Preterm premature rupture of membranes (PPROM) represents 1-2% of all pregnancies and results frequently in preterm birth. To date, studies on the use of tocolytic agents in PPROM are limited and have had relatively small sample sizes. The objective of this study is to determine if subjects with PPROM between 24-32 weeks gestation benefit from a 48 hour course of indomethacin.
This was a double-blinded randomized controlled trial. Consenting subjects with confirmed preterm premature rupture of membranes between 24-32 weeks gestation were included. All subjects received corticosteroids and antibiotic therapy and were randomized to receive indomethacin or placebo for 48 hours. The primary outcome was to determine if a course of indomethacin will increase the proportion of subjects between 24-32 weeks gestation beyond 48 hours. Both maternal and neonatal outcomes were also examined. A sample size of 65 subjects in each arm was needed for 80% power to detect a reduction in the percentage of women delivering within 48 hours from 50% to 25%
This study was concluded prematurely due to a lack of enrollment. A total of 49 subjects met inclusion and exclusion criteria and were enrolled in the study. With regard to the primary outcome of this study, there were no differences in the proportion of subjects pregnant beyond 48 hours (indomethacin 56% vs placebo 44% p=0.58) or in the latency period (indomethacin 337+500 hrs vs 372+485 hrs, p=0.41). There were also no differences in the frequency of subjects with chorioamnionitis (p=0.74) or endometritis (p=0.99). In terms of neonatal outcomes, there was no differences noted in respiratory distress (p=0.55), intraventricular hemorrhage (p=0.22), necrotizing enterocolitis (p=0.99), retinopathy of prematurity (p=0.39), patent ductus arteriosus (p=0.99) or death (p=0.99).
This limited study demonstrates no benefits for the use of indomethacin as a tocolytic agent in subjects with PPROM over placebo in terms of extending the length of gestation or with neonatal outcomes.
© 2008 Mosby, Inc. Published by Elsevier Inc. All rights reserved.