Objective: To introduce a new handmade device, the double Foley catheter (DFC), and compare it with the Foley catheter (FC) and Cook cervical ripening balloon for its effectiveness in labor induction.
Methods: This prospective randomized controlled trial included 222 patients with unfavorable cervices. The patients were randomly allocated to the DFC, FC, and Cook cervical ripening balloon groups (n = 74 patients per group). The outcomes were evaluated using SPSS v. 23.
Results: Bishop scores successfully increased with all three methods (P = 0.000 for all groups), and the rates of vaginal delivery within 24 and 48 h were similar (P = 0.101 and P = 0.390, respectively). The pain scores of the DFC and Cook cervical ripening balloon groups were similar, but were lower than those of the FC group (P = 0.011). The overall maternal satisfaction scores of the DFC and Cook cervical ripening balloon groups were not significantly different but were higher than those of the FC group (P = 0.014).
Conclusion: The maternal safety and success rate of labor induction were comparable between groups. However, the FC group had a higher pain score during catheter insertion and a lower maternal satisfaction rate. Moreover, considering the high cost of the Cook cervical ripening balloon, the DFC has an advantage, especially in low-resource countries.
Keywords: Cook cervical ripening balloon; Foley catheter; double Foley catheter; double-balloon catheter; handmade device; induction of labor; mechanical method; new method.
© 2021 International Federation of Gynecology and Obstetrics.