeze by age 3 years,” Dr. Litonjua reported, and relative risk at age 3 years was identical in black and white children. Maternal levels of 25OHD in the first trimester, however, “modified the effects of supplementation such that children born to women with higher levels and [who] were in the treatment arm had lowest risks for asthma/recurrent wheeze,” he said.
The greater reduction among women with higher baseline levels and supplementation suggests that higher levels than 30 ng/mL may be necessary for the prevention of asthma or allergies, Dr. Litonjua said. Personalized dosing or earlier supplementation may, therefore, be needed, he said.
“One of the main findings from our trial was that there were no serious adverse effects,” he said. Other trials, however, have found concerns with vitamin D toxicity. One challenge in the study was very low adherence: Only about half the women regularly took their vitamin D supplements at first, Dr. Litonjua said, although they were eventually able to raise adherence to around 80%.
The research was funded by the National Heart, Lung, and Blood Institute. Dr. Litonjua reported royalties from UpToDate and Springer Humana Press and consultation fees from AstraZeneca.
AT PAS 2017
Key clinical point: Higher levels of vitamin D3 in pregnancy led to a reduced risk of asthma or allergies in subsequent children at high risk for the condition.
Major finding: (P = .051).
Data source: A randomized controlled trial at three clinical centers from October 2009 through January 2015, involving 881 pregnant women whose children had a high risk of asthma or allergies and 806 subsequent children.
Disclosures: The research was funded by the National Heart, Lung, and Blood Institute. Dr. Litonjua reported royalties from UpToDate and Springer Humana Press, and consultation fees from AstraZeneca.
HCV pregnancy increase suggests need for broader screening
Hepatitis C virus (HCV) infection among women giving birth increased 89% from 1.8 cases per 1,000 live births in 2009 to 3.4 cases in 2014, translating to about 35 infants exposed to the virus per day in the United States in 2014, according to the May 11 Morbidity and Mortality Weekly Report.
The highest rate in 2014 was in West Virginia, with 22.6 cases per 1,000 live births. The lowest was in Hawaii, with 0.7 cases.
“The prevalence of maternal HCV infection appears to have increased sharply in the United States. ... Ensuring that women of childbearing age have access to HCV testing and treatment and consideration of universal screening among women of reproductive age residing in areas with high HCV prevalence might mitigate risk and prevent transmission,” said investigators led by Stephen Patrick, MD, of the division of neonatology at Vanderbilt University, Nashville (MMWR. 2017;66[18]:470-3).
Both the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists recommend selective screening of pregnant women at high risk for HCV infection, including intravenous drug users and long-term hemodialysis patients.
“These data might inform expansion of the definition of women at risk.” Generally, about 6% of infants will pick up HCV from their mother during delivery. Screening and treating women of childbearing could reduce the risk, the investigators said.
The analysis was based on U.S. birth certificate data. Risk factors were identified using Tennessee birth certificates.
Hepatitis C virus (HCV) infection among women giving birth increased 89% from 1.8 cases per 1,000 live births in 2009 to 3.4 cases in 2014, translating to about 35 infants exposed to the virus per day in the United States in 2014, according to the May 11 Morbidity and Mortality Weekly Report.
The highest rate in 2014 was in West Virginia, with 22.6 cases per 1,000 live births. The lowest was in Hawaii, with 0.7 cases.
“The prevalence of maternal HCV infection appears to have increased sharply in the United States. ... Ensuring that women of childbearing age have access to HCV testing and treatment and consideration of universal screening among women of reproductive age residing in areas with high HCV prevalence might mitigate risk and prevent transmission,” said investigators led by Stephen Patrick, MD, of the division of neonatology at Vanderbilt University, Nashville (MMWR. 2017;66[18]:470-3).
Both the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists recommend selective screening of pregnant women at high risk for HCV infection, including intravenous drug users and long-term hemodialysis patients.
“These data might inform expansion of the definition of women at risk.” Generally, about 6% of infants will pick up HCV from their mother during delivery. Screening and treating women of childbearing could reduce the risk, the investigators said.
The analysis was based on U.S. birth certificate data. Risk factors were identified using Tennessee birth certificates.
Hepatitis C virus (HCV) infection among women giving birth increased 89% from 1.8 cases per 1,000 live births in 2009 to 3.4 cases in 2014, translating to about 35 infants exposed to the virus per day in the United States in 2014, according to the May 11 Morbidity and Mortality Weekly Report.
The highest rate in 2014 was in West Virginia, with 22.6 cases per 1,000 live births. The lowest was in Hawaii, with 0.7 cases.
“The prevalence of maternal HCV infection appears to have increased sharply in the United States. ... Ensuring that women of childbearing age have access to HCV testing and treatment and consideration of universal screening among women of reproductive age residing in areas with high HCV prevalence might mitigate risk and prevent transmission,” said investigators led by Stephen Patrick, MD, of the division of neonatology at Vanderbilt University, Nashville (MMWR. 2017;66[18]:470-3).
Both the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists recommend selective screening of pregnant women at high risk for HCV infection, including intravenous drug users and long-term hemodialysis patients.
“These data might inform expansion of the definition of women at risk.” Generally, about 6% of infants will pick up HCV from their mother during delivery. Screening and treating women of childbearing could reduce the risk, the investigators said.
The analysis was based on U.S. birth certificate data. Risk factors were identified using Tennessee birth certificates.
FROM MMWR