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Randomized Controlled Trial
. 2016;29(3):487-92.
doi: 10.3109/14767058.2015.1007036. Epub 2015 Feb 19.

Comparing vaginal misoprostol versus Foley catheter plus vaginal isosorbide mononitrate for labor induction

Affiliations
Randomized Controlled Trial

Comparing vaginal misoprostol versus Foley catheter plus vaginal isosorbide mononitrate for labor induction

Waleed El-Khayat et al. J Matern Fetal Neonatal Med. 2016.

Retraction in

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01506388.

Keywords: Cervical ripening; foley catheter; isosorbide mononitrate; labor induction; misoprostol.

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