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

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: 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.