Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
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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.

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