A randomized controlled trial of sequential vs simultaneous use of Foley balloon catheter and oxytocin for induction of labor in nulliparous pregnant women

BACKGROUND: Although recent evidence suggests the simultaneous approach use of oxytocin for induction of labor in nullipara, there is limited data from low-income settings that support this. OBJECTIVE: This study aimed to determine whether induction of labor with simultaneous use of oxytocin and a Foley balloon catheter decreases the induction of labor to delivery interval in nulliparous women, compared with sequential use of a Foley balloon catheter followed by oxytocin. STUDY DESIGN: This was a randomized controlled trial of nulliparous women with singleton pregnancies presenting for induction of labor at >28 weeks of gestation at St. Paul's Hospital Millennium Medical College (Addis Ababa, Ethiopia). The participants were randomly assigned to either the simultaneous group (the use of oxytocin and a Foley balloon catheter for induction of labor) or the sequential group (overnight intracervical Foley balloon catheter placement followed by the use of oxytocin the next morning). The primary outcome was induction of labor to delivery interval. Comparisons between the groups were made using the Student t test or Wilcoxon rank-sum test and chi-square test on Stata (version 15; StataCorp LLC, College Station, TX). This study is registered with the Pan African Clinical Trials Registry (identifier: PACTR201709002509200). RESULTS: From November 2019 to March 2020, a total of 140 women were randomly assigned to the simultaneous group (70 women) or the sequential group (70 women). The median oxytocin initiation to delivery intervals were 6.09 hours (range, 4.03–10.7) in the sequential group and 8.1 hours (range, 4.7–11.6) in the simultaneous group (P=.46). The mean Foley balloon catheter insertion to delivery intervals were 16.09±5.7 hours in the sequential group and 8.06±4.2 hours in the simultaneous group (P<.001). Cesarean delivery rate, composite neonatal outcomes, and chorioamnionitis were not different between the 2 groups. CONCLUSION: In nulliparous pregnant women, induction of labor using the simultaneous approach did not shorten the oxytocin initiation to delivery interval compared with the sequential approach. Moreover, both approaches showed no difference in the rates of adverse maternal and neonatal outcomes.