ABSTRACT
SUMMARY OBJECTIVE: This study aimed to analyze the effects of Foley catheter combined with misoprostol in the labor induction process. METHODS: This is a nonblinded, block randomized, controlled trial that compared the association between transcervical Foley catheter/vaginal misoprostol 25 μg combination and vaginal misoprostol 25 μg alone in normal-risk and healthy pregnant women undergoing labor induction in the south of Brazil. RESULTS: A total of 230 patients with indications for labor induction were evaluated and classified into the "combined" group (Foley catheter plus misoprostol), consisting of 107 patients, and the "misoprostol" group (misoprostol only), consisting of 123 patients. The "combined" group was observed to have a shorter labor induction time (p=0.008). In addition, there was a lower need for misoprostol use for overall cervical ripening (p<0.001) and a lower relative risk of needing a second, third, or fourth misoprostol tablet in the "combined" group (risk ratio [RR] 0.80, 95% confidence interval [CI] 0.71-0.91; RR 0.41; 95%CI 0.31-0.56; and RR 0.29, 95%CI 0.17-0.52, respectively) (p<0.001). No statistically significant difference was found in induction failure rate, cesarean section rate, or perinatal outcomes. CONCLUSION: A combination of methods leads to shorter labor induction, lower need for misoprostol doses, and lower risk of cesarean section, with no increase in the rate of perinatal complications. REBEC number is RBR-7xcjz3z.