A comparison of oral and vaginal misoprostol for induction of labour at term: a randomised trial

Objective To compare the efficacy of oral with vaginal misoprostol for induction of labour at term. Design Randomised trial. Setting Tertiary Care hospital. Participants One hundred and sixty‐seven women requiring induction of labour. Methods The women were randomised to receive 50 μg of misoprostol orally or vaginally every 6 h until the cervix was favourable for amniotomy, spontaneous rupture of membranes, or active labour occurred. Sample size was calculated with a two‐tailed alpha of 0.05 and a power of 95% to detect a 5 h difference in induction‐to‐delivery time. Student's t test was used for comparison of normally distributed continuous variables and the Mann‐Whitney U test was used for non‐Gaussian distributed continuous variables. Fisher's exact and χ 2 tests were used for comparison of categorical variables. The main outcome measure was induction to delivery time. Results The median induction to delivery time was significantly shorter with vaginal misoprostol (15.7 h range 4.3‐55.7), compared with oral misoprostol (23.0 h range 3.2‐141.7, P= 0.0013). The median number of doses was also significantly less in the vaginal misoprostol group, 1 (range 1‐3), compared with the oral group, 2 (range 1‐8), ( P <0.0001 ). The significant differences in outcome held true when nulliparous and multiparous women were analysed separately. There were no differences between the two routes of administration with respect to rates of hyperstimulation or neonatal asphyxia. There were more caesarean sections in the vaginal misoprostol group, but the difference was not statistically significant. Conclusions Compared with oral misoprostol, vaginal misoprostol for induction of labour at term results in a shorter induction‐to‐delivery time, with fewer doses required per patient. Vaginal misoprostol may be associated with higher rates of caesarean section than oral misoprostol.