Sequential use of foley catheter and misoprostol versus misoprostol alone for induction of labor: a multicenter randomized controlled trial

Issenova S. Sultanmuratova D. Issina G. Nakhanova Z. Kenzhegaliyeva A. Attar R.
2025 Elsevier Inc.

American Journal of Obstetrics and Gynecology MFM
2025

Background: Labor induction is a critical intervention used when prolonging pregnancy poses risks to maternal or fetal health. While combined methods of cervical ripening have been studied, evidence specifically regarding sequential use (as opposed to simultaneous administration) remains limited. Objective: To compare the efficacy and safety of a sequential labor induction method (Foley catheter followed by misoprostol) versus misoprostol alone in term pregnancies. Study Design: This multicenter, randomized controlled trial (NCT06249815) was conducted at 2 hospitals in Almaty, Kazakhstan. A total of 400 women with singleton term pregnancies, cephalic presentation, and unfavorable cervices (Modified Bishop Score ≤6) requiring labor induction were enrolled. Participants were randomly assigned to: • Group A (n=200): Foley catheter insertion for 12-18 hours followed by oral misoprostol. • Group B (n=200): Oral misoprostol alone. Primary outcome: Vaginal delivery. Secondary outcomes: Cesarean delivery, uterine hyperstimulation, fetal distress, Apgar scores, postpartum hemorrhage, chorioamnionitis, perineal trauma, operative vaginal birth, blood transfusion, and labor augmentation. Results: The sequential method significantly increased the probability of vaginal delivery compared to misoprostol alone (77.5% vs 69.5%; adjusted RR=1.16; 95% CI: 1.04–1.29; P=.009). The total dose of misoprostol required was significantly lower in the sequential group (P<.001). A higher incidence of chorioamnionitis was observed in the sequential group (OR=3.82; 95% CI: 1.05–13.9; P=.03). Conclusion: The sequential method increases the probability of vaginal delivery while requiring a lower total misoprostol dose, without increasing the rate of major maternal or neonatal complications. However, it may be associated with a higher risk of chorioamnionitis, which warrants further investigation. These findings support its consideration as a clinically effective and pharmacologically conservative alternative for labor induction in women with an unfavorable cervix.

chorioamnionitis , foley catheter , induction of labor , misoprostol , sequential method , vaginal delivery

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Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan
Kazakhstan’s Medical University “KSPH”, Almaty, Kazakhstan
Center for Perinatology and Pediatric Cardiac Surgery, Almaty, Kazakhstan
City Perinatal Center, Almaty, Kazakhstan
Yeditepe University Medical School, Istanbul, Turkey

Asfendiyarov Kazakh National Medical University
Kazakhstan’s Medical University “KSPH”
Center for Perinatology and Pediatric Cardiac Surgery
City Perinatal Center
Yeditepe University Medical School

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