ATLANTA (Feb. 1, 2016)--In a study to be presented on Feb. 4 in the oral plenary session at 8 a.m. EST, at the Society for Maternal-Fetal Medicine's annual meeting, The Pregnancy Meeting™, in Atlanta, researchers with the Eunice Kennedy Shriver National Institute of Child Health and Human Development and Maternal-Fetal Medicine Units Network (MFMU) found that the administration of antenatal steroids in pregnancies at risk for late preterm delivery prevents respiratory and other neonatal complications.
The study, titled Antenatal Late Preterm Steroids (ALPS): a Randomized Trial to Reduce Neonatal Respiratory Morbidity was a randomized, double-blind, placebo-controlled, trial at 17 tertiary medical centers around the United States from Oct. 2010 to Feb. 2015. The study enrolled 2,831 women with singleton pregnancies at high risk for late preterm delivery (34 0/7 to 36 6/7 weeks) who were randomized to receive antenatal betamethasone intramuscularly or a matching placebo. This study found a significant decrease in neonatal respiratory complications in the group given the steroid treatment. Investigators also found that these babies were less likely to have prolonged intensive care nursery stays, less likely to need post natal treatment for respiratory complications, and less likely to develop bronchopulmonary dysplasia, which is a sign of chronic lung disease.
Lead investigator, Cynthia Gyamfi-Bannerman, M.D., MSc, the Ellen Jacobson Levine and Eugene Jacobson Associate Professor of Women's Health (in Obstetrics and Gynecology) from Columbia University Medical Center, put the findings in context: "The majority of preterm deliveries occur in the late preterm period. We now have a treatment that can significantly improve outcomes for these at risk babies." The study was co-funded by the NHLBI, with the aid of program officer Carol Blaisdell, M.D. and the NICHD under the guidance of Uma Reddy, M.D.
Given that more than 300,000 pregnancies deliver in the late preterm period each year in the U.S., this study will have significant impact on health of the newborns and infants.
###
A copy of the abstract is available at http://www.smfmnewsroom.org and below. For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell).
The Society for Maternal-Fetal Medicine (est. 1977) is the premiere membership organization for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine. The society is devoted to reducing high-risk pregnancy complications by sharing expertise through continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual meeting in which groundbreaking new ideas and research in the area of maternal-fetal medicine are shared and discussed. For more information visit http://www.smfm.org.
Abstract 1: Antenatal Late Preterm Steroids (ALPS): a Randomized Trial to Reduce Neonatal Respiratory Morbidity
Author: Cynthia Gyamfi-Bannerman1
1for the Eunice Kennedy Shriver NICHD MFMU Network, Bethesda, Md
Objective: Infants born in the late preterm period are more susceptible to adverse neonatal outcome, particularly respiratory morbidity, than those born at term. Our objective was to assess whether administration of betamethasone (BMZ) in pregnancies at risk for late preterm delivery would decrease respiratory and other neonatal morbidities.
Study Design: We performed a multicenter, double-blind, randomized controlled trial at 17 tertiary medical centers from 10/2010 to 2/2015. Women with non-anomalous, singleton gestations at high risk for indicated or spontaneous late preterm delivery (34 0/7 to 36 6/7 weeks) were randomized to 12 mg betamethasone intramuscularly or a matching placebo. A second dose was given at 24 hours if the patient was undelivered. The primary outcome was a composite of respiratory morbidity occurring by the first 72 hours of life including continuous positive airway pressure (CPAP) or high flow nasal cannula (HFNC) for ?2 hours, oxygen (O2) requirement with FiO2 of ?30% for ?4 hours, any mechanical ventilation or perinatal death. A more severe respiratory morbidity extending O2 requirement to ?24 hours and CPAP/HFNC to ?12 hours was a pre-specified secondary endpoint. Charts of all infants admitted to special care were centrally reviewed to verify respiratory outcomes. Our required sample size was 2,800.
Results: 2,831 patients were randomized (1402 placebo, 1429 BMZ). Of those, 60% received 2 doses and 65.2% were <36 weeks. There was a significant reduction in the incidence of the primary outcome in the BMZ group compared with placebo (Table). Severe respiratory morbidity, TTN and surfactant use were also reduced. There were no significant differences in the incidence of chorioamnionitis or neonatal sepsis, but hypoglycemia was more common in the BMZ group. Conclusion: Administration of betamethasone for women at risk for late preterm delivery was associated with decreased serious neonatal respiratory morbidity and the need for surfactant.