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PPROM is an important clinical problem. Our previous PPROMEXIL trial (ISRCTN29313500) compared the effectiveness of induction of labor (IL) to expectant management (EM) after PPROM between 34 and 37 weeks of gestational age (GA) in 532 pregnant women. This study showed that the incidence neonatal sepsis was low, and induction of labor did not reduce the risk of neonatal sepsis. Since the incidence of the primary outcome measure was lower than expected, we performed a second trial PPROMEXIL-2, aiming to randomize 200 patients.
The study was performed in a multicenter setting within the Dutch obstetric research consortium, in which 60 hospitals in the Netherlands collaborated. Pregnant women with prolonged (>24h) PPROM at a GA from 34 to 37 weeks, not in labor, were eligible. Patients were randomized to IL or EM. The primary outcome measure was neonatal sepsis, which was defined as a positive blood culture, biochemical infection parameters or clinical signs of infection. Secondary outcomes were among others, RDS, chorioamnionitis, and mode of delivery. In addition we performed a meta-analysis combining our data with previous studies.
Between December 2009 and January 2011, we randomized 199 women. Time between randomization and delivery was 1.6 days and 4.9 days (MD -3.2 days, 95%CI 2.1 to 4.4) after induction and expectant management, respectively. Neonatal sepsis was seen in 3 neonates (3.0%) in the IL-group versus 5 neonates (5.4%) in the EM-group (RR 0.55, 95%CI 0.14 to 2.2). There was one case of neonatal death in the IL-group, which was due to severe neonatal blood loss during delivery. There were no significant differences in other neonatal outcomes. Clinical chorioamnionitis was seen more often in the EM-group (4.1% vs 0%; p=0.04), whereas other maternal outcome and mode of delivery,were comparable. Meta-analysis of 1419 women included in 9 studies showed no difference in the risk of neonatal sepsis among treatment strategy (risk ratio .84 95%CI .53 to 1.3).
The risk of neonatal sepsis after PPROM near term is low. Induction of labor does not reduce this risk.