Foley catheter and controlled release dinoprostone versus foley catheter labor induction in nulliparas: a randomized trial

• Published in: Archives of gynecology and obstetrics Vol. 306; no. 4; pp. 1027 - 1036
• Main Authors: Vallikkannu, Narayanan, Laboh, Naumi, Tan, Peng Chiong, Hong, Jesrine Gek Shan, Hamdan, Mukhri, Lim, Boon Kiong
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.10.2022; Springer Nature B.V
• Subjects: Catheters; Cervix; Cesarean section; Childbirth & labor; Collagen; Endocrinology; Gynecology; Heart rate; Human Genetics; Induced labor; Maternal-Fetal Medicine; Medicine; Medicine & Public Health; Obstetrics; Obstetrics/Perinatology/Midwifery; Smooth muscle; Vagina; Womens health; Vaginal delivery; Controlled release dinoprostone; Labor induction; Foley catheter; Dinoprostone insert; Induction to vaginal delivery interval; Cesarean; Maternal satisfaction
• ISSN: 1432-0711; 0932-0067; 1432-0711
• DOI: 10.1007/s00404-021-06383-2

Purpose To evaluate Foley catheter and controlled release dinoprostone insert compared to foley catheter alone on induction to delivery interval and maternal satisfaction. Methods A randomized trial was conducted in a university hospital in Malaysia from December 2018 to May 2019. Term nulliparas with unfavorable cervix (Bishop score ≤ 5) scheduled for labor induction were randomized to Foley catheter and controlled release dinoprostone insert simultaneously or Foley catheter alone. Primary outcomes were induction to delivery interval (hours) and maternal satisfaction on birth experience (assessed by 11-point Visual Numerical Rating Scale VNRS 0–10, higher score more satisfied). Results Induction to vaginal delivery intervals was mean ± standard deviation 22.5 ± 10.4 vs. 35.1 ± 14.9 h, P  =  < 0.001 but maternal satisfaction on birth experience was not significantly different median[interquartile range] VNRS 8[7–9] vs. 8[7–9], P  = 0.12 for Foley catheter-controlled-release dinoprostone and Foley catheter alone arms, respectively. Cesarean delivery rates were 35/102(34.3%) vs. 50/101(49.5%), P  = 0.02 RR 0.7 95% CI 0.5–0.9 NNTb 6.3 95% CI 3.5–39.4, pain score at 6 h after catheter insertion 5[2–8] vs. 1[1–3], P  < 0.001, Bishop score at trial devices removal 9[9–10] vs. 8[7–9], P  = 0.001, requirement for oxytocin induction or augmentation 39/102(38.2%) vs. 76/101(75.2%) NNTb 3 95% CI 2.0–4.1, P  < 0.001 and amniotomy rates 73/99(73.7%) vs. 81/95(85.3%), P  = 0.052 RR 0.9 85% CI 0.8–1.0 in Foley catheter-controlled-release dinoprostone and Foley catheter alone arms respectively. Conclusion In nulliparas with unripe cervixes at term, combined Foley catheter and controlled release dinoprostone vaginal insert compared to Foley catheter alone reduces the induction to vaginal delivery interval and cesarean delivery rate but satisfaction was not significantly increased. Clinical trial registration ISRCTN2282883, 03/12/2018, “prospectively registered” ( https://doi.org/10.1186/ISRCTN12282883 ).