Comparison of vaginal misoprostol tablets and prostaglandin E2 gel for the induction of labor in premature rupture of membranes at term: a randomized comparative trial.

AIM

To compare immediate induction with vaginal misoprostol tablets and immediate induction with vaginal dinoprostone (naturally occurring prostaglandin E2 [PGE2]) gel in women with premature rupture of membranes (PROM) at term.

METHODS

Two hundred and twelve women with PROM at term were assigned randomly to receive either an intravaginal 25 µg misoprostol tablet, 4-hourly, with a maximum of five doses, or 0.5 mg intravaginal PGE2 gel, 6-hourly, with a maximum of two doses. The primary outcome measures were the admission-to-delivery interval and the induction-to-delivery interval. Secondary outcomes included cesarean section rate, mode of delivery, and maternal and neonatal safety outcome. Results were calculated applying Fisher's exact test, χ2-test, t-test and calculating the P-value using an alpha level of 0.05 for Type I errors.

RESULTS

The mean time from admission to delivery was 13.53 h in the misoprostol group and 12.30 h in the PGE2 group (P = 0.090). The induction-to-delivery interval was also comparable between the groups (10.75 h vs. 9.37 h), while the cesarean section rate did not differ significantly between them (7.61% vs. 15.30%). More women in the misoprostol group had an instrumental delivery (12.38% vs. 2.94%). The only significant difference in neonatal outcome was a greater number of babies born with Apgar score < 7 at 1 min in the misoprostol group. Maternal outcomes were not significantly different, except for a higher number of digital vaginal examinations in the misoprostol group.

CONCLUSION

Vaginal misoprostol is equally efficacious in labor induction and demonstrates a similar fetal and maternal safety profile to PGE2 gel.