RESUMO
OBJECTIVE(S): To compare the effectiveness and safety of intra-cervical Foley catheter combined with intra-vaginal isosorbide mononitrate (IMN) versus intra-vaginal misoprostol for cervical ripening and labor induction in pregnant women with unripe cervices. METHODS: Open-labeled randomized controlled trial in Cairo university hospital, Cairo, Egypt during 2012-2014. Three hundred and ninety-five pregnant women at term or post-term with an indication for labor induction and unripe cervix were included in the study. The subjects were randomly divided into two groups. Vaginal misoprostol was used in group 1 (n = 197) and intra-cervical Foley catheter plus vaginal IMN in group 2 (n = 198). Our main outcome measure was cesarean section rate. RESULTS: Among the 395 included patients there were significantly lower duration of induction of labor (p < 0.001) in group 1with lower cesarean section rates [22.8% in group 1versus 33.3% in group 2; RR 0.7 (0.6-0.9), (p = 0.020)]. Whereas the uterine hyperstimulation (p < 0.001) was significantly higher in group 1. There were no significant differences between both groups as regard patients' demographic characteristics. CONCLUSIONS(S): Vaginal misoprostol is more effective but less safe than Foley catheter combined with vaginal IMN for induction of labor in term and post-term pregnancy.