Low dose intravaginal misoprostol versus intracervical baloon catheter for pre-induction cervical ripening.

BACKGROUND The efficacy and safety of low dose misoprostol as a ripening agent compared to the widely used balloon catheter in developing countries is undetermined. OBJECTIVE To compare the safety and efficacy of a low dose intravaginal misoprostol and intracervical Foley's catheter for cervical ripening. DESIGN A prospective randomized controlled trial. SETTING Zonal General Hospital, Kwale, Nigeria from June 1, 1998 to May 30, 2001. METHODS Candidates for pre-induction cervical ripening were randomized to receive either 250 mcg of intravaginal misoprostol every four hours (n = 60) or intracervical Foley's catheter (n = 61). MAIN OUTCOME MEASURES Failure to achieve cervical ripening within 24 hours, need for augmentation, maternal and foetal complications. RESULTS Failure to achieve cervical ripening within two hours was reduced with misoprostol (Relative Risk [RR] 0.63, 95% Confidence Interval [CI] 0.43 - 0.92). Need for oxytocin augmentation was less in the misoprostol group (RR 0.76, 95% CI 0.64 to 0.91). No significant differences existed in rates for uterine hyperstimulation, Caesarean section, maternal and neonatal morbidity. CONCLUSION Intravaginal misoprostol in a low dose was compared to intracervical balloon catheter for pre-induction ripening of the cervix.