A randomized controlled trial comparing vaginal misoprostol versus Foley catheter plus oxytocin for labor induction

Abstract

Objective. To compare effectiveness and safety of 25 μg vaginal misoprostol versus Foley catheter and oxytocin for cervical ripening and labor induction in pregnant women with unripe cervices. Design. Randomized controlled trial. Setting. A public maternity in Recife, Brazil. Sample. A total of 240 pregnant women. Methods. Women with a term or post-term, live, singleton fetus in cephalic presentation, intact membranes, Bishop score <6, not in labor, medically indicated for labor induction. They were randomly divided in Group 1, where 119 women received 25 μg of intravaginal misoprostol every 6 hours for a maximum of four doses; and Group 2, where 121 women had a 14-F Foley catheter inserted into their cervical canal. Once past the internal os, the balloon was inflated. Intravenous oxytocin was initiated after the balloon was spontaneously extruded from the cervix or after 24 hours. Results. There were no significant differences between the groups regarding baseline characteristics. Misoprostol was more effective in inducing labor than Foley catheter and oxytocin. Mean induction-to-vaginal delivery time with misoprostol was shorter (17.3 vs. 20.2 hours, p=0.016). There were more vaginal deliveries in the misoprostol group at 12 (p < 0.001) and 18 (p=0.007) hours, but the difference was no longer statistically significant at 24 and 48 hours. There were no significant differences in uterine contraction abnormalities, puerperal infection or neonatal outcomes. Conclusions. Vaginal misoprostol is more effective than and as safe as Foley catheter and oxytocin for induction of labor in term and post-term pregnancy. © 2010 Informa UK Ltd.