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Objective: To investigate whether the addition of oxytocin to cervical ripening with a Foley catheter (FC) among nulliparous women shortens the time to delivery. Methods: In this double-blinded randomized trial conducted at Moi Teaching and Referral Hospital, 220 women were randomly assigned to FC plus low-dose oxytocin as treatment or FC plus placebo as controls in a 1:1 ratio. A modified intention-to-treat analysis was performed using SPSS v24. The protocol was approved by the institutional ethics committee and registered at www.ctr.pharmacyboardkenya.org; ECCT/19/08/02. Results: Baseline characteristics were similar. Time to delivery was shorter by 3 h in the treatment group compared with the controls (25.4 versus 28.4 h, P = 0.002). The treatment group had a 22% increased likelihood of delivery within 24 h compared with the controls (53.3% versus 43.1%, relative risk [RR] 1.22, 95% confidence interval [CI] 0.938-1.579, P = 0.135). The controls were however twice more likely to deliver by cesarean section than the treatment group (39% versus 21%, RR 2.32, 95% CI 1.16-2.73, P = 0.006). There were no significant differences in neonatal or other maternal outcomes.
Conclusion: FC with adjunctive oxytocin for cervical ripening in nulliparous women results in a shorter time to delivery and reduced cesarean deliveries when compared with FC alone. |
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