Immediate induction of labor in premature rupture of membranes at term (PROMT)-vaginal Misoprostol tablet versus PGE2 gel: a randomized comparative study

Background: The aim of the study is to compare immediate induction with vaginal misoprostol tablet and immediate induction with vaginal PGE2 gel in women with premature rupture of membranes at term (PROMT).Methods: Nine hundred thirty-two women with PROM at term were assigned randomly to receive intravaginal 25μg misoprostol tablet, 4 hourly with a maximum of 5 doses or 0.5 mg vaginal PGE2 gel 6 hourly with a maximum of 2 doses. The primary outcome measures were cesarean section rate, admission to delivery interval and induction to delivery interval. Secondary outcomes included, mode of delivery, and maternal and neonatal safety outcome. Results were calculated applying Fisher Exact Test, Chi square test, t test and calculating the P-value using an alpha level of 0.05 for Type I error.Results: The mean time from admission to delivery was 13.16 hours in the misoprostol group and 13.56 hours in the PGE2 group (P= 0.3014). Induction to delivery interval was also comparable between the groups (10.23 h versus 10.18 h).Caesarean section rate did not differ significantly between groups (12.13% versus 15.74% ,P=0.135 RR 0.783 95% CI 0.568-1.079).More women in misoprostol group had instrumental delivery (7.57% versus 4.25%, P=0.031, RR 1.089 95% CI 1.04-3.03).The  neonatal outcomes were comparable between the groups . Maternal outcomes were not significantly different except incidence of analgesic use (P=0.009 RR 1.62 95% CI 1.03-1.30), meconium stained liquor (P=.0096 RR 2.03 CI 1.17-3.53) and   number of digital vaginal examinations (P<.0001) in misoprostol group.Conclusions: Vaginal misoprostol is equally efficacious in labor induction and demonstrates a similar fetal and maternal safety profile to PGE2 gel