INTERNATIONAL JOURNAL OF GYNECOLOGY & OBSTETRICS, vol.155, no.3, pp.496-504, 2021 (SCI-Expanded, Scopus)
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.