A randomized comparison of vaginal prostaglandin E-2 with oxytocin plus amniotomy for induction of labour in women with intermediately ripe cervices

Objective: To compare the effects of oxytocin and amniotomy or vaginal prostaglandin E-2 (PGE(2)) for induction of labour. Study design: We conducted a randomized clinical trial. Eligible for the trial were women with normal pregnancy, parity 0-3, with intact membranes, >40 weeks of gestation documented by ultrasound examination before 20 weeks gestation, observed in a network of 13 general and teaching hospitals in Italy. Inclusion criteria were cervical Bishop's score 5-7, less than six uterine contractions per hour, single pregnancy, cephalic presentation, no history of cesarean section and uterine surgery. Eligible women were randomly assigned by phone to oxytocin plus amniotomy (163 women) or vaginal PGE(2) 2 mg, two doses at 6-h intervals (157 women). Results: Overall, 50 women (15.6%) delivered by cesarean section, 22 (13.5%) randomized to oxytocin, and 28 (17.8%) randomized to PGE(2) (not significant). Twelve hours after randomization, induction had failed in 26 women of the 163 randomized to oxytocin plus amniotomy (21.6%) and 34 out of the 157 randomized to PGE(2) (15.9%): the difference was not significant. Neonatal outcome was similar in the two groups. Conclusions: This study did not find marked differences in labour and neonatal outcome between women randomized to oxytocin plus amniotomy or vaginal PGE(2). A shorter induction delivery interval in the group receiving amniotomy and oxytocin after PGE(2) priming was observed. (C) 1998 Elsevier Science Ireland Ltd All rights reserved