A randomized controlled trial of vaginal misoprostol tablet and intracervical dinoprostone gel in labor induction of women with prolonged pregnancies

Background: Objective of the study was to compare the efficacy of vaginal misoprostol and intracervical dinoprostone gel for induction of labor in women with unfavorable cervix beyond 41 weeks (287 days) of gestation.Methods: This randomized controlled trial was performed at a teaching hospital between January 2011 and December 2012. 192 women with singleton uncomplicated pregnancy with no previous uterine scar not going into spontaneous labor at 288th days of gestation .Misoprostol(25 mcg tablet)in the posterior vaginal fornix, four hourly, maximum six doses or Dinoprostone (0.5 mg gel) intracervical instillation ,six hourly, maximum three doses were given.Oxytocin was administered if needed. Primary outcome: Induction delivery interval (IDI) with incidence of delivery within 12 hours and 24 hours; mode of delivery: vaginal or caesarean section. Secondary outcome: maternal side effects, neonatal outcome. For statistical analysis chi-square test, student t- test and P-value determination were done.Results: The mean IDI was shorter in the misoprostol group compared to the dinoprostone group (p<0.001) with more delivery within <12 hours (p<0.001) and within <24 hours (p<0.05). Caesarean section rate was lower in misoprostol group compared to dinoprostone group (12.76% versus 23.07%) but this difference was not statistically significant (p>0.05). Adverse neonatal outcome (5-minutes Apgar score<7) with NICU admission was more in misoprostol group compared to dinoprostone group (0.04%versus0.01%) but this difference was also not statistically significant(p>0.05).Conclusions: Vaginal misoprostol tablet is a safe and more effective method of induction of labour when compared with intracervical dinoprostone gel in prolonged pregnancies.