SO SÁNH KẾT QUẢ KHỞI PHÁT CHUYỂN DẠ BẰNG PROPESS VÀ FOLEY BÓNG ĐÔI CẢI TIẾN Ở THAI PHỤ ≥37 TUẦN TẠI BỆNH VIỆN SẢN NHI NGHỆ AN NĂM 2025

Abstract

Background: Induction of labor (IOL) is frequently indicated when the cervix is unfavorable and requires a method that balances effectiveness and safety. Evidence suggests both double-balloon catheters and dinoprostone are effective in increasing vaginal delivery rates, yet differences in safety profiles and oxytocin requirements remain debated. A head-to-head comparison in a provincial practice setting is therefore needed to guide optimal choice. Objective: To compare the effectiveness and safety of Propess versus a modified double-balloon Foley catheter for IOL in term women with an unfavorable cervix. Methods: Open-label randomized clinical trial at Nghe An Obstetrics and Pediatrics Hospital, March–September 2025; n=150, stratified by Bishop score and randomized 1:1 (Propess 75; double-balloon 75). Intention-to-treat analysis. Primary endpoint: vaginal delivery within ≤48 hours. Results: Vaginal delivery ≤48 hours did not differ significantly (Propess 62.7% vs double-balloon 72.0%; RR 1.24; 95% CI 0.86–1.81; p=0.22). Oxytocin augmentation was higher with the double-balloon (76.0% vs 18.9%; RR 3.48; 95% CI 2.28–5.30; p<0.001). Although the 5-minute Apgar differed statistically, medians were 10 (IQR 0) in both groups, indicating minimal clinical difference; NICU admission was rare (0 vs 1). Neonatal birthweight was slightly lower with the double-balloon (2800 vs 3000 g; p=0.04). Complications: Propess was associated with more premature rupture of membranes (38.7% vs 9.3%) and tachysystole (18.7% vs 0%). Fetal heart rate abnormalities were less frequent with the double-balloon (1.3% vs 12.0%). In interaction analyses, parity ≥1 strongly increased the probability of vaginal delivery in both groups, with a larger effect for the double-balloon (OR≈287.6 vs 20.8; interaction p=0.04). Conclusions: The two methods were comparable for vaginal delivery within 48 hours. The modified double-balloon Foley required more oxytocin but was associated with fewer tachysystole events and premature rupture of membranes; neonatal outcomes were broadly similar with differences of limited clinical significance.