Efficacy and Safety of Labor Induction by Oral Versus Vaginal Misoprostol: A Randomized Controlled Clinical Trial

Abstract

Background: Labor induction is one of the most common practices in obstetrics in developed countries. But, in developing countries, its prevalence is low. This study seeks to compare the efficacy and safety of oral versus vaginal Misoprostol in an area with limited resource. Patients and Methods: This is a single-blind, randomized controlled clinical trial, conducted at Kisangani, in Democratic Republic of Congo, from September 1, 2022 to February 01, 2023. The study was prospective, had the approval of the ethics committee of Kisangani University, and women signed the informed consent. The sample was 177 patients, of which 89 received oral Misoprostol and 88 for vaginal route. Were included, primiparous and multiparous who controlled their date of last menstruation, and who had a term progressive pregnancy, mono-fetal, in cephalic presentation, fetal heart rate (FHR) within the norms, and had no contraindications of labor induction. Fifty micrograms of Misoprostol were administered either orally or vaginally every six hours. The primary outcomes were the time from drug administrations to uterine contractions, labor time, and vaginal delivery rate. For secondary outcomes, the course of labor as well as the maternal and perinatal prognosis was assessed. The data were encoded on an Excel 2013 sheet and analyzed using EPI INFO and SPSS software. Results: Labor was induced after 6.18±4.11 h for oral Misoprostol versus 4.03±1.99 h for the vaginal route (p=0.00). The duration of labor was 10.85±3.59 h for the oral route, 9.39±2.55 h for the vaginal route. The time from the first dose to delivery was 16.88±6.11 h for the oral route, 13.03±3.32 h for the vaginal route. The delivery rate within 24 hours was 98.9% (87/88) for the vaginal route and 88.8% (79/89) for the oral route (p=0.00). The rate of caesarean section was 6.7% for the oral route, 12.5% for the vaginal. Conclusion: Misoprostol is effective both orally and vaginally. Administered vaginally, it is associated with a reduction in the duration of labor, while it improves maternal and perinatal prognosis.