Objective: To compare the effectiveness of titrated orally and vaginally administered misoprostol for induction of labour.
Study design: Unmasked randomized controlled trial.
Setting: Department of Obstetrics and Gynaecology University of Zimbabwe, Harare.
Subjects: Pregnant women with singleton foetus in cephalic presentation booked for induction of labour, were randomized to receive titrated orally or vaginally administered misoprostol.
Main outcome measures: The main outcomes were the duration of labour and induction to delivery interval. The secondary outcomes were neonatal and maternal complications.
Methods: 134 women were recruited into the study; 69 and 65 were randomized into orally and vaginally administered misoprostol respectively.
Results: The baseline characteristics in the two groups were similar. Women induced with titrated oral misoprostol suspension had a shorter interval from administration of the drug to initiation of uterine contractions (OR = 0.94 .95% CI 0.42 to 2.12) and a longer duration of labour (OR = 0.36; 95% CI 0.16 to 0.79). Labour was augmented with oxytocin in the oral group. The mean drug dose was 28mcg in the oral group. There was no difference in the mode of delivery between the two groups. Hypertonic uterine contractions were not detected. Ruptured uterus did not occur in the study population. There were more neonatal admissions in the vaginal than the oral group (OR = 1.03 .95% CI 0.29 to 1.39).
Conclusion: Titrated oral misoprostol suspension is as effective and safe as vaginal misoprostol for induction of labour even in poor resource countries where intrapartum monitoring is inadequate.