Titrated oral misoprostol as a safe route for induction of labour at term (a clinical trial)

Abstract

Objective:To assess safety and efficacy of induction of labour at term by low doses of oral misoprostol in the form of titration versus the standard regimen of vaginal misoprostol in the term of induction delivery interval, operative interventions and fetal outcome. Methods:Clinical comparative study was carried out for a period of one year from November 2008 to October 2009 at Zagazig university hospital. The study protocol was approved by the ethics committee of our hospital. One hundred women at term with indication of labour and Bishop score less than or equal 5, no either Obstetric or maternal contraindications for induction of labour were randomly assigned to receive oral (titrated) or vaginal misoprostol for induction of labour. The oral group received a basal of 20ml misoprostol solution (1mcg/ml) every hour for four doses and then were titrated according uterine response individually, the vaginal group received 25 mcg every 4 hours(maximum number of doses limited to six) until cervix became more favorable. The induction delivery interval, oxytocin need, mode of delivery, frequency of side effects and neonatal and maternal outcome were assessed. Chi-square or Fisher exact test, Student's T-test and Wilcoxon rank sum test were used for analysis the data statistically. Results:The oral misoprostol group had 50 women (50%) and was given it in the form of titrated oral solution and vaginal misoprostol group had 50 women (50%). Vaginal delivery occurred within 12 hours in 38 women (76%) in oral group and in 12 women (24%) in vaginal group. The median interval from starting induction by misoprostol to vaginal delivery was significantly shorter in oral titrated misoprostol group (7.5 h) compared with vaginal misoprostol group (16.1h) with P value <0.01.The incidence of hyper-stimulation in oral group was 0.0% compared with 12% in vaginal group with P value <0.01 which is significantly different. More women had nausea 8% in oral group but fewer infants had Apgar score less than 7 at 1 minute in oral group than in vaginal group.  Conclusion:Oral misoprostol in the form of titration is associated with lower incidence of uterine hyper-stimulation and lower cesarean delivery rate, better fetal outcome than vaginal misoprostol for labour induction at term in patients with unripe cervix.