Foley Catheter for Induction of Labor at Term: An Open-Label, Randomized Controlled Trial

• DOI: 10.1371/journal.pone.0136856
• Publication Date: 2015-08-31T13:46:30Z
• Authors: Ning Gu; Tong Ru; Zhiqun Wang; Yimin Dai; Mingming Zheng; Biyun Xu; Yali Hu
• Keywords: Foley catheter; Bishop score; Foley; Labor Induction

Objective This study aimed to determine the optimal Foley catheter balloon volume (30-mL vs. 80-mL) and maximum time for cervical ripening (12 hours 24 hours) improve vaginal delivery rate within of induction. Methods We conducted an open-label, randomized controlled trial in a teaching hospital China. Women with term singleton pregnancy, cephalic presentation, intact membrane unfavorable cervix (Bishop score <6) were randomly allocated, 1:1:1:1 ratio, receive either one four treatments: (1) 30-mL 12 hours, (2) (3) 80-mL (4) hours. The primary outcome was Secondary outcomes included cesarean section maternal/neonatal morbidity. Data analyzed on per-protocol basis. Results Five hundred women recruited (126 each group); nine did not assigned intervention. More achieved 12-hour groups than 24-hour (30-mL/12 hours: 54.5%, 30-mL/24 33.1%, 80-mL/12 46.4%, 80-mL/24 24.0%, p < 0.001). Cesarean rates incidence chorioaminonitis comparable among groups. After adjustment confounding factors, both size affect proportion delivered vaginally Conclusion For at term, induction labor is safe effective. Higher (80-mL 30-mL) longer (24 would shorten interval or reduce rate. Trial Registration Chinese Clinical registry (ChiCTR-TRC-13003044)