Concurrent use of Foley catheter and misoprostol for induction of labor: a randomized clinical trial of efficacy and safety.

AIM

The aim of this study was to compare the efficacy of combined intracervical Foley catheter and low-dose vaginal misoprostol with low-dose vaginal misoprostol alone for induction of labor.

MATERIAL AND METHODS

This prospective non-blinded randomized controlled trial was conducted over a 2-year period in 126 pregnant women planned for induction of labor at a tertiary care centre. Women at ≥ 28 gestational weeks with a singleton fetus in cephalic presentation, intact membranes and a Bishop score of ≤ 4 were randomized for labor induction with either a combination of Foley catheter and misoprostol or only misoprostol. The primary outcome variable was the induction-to-delivery interval between the two groups. The secondary outcome variables included rate of vaginal deliveries, uterine hyperstimulation, cesarean section rate, Apgar scores at 1 and 5 min, neonatal intensive care unit admissions and chorioamnionitis.

RESULTS

The mean induction-to-delivery interval and rate of vaginal deliveries were not significantly different between the groups (26.52 h in the combination group and 27.64 h in the misoprostol group, P = 0.65; 65.07% and 65.07%, respectively, P = 0.9). Uterine hyperstimulation and meconium-stained liquor were significantly more prevalent in the misoprostol group (P = 0.001). Neonatal outcomes did not differ significantly between the groups.

CONCLUSION

The addition of Foley catheter to misoprostol did not cause any statistically significant benefit in reducing the induction-to-delivery time. However, it reduced the incidence of uterine hyperstimulation and meconium-stained liquor.