Oral misoprostol alone compared to oral misoprostol followed by oxytocin
in India: a multicentre randomised trial in women induced for
hypertension of pregnancy.
Abstract
Objective: To assess whether, in those requiring ongoing
uterine stimulation after cervical ripening with oral misoprostol and
membrane rupture, augmentation with low dose oral misoprostol is
superior to intravenous oxytocin. Design: Open-label,
superiority randomised trial Setting: Government hospitals in
India Population: Women induced with oral misoprostol for
hypertensive disease in pregnancy and requiring ongoing induction after
membrane rupture Methods: Participants received misoprostol
(25mcg orally two hourly) or titrated oxytocin through an infusion pump.
Main Outcome Measure: Caesarean birth Results: 520
women were randomised and the baseline characteristics were comparable
between the groups. The caesarean section rate was not reduced by the
use of misoprostol (misoprostol 32.3% vs oxytocin 27.3%; adjusted odds
ratio 1.226 (95% CI 0.81-1.85, p=0.33)). There were no differences in
rates of hyperstimulation, fetal heart rate abnormalities, or maternal
side effects, although the geometric mean time from randomisation to
birth was 31 minutes longer with misoprostol. Fewer babies in the
misoprostol arm were admitted to the special care unit (10 vs 21 in the
oxytocin group) and there were no neonatal deaths in the misoprostol
group, compared to 3 in the oxytocin arm. Women’s acceptability ratings
were high in both study groups. Conclusion: Following cervical
preparation with oral misoprostol and membrane rupture, the use of
ongoing oral misoprostol for augmentation did not significantly reduce
caesarean rates compared to oxytocin. The method, however, was safe for
both mother and baby.