Efficacy and safety of sublingual versus vaginal misoprostol for labor induction in pregnancy with live fetus in Mulago Hospital, Uganda

Abstract

Background: Induction of labour is artificial stimulation of uterine contractions, with the intention of accomplishing delivery prior to onset of spontaneous labor. Misoprostol, a synthetic prostaglandin E1 analogue has been found to be as effective as dinoprostone and oxytocin in inducing labor. There are different methods of administering misoprostol, the common ones being oral and vaginal. Misoprostol is used under FIGO guidelines for induction but there are no studies done on the comparison of efficacy and safety of misoprostol administered sublingually or vaginally for induction of labor in women with live fetus. Objective: To compare the efficacy and safety of sublingual versus vaginal misoprostol in their recommended doses, administered for induction of labor, in pregnant women with a live fetus at Mulago hospital, Uganda. Methods: A Randomized clinical trial, done in Mulago National Referral Hospital Labour suite in Kampala, Uganda. Women at gestation age of ≥34 completed weeks, with a live fetus, scheduled for induction of labor, were included after informed consent. We excluded patients with known gross fetal anomalies, multiple pregnancy and allergy to misoprostol. 156 pregnant women, were randomly selected using block randomization method, and assigned to the 2 arms: vaginal (80) and sublingual (76) routes of administering misoprostol for induction of labor. They were then followed through labor and delivery. Data was cleaned and entered using EpiData version 2.1b and analyzed using STATA version 11. Results: Demographic characteristics (age, marital status) and clinical characteristics (gestational age, indication for induction, initial Bishop score) were similar in the two groups. The mean (± standard deviation [SD]) interval from start of induction to vaginal delivery was 12.79± 9.72 hours for sublingual group and 13.30 ± 8.31 for vaginal group (P = .37). More participants in the vaginal group delivered vaginally in <24 hours than in the sublingual group (61 (49.5%) versus 56 (40.9%), P = .98). Sixty six participants (86.8%) who received sublingual misoprostol delivered vaginally, compared with seventy one participants (88.8%) who received vaginal misoprostol (P = .71). The rate of failed induction in the sublingual group was 19 (25%) compared to 18 (22.5%) in the vaginal group (P = .71). There was no uterine hyperstimulation in either group. Frequencies of intrapartum complications (fever, nausea/vomiting, FD/MSL) and birth outcomes were similar between the groups. However, there was a statistically significant difference in APGAR score <7 in the 1st minute between the sublingual and vaginal group (P = .006). Conclusion: The administration of misoprostol 25 mcg by the sublingual route was as efficacious and safe as the same dose administered vaginally.