Randomized trial to evaluate combined nipple stimulation and Foley balloon for improved cervical ripening

Labor induction rates are rising globally, with successful cervical ripening being a critical factor for positive outcomes. Mechanical methods, such as the Foley balloon catheter, are widely used and considered safe. Concurrently, nipple stimulation offers a physiological approach by promoting endogenous oxytocin release, which stimulates uterine contractions. Despite the individual benefits, the synergistic effect of combining nipple stimulation with a balloon catheter for cervical ripening has not been systematically evaluated, representing a key gap in current labor induction protocols.

This prospective, randomized, double-blinded controlled trial will enroll an estimated 164 term pregnant patients (37-42 weeks' gestation) with a singleton, cephalic pregnancy and an unfavorable cervix (Bishop score <6) requiring labor induction. Participants will be randomized to receive either a Foley balloon catheter plus standardized nipple stimulation or a Foley balloon catheter alone. The primary outcomes are the change in Bishop score after catheter removal and the time from catheter insertion to delivery. Secondary outcomes include the need for additional induction methods, mode of delivery, maternal and neonatal outcomes, pain, patient satisfaction, and breastfeeding rates.

This is a prospective, randomized, double-blinded controlled trial protocol, and as such, no findings are available yet. The study aims to evaluate whether the addition of nipple stimulation to Foley balloon catheter cervical ripening improves Bishop score after catheter removal and shortens the time from catheter insertion to delivery. Secondary outcomes, which will also be assessed upon trial completion, include the need for additional induction methods, mode of delivery, maternal and neonatal outcomes, pain, patient satisfaction, and breastfeeding rates. The trial is currently recruiting participants.