A Randomized Clinical Trial Comparing Oral and Vaginal Misoprostol for Induction of Labour at Term in Kenyatta National Hospital(K.n.h.)

Abstract

Introduction Induction of labour is the process of artificially stimulating the uterus so as to start labour. It’s usually done at the age of viability to avert a foreseen adverse outcome associated with continuation of the pregnancy. The indications for induction of labour differ. The incidence varies from country to country. In developed countries for instance, induction of labour varies between 20-35% but it has been found to be much lower in developing countries. In Niger for example, induction of labour is as low as 1.4%. Globally, an average of 9.6% of pregnant women will require induction of labour. Misoprostol (PGE1) has proved very effective in induction of labour. In addition, it’s cheap, heat stable therefore easy to store and transport and widely available. However, the ideal route of administration, dose and frequency are yet to be determined. Generally, women all over the world find vaginal examination uncomfortable. Therefore oral administration may be more comfortable and acceptable. A dose given less frequently than the current 2hourly solution will be better for the already constrained low resource settings. Broad objective To compare the efficacy of 25μg vaginal misoprostol 4hourly and 50μg oral misoprostol 4hourly for induction of labour, neonatal and maternal outcomes. Methodology Study participants were randomly assigned to 2 groups; oral misoprostol 50μg 4hourly and the other group assigned to vaginal misoprostol 25μg 4hourly to a maximum of 4 and 5doses respectively. The average duration from induction to delivery and proportion of deliveries occurring within 24hours of induction was determined. The primary dependent variable was the proportion of deliveries within 24hours of induction, while the secondary dependent variables were the maternal and perinatal outcomes. The independent variables include; the route and the dosage of administration of misoprostol and the socio-demographic characteristics. x Results In this study, 77 study subjects received oral misoprostol while 75 received vaginal misoprostol for induction of labour. Among the participants who received vaginal misoprostol 52 (68.0) had a successful vaginal delivery within 24 hours compared to 40 (53.0%) of those that received oral misoprostol (P-value =0.09). The average duration taken from the onset of induction of labour until delivery was 17.9 hours for the participants who received oral misoprostol as compared to 21.7 hours in the group that received vaginal misoprostol (P-value =0.024). There was no statistically significant difference observed in the maternal and early perinatal outcomes between the two groups. Conclusion Oral misoprostol at 50μg 4hourly is as effective as vaginal misoprostol 25μg 4 hourly for induction of labour at term.