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Type: Journal article
Title: Induction of labor versus expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks: a randomized controlled trial
Author: van der Ham, D.
Vijgen, S.
Nijhuis, J.
van Beek, J.
Opmeer, B.
Mulder, A.
Moonen, R.
Groenewout, M.
van Pampus, M.
Mantel, G.
Bloemenkamp, K.
van Wijngaarden, W.
Sikkema, M.
Haak, M.
Pernet, P.
Porath, M.
Molkenboer, J.
Kuppens, S.
Kwee, A.
Kars, M.
et al.
Citation: PLoS Medicine, 2012; 9(4):e1001208-1-e1001208-16
Publisher: Public Library of Science
Issue Date: 2012
ISSN: 1549-1277
Editor: Middleton, P.
Statement of
David P. van der Ham, Sylvia M. C. Vijgen, Jan G. Nijhuis, Johannes J. van Beek, Brent C. Opmeer, Antonius L. M. Mulder, Rob Moonen, Mariët Groenewout, Mariëlle G. van Pampus, Gerald D. Mantel, Kitty W. M. Bloemenkamp, Wim J. van Wijngaarden, Marko Sikkema, Monique C. Haak, Paula J. M. Pernet, Martina Porath, Jan F. M. Molkenboer, Simone Kuppens, Anneke Kwee, Michael E. Kars, Mallory Woiski, Martin J. N. Weinans, Hajo I. J. Wildschut, Bettina M. C. Akerboom, Ben W. J. Mol, Christine Willekes, on behalf of the PPROMEXIL trial group
Abstract: BACKGROUND At present, there is insufficient evidence to guide appropriate management of women with preterm prelabor rupture of membranes (PPROM) near term. METHODS AND FINDINGS We conducted an open-label randomized controlled trial in 60 hospitals in The Netherlands, which included non-laboring women with >24 h of PPROM between 34+0 and 37+0 wk of gestation. Participants were randomly allocated in a 1:1 ratio to induction of labor (IoL) or expectant management (EM) using block randomization. The main outcome was neonatal sepsis. Secondary outcomes included mode of delivery, respiratory distress syndrome (RDS), and chorioamnionitis. Patients and caregivers were not blinded to randomization status. We updated a prior meta-analysis on the effect of both interventions on neonatal sepsis, RDS, and cesarean section rate. From 1 January 2007 to 9 September 2009, 776 patients in 60 hospitals were eligible for the study, of which 536 patients were randomized. Four patients were excluded after randomization. We allocated 266 women (268 neonates) to IoL and 266 women (270 neonates) to EM. Neonatal sepsis occurred in seven (2.6%) newborns of women in the IoL group and in 11 (4.1%) neonates in the EM group (relative risk [RR] 0.64; 95% confidence interval [CI] 0.25 to 1.6). RDS was seen in 21 (7.8%, IoL) versus 17 neonates (6.3%, EM) (RR 1.3; 95% CI 0.67 to 2.3), and a cesarean section was performed in 36 (13%, IoL) versus 37 (14%, EM) women (RR 0.98; 95% CI 0.64 to 1.50). The risk for chorioamnionitis was reduced in the IoL group. No serious adverse events were reported. Updating an existing meta-analysis with our trial results (the only eligible trial for the update) indicated RRs of 1.06 (95% CI 0.64 to 1.76) for neonatal sepsis (eight trials, 1,230 neonates) and 1.27 (95% CI 0.98 to 1.65) for cesarean section (eight trials, 1,222 women) for IoL compared with EM. CONCLUSIONS In women whose pregnancy is complicated by late PPROM, neither our trial nor the updated meta-analysis indicates that IoL substantially improves pregnancy outcomes compared with EM. TRIAL REGISTRATION Current Controlled Trials ISRCTN29313500
Keywords: PPROMEXIL trial group
Pregnancy Complications, Infectious
Respiratory Distress Syndrome, Newborn
Fetal Membranes, Premature Rupture
Infant, Newborn, Diseases
Monitoring, Physiologic
Pregnancy Outcome
Cesarean Section
Labor, Induced
Gestational Age
Labor, Obstetric
Middle Aged
Infant, Newborn
Young Adult
Rights: © 2012 van der Ham et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
DOI: 10.1371/journal.pmed.1001208
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Paediatrics publications

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