Abstract

In modern obstetrics, around 30% of cases require induction of labour for various reasons. Misoprostol is gaining popularity as a pharmacological inducing agent, though the route and dosage of administration is not standardised. The objective of the study is to compare the safety and efficacy of the two routes of Misoprostol administration - Oral (25 μ gm 4th hourly) and Vaginal (25 μ gm 4th hourly), for induction between gestation age 34-40 weeks. Methods: In this randomized trial, 100 women having crossed the expected date of delivery without going into spontaneous labour were considered for labour induction and were divided into two equal groups. Group A received 25 μ gm Misoprostol orally 4th hourly and Group B received 25 μ gm Misoprostol vaginally 4th hourly. Labour characteristics and maternal and foetal outcome were compared. Results: The mean induction to delivery interval was longer in oral group (oral 22.40 hrs vs. vaginal 16.26 hrs, p<0.001). More cases required Oxytocin augmentation in oral group (oral 70% vs. vaginal 80% cases, p=0.01). Fewer cases delivered vaginally in oral group (oral 88% vs. vaginal 92% cases), though the results were statistically insignificant (p=0.67). Mean number of doses of Misoprostol required for induction of labour was more in oral group (oral 3 vs. vaginal 2, p <0.0001). Higher rate of uterine Hyperstimulation was associated with vaginal group, though the difference was statistically insignificant (p >0.05). Vaginal group had higher rate of meconium stained amniotic fluid (vaginal 30% vs. oral 26% cases, p =0.346) and NICU admissions (40% vaginal vs. oral 86% cases had respiratory distress and LBW, meconium 14% oral vs. 50% vaginal), and they differed statistically between the groups (p=0.00001). Bishop Score improvement after 1st dose of Misoprostol was better in vaginal group and could be attributed to the direct action of Misoprostol on uterus and cervix in vaginal administration. Oral group witnessed three cases of failed induction, which was nil in the vaginal group. Oral group witnessed more number of c-sections mainly because the failure of induction was more in oral group. Maternal complications, such as Uterine Hyperstimulation were seen only in vaginal group. Conclusion: Vaginal Misoprostol administered every 4 hours is more effective for induction of labour than oral Misoprostol administered every 4 hours. Vaginal Misoprostol has statistically significant better efficacy whereas oral Misoprostol seems to be safer in terms of maternal and foetal outcome. The limitation of the present study is small sample size, studies with larger samples in different zones of the country will help us to establish the efficacy of oral Misoprostol.

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