BackgroundInfants who are born at 34 to 36 weeks of gestation (late preterm) are at greater risk for adverse respiratory and other outcomes than those born at 37 weeks of gestation or later. An independent data and safety monitoring committee monitored the trial.
Details regarding the power analysis are provided in the Analyses were performed according to the intention-to-treat principle. — both in Ohio; the University of Utah Health Sciences Center, Salt Lake City (E.A.S.C. — all in Texas; the University of Alabama at Birmingham, Birmingham (A.T.N.T. Their use increased especially after a consensus conference held by the National Institutes of Health in 1994, which concluded that there was strong evidence that glucocorticoids reduce adverse neonatal outcomes, including death, the respiratory distress syndrome, and other complications, when administered to women who are likely to deliver before 34 weeks of gestation.We conducted the trial at 17 university-based clinical centers participating in the Maternal–Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Of 24,133 women who underwent screening, 2831 eligible participants underwent randomization (with 1429 assigned to the betamethasone group and 1402 to the placebo group) (A total of 860 of 1429 women (60.2%) in the betamethasone group and 826 of 1402 (58.9%) in the placebo group received the prespecified two doses of study medication.
All Rights Reserved. We used a group sequential method to control the type I error with the Lan–DeMets characterization of the O’Brien–Fleming boundary.Recruitment began in October 2010 and concluded in February 2015. Betamethasone and calcipotriene topical (for the skin) is a combination medicine used to treat plaque psoriasis. Patient education: C-section (cesarean delivery) (Beyond the Basics) We estimated that 2800 women would provide a power of at least 85% to detect a relative decrease of 33% in the rate of the primary outcome, from 9.5% in the placebo group to 6.3% in the betamethasone group, with a two-sided type I error rate of 5%. These benefits were found despite the challenges in predicting the timing of delivery, which resulted in the administration of two doses of the study drugs to only 60% of participants.Our findings are consistent with the results of the Antenatal Steroids for Term Elective Caesarean Section (ASTECS) trial, in which women were randomly assigned to receive either antenatal glucocorticoids or no glucocorticoids at the time of elective cesarean delivery at term. However, follow-up into childhood is needed to inform later outcomes of treatment.Our study protocol did not allow the use of other prenatal interventions, such as tocolysis, so that we could determine whether the difference in the primary outcome was due to the use of antenatal betamethasone. ); the University of Texas Health Science Center at Children’s Memorial Hermann Hospital, Houston (S.C.B. There were no stillbirths or neonatal deaths within 72 hours. ).Address reprint requests to Dr. Gyamfi-Bannerman at the Division of Maternal–Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Medical Center, 622 W. 168th St., PH-16, New York, NY 10032, or at A complete list of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal–Fetal Medicine Units Network is provided in the Tap into groundbreaking research and clinically relevant insights Almost all adverse events (95%) were local reactions at the injection site (Table S4 in the Two women in each study group were lost to follow-up, so outcome information was available for 2827 neonates.