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Status asthmaticus risk upped fourfold with IV labetalol for preeclampsia
DALLAS – A maternal death occurred at Columbia University Medical Center after a patient with asthma was given intravenous labetalol, prompting a study that found an elevated risk of status asthmaticus associated with intravenous (IV) labetalol administration but not with the uterotonic carboprost.
“Overall, 71.4% of status asthmaticus cases occurred among women receiving IV labetalol,” said Whitney A. Booker, MD, speaking about the findings at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The risk of status asthmaticus didn’t reach statistical significance when women with asthma who experienced postpartum hemorrhage were given carboprost, compared with other uterotonics (3.1 vs. 1.0 per 1,000 patients; P = .56).
“Some regularly used medications in obstetrics can trigger bronchospasm,” said Dr. Booker; the American College of Obstetricians and Gynecologists lists both carboprost and labetalol as contraindicated for use in patients with asthma because of the potential for bronchospasm with each medication.
However, she said, data on the actual risk of bronchospasm when these medications are used in obstetric patients is limited.
The retrospective cohort study constructed by Dr. Booker and her colleagues at Columbia University Medical Center’s department of obstetrics and gynecology tapped 10 years’ worth of data from a large inpatient drug utilization database.
Dr. Booker, a maternal-fetal medicine fellow, said that patients were included if they were admitted for delivery and had a diagnosis of preeclampsia or postpartum hemorrhage. Of the 5.7 million hospitalizations from 2006 to 2015, 2.5% were for postpartum hemorrhage, and 4.2% for preeclampsia.
Of the patients with hemorrhage, 5,633 had a prior history of asthma, as did 12,486 of the patients with preeclampsia. In both groups, a little more than a third of patients were younger than 25 years, and about a quarter were black. Half were on Medicaid, and most were in urban areas and cared for in a teaching hospital.
The first outcome that Dr. Booker and her colleagues looked at was how practice patterns for postpartum hemorrhage varied according to whether patients had asthma; to do so, they looked at receipt of carboprost, misoprostol, and methylergonovine. A similar analysis was performed for the second outcome addressing patients with preeclampsia, in which investigators examined the use of both IV and oral labetalol, hydralazine, and nifedipine. For this and the hemorrhage outcome, the investigators performed multivariable analysis, with receipt of carboprost and IV labetalol as the outcomes of interest.
Finally, the investigators assessed the risk of status asthmaticus by comparing receipt of either carboprost (for postpartum hemorrhage) or IV labetalol (for preeclampsia) with receipt of the other medications to treat these conditions.
They found that overall, 11.4% of patients with asthma and 18% of patients without asthma received carboprost to treat postpartum hemorrhage, which makes for an adjusted risk model of 0.68 (95% confidence interval, 0.62-0.74) for receipt of carboprost for patients with asthma versus those without.
However, the pattern was different for IV labetalol: 18.5% of patients with asthma and preeclampsia received labetalol, compared with 16.7% of those without asthma. After statistical adjustment, patients with asthma had a risk ratio of 0.93 (95% CI, 0.90-0.97) for receiving IV labetalol for preeclampsia.
The analysis showed that pregnant patients with asthma were less likely to be given carboprost than labetalol, although the actual risk of status asthmaticus was higher when patients with asthma received labetalol than when they received carboprost.
“Given similar theoretical risks, obstetric providers currently administer carboprost differently than labetalol. ... Obstetricians should proceed with caution prior to giving labetalol to patients with underlying asthma,” said Dr. Booker.
During the discussion after the presentation, one attendee suggested that a next step might be to examine claims databases in conjunction with the findings of Dr. Booker’s current work in order to see whether there’s an association between asthma medication prescription fills – a surrogate for disease severity – and the risk of bronchospasm. Dr. Booker agreed that this might be a promising line of inquiry.
Dr. Booker and her colleagues reported that they had no conflicts of interest. The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
SOURCE: Booker W et al. Am J Obstet Gynecol. 2018 Jan;218:S51.
I teach my residents and fellows the “rule of thirds”: One-third of asthma patients get worse during pregnancy; one-third get better; one-third stay the same.” Asthma during pregnancy remains a challenging problem, with physicians striving to treat two complicated patients (mother and child) safely and effectively. We learn now that the use of labetalol, a beta-blocker, to treat preeclampsia in pregnant asthma patients may be associated with an increased incidence of status asthmaticus. Until we learn more about these occurrences, we should use great caution in treating pregnant asthma patients with labetalol and other beta-blockers
I teach my residents and fellows the “rule of thirds”: One-third of asthma patients get worse during pregnancy; one-third get better; one-third stay the same.” Asthma during pregnancy remains a challenging problem, with physicians striving to treat two complicated patients (mother and child) safely and effectively. We learn now that the use of labetalol, a beta-blocker, to treat preeclampsia in pregnant asthma patients may be associated with an increased incidence of status asthmaticus. Until we learn more about these occurrences, we should use great caution in treating pregnant asthma patients with labetalol and other beta-blockers
I teach my residents and fellows the “rule of thirds”: One-third of asthma patients get worse during pregnancy; one-third get better; one-third stay the same.” Asthma during pregnancy remains a challenging problem, with physicians striving to treat two complicated patients (mother and child) safely and effectively. We learn now that the use of labetalol, a beta-blocker, to treat preeclampsia in pregnant asthma patients may be associated with an increased incidence of status asthmaticus. Until we learn more about these occurrences, we should use great caution in treating pregnant asthma patients with labetalol and other beta-blockers
DALLAS – A maternal death occurred at Columbia University Medical Center after a patient with asthma was given intravenous labetalol, prompting a study that found an elevated risk of status asthmaticus associated with intravenous (IV) labetalol administration but not with the uterotonic carboprost.
“Overall, 71.4% of status asthmaticus cases occurred among women receiving IV labetalol,” said Whitney A. Booker, MD, speaking about the findings at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The risk of status asthmaticus didn’t reach statistical significance when women with asthma who experienced postpartum hemorrhage were given carboprost, compared with other uterotonics (3.1 vs. 1.0 per 1,000 patients; P = .56).
“Some regularly used medications in obstetrics can trigger bronchospasm,” said Dr. Booker; the American College of Obstetricians and Gynecologists lists both carboprost and labetalol as contraindicated for use in patients with asthma because of the potential for bronchospasm with each medication.
However, she said, data on the actual risk of bronchospasm when these medications are used in obstetric patients is limited.
The retrospective cohort study constructed by Dr. Booker and her colleagues at Columbia University Medical Center’s department of obstetrics and gynecology tapped 10 years’ worth of data from a large inpatient drug utilization database.
Dr. Booker, a maternal-fetal medicine fellow, said that patients were included if they were admitted for delivery and had a diagnosis of preeclampsia or postpartum hemorrhage. Of the 5.7 million hospitalizations from 2006 to 2015, 2.5% were for postpartum hemorrhage, and 4.2% for preeclampsia.
Of the patients with hemorrhage, 5,633 had a prior history of asthma, as did 12,486 of the patients with preeclampsia. In both groups, a little more than a third of patients were younger than 25 years, and about a quarter were black. Half were on Medicaid, and most were in urban areas and cared for in a teaching hospital.
The first outcome that Dr. Booker and her colleagues looked at was how practice patterns for postpartum hemorrhage varied according to whether patients had asthma; to do so, they looked at receipt of carboprost, misoprostol, and methylergonovine. A similar analysis was performed for the second outcome addressing patients with preeclampsia, in which investigators examined the use of both IV and oral labetalol, hydralazine, and nifedipine. For this and the hemorrhage outcome, the investigators performed multivariable analysis, with receipt of carboprost and IV labetalol as the outcomes of interest.
Finally, the investigators assessed the risk of status asthmaticus by comparing receipt of either carboprost (for postpartum hemorrhage) or IV labetalol (for preeclampsia) with receipt of the other medications to treat these conditions.
They found that overall, 11.4% of patients with asthma and 18% of patients without asthma received carboprost to treat postpartum hemorrhage, which makes for an adjusted risk model of 0.68 (95% confidence interval, 0.62-0.74) for receipt of carboprost for patients with asthma versus those without.
However, the pattern was different for IV labetalol: 18.5% of patients with asthma and preeclampsia received labetalol, compared with 16.7% of those without asthma. After statistical adjustment, patients with asthma had a risk ratio of 0.93 (95% CI, 0.90-0.97) for receiving IV labetalol for preeclampsia.
The analysis showed that pregnant patients with asthma were less likely to be given carboprost than labetalol, although the actual risk of status asthmaticus was higher when patients with asthma received labetalol than when they received carboprost.
“Given similar theoretical risks, obstetric providers currently administer carboprost differently than labetalol. ... Obstetricians should proceed with caution prior to giving labetalol to patients with underlying asthma,” said Dr. Booker.
During the discussion after the presentation, one attendee suggested that a next step might be to examine claims databases in conjunction with the findings of Dr. Booker’s current work in order to see whether there’s an association between asthma medication prescription fills – a surrogate for disease severity – and the risk of bronchospasm. Dr. Booker agreed that this might be a promising line of inquiry.
Dr. Booker and her colleagues reported that they had no conflicts of interest. The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
SOURCE: Booker W et al. Am J Obstet Gynecol. 2018 Jan;218:S51.
DALLAS – A maternal death occurred at Columbia University Medical Center after a patient with asthma was given intravenous labetalol, prompting a study that found an elevated risk of status asthmaticus associated with intravenous (IV) labetalol administration but not with the uterotonic carboprost.
“Overall, 71.4% of status asthmaticus cases occurred among women receiving IV labetalol,” said Whitney A. Booker, MD, speaking about the findings at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The risk of status asthmaticus didn’t reach statistical significance when women with asthma who experienced postpartum hemorrhage were given carboprost, compared with other uterotonics (3.1 vs. 1.0 per 1,000 patients; P = .56).
“Some regularly used medications in obstetrics can trigger bronchospasm,” said Dr. Booker; the American College of Obstetricians and Gynecologists lists both carboprost and labetalol as contraindicated for use in patients with asthma because of the potential for bronchospasm with each medication.
However, she said, data on the actual risk of bronchospasm when these medications are used in obstetric patients is limited.
The retrospective cohort study constructed by Dr. Booker and her colleagues at Columbia University Medical Center’s department of obstetrics and gynecology tapped 10 years’ worth of data from a large inpatient drug utilization database.
Dr. Booker, a maternal-fetal medicine fellow, said that patients were included if they were admitted for delivery and had a diagnosis of preeclampsia or postpartum hemorrhage. Of the 5.7 million hospitalizations from 2006 to 2015, 2.5% were for postpartum hemorrhage, and 4.2% for preeclampsia.
Of the patients with hemorrhage, 5,633 had a prior history of asthma, as did 12,486 of the patients with preeclampsia. In both groups, a little more than a third of patients were younger than 25 years, and about a quarter were black. Half were on Medicaid, and most were in urban areas and cared for in a teaching hospital.
The first outcome that Dr. Booker and her colleagues looked at was how practice patterns for postpartum hemorrhage varied according to whether patients had asthma; to do so, they looked at receipt of carboprost, misoprostol, and methylergonovine. A similar analysis was performed for the second outcome addressing patients with preeclampsia, in which investigators examined the use of both IV and oral labetalol, hydralazine, and nifedipine. For this and the hemorrhage outcome, the investigators performed multivariable analysis, with receipt of carboprost and IV labetalol as the outcomes of interest.
Finally, the investigators assessed the risk of status asthmaticus by comparing receipt of either carboprost (for postpartum hemorrhage) or IV labetalol (for preeclampsia) with receipt of the other medications to treat these conditions.
They found that overall, 11.4% of patients with asthma and 18% of patients without asthma received carboprost to treat postpartum hemorrhage, which makes for an adjusted risk model of 0.68 (95% confidence interval, 0.62-0.74) for receipt of carboprost for patients with asthma versus those without.
However, the pattern was different for IV labetalol: 18.5% of patients with asthma and preeclampsia received labetalol, compared with 16.7% of those without asthma. After statistical adjustment, patients with asthma had a risk ratio of 0.93 (95% CI, 0.90-0.97) for receiving IV labetalol for preeclampsia.
The analysis showed that pregnant patients with asthma were less likely to be given carboprost than labetalol, although the actual risk of status asthmaticus was higher when patients with asthma received labetalol than when they received carboprost.
“Given similar theoretical risks, obstetric providers currently administer carboprost differently than labetalol. ... Obstetricians should proceed with caution prior to giving labetalol to patients with underlying asthma,” said Dr. Booker.
During the discussion after the presentation, one attendee suggested that a next step might be to examine claims databases in conjunction with the findings of Dr. Booker’s current work in order to see whether there’s an association between asthma medication prescription fills – a surrogate for disease severity – and the risk of bronchospasm. Dr. Booker agreed that this might be a promising line of inquiry.
Dr. Booker and her colleagues reported that they had no conflicts of interest. The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
SOURCE: Booker W et al. Am J Obstet Gynecol. 2018 Jan;218:S51.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point: IV labetalol receipt meant a fourfold increase in risk of status asthmaticus for women with preeclampsia and asthma.
Major finding: Status asthmaticus occurred in 6.5 per 1,000 patients given IV labetalol, and 1.7 per 1,000 given a different antihypertensive.
Study details: Retrospective review of 10 years’ data from a national inpatient database, which gathered data on 18,149 women with asthma and either preeclampsia or postpartum hemorrhage.
Disclosures: The study was sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The study authors had no conflicts of interest.
Source: Booker W et al. Am J Obstet Gynecol. 2018 Jan;218:S51.
Prenatal betamethasone could save millions in care costs for women at risk of late preterm delivery
DALLAS – If betamethasone became a routine part of managing women at risk for late preterm birth, the U.S. health care system could save up to $200 million in direct costs every year.
A significant decrease in the cost of managing newborn respiratory morbidity would account for most of the savings, Cynthia Gyamfi-Bannerman, MD, said at the meeting sponsored by the Society for Maternal-Fetal Medicine. Not only was betamethasone treatment cost effective at its base price, but treatment retained economic dominance over no treatment even when its cost was inflated up to 500%.
She presented a cost analysis of the 2016 PARENT trial. PARENT randomized 2,831 women at risk of late preterm delivery to two injections of betamethasone or matching placebo 24 hours apart. Infants exposed to betamethasone were 20% less likely to experience the primary endpoint – a composite of the need for continuous positive airway pressure or high-flow nasal cannula, supplemental oxygen, extracorporeal membrane oxygenation, or mechanical ventilation. They were also significantly less likely to be stillborn or to die within 72 hours of delivery.
“We found that antenatal betamethasone significantly decreased perinatal morbidity and mortality,” she said. “However, the costs of this intervention were unknown. Therefore, we compared the cost-effectiveness of treatment with no treatment in these women.”
Dr. Gyamfi-Bannerman described the study as a cost-minimization analysis. “The analysis took a third-party payer approach with a time horizon to first hospital discharge to home.”
Maternal costs were based on Medicaid rates. These included the cost of the betamethasone, and any out- or inpatient visits necessary to administer the drug. The neonatal costs included all direct medical costs for the newborn, including neonatal ICU admissions and any respiratory therapy the infant required.
The analysis included all mother-infant pairs in PARENT who had at least one dose of their assigned study drug and full follow-up. This comprised 1,425 pairs who received betamethasone and 1,396 who received placebo. The total mean cost of maternal/newborn care in the betamethasone group was $4,774, compared with $5,473 in the placebo group – a significant difference.
The cost-effectiveness analysis, with effectiveness defined as the proportion not reaching the primary outcome, significantly favored betamethasone as well (88.4% vs. 85.5%).
Dr. Gyamfi-Bannerman also examined cost-effectiveness in a variety of pricing scenarios, from looking at betamethasone at its base cost with hospital and physician services priced at 50% of the current level, to betamethasone inflated by 500% and other costs by 200%.
“In almost every estimate, betamethasone remained the cost-effective management option,” she said. “ and was cost effective across most of our variable estimate.”
She had no financial disclosures.
SOURCE: Gyamfi-Bannerman C et al. Am J Obstet Gynecol. 2018;218:S14.
DALLAS – If betamethasone became a routine part of managing women at risk for late preterm birth, the U.S. health care system could save up to $200 million in direct costs every year.
A significant decrease in the cost of managing newborn respiratory morbidity would account for most of the savings, Cynthia Gyamfi-Bannerman, MD, said at the meeting sponsored by the Society for Maternal-Fetal Medicine. Not only was betamethasone treatment cost effective at its base price, but treatment retained economic dominance over no treatment even when its cost was inflated up to 500%.
She presented a cost analysis of the 2016 PARENT trial. PARENT randomized 2,831 women at risk of late preterm delivery to two injections of betamethasone or matching placebo 24 hours apart. Infants exposed to betamethasone were 20% less likely to experience the primary endpoint – a composite of the need for continuous positive airway pressure or high-flow nasal cannula, supplemental oxygen, extracorporeal membrane oxygenation, or mechanical ventilation. They were also significantly less likely to be stillborn or to die within 72 hours of delivery.
“We found that antenatal betamethasone significantly decreased perinatal morbidity and mortality,” she said. “However, the costs of this intervention were unknown. Therefore, we compared the cost-effectiveness of treatment with no treatment in these women.”
Dr. Gyamfi-Bannerman described the study as a cost-minimization analysis. “The analysis took a third-party payer approach with a time horizon to first hospital discharge to home.”
Maternal costs were based on Medicaid rates. These included the cost of the betamethasone, and any out- or inpatient visits necessary to administer the drug. The neonatal costs included all direct medical costs for the newborn, including neonatal ICU admissions and any respiratory therapy the infant required.
The analysis included all mother-infant pairs in PARENT who had at least one dose of their assigned study drug and full follow-up. This comprised 1,425 pairs who received betamethasone and 1,396 who received placebo. The total mean cost of maternal/newborn care in the betamethasone group was $4,774, compared with $5,473 in the placebo group – a significant difference.
The cost-effectiveness analysis, with effectiveness defined as the proportion not reaching the primary outcome, significantly favored betamethasone as well (88.4% vs. 85.5%).
Dr. Gyamfi-Bannerman also examined cost-effectiveness in a variety of pricing scenarios, from looking at betamethasone at its base cost with hospital and physician services priced at 50% of the current level, to betamethasone inflated by 500% and other costs by 200%.
“In almost every estimate, betamethasone remained the cost-effective management option,” she said. “ and was cost effective across most of our variable estimate.”
She had no financial disclosures.
SOURCE: Gyamfi-Bannerman C et al. Am J Obstet Gynecol. 2018;218:S14.
DALLAS – If betamethasone became a routine part of managing women at risk for late preterm birth, the U.S. health care system could save up to $200 million in direct costs every year.
A significant decrease in the cost of managing newborn respiratory morbidity would account for most of the savings, Cynthia Gyamfi-Bannerman, MD, said at the meeting sponsored by the Society for Maternal-Fetal Medicine. Not only was betamethasone treatment cost effective at its base price, but treatment retained economic dominance over no treatment even when its cost was inflated up to 500%.
She presented a cost analysis of the 2016 PARENT trial. PARENT randomized 2,831 women at risk of late preterm delivery to two injections of betamethasone or matching placebo 24 hours apart. Infants exposed to betamethasone were 20% less likely to experience the primary endpoint – a composite of the need for continuous positive airway pressure or high-flow nasal cannula, supplemental oxygen, extracorporeal membrane oxygenation, or mechanical ventilation. They were also significantly less likely to be stillborn or to die within 72 hours of delivery.
“We found that antenatal betamethasone significantly decreased perinatal morbidity and mortality,” she said. “However, the costs of this intervention were unknown. Therefore, we compared the cost-effectiveness of treatment with no treatment in these women.”
Dr. Gyamfi-Bannerman described the study as a cost-minimization analysis. “The analysis took a third-party payer approach with a time horizon to first hospital discharge to home.”
Maternal costs were based on Medicaid rates. These included the cost of the betamethasone, and any out- or inpatient visits necessary to administer the drug. The neonatal costs included all direct medical costs for the newborn, including neonatal ICU admissions and any respiratory therapy the infant required.
The analysis included all mother-infant pairs in PARENT who had at least one dose of their assigned study drug and full follow-up. This comprised 1,425 pairs who received betamethasone and 1,396 who received placebo. The total mean cost of maternal/newborn care in the betamethasone group was $4,774, compared with $5,473 in the placebo group – a significant difference.
The cost-effectiveness analysis, with effectiveness defined as the proportion not reaching the primary outcome, significantly favored betamethasone as well (88.4% vs. 85.5%).
Dr. Gyamfi-Bannerman also examined cost-effectiveness in a variety of pricing scenarios, from looking at betamethasone at its base cost with hospital and physician services priced at 50% of the current level, to betamethasone inflated by 500% and other costs by 200%.
“In almost every estimate, betamethasone remained the cost-effective management option,” she said. “ and was cost effective across most of our variable estimate.”
She had no financial disclosures.
SOURCE: Gyamfi-Bannerman C et al. Am J Obstet Gynecol. 2018;218:S14.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point: If widely adopted, prenatal betamethasone could save up to $200 million per year by preventing neonatal respiratory morbidity.
Major finding: The total mean maternal/newborn care cost was $4,774 in the betamethasone group and $5,473 in the placebo group.
Study details: The cost analysis of the PARENT trial comprised 2,821 mother/infant pairs.
Disclosures: Dr. Gyamfi-Bannerman had no financial disclosures.
Source: Gyamfi-Bannerman C et al. Am J Obstet Gynecol. 2018;218:S14.
Cerclage plus progesterone for preventing preterm births
DALLAS – Placing a cerclage conferred additional benefit over vaginal progesterone alone for women with extreme short cervixes and singleton pregnancies, in a recent study. Those who received rescue cerclage in addition to vaginal progesterone had a 92% overall reduction in spontaneous preterm birth rates, and infants had fewer neonatal ICU admissions and neonatal complications.
The single-center retrospective cohort study of 75 women with cervical length less than 10 cm who were receiving vaginal progesterone was presented by Christopher Enakpene, MD, at the meeting sponsored by the Society for Maternal-Fetal Medicine.
Women who received rescue cerclage in addition to progesterone delivered at a mean 34.3 weeks gestational age, compared with 27.5 weeks for those receiving progesterone alone (P less than .001).
There were 13 neonatal ICU admissions for infants born to the 36 patients in the cerclage group, compared with 23 for the 39 women receiving progesterone alone (P = .009). And there were seven perinatal or neonatal deaths among the group who did not receive cerclage; no deaths occurred in the cerclage group.
“Premature cervical ripening plays a significant role in spontaneous preterm birth,” said Dr. Enakpene. “And studies have shown that, the shorter the cervix, the higher the risk of spontaneous preterm birth.”
Preterm birth, said Dr. Enakpene, is the top cause of neonatal morbidity and mortality both in the United States and worldwide; it is associated with 70% of neonatal deaths and half of all neurodevelopmental delay, he said.
At the University of Illinois at Chicago, where Dr. Enakpene is a maternal-fetal medicine fellow in the department of obstetrics and gynecology, all pregnant women are screened for cervical length by transvaginal ultrasound during their second trimester.
If screening reveals cervical length of less than 20 mm, the patient receives vaginal progesterone, “the current standard of care in singleton pregnancy with incidental short cervix,” said Dr. Enakpene. Vaginal progesterone can reduce the risk of spontaneous preterm birth by about half, he said.
At his facility, women with a short cervix then receive serial cervical length assessments every week or 2 until 24 weeks’ gestation, to identify women whose cervixes continue to shorten. For these women, it’s usually physician preference that determines whether cerclage is placed to reinforce the progressively shortening cervix, said Dr. Enakpene.
There had been previous retrospective work showing that cerclage was more effective at preventing spontaneous preterm birth than was doing nothing when a woman with a singleton pregnancy had a short cervix. However, Dr. Enakpene said that vaginal progesterone alone had not been compared with continuing progesterone and adding a cerclage.
During the study period, 310 women with cervical length of less than 20 mm were placed on progesterone. These women were included in the study cohort if, over the course of at least two cervical length measurements, their cervix shortened to less than 10 mm while they were on vaginal progesterone. They could not have indications that delivery was imminent when the 10 mm threshold was met, said Dr. Enakpene.
Women with known intrauterine fetal death, an undesired pregnancy, or any sign of intra-amniotic infection or fetal anomalies were excluded from the study.
A total of 75 women met final inclusion criteria, and received cerclage (n = 36), or not (n = 39) according to physician judgment. Demographic and pregnancy-specific characteristics were generally similar between the two groups.
In their statistical analysis, Dr. Enakpene and his colleagues used Kaplan-Meier survival analysis to look at pregnancy latency over time for women who did – or didn’t – receive a cerclage. There were significantly fewer spontaneous preterm births before 24, 28, and 34 weeks gestational age in the cerclage group (P less than .001 for all).
Dr. Enakpene acknowledged the study’s limitations, including its retrospective nature, the small sample size, and the fact that cerclage placement was done by the preference of the attending physician. However, this study was the first to examine rescue cerclage as add-on to vaginal progesterone, he said, adding, “Following this study, we are designing a prospective randomized interventional study to address this important topic.”
Dr. Enakpene reported that he had no conflicts of interest, and reported no outside sources of funding.
SOURCE: Enakpene C et al. Am J Obstet Gynecol. 2018 Jan;218:S72-S73.
DALLAS – Placing a cerclage conferred additional benefit over vaginal progesterone alone for women with extreme short cervixes and singleton pregnancies, in a recent study. Those who received rescue cerclage in addition to vaginal progesterone had a 92% overall reduction in spontaneous preterm birth rates, and infants had fewer neonatal ICU admissions and neonatal complications.
The single-center retrospective cohort study of 75 women with cervical length less than 10 cm who were receiving vaginal progesterone was presented by Christopher Enakpene, MD, at the meeting sponsored by the Society for Maternal-Fetal Medicine.
Women who received rescue cerclage in addition to progesterone delivered at a mean 34.3 weeks gestational age, compared with 27.5 weeks for those receiving progesterone alone (P less than .001).
There were 13 neonatal ICU admissions for infants born to the 36 patients in the cerclage group, compared with 23 for the 39 women receiving progesterone alone (P = .009). And there were seven perinatal or neonatal deaths among the group who did not receive cerclage; no deaths occurred in the cerclage group.
“Premature cervical ripening plays a significant role in spontaneous preterm birth,” said Dr. Enakpene. “And studies have shown that, the shorter the cervix, the higher the risk of spontaneous preterm birth.”
Preterm birth, said Dr. Enakpene, is the top cause of neonatal morbidity and mortality both in the United States and worldwide; it is associated with 70% of neonatal deaths and half of all neurodevelopmental delay, he said.
At the University of Illinois at Chicago, where Dr. Enakpene is a maternal-fetal medicine fellow in the department of obstetrics and gynecology, all pregnant women are screened for cervical length by transvaginal ultrasound during their second trimester.
If screening reveals cervical length of less than 20 mm, the patient receives vaginal progesterone, “the current standard of care in singleton pregnancy with incidental short cervix,” said Dr. Enakpene. Vaginal progesterone can reduce the risk of spontaneous preterm birth by about half, he said.
At his facility, women with a short cervix then receive serial cervical length assessments every week or 2 until 24 weeks’ gestation, to identify women whose cervixes continue to shorten. For these women, it’s usually physician preference that determines whether cerclage is placed to reinforce the progressively shortening cervix, said Dr. Enakpene.
There had been previous retrospective work showing that cerclage was more effective at preventing spontaneous preterm birth than was doing nothing when a woman with a singleton pregnancy had a short cervix. However, Dr. Enakpene said that vaginal progesterone alone had not been compared with continuing progesterone and adding a cerclage.
During the study period, 310 women with cervical length of less than 20 mm were placed on progesterone. These women were included in the study cohort if, over the course of at least two cervical length measurements, their cervix shortened to less than 10 mm while they were on vaginal progesterone. They could not have indications that delivery was imminent when the 10 mm threshold was met, said Dr. Enakpene.
Women with known intrauterine fetal death, an undesired pregnancy, or any sign of intra-amniotic infection or fetal anomalies were excluded from the study.
A total of 75 women met final inclusion criteria, and received cerclage (n = 36), or not (n = 39) according to physician judgment. Demographic and pregnancy-specific characteristics were generally similar between the two groups.
In their statistical analysis, Dr. Enakpene and his colleagues used Kaplan-Meier survival analysis to look at pregnancy latency over time for women who did – or didn’t – receive a cerclage. There were significantly fewer spontaneous preterm births before 24, 28, and 34 weeks gestational age in the cerclage group (P less than .001 for all).
Dr. Enakpene acknowledged the study’s limitations, including its retrospective nature, the small sample size, and the fact that cerclage placement was done by the preference of the attending physician. However, this study was the first to examine rescue cerclage as add-on to vaginal progesterone, he said, adding, “Following this study, we are designing a prospective randomized interventional study to address this important topic.”
Dr. Enakpene reported that he had no conflicts of interest, and reported no outside sources of funding.
SOURCE: Enakpene C et al. Am J Obstet Gynecol. 2018 Jan;218:S72-S73.
DALLAS – Placing a cerclage conferred additional benefit over vaginal progesterone alone for women with extreme short cervixes and singleton pregnancies, in a recent study. Those who received rescue cerclage in addition to vaginal progesterone had a 92% overall reduction in spontaneous preterm birth rates, and infants had fewer neonatal ICU admissions and neonatal complications.
The single-center retrospective cohort study of 75 women with cervical length less than 10 cm who were receiving vaginal progesterone was presented by Christopher Enakpene, MD, at the meeting sponsored by the Society for Maternal-Fetal Medicine.
Women who received rescue cerclage in addition to progesterone delivered at a mean 34.3 weeks gestational age, compared with 27.5 weeks for those receiving progesterone alone (P less than .001).
There were 13 neonatal ICU admissions for infants born to the 36 patients in the cerclage group, compared with 23 for the 39 women receiving progesterone alone (P = .009). And there were seven perinatal or neonatal deaths among the group who did not receive cerclage; no deaths occurred in the cerclage group.
“Premature cervical ripening plays a significant role in spontaneous preterm birth,” said Dr. Enakpene. “And studies have shown that, the shorter the cervix, the higher the risk of spontaneous preterm birth.”
Preterm birth, said Dr. Enakpene, is the top cause of neonatal morbidity and mortality both in the United States and worldwide; it is associated with 70% of neonatal deaths and half of all neurodevelopmental delay, he said.
At the University of Illinois at Chicago, where Dr. Enakpene is a maternal-fetal medicine fellow in the department of obstetrics and gynecology, all pregnant women are screened for cervical length by transvaginal ultrasound during their second trimester.
If screening reveals cervical length of less than 20 mm, the patient receives vaginal progesterone, “the current standard of care in singleton pregnancy with incidental short cervix,” said Dr. Enakpene. Vaginal progesterone can reduce the risk of spontaneous preterm birth by about half, he said.
At his facility, women with a short cervix then receive serial cervical length assessments every week or 2 until 24 weeks’ gestation, to identify women whose cervixes continue to shorten. For these women, it’s usually physician preference that determines whether cerclage is placed to reinforce the progressively shortening cervix, said Dr. Enakpene.
There had been previous retrospective work showing that cerclage was more effective at preventing spontaneous preterm birth than was doing nothing when a woman with a singleton pregnancy had a short cervix. However, Dr. Enakpene said that vaginal progesterone alone had not been compared with continuing progesterone and adding a cerclage.
During the study period, 310 women with cervical length of less than 20 mm were placed on progesterone. These women were included in the study cohort if, over the course of at least two cervical length measurements, their cervix shortened to less than 10 mm while they were on vaginal progesterone. They could not have indications that delivery was imminent when the 10 mm threshold was met, said Dr. Enakpene.
Women with known intrauterine fetal death, an undesired pregnancy, or any sign of intra-amniotic infection or fetal anomalies were excluded from the study.
A total of 75 women met final inclusion criteria, and received cerclage (n = 36), or not (n = 39) according to physician judgment. Demographic and pregnancy-specific characteristics were generally similar between the two groups.
In their statistical analysis, Dr. Enakpene and his colleagues used Kaplan-Meier survival analysis to look at pregnancy latency over time for women who did – or didn’t – receive a cerclage. There were significantly fewer spontaneous preterm births before 24, 28, and 34 weeks gestational age in the cerclage group (P less than .001 for all).
Dr. Enakpene acknowledged the study’s limitations, including its retrospective nature, the small sample size, and the fact that cerclage placement was done by the preference of the attending physician. However, this study was the first to examine rescue cerclage as add-on to vaginal progesterone, he said, adding, “Following this study, we are designing a prospective randomized interventional study to address this important topic.”
Dr. Enakpene reported that he had no conflicts of interest, and reported no outside sources of funding.
SOURCE: Enakpene C et al. Am J Obstet Gynecol. 2018 Jan;218:S72-S73.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point: Women receiving rescue cerclage plus progesterone had fewer spontaneous preterm births.
Major finding: Those who also received cerclage delivered at 34.3 weeks gestational age, compared with 27.5 weeks for those on progesterone alone (P less than .001).
Study details: Retrospective cohort study of 75 women with singleton pregnancies and very short cervixes.
Disclosures: Dr. Enakpene reported no outside sources of funding and had no conflicts of interest.
Source: Enakpene C et al. Am J Obstet Gynecol. 2018 Jan;218:S72-S73.
An intervention to track fetal movement attempts to prevent stillbirth
DALLAS – A hospital-wide intervention designed to prevent stillbirth by focusing on reduced fetal movement failed to do so – but did result in significant increases in labor induction and cesarean sections.
After the interventions was implemented, hospitals achieved a stillbirth rate of 4 per 1,000 – not significantly different than the 4.4 per 1,000 rate in the controls, Jane Norman, MD, reported at the meeting sponsored by the Society for Maternal-Fetal Medicine. On the other hand, the risk of a C-section increased by 9% and the risk of a labor induction by 8%, said Prof. Norman of the University of Edinburgh.
The results are disappointing, but consistent with most of the literature on this topic, she said.
“There is very good evidence that, if you ask women to count kicks, it doesn’t prevent stillbirth,” said Dr. Norman, referring to a 2015 Cochrane review. That paper, which examined five studies comprising more than 71,000 women, found that rates of stillbirth were similar between those who employed kick counts and those who did not.
Still, said Dr. Norman, there is evidence that stillbirth often is preceded by a period of reduced fetal movement. And a 2009 quality improvement project conducted in Oslo has driven enthusiasm for the idea of implementing some form of maternal and provider awareness of this area of obstetric care.
Stillbirth rates fell about 2% after the participating hospitals provided written information to women about fetal activity and reduced fetal movement, including an invitation to monitor fetal movements and formalized clinical guidelines for management of reduced fetal movement.
“There is a huge interest in the United Kingdom right now in using reduced fetal movement as an alert to act on to prevent stillbirth,” Dr. Norman said. “The National Health Service has recommended that we talk with women and clinicians about reduced fetal movement,” and try to incorporate it into clinical care.
Dr. Norman and her team wanted to emulate the Oslo experience, with a target of a 30% reduction in stillbirth rate.
The AFFIRM trial employed a clinical management guideline and patient education handout to raise awareness of reduced fetal movement as a trigger to investigate fetal well-being. The study used hospital records from 37 institutions in the United Kingdom and Ireland, which sequentially implemented the package. Hospitals were grouped into eight clusters. The trial began in January 2014. The first cluster began the intervention in mid-March; a new cluster came online every 3 months thereafter, until April 2016. Each cluster used its own baseline data as control.
The leaflet educated women about what fetal movements should feel like in all stages of pregnancy and what to expect from normal fetal movement. It encouraged them to report any lessening or cessation of fetal movement to their health care provider without delay.
The clinical guideline was matched to different gestational stages, but generally advocated cardiotocography and scans to estimate amniotic fluid volume and fetal size in cases of reduced movement with a low threshold for early delivery if there were abnormal findings at 37 weeks or later.
The final sample comprised 385,582 births, with 157,692 in the control period and 227,860 in the intervention period. The mean age of women was 30 years; 50% were white, 50% were overweight or obese, and 15% smoked. About 40% were nulliparous.
In the control arm, there were 691 stillbirths at 24 weeks’ gestational age or older (4.4/1,000). In the intervention arm, there were 921 events (4.06/1,000). The 10% risk reduction was not statistically significant.
The investigators also examined stillbirths occurring at 22 weeks or older, 28 weeks or older, and 37 weeks or older. Again, there were no significant between-group differences. Nor was there a difference in the perinatal mortality rate (0.68% vs. 0.62%).
There were, however, differences in interventions. The risk of a C-section increased by 5% (25.5% vs. 28.5%; adjusted odds ratio, 1.05), and the risk of induction by 9% (33.6% vs. 39.8%; AOR, 1.09). Most of the induction risk was driven by an 11% increase in induction risk at 39 weeks or older. The team also found a 5% increase in the chance of an elective delivery at 39 weeks or older (45.2% vs. 52.4%; AOR, 1.05)
There was a corresponding significant 10% decrease in the chance of spontaneous vaginal delivery (59.8% vs. 57.4%; AOR, 0.90).
Although there was no overall increase in the risk of a neonatal ICU admission, there was a significant 12% increase in the risk of a neonatal ICU admission of at least 48 hours (6.2% vs. 6.7%; AOR, 1.12). There were no other significant differences in neonatal outcomes (gestational age, size at birth, preterm delivery).
“We also looked at the potential impact if we implemented this intervention on a population of 10,000 pregnancies,” Dr. Norman said. “We would have 5 fewer stillbirths – but potentially anywhere from 11 fewer to 3 more. However, we would have 162 more cesarean deliveries and 108 more inductions.”
The AFFIRM trial was sponsored by the University of Edinburgh and the National Health Service. Dr. Norman had no financial disclosures.
SOURCE: Norman JE et al. Am J Obstet Gynecol. 2018;218,S603.
DALLAS – A hospital-wide intervention designed to prevent stillbirth by focusing on reduced fetal movement failed to do so – but did result in significant increases in labor induction and cesarean sections.
After the interventions was implemented, hospitals achieved a stillbirth rate of 4 per 1,000 – not significantly different than the 4.4 per 1,000 rate in the controls, Jane Norman, MD, reported at the meeting sponsored by the Society for Maternal-Fetal Medicine. On the other hand, the risk of a C-section increased by 9% and the risk of a labor induction by 8%, said Prof. Norman of the University of Edinburgh.
The results are disappointing, but consistent with most of the literature on this topic, she said.
“There is very good evidence that, if you ask women to count kicks, it doesn’t prevent stillbirth,” said Dr. Norman, referring to a 2015 Cochrane review. That paper, which examined five studies comprising more than 71,000 women, found that rates of stillbirth were similar between those who employed kick counts and those who did not.
Still, said Dr. Norman, there is evidence that stillbirth often is preceded by a period of reduced fetal movement. And a 2009 quality improvement project conducted in Oslo has driven enthusiasm for the idea of implementing some form of maternal and provider awareness of this area of obstetric care.
Stillbirth rates fell about 2% after the participating hospitals provided written information to women about fetal activity and reduced fetal movement, including an invitation to monitor fetal movements and formalized clinical guidelines for management of reduced fetal movement.
“There is a huge interest in the United Kingdom right now in using reduced fetal movement as an alert to act on to prevent stillbirth,” Dr. Norman said. “The National Health Service has recommended that we talk with women and clinicians about reduced fetal movement,” and try to incorporate it into clinical care.
Dr. Norman and her team wanted to emulate the Oslo experience, with a target of a 30% reduction in stillbirth rate.
The AFFIRM trial employed a clinical management guideline and patient education handout to raise awareness of reduced fetal movement as a trigger to investigate fetal well-being. The study used hospital records from 37 institutions in the United Kingdom and Ireland, which sequentially implemented the package. Hospitals were grouped into eight clusters. The trial began in January 2014. The first cluster began the intervention in mid-March; a new cluster came online every 3 months thereafter, until April 2016. Each cluster used its own baseline data as control.
The leaflet educated women about what fetal movements should feel like in all stages of pregnancy and what to expect from normal fetal movement. It encouraged them to report any lessening or cessation of fetal movement to their health care provider without delay.
The clinical guideline was matched to different gestational stages, but generally advocated cardiotocography and scans to estimate amniotic fluid volume and fetal size in cases of reduced movement with a low threshold for early delivery if there were abnormal findings at 37 weeks or later.
The final sample comprised 385,582 births, with 157,692 in the control period and 227,860 in the intervention period. The mean age of women was 30 years; 50% were white, 50% were overweight or obese, and 15% smoked. About 40% were nulliparous.
In the control arm, there were 691 stillbirths at 24 weeks’ gestational age or older (4.4/1,000). In the intervention arm, there were 921 events (4.06/1,000). The 10% risk reduction was not statistically significant.
The investigators also examined stillbirths occurring at 22 weeks or older, 28 weeks or older, and 37 weeks or older. Again, there were no significant between-group differences. Nor was there a difference in the perinatal mortality rate (0.68% vs. 0.62%).
There were, however, differences in interventions. The risk of a C-section increased by 5% (25.5% vs. 28.5%; adjusted odds ratio, 1.05), and the risk of induction by 9% (33.6% vs. 39.8%; AOR, 1.09). Most of the induction risk was driven by an 11% increase in induction risk at 39 weeks or older. The team also found a 5% increase in the chance of an elective delivery at 39 weeks or older (45.2% vs. 52.4%; AOR, 1.05)
There was a corresponding significant 10% decrease in the chance of spontaneous vaginal delivery (59.8% vs. 57.4%; AOR, 0.90).
Although there was no overall increase in the risk of a neonatal ICU admission, there was a significant 12% increase in the risk of a neonatal ICU admission of at least 48 hours (6.2% vs. 6.7%; AOR, 1.12). There were no other significant differences in neonatal outcomes (gestational age, size at birth, preterm delivery).
“We also looked at the potential impact if we implemented this intervention on a population of 10,000 pregnancies,” Dr. Norman said. “We would have 5 fewer stillbirths – but potentially anywhere from 11 fewer to 3 more. However, we would have 162 more cesarean deliveries and 108 more inductions.”
The AFFIRM trial was sponsored by the University of Edinburgh and the National Health Service. Dr. Norman had no financial disclosures.
SOURCE: Norman JE et al. Am J Obstet Gynecol. 2018;218,S603.
DALLAS – A hospital-wide intervention designed to prevent stillbirth by focusing on reduced fetal movement failed to do so – but did result in significant increases in labor induction and cesarean sections.
After the interventions was implemented, hospitals achieved a stillbirth rate of 4 per 1,000 – not significantly different than the 4.4 per 1,000 rate in the controls, Jane Norman, MD, reported at the meeting sponsored by the Society for Maternal-Fetal Medicine. On the other hand, the risk of a C-section increased by 9% and the risk of a labor induction by 8%, said Prof. Norman of the University of Edinburgh.
The results are disappointing, but consistent with most of the literature on this topic, she said.
“There is very good evidence that, if you ask women to count kicks, it doesn’t prevent stillbirth,” said Dr. Norman, referring to a 2015 Cochrane review. That paper, which examined five studies comprising more than 71,000 women, found that rates of stillbirth were similar between those who employed kick counts and those who did not.
Still, said Dr. Norman, there is evidence that stillbirth often is preceded by a period of reduced fetal movement. And a 2009 quality improvement project conducted in Oslo has driven enthusiasm for the idea of implementing some form of maternal and provider awareness of this area of obstetric care.
Stillbirth rates fell about 2% after the participating hospitals provided written information to women about fetal activity and reduced fetal movement, including an invitation to monitor fetal movements and formalized clinical guidelines for management of reduced fetal movement.
“There is a huge interest in the United Kingdom right now in using reduced fetal movement as an alert to act on to prevent stillbirth,” Dr. Norman said. “The National Health Service has recommended that we talk with women and clinicians about reduced fetal movement,” and try to incorporate it into clinical care.
Dr. Norman and her team wanted to emulate the Oslo experience, with a target of a 30% reduction in stillbirth rate.
The AFFIRM trial employed a clinical management guideline and patient education handout to raise awareness of reduced fetal movement as a trigger to investigate fetal well-being. The study used hospital records from 37 institutions in the United Kingdom and Ireland, which sequentially implemented the package. Hospitals were grouped into eight clusters. The trial began in January 2014. The first cluster began the intervention in mid-March; a new cluster came online every 3 months thereafter, until April 2016. Each cluster used its own baseline data as control.
The leaflet educated women about what fetal movements should feel like in all stages of pregnancy and what to expect from normal fetal movement. It encouraged them to report any lessening or cessation of fetal movement to their health care provider without delay.
The clinical guideline was matched to different gestational stages, but generally advocated cardiotocography and scans to estimate amniotic fluid volume and fetal size in cases of reduced movement with a low threshold for early delivery if there were abnormal findings at 37 weeks or later.
The final sample comprised 385,582 births, with 157,692 in the control period and 227,860 in the intervention period. The mean age of women was 30 years; 50% were white, 50% were overweight or obese, and 15% smoked. About 40% were nulliparous.
In the control arm, there were 691 stillbirths at 24 weeks’ gestational age or older (4.4/1,000). In the intervention arm, there were 921 events (4.06/1,000). The 10% risk reduction was not statistically significant.
The investigators also examined stillbirths occurring at 22 weeks or older, 28 weeks or older, and 37 weeks or older. Again, there were no significant between-group differences. Nor was there a difference in the perinatal mortality rate (0.68% vs. 0.62%).
There were, however, differences in interventions. The risk of a C-section increased by 5% (25.5% vs. 28.5%; adjusted odds ratio, 1.05), and the risk of induction by 9% (33.6% vs. 39.8%; AOR, 1.09). Most of the induction risk was driven by an 11% increase in induction risk at 39 weeks or older. The team also found a 5% increase in the chance of an elective delivery at 39 weeks or older (45.2% vs. 52.4%; AOR, 1.05)
There was a corresponding significant 10% decrease in the chance of spontaneous vaginal delivery (59.8% vs. 57.4%; AOR, 0.90).
Although there was no overall increase in the risk of a neonatal ICU admission, there was a significant 12% increase in the risk of a neonatal ICU admission of at least 48 hours (6.2% vs. 6.7%; AOR, 1.12). There were no other significant differences in neonatal outcomes (gestational age, size at birth, preterm delivery).
“We also looked at the potential impact if we implemented this intervention on a population of 10,000 pregnancies,” Dr. Norman said. “We would have 5 fewer stillbirths – but potentially anywhere from 11 fewer to 3 more. However, we would have 162 more cesarean deliveries and 108 more inductions.”
The AFFIRM trial was sponsored by the University of Edinburgh and the National Health Service. Dr. Norman had no financial disclosures.
SOURCE: Norman JE et al. Am J Obstet Gynecol. 2018;218,S603.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point: Reduced fetal movements as an alert for investigation didn’t reduce stillbirth rates.
Major finding: Hospitals achieved a stillbirth rate of 4/1,000 – not significantly different than the 4.4/1,000 rate before the intervention.
Study details: The randomized, cluster trial comprised 37 hospitals in the United Kingdom and Ireland.
Disclosures: The University of Edinburgh and the National Health Service sponsored the trial. Dr. Norman had no financial disclosures.
Source: Norman JE et al. Am J Obstet Gynecol. 2018;218,S603.
Barbed sutures shorten cesarean closure time, reduce blood loss
DALLAS – Using knotless barbed sutures to close the uterine incision after cesarean delivery reduced operating time and blood loss, according to a recent randomized controlled study.
“On average, knotless barbed sutures were 1 minute and 43 seconds faster,” said David Peleg, MD, discussing the study results at the meeting sponsored by the Society for Maternal-Fetal Medicine. Average uterine closure time with knotless barbed sutures was 3 minutes and 37 seconds; with smooth sutures, average closure time was 5 minutes and 20 seconds (103-second difference; 95% confidence interval, 67.69-138.47 seconds; P less than .001).
Barbed sutures, in contrast, are usually made of monofilament with barbs created by the addition of tiny diagonal cuts made just partway through the suture material. When the suture is pulled through with the angle of the barbs, it pulls smoothly, but pulling back against the barb angle causes the barbs to protrude and catch against tissue, preventing slippage and eliminating the need for knots.
The fact that the monofilament has been partially cut to create the barbs can also reduce tensile strength, but some of the other disadvantages of smooth sutures are avoided, said Dr. Peleg.
The suture material used for the study was bidirectional, with the barbs running in opposite directions from the midline and a needle swaged onto each end; other barbed suture systems have an integral loop at one end of a unidirectionally barbed length of suture material that is used to anchor the first suture. The brand used was Stratafix.
The prospective study was necessarily unblinded, and compared the knotless barbed sutures with smooth sutures using polyglactin 910 braided material (Vicryl) for use during closure of the uterine incision during cesarean section procedures.
Patients were eligible if they were having an elective cesarean section after at least 38 weeks’ gestation, or if they were having a cesarean for the usual obstetric indications after laboring. Women with previous cesareans who failed a trial of labor were eligible.
The primary outcome was the length of time to close the uterine incision, measured from the start of suturing until hemostasis was achieved; the time included hemostatic suturing.
After a small pilot study that established a baseline suturing time with polyglactin 910 sutures of 6 minutes (standard deviation, 2 minutes and 10 seconds), Dr. Peleg and his collaborators determined that they would need to enroll at least 34 women per study arm to detect a decrease of 25% in suture time – to 4.5 minutes – with barbed sutures.
“The decrease in closure time is not linear,” said Dr. Peleg, so they increased their sample size by 50%, to 51 patients in each group, to ensure statistical significance of the results.
One of the challenges of a surgical randomized controlled trial is ensuring uniform technique; for this study, all patients had epidural or spinal anesthesia and antibiotics before opening. Surgeon clinical judgment was used to determine whether a Pfannenstiel or low transverse incision was made. In either case, there was no closure of the parietal peritoneum or the rectus muscles, and subcutaneous closure was used if tissues were greater than 2 cm in depth. Subcuticular stitches were used if possible.
Looking at secondary outcomes, there was a trend toward shorter total operative time with barbed sutures that didn’t reach statistical significance (20.1 min for barbed sutures vs. 23.1 for conventional, P = .062). However, fewer hemostatic sutures were required when barbed sutures were used: Extra sutures were used in 16 of the barbed group vs. 41 who had conventional sutures (P less than .001). Those receiving barbed sutures also had significantly less blood loss and estimated total blood loss during uterine closure than the conventional suture group (P = .005 and P = .002, respectively).
No study patients experienced serious postoperative complications; there were no infections, hematomas, or other wound complications, said Dr. Peleg of Bar-Ilan University, Zefat, Israel.
On the pro side for wider implementation of the use of barbed sutures for uterine closure stand the quicker closure and better hemostasis, along with the theoretical benefits of having no knots. Additionally, said Dr. Peleg, “there’s a gentle learning curve – it’s relatively easy to get used to the technique” of using barbed sutures. And, he said, “surgeons find them satisfying to use.”
However, he acknowledged the extra expense of barbed suture material – depending on the location and supplier, he estimated the cost could run from 7- to 20-fold for the barbed sutures, which he said cost $23.50 apiece. Also, he said, though the results were statistically significant, “Are they clinically significant? Does a difference in closure time of one minute 43 seconds, and a decrease in blood loss of 47 milliliters matter?”
Other considerations, he said, will require longer-term study. Polydioxanone, used for the barbed sutures, has a longer absorption time – a factor with unknown clinical implications in this application. Other longer-term outcomes, such as vaginal birth after cesarean success rates, rates of uterine rupture, the thickness of the uterine scar, and rates of adhesions and placenta accreta, will need to be tracked for years.
The authors reported no conflicts of interest and specifically reported that they had no relevant consulting or research agreements with suture manufacturers or marketers.
SOURCE: Peleg D et al. The Pregnancy Meeting Abstract 32.
DALLAS – Using knotless barbed sutures to close the uterine incision after cesarean delivery reduced operating time and blood loss, according to a recent randomized controlled study.
“On average, knotless barbed sutures were 1 minute and 43 seconds faster,” said David Peleg, MD, discussing the study results at the meeting sponsored by the Society for Maternal-Fetal Medicine. Average uterine closure time with knotless barbed sutures was 3 minutes and 37 seconds; with smooth sutures, average closure time was 5 minutes and 20 seconds (103-second difference; 95% confidence interval, 67.69-138.47 seconds; P less than .001).
Barbed sutures, in contrast, are usually made of monofilament with barbs created by the addition of tiny diagonal cuts made just partway through the suture material. When the suture is pulled through with the angle of the barbs, it pulls smoothly, but pulling back against the barb angle causes the barbs to protrude and catch against tissue, preventing slippage and eliminating the need for knots.
The fact that the monofilament has been partially cut to create the barbs can also reduce tensile strength, but some of the other disadvantages of smooth sutures are avoided, said Dr. Peleg.
The suture material used for the study was bidirectional, with the barbs running in opposite directions from the midline and a needle swaged onto each end; other barbed suture systems have an integral loop at one end of a unidirectionally barbed length of suture material that is used to anchor the first suture. The brand used was Stratafix.
The prospective study was necessarily unblinded, and compared the knotless barbed sutures with smooth sutures using polyglactin 910 braided material (Vicryl) for use during closure of the uterine incision during cesarean section procedures.
Patients were eligible if they were having an elective cesarean section after at least 38 weeks’ gestation, or if they were having a cesarean for the usual obstetric indications after laboring. Women with previous cesareans who failed a trial of labor were eligible.
The primary outcome was the length of time to close the uterine incision, measured from the start of suturing until hemostasis was achieved; the time included hemostatic suturing.
After a small pilot study that established a baseline suturing time with polyglactin 910 sutures of 6 minutes (standard deviation, 2 minutes and 10 seconds), Dr. Peleg and his collaborators determined that they would need to enroll at least 34 women per study arm to detect a decrease of 25% in suture time – to 4.5 minutes – with barbed sutures.
“The decrease in closure time is not linear,” said Dr. Peleg, so they increased their sample size by 50%, to 51 patients in each group, to ensure statistical significance of the results.
One of the challenges of a surgical randomized controlled trial is ensuring uniform technique; for this study, all patients had epidural or spinal anesthesia and antibiotics before opening. Surgeon clinical judgment was used to determine whether a Pfannenstiel or low transverse incision was made. In either case, there was no closure of the parietal peritoneum or the rectus muscles, and subcutaneous closure was used if tissues were greater than 2 cm in depth. Subcuticular stitches were used if possible.
Looking at secondary outcomes, there was a trend toward shorter total operative time with barbed sutures that didn’t reach statistical significance (20.1 min for barbed sutures vs. 23.1 for conventional, P = .062). However, fewer hemostatic sutures were required when barbed sutures were used: Extra sutures were used in 16 of the barbed group vs. 41 who had conventional sutures (P less than .001). Those receiving barbed sutures also had significantly less blood loss and estimated total blood loss during uterine closure than the conventional suture group (P = .005 and P = .002, respectively).
No study patients experienced serious postoperative complications; there were no infections, hematomas, or other wound complications, said Dr. Peleg of Bar-Ilan University, Zefat, Israel.
On the pro side for wider implementation of the use of barbed sutures for uterine closure stand the quicker closure and better hemostasis, along with the theoretical benefits of having no knots. Additionally, said Dr. Peleg, “there’s a gentle learning curve – it’s relatively easy to get used to the technique” of using barbed sutures. And, he said, “surgeons find them satisfying to use.”
However, he acknowledged the extra expense of barbed suture material – depending on the location and supplier, he estimated the cost could run from 7- to 20-fold for the barbed sutures, which he said cost $23.50 apiece. Also, he said, though the results were statistically significant, “Are they clinically significant? Does a difference in closure time of one minute 43 seconds, and a decrease in blood loss of 47 milliliters matter?”
Other considerations, he said, will require longer-term study. Polydioxanone, used for the barbed sutures, has a longer absorption time – a factor with unknown clinical implications in this application. Other longer-term outcomes, such as vaginal birth after cesarean success rates, rates of uterine rupture, the thickness of the uterine scar, and rates of adhesions and placenta accreta, will need to be tracked for years.
The authors reported no conflicts of interest and specifically reported that they had no relevant consulting or research agreements with suture manufacturers or marketers.
SOURCE: Peleg D et al. The Pregnancy Meeting Abstract 32.
DALLAS – Using knotless barbed sutures to close the uterine incision after cesarean delivery reduced operating time and blood loss, according to a recent randomized controlled study.
“On average, knotless barbed sutures were 1 minute and 43 seconds faster,” said David Peleg, MD, discussing the study results at the meeting sponsored by the Society for Maternal-Fetal Medicine. Average uterine closure time with knotless barbed sutures was 3 minutes and 37 seconds; with smooth sutures, average closure time was 5 minutes and 20 seconds (103-second difference; 95% confidence interval, 67.69-138.47 seconds; P less than .001).
Barbed sutures, in contrast, are usually made of monofilament with barbs created by the addition of tiny diagonal cuts made just partway through the suture material. When the suture is pulled through with the angle of the barbs, it pulls smoothly, but pulling back against the barb angle causes the barbs to protrude and catch against tissue, preventing slippage and eliminating the need for knots.
The fact that the monofilament has been partially cut to create the barbs can also reduce tensile strength, but some of the other disadvantages of smooth sutures are avoided, said Dr. Peleg.
The suture material used for the study was bidirectional, with the barbs running in opposite directions from the midline and a needle swaged onto each end; other barbed suture systems have an integral loop at one end of a unidirectionally barbed length of suture material that is used to anchor the first suture. The brand used was Stratafix.
The prospective study was necessarily unblinded, and compared the knotless barbed sutures with smooth sutures using polyglactin 910 braided material (Vicryl) for use during closure of the uterine incision during cesarean section procedures.
Patients were eligible if they were having an elective cesarean section after at least 38 weeks’ gestation, or if they were having a cesarean for the usual obstetric indications after laboring. Women with previous cesareans who failed a trial of labor were eligible.
The primary outcome was the length of time to close the uterine incision, measured from the start of suturing until hemostasis was achieved; the time included hemostatic suturing.
After a small pilot study that established a baseline suturing time with polyglactin 910 sutures of 6 minutes (standard deviation, 2 minutes and 10 seconds), Dr. Peleg and his collaborators determined that they would need to enroll at least 34 women per study arm to detect a decrease of 25% in suture time – to 4.5 minutes – with barbed sutures.
“The decrease in closure time is not linear,” said Dr. Peleg, so they increased their sample size by 50%, to 51 patients in each group, to ensure statistical significance of the results.
One of the challenges of a surgical randomized controlled trial is ensuring uniform technique; for this study, all patients had epidural or spinal anesthesia and antibiotics before opening. Surgeon clinical judgment was used to determine whether a Pfannenstiel or low transverse incision was made. In either case, there was no closure of the parietal peritoneum or the rectus muscles, and subcutaneous closure was used if tissues were greater than 2 cm in depth. Subcuticular stitches were used if possible.
Looking at secondary outcomes, there was a trend toward shorter total operative time with barbed sutures that didn’t reach statistical significance (20.1 min for barbed sutures vs. 23.1 for conventional, P = .062). However, fewer hemostatic sutures were required when barbed sutures were used: Extra sutures were used in 16 of the barbed group vs. 41 who had conventional sutures (P less than .001). Those receiving barbed sutures also had significantly less blood loss and estimated total blood loss during uterine closure than the conventional suture group (P = .005 and P = .002, respectively).
No study patients experienced serious postoperative complications; there were no infections, hematomas, or other wound complications, said Dr. Peleg of Bar-Ilan University, Zefat, Israel.
On the pro side for wider implementation of the use of barbed sutures for uterine closure stand the quicker closure and better hemostasis, along with the theoretical benefits of having no knots. Additionally, said Dr. Peleg, “there’s a gentle learning curve – it’s relatively easy to get used to the technique” of using barbed sutures. And, he said, “surgeons find them satisfying to use.”
However, he acknowledged the extra expense of barbed suture material – depending on the location and supplier, he estimated the cost could run from 7- to 20-fold for the barbed sutures, which he said cost $23.50 apiece. Also, he said, though the results were statistically significant, “Are they clinically significant? Does a difference in closure time of one minute 43 seconds, and a decrease in blood loss of 47 milliliters matter?”
Other considerations, he said, will require longer-term study. Polydioxanone, used for the barbed sutures, has a longer absorption time – a factor with unknown clinical implications in this application. Other longer-term outcomes, such as vaginal birth after cesarean success rates, rates of uterine rupture, the thickness of the uterine scar, and rates of adhesions and placenta accreta, will need to be tracked for years.
The authors reported no conflicts of interest and specifically reported that they had no relevant consulting or research agreements with suture manufacturers or marketers.
SOURCE: Peleg D et al. The Pregnancy Meeting Abstract 32.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point: Closure time and blood loss were less with barbed sutures closing the uterine incision.
Major finding: Average uterine incision closure time was 3:37 minutes with knotless barbed sutures and 5:20 minutes with conventional smooth sutures.
Study details: Randomized controlled trial of 102 women undergoing cesarean section.
Disclosures: The study had no external sources of funding, and the study authors reported no relevant outside support.
Source: Peleg D et al. The Pregnancy Meeting Abstract 32.
These amniotic biomarkers predicted pPROM in women undergoing fetal surgery for spinal cord defect
DALLAS – Two molecular biomarkers in amniotic fluid seem to predict preterm premature rupture of membranes (pPROM) and subsequent premature delivery in women whose fetuses undergo surgical repair of spinal cord defects.
Matrix metalloproteinase–8 (MMP-8) and lactic acid levels were significantly higher in these women than in a comparator group of women who did not deliver a premature infant after the repair, Aikaterini Athanasiou, MD, said at the meeting sponsored by the Society for Maternal Fetal Medicine.
“Based on this pilot study, it appears that elevated amniotic levels of lactic acid and MMP-8 at time of surgery might identify a subset of women with increased susceptibility for pPROM and shorter time to delivery,” said Dr. Athanasiou, a fellow in obstetrics and gynecology at Cornell University, New York. She presented the work on behalf of primary author Antonio Moron, MD, PhD, of the Federal University of São Paulo.
Dr. Athanasiou was part of the Cornell team that conducted molecular assays on amniotic fluid samples drawn from 26 women carrying fetuses about to have corrective surgery for spinal defects in the fetuses. The women were all patients at the Federal Hospital of São Paulo. Samples were drawn immediately before surgery commenced, frozen, and shipped to Cornell for assay.
After surgical repair, 7 of the women (27%) later experienced pPROM and 19 did not.
At baseline, there were no significant differences between the groups. Women were a mean age of 32 years, with a mean of two prior pregnancies. There were no differences in prior cesarean and vaginal births, smoking status, and fetal gender. The defect was most commonly a myelomeningocele (about 70% of each group). Rachischisis was next most common, occurring in 27% of the pPROM group and 21% of the non-pPROM group. There were two cases of encephalocele, both in the non-pPROM group.
The length of surgery was not significantly different between those who experienced pPROM and those who did not (121 vs. 130 minutes). Wound healing time was 7 days for each group, as was the mean length of hospital stay.
Both groups went a mean of 57 days from surgery to delivery, although the fetal gestational age was almost a week younger in the pPROM group (33.7 vs. 34.4 weeks). These infants were also smaller at birth (2,247 g vs. 2,410 g).
The Cornell team examined five potential biomarkers in each amniotic fluid sample: MMP-8, MMP-9, MMP-2, lactic acid, and interleukin-6 (IL-6). The levels of IL-6, MMP-2, and MMP-9 were similar between groups.
However, lactic acid was significantly higher in the pPROM group (7.1 vs. 5.9 mU/mL). MMP-8 was also significantly elevated in the pPROM group (1.7 vs. 0.6 mcg/mL).
Dr. Athanasiou and her colleagues also observed an inverse relationship between MMP-8 levels and gestational age at delivery, which was statistically significant. There was also an inverse relationship between lactic acid levels and gestational age, but this did not reach statistical significance.
“While further investigations are needed to verify our findings, our data suggest that these differences are present before fetal surgery and that an increase in intra-amniotic anaerobic glycolysis as evidenced by elevated lactic acid may enhance MMP-8 production, which will weaken the maternal-fetal membranes,” Dr. Athanasiou said. “The mechanism may not be related to inflammation, as evidenced by the lack of association between pPROM and IL-6.”
She had no financial disclosures.
SOURCE: Moron A et al. Am J Obstet Gynecol. 2018 Jan:218(1);S64.
DALLAS – Two molecular biomarkers in amniotic fluid seem to predict preterm premature rupture of membranes (pPROM) and subsequent premature delivery in women whose fetuses undergo surgical repair of spinal cord defects.
Matrix metalloproteinase–8 (MMP-8) and lactic acid levels were significantly higher in these women than in a comparator group of women who did not deliver a premature infant after the repair, Aikaterini Athanasiou, MD, said at the meeting sponsored by the Society for Maternal Fetal Medicine.
“Based on this pilot study, it appears that elevated amniotic levels of lactic acid and MMP-8 at time of surgery might identify a subset of women with increased susceptibility for pPROM and shorter time to delivery,” said Dr. Athanasiou, a fellow in obstetrics and gynecology at Cornell University, New York. She presented the work on behalf of primary author Antonio Moron, MD, PhD, of the Federal University of São Paulo.
Dr. Athanasiou was part of the Cornell team that conducted molecular assays on amniotic fluid samples drawn from 26 women carrying fetuses about to have corrective surgery for spinal defects in the fetuses. The women were all patients at the Federal Hospital of São Paulo. Samples were drawn immediately before surgery commenced, frozen, and shipped to Cornell for assay.
After surgical repair, 7 of the women (27%) later experienced pPROM and 19 did not.
At baseline, there were no significant differences between the groups. Women were a mean age of 32 years, with a mean of two prior pregnancies. There were no differences in prior cesarean and vaginal births, smoking status, and fetal gender. The defect was most commonly a myelomeningocele (about 70% of each group). Rachischisis was next most common, occurring in 27% of the pPROM group and 21% of the non-pPROM group. There were two cases of encephalocele, both in the non-pPROM group.
The length of surgery was not significantly different between those who experienced pPROM and those who did not (121 vs. 130 minutes). Wound healing time was 7 days for each group, as was the mean length of hospital stay.
Both groups went a mean of 57 days from surgery to delivery, although the fetal gestational age was almost a week younger in the pPROM group (33.7 vs. 34.4 weeks). These infants were also smaller at birth (2,247 g vs. 2,410 g).
The Cornell team examined five potential biomarkers in each amniotic fluid sample: MMP-8, MMP-9, MMP-2, lactic acid, and interleukin-6 (IL-6). The levels of IL-6, MMP-2, and MMP-9 were similar between groups.
However, lactic acid was significantly higher in the pPROM group (7.1 vs. 5.9 mU/mL). MMP-8 was also significantly elevated in the pPROM group (1.7 vs. 0.6 mcg/mL).
Dr. Athanasiou and her colleagues also observed an inverse relationship between MMP-8 levels and gestational age at delivery, which was statistically significant. There was also an inverse relationship between lactic acid levels and gestational age, but this did not reach statistical significance.
“While further investigations are needed to verify our findings, our data suggest that these differences are present before fetal surgery and that an increase in intra-amniotic anaerobic glycolysis as evidenced by elevated lactic acid may enhance MMP-8 production, which will weaken the maternal-fetal membranes,” Dr. Athanasiou said. “The mechanism may not be related to inflammation, as evidenced by the lack of association between pPROM and IL-6.”
She had no financial disclosures.
SOURCE: Moron A et al. Am J Obstet Gynecol. 2018 Jan:218(1);S64.
DALLAS – Two molecular biomarkers in amniotic fluid seem to predict preterm premature rupture of membranes (pPROM) and subsequent premature delivery in women whose fetuses undergo surgical repair of spinal cord defects.
Matrix metalloproteinase–8 (MMP-8) and lactic acid levels were significantly higher in these women than in a comparator group of women who did not deliver a premature infant after the repair, Aikaterini Athanasiou, MD, said at the meeting sponsored by the Society for Maternal Fetal Medicine.
“Based on this pilot study, it appears that elevated amniotic levels of lactic acid and MMP-8 at time of surgery might identify a subset of women with increased susceptibility for pPROM and shorter time to delivery,” said Dr. Athanasiou, a fellow in obstetrics and gynecology at Cornell University, New York. She presented the work on behalf of primary author Antonio Moron, MD, PhD, of the Federal University of São Paulo.
Dr. Athanasiou was part of the Cornell team that conducted molecular assays on amniotic fluid samples drawn from 26 women carrying fetuses about to have corrective surgery for spinal defects in the fetuses. The women were all patients at the Federal Hospital of São Paulo. Samples were drawn immediately before surgery commenced, frozen, and shipped to Cornell for assay.
After surgical repair, 7 of the women (27%) later experienced pPROM and 19 did not.
At baseline, there were no significant differences between the groups. Women were a mean age of 32 years, with a mean of two prior pregnancies. There were no differences in prior cesarean and vaginal births, smoking status, and fetal gender. The defect was most commonly a myelomeningocele (about 70% of each group). Rachischisis was next most common, occurring in 27% of the pPROM group and 21% of the non-pPROM group. There were two cases of encephalocele, both in the non-pPROM group.
The length of surgery was not significantly different between those who experienced pPROM and those who did not (121 vs. 130 minutes). Wound healing time was 7 days for each group, as was the mean length of hospital stay.
Both groups went a mean of 57 days from surgery to delivery, although the fetal gestational age was almost a week younger in the pPROM group (33.7 vs. 34.4 weeks). These infants were also smaller at birth (2,247 g vs. 2,410 g).
The Cornell team examined five potential biomarkers in each amniotic fluid sample: MMP-8, MMP-9, MMP-2, lactic acid, and interleukin-6 (IL-6). The levels of IL-6, MMP-2, and MMP-9 were similar between groups.
However, lactic acid was significantly higher in the pPROM group (7.1 vs. 5.9 mU/mL). MMP-8 was also significantly elevated in the pPROM group (1.7 vs. 0.6 mcg/mL).
Dr. Athanasiou and her colleagues also observed an inverse relationship between MMP-8 levels and gestational age at delivery, which was statistically significant. There was also an inverse relationship between lactic acid levels and gestational age, but this did not reach statistical significance.
“While further investigations are needed to verify our findings, our data suggest that these differences are present before fetal surgery and that an increase in intra-amniotic anaerobic glycolysis as evidenced by elevated lactic acid may enhance MMP-8 production, which will weaken the maternal-fetal membranes,” Dr. Athanasiou said. “The mechanism may not be related to inflammation, as evidenced by the lack of association between pPROM and IL-6.”
She had no financial disclosures.
SOURCE: Moron A et al. Am J Obstet Gynecol. 2018 Jan:218(1);S64.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point: Lactic acid and MMP-8 in amniotic fluid may have utility as biomarkers predictive of pPROM in women who undergo fetal surgery for spinal cord defects.
Major finding: Women who experienced pPROM had higher amniotic lactic acid (7.1 vs. 5.9 mU/mL) and MMP-8 (1.7 vs. 0.6 mcg/mL) at time of fetal surgery.
Study details: The prospective study comprised 26 women.
Disclosures: Dr. Athanasiou had no financial disclosures.
Source: Moron A et al. Am J Obstet Gynecol. 2018 Jan:218(1);S64.
Placental transfusion volume unaffected by oxytocin timing
DALLAS – Timing of maternal oxytocin administration did not affect total placental transfusion volume accomplished via delayed umbilical cord clamping, according to a recent randomized, controlled trial.
Of 144 infants born to women who consented to randomization, those whose mothers received intravenous oxytocin within 15 seconds of delivery (n = 70) gained a mean 86 g (standard deviation, 48; 95% confidence interval, 74-97) in the 3 minutes after delivery, before umbilical cord clamping. Infants whose mothers received oxytocin when the umbilical cord was clamped 3 minutes after delivery (n = 74) gained 87 g (SD, 50; 95% CI, 75-98; P for difference between groups = .92). The findings were presented during an abstract session at the meeting sponsored by the Society for Maternal-Fetal Medicine.
It had not previously been known whether immediate oxytocin administration enhanced or diminished placental transfusion volume, said Daniela Satragno, MD, the study’s first author.
The investigators had hypothesized that immediate oxytocin administration would increase the volume of placental transfusion, said Dr. Satragno, of Argentina’s Foundation for Maternal and Child Health. However, their study didn’t bear this out. “When umbilical cord clamping is delayed for 3 minutes, infants receive a clinically significant placental transfusion which is not modified by the administration of IV oxytocin immediately after birth,” wrote Dr. Satragno and her coauthors in the abstract accompanying the presentation.
The study in the American Journal of Obstetrics & Gynecology included healthy term infants born via vaginal delivery; Dr. Satragno said that consent was obtained from mothers in early labor, and that study recruiters did not approach women who were in more advanced stages of labor because of ethical concerns. Women with high-risk pregnancies and those with known fetal anomalies were excluded, as were any who required forceps deliveries, neonatal resuscitation, and those whose deliveries involved a short umbilical cord or a nuchal cord.
In order to estimate the volume of placental transfusion, all infants were weighed on a 1-g precision scale placed at the level of the vagina both immediately after birth and after the umbilical cord was clamped at 3 minutes after delivery. All participating mothers received 10 IU of oxytocin, with the timing varying by intervention arm. A figure of 1.05 g/cc of blood was used to calculate transfusion volume, with change in infant weight used as a proxy for transfusion volume.
Hematocrit levels were also similar between the two groups: infants whose mothers received immediate oxytocin had a mean hematocrit of 57% (SD, 5), while those whose mothers had delayed oxytocin administration had a mean hematocrit of 56.8% (SD, 6).
Dr. Satragno and her collaborators also looked at a number of other secondary outcome measures, including incidence of jaundice and polycythemia in the infant, and maternal postpartum hemorrhage. There were no such adverse events that reached the level of clinical relevance among any of the mothers or infants in the study population, she said.
A larger study had been planned, said Dr. Satragno, but the data safety monitoring board recommended stopping the study for futility after the prespecified interim analysis of data from 144 patients – just 25% of the originally planned sample size.
In response to an audience question, Dr. Satragno acknowledged that blinding was not feasible with their study design, but that she did not think that this affected physician management in the first few minutes postpartum. She noted that delayed cord clamping has been an area of active research at her institution, and protocols are well established.
“Based on the available data, a recalculation of the sample size for a difference of 20% in the volume of placental transfusion would result in a trial of an unrealistically large magnitude,” said Dr. Satragno.
The study was funded by the Foundation for Maternal and Child Health. The authors reported no conflicts of interest.
SOURCE: Satragno D et al. Am J Obstet Gynecol. 2018 Jan;218:S26.
DALLAS – Timing of maternal oxytocin administration did not affect total placental transfusion volume accomplished via delayed umbilical cord clamping, according to a recent randomized, controlled trial.
Of 144 infants born to women who consented to randomization, those whose mothers received intravenous oxytocin within 15 seconds of delivery (n = 70) gained a mean 86 g (standard deviation, 48; 95% confidence interval, 74-97) in the 3 minutes after delivery, before umbilical cord clamping. Infants whose mothers received oxytocin when the umbilical cord was clamped 3 minutes after delivery (n = 74) gained 87 g (SD, 50; 95% CI, 75-98; P for difference between groups = .92). The findings were presented during an abstract session at the meeting sponsored by the Society for Maternal-Fetal Medicine.
It had not previously been known whether immediate oxytocin administration enhanced or diminished placental transfusion volume, said Daniela Satragno, MD, the study’s first author.
The investigators had hypothesized that immediate oxytocin administration would increase the volume of placental transfusion, said Dr. Satragno, of Argentina’s Foundation for Maternal and Child Health. However, their study didn’t bear this out. “When umbilical cord clamping is delayed for 3 minutes, infants receive a clinically significant placental transfusion which is not modified by the administration of IV oxytocin immediately after birth,” wrote Dr. Satragno and her coauthors in the abstract accompanying the presentation.
The study in the American Journal of Obstetrics & Gynecology included healthy term infants born via vaginal delivery; Dr. Satragno said that consent was obtained from mothers in early labor, and that study recruiters did not approach women who were in more advanced stages of labor because of ethical concerns. Women with high-risk pregnancies and those with known fetal anomalies were excluded, as were any who required forceps deliveries, neonatal resuscitation, and those whose deliveries involved a short umbilical cord or a nuchal cord.
In order to estimate the volume of placental transfusion, all infants were weighed on a 1-g precision scale placed at the level of the vagina both immediately after birth and after the umbilical cord was clamped at 3 minutes after delivery. All participating mothers received 10 IU of oxytocin, with the timing varying by intervention arm. A figure of 1.05 g/cc of blood was used to calculate transfusion volume, with change in infant weight used as a proxy for transfusion volume.
Hematocrit levels were also similar between the two groups: infants whose mothers received immediate oxytocin had a mean hematocrit of 57% (SD, 5), while those whose mothers had delayed oxytocin administration had a mean hematocrit of 56.8% (SD, 6).
Dr. Satragno and her collaborators also looked at a number of other secondary outcome measures, including incidence of jaundice and polycythemia in the infant, and maternal postpartum hemorrhage. There were no such adverse events that reached the level of clinical relevance among any of the mothers or infants in the study population, she said.
A larger study had been planned, said Dr. Satragno, but the data safety monitoring board recommended stopping the study for futility after the prespecified interim analysis of data from 144 patients – just 25% of the originally planned sample size.
In response to an audience question, Dr. Satragno acknowledged that blinding was not feasible with their study design, but that she did not think that this affected physician management in the first few minutes postpartum. She noted that delayed cord clamping has been an area of active research at her institution, and protocols are well established.
“Based on the available data, a recalculation of the sample size for a difference of 20% in the volume of placental transfusion would result in a trial of an unrealistically large magnitude,” said Dr. Satragno.
The study was funded by the Foundation for Maternal and Child Health. The authors reported no conflicts of interest.
SOURCE: Satragno D et al. Am J Obstet Gynecol. 2018 Jan;218:S26.
DALLAS – Timing of maternal oxytocin administration did not affect total placental transfusion volume accomplished via delayed umbilical cord clamping, according to a recent randomized, controlled trial.
Of 144 infants born to women who consented to randomization, those whose mothers received intravenous oxytocin within 15 seconds of delivery (n = 70) gained a mean 86 g (standard deviation, 48; 95% confidence interval, 74-97) in the 3 minutes after delivery, before umbilical cord clamping. Infants whose mothers received oxytocin when the umbilical cord was clamped 3 minutes after delivery (n = 74) gained 87 g (SD, 50; 95% CI, 75-98; P for difference between groups = .92). The findings were presented during an abstract session at the meeting sponsored by the Society for Maternal-Fetal Medicine.
It had not previously been known whether immediate oxytocin administration enhanced or diminished placental transfusion volume, said Daniela Satragno, MD, the study’s first author.
The investigators had hypothesized that immediate oxytocin administration would increase the volume of placental transfusion, said Dr. Satragno, of Argentina’s Foundation for Maternal and Child Health. However, their study didn’t bear this out. “When umbilical cord clamping is delayed for 3 minutes, infants receive a clinically significant placental transfusion which is not modified by the administration of IV oxytocin immediately after birth,” wrote Dr. Satragno and her coauthors in the abstract accompanying the presentation.
The study in the American Journal of Obstetrics & Gynecology included healthy term infants born via vaginal delivery; Dr. Satragno said that consent was obtained from mothers in early labor, and that study recruiters did not approach women who were in more advanced stages of labor because of ethical concerns. Women with high-risk pregnancies and those with known fetal anomalies were excluded, as were any who required forceps deliveries, neonatal resuscitation, and those whose deliveries involved a short umbilical cord or a nuchal cord.
In order to estimate the volume of placental transfusion, all infants were weighed on a 1-g precision scale placed at the level of the vagina both immediately after birth and after the umbilical cord was clamped at 3 minutes after delivery. All participating mothers received 10 IU of oxytocin, with the timing varying by intervention arm. A figure of 1.05 g/cc of blood was used to calculate transfusion volume, with change in infant weight used as a proxy for transfusion volume.
Hematocrit levels were also similar between the two groups: infants whose mothers received immediate oxytocin had a mean hematocrit of 57% (SD, 5), while those whose mothers had delayed oxytocin administration had a mean hematocrit of 56.8% (SD, 6).
Dr. Satragno and her collaborators also looked at a number of other secondary outcome measures, including incidence of jaundice and polycythemia in the infant, and maternal postpartum hemorrhage. There were no such adverse events that reached the level of clinical relevance among any of the mothers or infants in the study population, she said.
A larger study had been planned, said Dr. Satragno, but the data safety monitoring board recommended stopping the study for futility after the prespecified interim analysis of data from 144 patients – just 25% of the originally planned sample size.
In response to an audience question, Dr. Satragno acknowledged that blinding was not feasible with their study design, but that she did not think that this affected physician management in the first few minutes postpartum. She noted that delayed cord clamping has been an area of active research at her institution, and protocols are well established.
“Based on the available data, a recalculation of the sample size for a difference of 20% in the volume of placental transfusion would result in a trial of an unrealistically large magnitude,” said Dr. Satragno.
The study was funded by the Foundation for Maternal and Child Health. The authors reported no conflicts of interest.
SOURCE: Satragno D et al. Am J Obstet Gynecol. 2018 Jan;218:S26.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point: The timing of oxytocin administration didn’t affect placental transfusion volume with delayed cord clamping.
Major finding: Placental transfusion volume was 86 g with immediate and 87 g with delayed oxytocin administration (P = .92), with infant weight used as proxy.
Study details: Randomized controlled trial of 144 healthy term infants delivered vaginally after uncomplicated pregnancy.
Disclosures: The study was sponsored by the Foundation for Maternal and Child Health, where Dr. Satragno is employed.
Source: Satragno D et al. Am J Obstet Gynecol. 2018 Jan;218:S26.
Ibuprofen appears safe with preeclampsia, study says
DALLAS – Compared to acetaminophen, ibuprofen does not prolong the time needed to control postpartum hypertension in women who experience preeclampsia with severe features, Nathan Blue MD, reported at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.
Ibuprofen did not exacerbate postpartum hypertension, as some studies have suggested, and women randomized to it for postpartum pain control reached their target blood pressure at a mean of 35 hours after delivery, similar to the 38 hours needed among women receiving acetaminophen.
Dr. Blue’s findings contradict the recommendation by the American College of Obstetricians and Gynecologists to avoid the use of ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) for pain control in women who experience preeclampsia or other hypertensive disorders of pregnancy.
“While our study was not meant to answer all questions about the potential problems of nonsteroidal anti-inflammatories [in this population], I would conclude from these results that providers and patients can make a decision together and feel good about the use of NSAIDs,” in the presence of postpartum hypertension, said Dr. Blue, a fellow at the University of New Mexico, Albuquerque.
These concerns led ACOG to issue its recommendation in 2013 against the use of NSAIDs in pregnant women with hypertension.
“This is problematic, because NSAIDs are particularly well-suited to address obstetric pain,” Dr. Blue said at the meeting. “They have been shown to be better than acetaminophen for perineal injury and they are associated with a reduced use of opioids after cesarean section.”
To investigate the effect of ibuprofen on postpartum hypertension, Dr. Blue and his colleagues conducted a double-blind randomized controlled trial of 100 women with preeclampsia with severe features. The study population also included women who had chronic hypertension complicated by preeclampsia with severe features, and women with HELLP syndrome – a constellation of hemolysis, elevated liver enzymes, and low platelet count.
Women were randomized to either 600 mg ibuprofen or 650 mg acetaminophen every 6 hours, around the clock, with the first dose delivered within 6 hours of delivery. All patients received at least eight doses of their assigned medication. The primary endpoint was the time required to achieve blood pressure control. “We defined blood pressure control as the number of hours from delivery to the last reading of at least 160/110 mm Hg before discharge,” Dr. Blue said. “Our rationale here was that persistence of a blood pressure of that level would require a delay in discharge of at least 24 hours.”
The study had a number of secondary outcomes, including time from delivery to last blood pressure reading of at least 150/100 mm Hg; postpartum mean arterial pressure; any blood pressure reading of 160/110 mm Hg or higher; need for antihypertensive drugs at discharge; prolongation of hospital stay due to hypertension; and the need for postpartum opioids.
There was a 6-week follow-up assessment, at which time women reported any continued antihypertensive or opioid use, obstetrical triage visits after discharge, and hospital readmission.
The study cohort was well-balanced at baseline. Women were a mean of 30 years old; about a third were nulliparous, and half had a vaginal delivery. Chronic hypertension requiring medication was present in about 15%. The maximum blood pressure before delivery was about 180/107.
There was no significant difference between the ibuprofen group and the acetaminophen group in the primary endpoint of time to blood pressure of 160/110 mm Hg or below (35.3 vs. 38 hours). Nor were there significant differences in any of the secondary endpoints, including time to achieve a blood pressure of less than 150/100 mm Hg (58 vs. 57 hours), postpartum mean arterial pressure, maximum systolic and diastolic blood pressures, or the number of women who needed a short-acting antihypertensive (30 vs. 26) and who went home on an antihypertensive (33 vs. 31).
There were also no significant between-group differences in opioid use, either on postpartum days 0, 1, or 2. The total morphine equivalent dose for each group was likewise not significantly different (77 vs. 88 mg).
Dr. Blue was able to contact 77 women at 6 weeks’ postpartum. He found that 6-week outcomes were also similar. There were no significant differences in the number who required continuing antihypertensive or opioids, no difference in obstetric triage visits, and no difference in hospital readmission.
“Our study does not support the hypothesis that NSAIDs adversely affect blood pressure control in patients with preeclampsia,” he said. “Not only did we not find a difference in the primary outcome, we found not even a suggestion of difference in any measure of blood pressure control.”
The University of New Mexico sponsored the study. Dr. Blue reported having no financial disclosures.
SOURCE: Blue et al. The Pregnancy Meeting 2018 Abstract LB04.
DALLAS – Compared to acetaminophen, ibuprofen does not prolong the time needed to control postpartum hypertension in women who experience preeclampsia with severe features, Nathan Blue MD, reported at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.
Ibuprofen did not exacerbate postpartum hypertension, as some studies have suggested, and women randomized to it for postpartum pain control reached their target blood pressure at a mean of 35 hours after delivery, similar to the 38 hours needed among women receiving acetaminophen.
Dr. Blue’s findings contradict the recommendation by the American College of Obstetricians and Gynecologists to avoid the use of ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) for pain control in women who experience preeclampsia or other hypertensive disorders of pregnancy.
“While our study was not meant to answer all questions about the potential problems of nonsteroidal anti-inflammatories [in this population], I would conclude from these results that providers and patients can make a decision together and feel good about the use of NSAIDs,” in the presence of postpartum hypertension, said Dr. Blue, a fellow at the University of New Mexico, Albuquerque.
These concerns led ACOG to issue its recommendation in 2013 against the use of NSAIDs in pregnant women with hypertension.
“This is problematic, because NSAIDs are particularly well-suited to address obstetric pain,” Dr. Blue said at the meeting. “They have been shown to be better than acetaminophen for perineal injury and they are associated with a reduced use of opioids after cesarean section.”
To investigate the effect of ibuprofen on postpartum hypertension, Dr. Blue and his colleagues conducted a double-blind randomized controlled trial of 100 women with preeclampsia with severe features. The study population also included women who had chronic hypertension complicated by preeclampsia with severe features, and women with HELLP syndrome – a constellation of hemolysis, elevated liver enzymes, and low platelet count.
Women were randomized to either 600 mg ibuprofen or 650 mg acetaminophen every 6 hours, around the clock, with the first dose delivered within 6 hours of delivery. All patients received at least eight doses of their assigned medication. The primary endpoint was the time required to achieve blood pressure control. “We defined blood pressure control as the number of hours from delivery to the last reading of at least 160/110 mm Hg before discharge,” Dr. Blue said. “Our rationale here was that persistence of a blood pressure of that level would require a delay in discharge of at least 24 hours.”
The study had a number of secondary outcomes, including time from delivery to last blood pressure reading of at least 150/100 mm Hg; postpartum mean arterial pressure; any blood pressure reading of 160/110 mm Hg or higher; need for antihypertensive drugs at discharge; prolongation of hospital stay due to hypertension; and the need for postpartum opioids.
There was a 6-week follow-up assessment, at which time women reported any continued antihypertensive or opioid use, obstetrical triage visits after discharge, and hospital readmission.
The study cohort was well-balanced at baseline. Women were a mean of 30 years old; about a third were nulliparous, and half had a vaginal delivery. Chronic hypertension requiring medication was present in about 15%. The maximum blood pressure before delivery was about 180/107.
There was no significant difference between the ibuprofen group and the acetaminophen group in the primary endpoint of time to blood pressure of 160/110 mm Hg or below (35.3 vs. 38 hours). Nor were there significant differences in any of the secondary endpoints, including time to achieve a blood pressure of less than 150/100 mm Hg (58 vs. 57 hours), postpartum mean arterial pressure, maximum systolic and diastolic blood pressures, or the number of women who needed a short-acting antihypertensive (30 vs. 26) and who went home on an antihypertensive (33 vs. 31).
There were also no significant between-group differences in opioid use, either on postpartum days 0, 1, or 2. The total morphine equivalent dose for each group was likewise not significantly different (77 vs. 88 mg).
Dr. Blue was able to contact 77 women at 6 weeks’ postpartum. He found that 6-week outcomes were also similar. There were no significant differences in the number who required continuing antihypertensive or opioids, no difference in obstetric triage visits, and no difference in hospital readmission.
“Our study does not support the hypothesis that NSAIDs adversely affect blood pressure control in patients with preeclampsia,” he said. “Not only did we not find a difference in the primary outcome, we found not even a suggestion of difference in any measure of blood pressure control.”
The University of New Mexico sponsored the study. Dr. Blue reported having no financial disclosures.
SOURCE: Blue et al. The Pregnancy Meeting 2018 Abstract LB04.
DALLAS – Compared to acetaminophen, ibuprofen does not prolong the time needed to control postpartum hypertension in women who experience preeclampsia with severe features, Nathan Blue MD, reported at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.
Ibuprofen did not exacerbate postpartum hypertension, as some studies have suggested, and women randomized to it for postpartum pain control reached their target blood pressure at a mean of 35 hours after delivery, similar to the 38 hours needed among women receiving acetaminophen.
Dr. Blue’s findings contradict the recommendation by the American College of Obstetricians and Gynecologists to avoid the use of ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) for pain control in women who experience preeclampsia or other hypertensive disorders of pregnancy.
“While our study was not meant to answer all questions about the potential problems of nonsteroidal anti-inflammatories [in this population], I would conclude from these results that providers and patients can make a decision together and feel good about the use of NSAIDs,” in the presence of postpartum hypertension, said Dr. Blue, a fellow at the University of New Mexico, Albuquerque.
These concerns led ACOG to issue its recommendation in 2013 against the use of NSAIDs in pregnant women with hypertension.
“This is problematic, because NSAIDs are particularly well-suited to address obstetric pain,” Dr. Blue said at the meeting. “They have been shown to be better than acetaminophen for perineal injury and they are associated with a reduced use of opioids after cesarean section.”
To investigate the effect of ibuprofen on postpartum hypertension, Dr. Blue and his colleagues conducted a double-blind randomized controlled trial of 100 women with preeclampsia with severe features. The study population also included women who had chronic hypertension complicated by preeclampsia with severe features, and women with HELLP syndrome – a constellation of hemolysis, elevated liver enzymes, and low platelet count.
Women were randomized to either 600 mg ibuprofen or 650 mg acetaminophen every 6 hours, around the clock, with the first dose delivered within 6 hours of delivery. All patients received at least eight doses of their assigned medication. The primary endpoint was the time required to achieve blood pressure control. “We defined blood pressure control as the number of hours from delivery to the last reading of at least 160/110 mm Hg before discharge,” Dr. Blue said. “Our rationale here was that persistence of a blood pressure of that level would require a delay in discharge of at least 24 hours.”
The study had a number of secondary outcomes, including time from delivery to last blood pressure reading of at least 150/100 mm Hg; postpartum mean arterial pressure; any blood pressure reading of 160/110 mm Hg or higher; need for antihypertensive drugs at discharge; prolongation of hospital stay due to hypertension; and the need for postpartum opioids.
There was a 6-week follow-up assessment, at which time women reported any continued antihypertensive or opioid use, obstetrical triage visits after discharge, and hospital readmission.
The study cohort was well-balanced at baseline. Women were a mean of 30 years old; about a third were nulliparous, and half had a vaginal delivery. Chronic hypertension requiring medication was present in about 15%. The maximum blood pressure before delivery was about 180/107.
There was no significant difference between the ibuprofen group and the acetaminophen group in the primary endpoint of time to blood pressure of 160/110 mm Hg or below (35.3 vs. 38 hours). Nor were there significant differences in any of the secondary endpoints, including time to achieve a blood pressure of less than 150/100 mm Hg (58 vs. 57 hours), postpartum mean arterial pressure, maximum systolic and diastolic blood pressures, or the number of women who needed a short-acting antihypertensive (30 vs. 26) and who went home on an antihypertensive (33 vs. 31).
There were also no significant between-group differences in opioid use, either on postpartum days 0, 1, or 2. The total morphine equivalent dose for each group was likewise not significantly different (77 vs. 88 mg).
Dr. Blue was able to contact 77 women at 6 weeks’ postpartum. He found that 6-week outcomes were also similar. There were no significant differences in the number who required continuing antihypertensive or opioids, no difference in obstetric triage visits, and no difference in hospital readmission.
“Our study does not support the hypothesis that NSAIDs adversely affect blood pressure control in patients with preeclampsia,” he said. “Not only did we not find a difference in the primary outcome, we found not even a suggestion of difference in any measure of blood pressure control.”
The University of New Mexico sponsored the study. Dr. Blue reported having no financial disclosures.
SOURCE: Blue et al. The Pregnancy Meeting 2018 Abstract LB04.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point:
Major finding: The mean time to achieve postpartum blood pressure control was 35 hours in the ibuprofen group and 38 hours in the acetaminophen group.
Study details: The randomized study comprised 100 women.
Disclosures: The University of New Mexico sponsored the study. Dr. Blue reported having no financial disclosures.
Source: Blue N et al. The Pregnancy Meeting 2018 Abstract LB04.
Is elective induction at 39 weeks a good idea?
DALLAS – Elective inductions at 39 weeks’ gestation were safe for the newborn and conferred dual benefits upon first-time mothers, reducing the risk of cesarean delivery by 16% and pregnancy-related hypertensive disorder by 36%, compared with women managed expectantly.
Infants delivered by elective inductions were smaller than those born to expectantly managed women and experienced a 29% reduction in the need for respiratory support at birth, William A. Grobman, MD, reported at the meeting, sponsored by the Society for Maternal-Fetal Medicine. They were no more likely than infants in the comparator group to experience dangerous perinatal outcomes, including low Apgar scores, meconium inhalation, hypoxia, or birth trauma, said Dr. Grobman, professor of obstetrics and gynecology at Northwestern University, Chicago.
The new data, however, may set a new standard by which to make this decision, Dr. Grobman said.
“I will leave it up to the professional organizations to determine the final outcome of these data, but it’s important to understand that the Choosing Wisely recommendation was based on observational data that essentially used an incorrect clinical comparator” of spontaneous labor, he said. The large study that Dr. Grobman and his colleagues conducted used expectant management (EM) as the comparator, allowing women to continue up to 42 weeks’ gestation. Using this comparator, he said, “Our data are largely with almost every observational study” and with a recently published randomized controlled trial by Kate F. Walker, a clinical research fellow at the University of Nottingham (England).
That study determined that labor induction between 39 weeks and 39 weeks, 6 days, in women older than 35 years had no significant effect on the rate of cesarean section and no adverse short-term effects on maternal or neonatal outcomes.
Dr. Grobman conducted his randomized trial at 41 hospitals in the National Institutes of Health’s Maternal-Fetal Medicine Units Network.
It randomized 6,106 healthy, nulliparous women to either elective induction from 39 weeks to 39 weeks, 4 days, or to EM. These women were asked to forgo elective delivery before 40 weeks, 5 days, but to be delivered by 42 weeks, 2 days.
The primary perinatal outcome was a composite endpoint that included fetal or neonatal death; respiratory support in the first 72 hours; 5-minute Apgar of 3 or lower; hypoxic ischemic encephalopathy; seizure; infection; meconium aspiration syndrome; birth trauma; intracranial or subgaleal hemorrhage; and hypotension requiring vasopressors.
The primary maternal outcome was a composite of cesarean delivery; hypertensive disorder of pregnancy; postpartum hemorrhage; chorioamnionitis; postpartum infection; labor pain; and the Labour Agentry Scale, a midwife-created measure of a laboring woman’s perception of her birth experience.
Women were a mean of 23.5 years old; about 44% of each group was privately insured. Prior pregnancy loss was more common among those randomized to EM (25.6% vs. 22.8%). Just over half were obese, with a body mass index of at least 30 kg/m2. Most (about 63%) had an unfavorable cervix, with a Bishop score of less than 5. The trial specified no particular induction regimen, Dr. Grobman said. “There were a variety of ripening agents and oxytocin regimens used.”
Infants in the elective induction group were born significantly earlier than were those in the EM group (39.3 vs. 40 weeks) and weighed significantly less (3,300 g vs. 3,380 g). Induction was safe for the newborn, with the primary endpoint occurring in 4.4%, compared with 5.4% of those in the EM group – not significantly different.
When investigators examined each outcome in the perinatal composite individually, only one – early respiratory support – was significantly different from the EM group. Infants in the induction group were 29% less likely to need respiratory support in the first 72 hours (3% vs. 4.2%; relative risk, 0.71). The rate of cesarean delivery also was significantly less among the induction group (18.6% vs. 22.2%; RR, 0.84).
None of these outcomes changed when the investigators controlled for race/ethnicity, Bishop score of less than 5, body mass index of 30 kg/m2 or more, or advanced maternal age.
Induction also was safe for mothers, and conferred a significant 36% reduction in the risk of pregnancy-related hypertensive disorders (9.1% vs. 14.1%; RR, 0.64). All other maternal outcomes were similar between the two groups.
The Agentry scale results also showed that women who were induced felt they were more in control of their birth experience, both at delivery and at 6 weeks’ postpartum. They also rated their worst labor pain and overall labor pain as significantly less than did women in the EM group.
“Our result suggest that policies directed toward avoidance of elective labor induction in nulliparous women would be unlikely to reduce the rate of cesarean section on a population level,” Dr. Grobman said. “To the contrary, our data show that, for every 28 nulliparous women to undergo elective induction at 39 weeks, one cesarean section would be avoided. Additionally, the number needed to treat to prevent one case of neonatal respiratory support is 83, and to prevent one case of hypertensive disease of pregnancy, 20. Our results should provide information useful to women as they consider their options, and can be incorporated into shared decision-making discussions with the provider.”
The study was sponsored by the National Institutes of Health. Dr. Grobman had no financial disclosures.
SOURCE: Grobman W. Am J Obstet Gynecol. 2018 Jan;218:S601.
DALLAS – Elective inductions at 39 weeks’ gestation were safe for the newborn and conferred dual benefits upon first-time mothers, reducing the risk of cesarean delivery by 16% and pregnancy-related hypertensive disorder by 36%, compared with women managed expectantly.
Infants delivered by elective inductions were smaller than those born to expectantly managed women and experienced a 29% reduction in the need for respiratory support at birth, William A. Grobman, MD, reported at the meeting, sponsored by the Society for Maternal-Fetal Medicine. They were no more likely than infants in the comparator group to experience dangerous perinatal outcomes, including low Apgar scores, meconium inhalation, hypoxia, or birth trauma, said Dr. Grobman, professor of obstetrics and gynecology at Northwestern University, Chicago.
The new data, however, may set a new standard by which to make this decision, Dr. Grobman said.
“I will leave it up to the professional organizations to determine the final outcome of these data, but it’s important to understand that the Choosing Wisely recommendation was based on observational data that essentially used an incorrect clinical comparator” of spontaneous labor, he said. The large study that Dr. Grobman and his colleagues conducted used expectant management (EM) as the comparator, allowing women to continue up to 42 weeks’ gestation. Using this comparator, he said, “Our data are largely with almost every observational study” and with a recently published randomized controlled trial by Kate F. Walker, a clinical research fellow at the University of Nottingham (England).
That study determined that labor induction between 39 weeks and 39 weeks, 6 days, in women older than 35 years had no significant effect on the rate of cesarean section and no adverse short-term effects on maternal or neonatal outcomes.
Dr. Grobman conducted his randomized trial at 41 hospitals in the National Institutes of Health’s Maternal-Fetal Medicine Units Network.
It randomized 6,106 healthy, nulliparous women to either elective induction from 39 weeks to 39 weeks, 4 days, or to EM. These women were asked to forgo elective delivery before 40 weeks, 5 days, but to be delivered by 42 weeks, 2 days.
The primary perinatal outcome was a composite endpoint that included fetal or neonatal death; respiratory support in the first 72 hours; 5-minute Apgar of 3 or lower; hypoxic ischemic encephalopathy; seizure; infection; meconium aspiration syndrome; birth trauma; intracranial or subgaleal hemorrhage; and hypotension requiring vasopressors.
The primary maternal outcome was a composite of cesarean delivery; hypertensive disorder of pregnancy; postpartum hemorrhage; chorioamnionitis; postpartum infection; labor pain; and the Labour Agentry Scale, a midwife-created measure of a laboring woman’s perception of her birth experience.
Women were a mean of 23.5 years old; about 44% of each group was privately insured. Prior pregnancy loss was more common among those randomized to EM (25.6% vs. 22.8%). Just over half were obese, with a body mass index of at least 30 kg/m2. Most (about 63%) had an unfavorable cervix, with a Bishop score of less than 5. The trial specified no particular induction regimen, Dr. Grobman said. “There were a variety of ripening agents and oxytocin regimens used.”
Infants in the elective induction group were born significantly earlier than were those in the EM group (39.3 vs. 40 weeks) and weighed significantly less (3,300 g vs. 3,380 g). Induction was safe for the newborn, with the primary endpoint occurring in 4.4%, compared with 5.4% of those in the EM group – not significantly different.
When investigators examined each outcome in the perinatal composite individually, only one – early respiratory support – was significantly different from the EM group. Infants in the induction group were 29% less likely to need respiratory support in the first 72 hours (3% vs. 4.2%; relative risk, 0.71). The rate of cesarean delivery also was significantly less among the induction group (18.6% vs. 22.2%; RR, 0.84).
None of these outcomes changed when the investigators controlled for race/ethnicity, Bishop score of less than 5, body mass index of 30 kg/m2 or more, or advanced maternal age.
Induction also was safe for mothers, and conferred a significant 36% reduction in the risk of pregnancy-related hypertensive disorders (9.1% vs. 14.1%; RR, 0.64). All other maternal outcomes were similar between the two groups.
The Agentry scale results also showed that women who were induced felt they were more in control of their birth experience, both at delivery and at 6 weeks’ postpartum. They also rated their worst labor pain and overall labor pain as significantly less than did women in the EM group.
“Our result suggest that policies directed toward avoidance of elective labor induction in nulliparous women would be unlikely to reduce the rate of cesarean section on a population level,” Dr. Grobman said. “To the contrary, our data show that, for every 28 nulliparous women to undergo elective induction at 39 weeks, one cesarean section would be avoided. Additionally, the number needed to treat to prevent one case of neonatal respiratory support is 83, and to prevent one case of hypertensive disease of pregnancy, 20. Our results should provide information useful to women as they consider their options, and can be incorporated into shared decision-making discussions with the provider.”
The study was sponsored by the National Institutes of Health. Dr. Grobman had no financial disclosures.
SOURCE: Grobman W. Am J Obstet Gynecol. 2018 Jan;218:S601.
DALLAS – Elective inductions at 39 weeks’ gestation were safe for the newborn and conferred dual benefits upon first-time mothers, reducing the risk of cesarean delivery by 16% and pregnancy-related hypertensive disorder by 36%, compared with women managed expectantly.
Infants delivered by elective inductions were smaller than those born to expectantly managed women and experienced a 29% reduction in the need for respiratory support at birth, William A. Grobman, MD, reported at the meeting, sponsored by the Society for Maternal-Fetal Medicine. They were no more likely than infants in the comparator group to experience dangerous perinatal outcomes, including low Apgar scores, meconium inhalation, hypoxia, or birth trauma, said Dr. Grobman, professor of obstetrics and gynecology at Northwestern University, Chicago.
The new data, however, may set a new standard by which to make this decision, Dr. Grobman said.
“I will leave it up to the professional organizations to determine the final outcome of these data, but it’s important to understand that the Choosing Wisely recommendation was based on observational data that essentially used an incorrect clinical comparator” of spontaneous labor, he said. The large study that Dr. Grobman and his colleagues conducted used expectant management (EM) as the comparator, allowing women to continue up to 42 weeks’ gestation. Using this comparator, he said, “Our data are largely with almost every observational study” and with a recently published randomized controlled trial by Kate F. Walker, a clinical research fellow at the University of Nottingham (England).
That study determined that labor induction between 39 weeks and 39 weeks, 6 days, in women older than 35 years had no significant effect on the rate of cesarean section and no adverse short-term effects on maternal or neonatal outcomes.
Dr. Grobman conducted his randomized trial at 41 hospitals in the National Institutes of Health’s Maternal-Fetal Medicine Units Network.
It randomized 6,106 healthy, nulliparous women to either elective induction from 39 weeks to 39 weeks, 4 days, or to EM. These women were asked to forgo elective delivery before 40 weeks, 5 days, but to be delivered by 42 weeks, 2 days.
The primary perinatal outcome was a composite endpoint that included fetal or neonatal death; respiratory support in the first 72 hours; 5-minute Apgar of 3 or lower; hypoxic ischemic encephalopathy; seizure; infection; meconium aspiration syndrome; birth trauma; intracranial or subgaleal hemorrhage; and hypotension requiring vasopressors.
The primary maternal outcome was a composite of cesarean delivery; hypertensive disorder of pregnancy; postpartum hemorrhage; chorioamnionitis; postpartum infection; labor pain; and the Labour Agentry Scale, a midwife-created measure of a laboring woman’s perception of her birth experience.
Women were a mean of 23.5 years old; about 44% of each group was privately insured. Prior pregnancy loss was more common among those randomized to EM (25.6% vs. 22.8%). Just over half were obese, with a body mass index of at least 30 kg/m2. Most (about 63%) had an unfavorable cervix, with a Bishop score of less than 5. The trial specified no particular induction regimen, Dr. Grobman said. “There were a variety of ripening agents and oxytocin regimens used.”
Infants in the elective induction group were born significantly earlier than were those in the EM group (39.3 vs. 40 weeks) and weighed significantly less (3,300 g vs. 3,380 g). Induction was safe for the newborn, with the primary endpoint occurring in 4.4%, compared with 5.4% of those in the EM group – not significantly different.
When investigators examined each outcome in the perinatal composite individually, only one – early respiratory support – was significantly different from the EM group. Infants in the induction group were 29% less likely to need respiratory support in the first 72 hours (3% vs. 4.2%; relative risk, 0.71). The rate of cesarean delivery also was significantly less among the induction group (18.6% vs. 22.2%; RR, 0.84).
None of these outcomes changed when the investigators controlled for race/ethnicity, Bishop score of less than 5, body mass index of 30 kg/m2 or more, or advanced maternal age.
Induction also was safe for mothers, and conferred a significant 36% reduction in the risk of pregnancy-related hypertensive disorders (9.1% vs. 14.1%; RR, 0.64). All other maternal outcomes were similar between the two groups.
The Agentry scale results also showed that women who were induced felt they were more in control of their birth experience, both at delivery and at 6 weeks’ postpartum. They also rated their worst labor pain and overall labor pain as significantly less than did women in the EM group.
“Our result suggest that policies directed toward avoidance of elective labor induction in nulliparous women would be unlikely to reduce the rate of cesarean section on a population level,” Dr. Grobman said. “To the contrary, our data show that, for every 28 nulliparous women to undergo elective induction at 39 weeks, one cesarean section would be avoided. Additionally, the number needed to treat to prevent one case of neonatal respiratory support is 83, and to prevent one case of hypertensive disease of pregnancy, 20. Our results should provide information useful to women as they consider their options, and can be incorporated into shared decision-making discussions with the provider.”
The study was sponsored by the National Institutes of Health. Dr. Grobman had no financial disclosures.
SOURCE: Grobman W. Am J Obstet Gynecol. 2018 Jan;218:S601.
AT THE PREGNANCY MEETING
Key clinical point: Induction at 39 weeks conferred some health benefits to nulliparous women and didn’t harm infants.
Major finding: Induction reduced risk of C-section by 16% and risk of pregnancy-related hypertensive disorder by 36%, compared with expectant management.
Study details: The study randomized 6,106 women to elective induction or expectant management with delivery by 42 weeks.
Disclosures: The National Institutes of Health sponsored the study; Dr. Grobman had no financial disclosures.
Source: Grobman W. Am J Obstet Gynecol. 2018 Jan;218:S601.