Abstract
At present, there is insufficient evidence to guide appropriate management of women with preterm prelabor rupture of membranes (PPROM) near term. 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. 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. Current Controlled Trials ISRCTN29313500
Highlights
Preterm prelabor rupture of membranes (PPROM) complicates 1%–5% of all pregnancies and accounts for 30%–40% of all preterm deliveries [1,2,3]
In women whose pregnancy is complicated by late PPROM, neither our trial nor the updated meta-analysis indicates that induction of labor (IoL) substantially improves pregnancy outcomes compared with expectant management (EM)
The Royal College of Obstetricians and Gynaecologists guidelines state that delivery should be considered at 34+0 wk of gestation and recommend that women with PPROM who are managed expectantly beyond 34 wk of gestation be counseled about the increased risk of chorioamnionitis and the presumed decreased risk of neonatal respiratory problems, admission for neonatal intensive care, and cesarean section [9]
Summary
Preterm prelabor rupture of membranes (PPROM) complicates 1%–5% of all pregnancies and accounts for 30%–40% of all preterm deliveries [1,2,3]. It is associated with increased fetal and maternal morbidity and mortality [4,5,6,7]. There are many reasons why some babies are born prematurely, but preterm prelabor rupture of the membranes (PPROM) accounts for 30%–40% of preterm deliveries. PPROM increases the mother’s risk of a womb infection called chorioamnionitis and the baby’s risk of neonatal sepsis (blood infection), and can trigger early labor
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