Induction of labor versus expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks: a randomized controlled trial

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, PPROMEXIL trial group, F Roumen, J E van de Riet, R Kok, M J C P Hanssen, B Dijkman, R Stigter, N W E Schuitemaker, F Delemarre, G Kleiverda, J Friederich, A J M Huisjes, C A van Meir, M van Huizen, J W de Leeuw, R J P Rijnders, M Heres, R Aardenburg, A C de Wit, A J van Loon, P van der Salm, C de Groot, D Perquin, J T J Brons, E van Beek, J Wilpshaar, E S A van den Akker, H A Bremer, K de Boer, J M Burggraaff, I M de Graaf, C M van Oirschot, N van Gemund, I M A van Dooren, R E Bernardus, A Drogtrop, M Buimer, A Koops, J P R Doornbos, A van Ginkel, 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, PPROMEXIL trial group, F Roumen, J E van de Riet, R Kok, M J C P Hanssen, B Dijkman, R Stigter, N W E Schuitemaker, F Delemarre, G Kleiverda, J Friederich, A J M Huisjes, C A van Meir, M van Huizen, J W de Leeuw, R J P Rijnders, M Heres, R Aardenburg, A C de Wit, A J van Loon, P van der Salm, C de Groot, D Perquin, J T J Brons, E van Beek, J Wilpshaar, E S A van den Akker, H A Bremer, K de Boer, J M Burggraaff, I M de Graaf, C M van Oirschot, N van Gemund, I M A van Dooren, R E Bernardus, A Drogtrop, M Buimer, A Koops, J P R Doornbos, A van Ginkel

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

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Figure 1. Trial profile.
Figure 1. Trial profile.
Figure 2. Kaplan-Meier curve for the interval…
Figure 2. Kaplan-Meier curve for the interval between randomization and birth.
Figure 3. Meta-analysis.
Figure 3. Meta-analysis.
Risk ratio according to Mantel-Haenszel (M–H) with fixed effects and 95% CIs for neonatal sepsis, culture-proven neonatal sepsis, RDS, and cesarean section rates.

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