A Randomised Study of Low-Dose Oral Misoprostol and Intracervical Prostaglandin E2 Gel for Cervical Ripening and Labour Induction in Term Pregnancy

Abstract

BACKGROUND Labour induction is one of the most frequent interventions all over the world in pregnant women. The rate of induction varies by location and in many centres, it is currently more than 20%. When the benefits of expeditious delivery are greater than the risks of continuing the pregnancy, inducing labour can be justified as a therapeutic intervention. The current study was done with the objective of comparing the efficacy, acceptability and safety of low-dose oral misoprostol tablet (25 ugm PGE1) and intracervical dinoprostone (PGE2) for labour induction and cervical ripening in women at term. In developing countries with low resources, misoprostol could be the preferred drug because of low cost and easy storage; however, monitoring the induced labour is a challenge. Aims and Objectives-To compare efficacy, acceptability and side effects of low-dose oral misoprostol with that of intracervical dinoprostone for cervical ripening and induction of labour. MATERIALS AND METHODS A prospective, randomised, controlled study wherein 100 pregnant women admitted to labour ward at 37 weeks or beyond with a single live foetus for induction of labour were included. The enrolled women were randomly divided into two equal Groups A and B. Group A women received oral tab Misoprostol 25 ugm every 2 hours for a maximum of 6 doses. Group B women received 0.5 mg intracervical dinoprostone gel 6 hourly, for a maximum of 3 doses. Outcomes in terms of improvement in Bishop's score, induction to delivery interval, number of doses required, requirement of any other means of ripening, induction and/or augmentation and mode of delivery were noted. Side effects and complications were compared. Foetal outcomes in terms of Apgar score and need for NICU admission was compared. The results observed were subjected to statistical analysis by SPSS: Chi-square/ Fisher's Exact test and Unpaired t-test. RESULTS The two groups were comparable in terms of age, parity, gravidity, period of gestation at induction and reasons for induction of labour. Successful priming was achieved in 100% women in Group A and 86% women in Group B. The 'p' value was 0.003, which is statistically significant. The number of women with a favourable score (≥ 6) was significantly higher in Group A. Successful induction was achieved in 88% and 66% women in Groups A and B respectively. The mean induction to delivery interval was shorter in Group A. Vaginal delivery was the outcome in 92% women with misoprostol induction and 74% women with dinoprostone induction. Side effects of prostaglandin inductions when compared in two groups showed no statistically significant differences. CONCLUSION Low-dose oral misoprostol is more effective than dinoprostone gel for cervical priming and labour induction without compromising safety. It has an advantage of decreasing the need of additional measures to achieve vaginal delivery, lower cost and patient acceptability as shown by VAS score.