title: Induction of labor versus expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks: a randomized controlled trial.
abstract: BACKGROUND
  At present, there is insufficient evidence to guide appropriate management of women with preterm prelabor rupture of membranes (PPROM) near term.
  
  
  RESULTS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN29313500
authors.affiliation: Department of Obstetrics and Gynecology, Maastricht University Medical Center, GROW-School for Oncology and Developmental Biology, Maastricht, The Netherlands. dpvanderham@gmail.com
authors.forename: David P
authors.initials: DP
authors.lastname: van der Ham
authors.forename: Sylvia M C
authors.initials: SM
authors.lastname: Vijgen
authors.forename: Jan G
authors.initials: JG
authors.lastname: Nijhuis
authors.forename: Johannes J
authors.initials: JJ
authors.lastname: van Beek
authors.forename: Brent C
authors.initials: BC
authors.lastname: Opmeer
authors.forename: Antonius L M
authors.initials: AL
authors.lastname: Mulder
authors.forename: Rob
authors.initials: R
authors.lastname: Moonen
authors.forename: Mariët
authors.initials: M
authors.lastname: Groenewout
authors.forename: Mariëlle G
authors.initials: MG
authors.lastname: van Pampus
authors.forename: Gerald D
authors.initials: GD
authors.lastname: Mantel
authors.forename: Kitty W M
authors.initials: KW
authors.lastname: Bloemenkamp
authors.forename: Wim J
authors.initials: WJ
authors.lastname: van Wijngaarden
authors.forename: Marko
authors.initials: M
authors.lastname: Sikkema
authors.forename: Monique C
authors.initials: MC
authors.lastname: Haak
authors.forename: Paula J M
authors.initials: PJ
authors.lastname: Pernet
authors.forename: Martina
authors.initials: M
authors.lastname: Porath
authors.forename: Jan F M
authors.initials: JF
authors.lastname: Molkenboer
authors.forename: Simone
authors.initials: S
authors.lastname: Kuppens
authors.forename: Anneke
authors.initials: A
authors.lastname: Kwee
authors.forename: Michael E
authors.initials: ME
authors.lastname: Kars
authors.forename: Mallory
authors.initials: M
authors.lastname: Woiski
authors.forename: Martin J N
authors.initials: MJ
authors.lastname: Weinans
authors.forename: Hajo I J
authors.initials: HI
authors.lastname: Wildschut
authors.forename: Bettina M C
authors.initials: BM
authors.lastname: Akerboom
authors.forename: Ben W J
authors.initials: BW
authors.lastname: Mol
authors.forename: Christine
authors.initials: C
authors.lastname: Willekes
mesh_terms: D000293:Adolescent; D000328:Adult; D002585:Cesarean Section; D002821:Chorioamnionitis / Q000517:prevention & control; D005260:Female; D005322:Premature Rupture of Fetal Membranes; D005333:Fetus; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000517:prevention & control*; D007751:Labor, Induced; D007743:Labor, Obstetric; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods*; D009426:Netherlands; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious; D011256:Pregnancy Outcome; D012127:Respiratory Distress Syndrome, Newborn / Q000517:prevention & control; D018805:Sepsis; D055815:Young Adult