Cervical ripening balloon as an alternative for induction of labour: a randomized controlled trial

Objective: To evaluate the use of cervical ripening balloon (CRB) for induction of labour (IOL) in Singapore. Design: Prospective cohort randomised controlled study comparing CRB to Prostin (PGE) for IOL Setting: Tertiary maternity hospital in Singapore. Population : Women aged 21 to 40 years old for IOL in a singleton term pregnancy without major fetal anomaly suitable for vaginal delivery were recruited unless they were in labour, had cervical dilatation ³3 cm, ruptured membrane, abnormal CTG, scarred uterus or malpresentation. Methods: Suitable women were recruited in the ante-natal period and randomized to receive either CRB or PGE on the day of IOL. Characteristics of the women, labour and birth outcomes, as well as their pain and satisfaction scores were obtained from case notes and by interviewing the women at IOL and after delivery. Main Outcome Measures: Characteristics of participants, labour outcomes, birth outcomes. Results: 98 women were enrolled for the study with 31 CRB and 52 PGE cases analysed. Both groups had similar maternal age, ethnic mix, proportion of primigravidae, weight, gestational age, cervical dilatation, indication for IOL, baby gender and birth weight. The induction to vaginal delivery time and vaginal delivery rate, as well as risk of low Apgar scores, meconium aspiration, pyrexia in labour, neonatal intensive care unit or intensive care unit admissions were also similar. Although only 1 (3.2%) in CRB arm failed to be induced compared with 9 (17.3%), this was not statistically significant (p = 0.082). Only 1 case of uterine hyperstimulation was observed and was from the PGE group. Conclusions : Both CRB and PGE are effective and complementary methods for IOL. The availability of both methods in an obstetric unit will allow women and clinicians choice in their method of IOL.