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Type: Journal article
Title: Management of late-preterm premature rupture of membranes: the PPROMEXIL-2 trial
Author: van der Ham, D.
van der Heyden, J.
Opmeer, B.
Mulder, A.
Moonen, R.
van Beek, J.
Franssen, M.
Bloemenkamp, K.
Sikkema, M.
de Groot, C.
Porath, M.
Kwee, A.
Woiski, M.
Duvekot, J.
Akerboom, B.
van Loon, A.
de Leeuw, J.
Willekes, C.
Mol, B.
Nijhuis, J.
Citation: American Journal of Obstetrics and Gynecology, 2012; 207(4):276.e1-276.e10
Publisher: Elsevier
Issue Date: 2012
ISSN: 0002-9378
Statement of
David P. van der Ham, Jantien L. van der Heyden, Brent C. Opmeer, Antonius L.M. Mulder, Rob M.J. Moonen, J. (Hans) J. van Beek, Maureen T.M. Franssen, Kitty W.M. Bloemenkamp, J. (Marko) M. Sikkema, Christianne J.M. de Groot, Martina Porath, Anneke Kwee, Mallory D. Woiski, J. (Hans) J. Duvekot, Bettina M.C. Akerboom, Aren J. van Loon, Jan W. de Leeuw, Christine Willekes, Ben W.J. Mol, Jan G. Nijhuis
Abstract: Objective: The evidence for the management of near term prelabor rupture of membranes is poor. From January 2007 until September 2009, we performed the PPROM Expectant Management versus Induction of Labor (PPROMEXIL) trial. In this trial, we showed that in women with preterm prelabor rupture of membranes (PPROM), the incidence of neonatal sepsis was low, and the induction of labor (IoL) did not reduce this risk. Because the PPROMEXIL trial was underpowered and because of a lower-than-expected incidence of neonatal sepsis, we performed a second trial (PPROMEXIL-2), aiming to randomize 200 patients to improve the evidence in near-term PPROM. Study Design: In a nationwide multicenter study, nonlaboring women with PPROM between 34 and 37 weeks' gestational age were eligible for inclusion. Patients were randomized to IoL or expectant management (EM). The primary outcome measure was neonatal sepsis. Results: From December 2009 until January 2011, we randomized 100 women to IoL and 95 to EM. Neonatal sepsis was seen in 3 neonates (3.0%) in the IoL-group versus 4 neonates (4.1%) in the EM group (relative risk, 0.74; 95% confidence interval, 0.17–3.2). One of the sepsis cases in the IoL group resulted in neonatal death because of asphyxia. There were no significant differences in secondary outcomes. Conclusion: The risk of neonatal sepsis after PPROM near term is low. Induction of labor does not reduce this risk.
Keywords: induction of labor; neonatal sepsis; PPROM Expectant Management versus Induction of Labor trial; preterm prelabor rupture of membranes
Rights: Copyright © 2012 Mosby, Inc. All rights reserved.
RMID: 0020136845
DOI: 10.1016/j.ajog.2012.07.024
Appears in Collections:Obstetrics and Gynaecology publications

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