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.
RCT Entities:
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.
Authors: Ivana Musilova; Ctirad Andrys; Marcela Drahosova; Barbora Zednikova; Helena Hornychova; Lenka Pliskova; Helena Zemlickova; Bo Jacobsson; Marian Kacerovsky Journal: Pediatr Res Date: 2017-12-20 Impact factor: 3.756
Authors: Diana M Bond; Philippa Middleton; Kate M Levett; David P van der Ham; Caroline A Crowther; Sarah L Buchanan; Jonathan Morris Journal: Cochrane Database Syst Rev Date: 2017-03-03
Authors: Rían Hayes; Jack Hartnett; Gergana Semova; Cian Murray; Katherine Murphy; Leah Carroll; Helena Plapp; Louise Hession; Jonathan O'Toole; Danielle McCollum; Edna Roche; Elinor Jenkins; David Mockler; Tim Hurley; Matthew McGovern; John Allen; Judith Meehan; Frans B Plötz; Tobias Strunk; Willem P de Boode; Richard Polin; James L Wynn; Marina Degtyareva; Helmut Küster; Jan Janota; Eric Giannoni; Luregn J Schlapbach; Fleur M Keij; Irwin K M Reiss; Joseph Bliss; Joyce M Koenig; Mark A Turner; Christopher Gale; Eleanor J Molloy Journal: Pediatr Res Date: 2021-11-06 Impact factor: 3.756
Authors: Sofia Aliaga; Jun Zhang; D Leann Long; Amy H Herring; Matthew Laughon; Kim Boggess; Uma M Reddy; Katherine Laughon Grantz Journal: Am J Perinatol Date: 2016-04-27 Impact factor: 1.862