Safety and Efficacy of Combined Oral Misoprostol and Foley Catheter Treatment in Comparison with Oral Misoprostol Alone for Labor Induction: A Randomized Clinical Trial study

Background: In the context of a rising trend in labor induction cases, limited research has explored the efficacy of the simultaneous use of misoprostol and Foley catheter methods. This clinical trial investigates the efficacy and safety of combining these labor induction techniques compared to the use of oral misoprostol alone. Methods: This randomized, open-label clinical trial was conducted on pregnant women candidates for induction of labor due to various medical indications referred to Shariati Hospital, Tehran. The oral misoprostol plus Foley catheter group received 50 mg of oral misoprostol every 4 hours, along with the insertion of a Foley catheter into the cervix under sterile conditions. The comparison group received only oral misoprostol. The Bishop scores in this study were measured prior to induction, and at 6 hours and 12 hours after the initiation of the intervention by a single specialist. Statistical comparisons included the number of deliveries within 24 hours, Bishop score, oxytocin dosage, and maternal and fetal complications. Results: The two groups were homogeneous in regard to age (27.11 ± 3.88 vs. 26.46 ± 4.95, P=0.26), gestational week (P = 0.44), and BMI (P = 0.88). The combination of the Foley catheter and oral misoprostol group showed significantly higher Bishop scores at 6 hours (P < 0.001) and 12 hours (P = 0.02). The oral misoprostol alone group exhibited a significantly higher rate of cases failing to deliver within 24 hours of induction compared to the combination treatment group (73.4% vs. 11.6%, P < 0.001). Furthermore, the oral misoprostol alone group demonstrated significantly higher incidences of adverse outcomes, including uterine tachysystole (17.6% vs. 3.85%, P < 0.001), NICU hospitalization (8% vs. 1.54%, P = 0.015), abnormal Apgar score at five minutes (4.8% vs. 0%, P=0.01), and meconium presence (7.2% vs. 1.54%, P = 0.03). Conclusion: This study suggests that the combined method for labor induction is more appropriate due to its quicker and more impactful results, along with lower complication rates.