The influence of various induction methods on adverse outcomes in small for gestational age neonates: A secondary analysis of the PROBAAT 1 and 2 trials

de Vaan, Marieke D.T.; Croll, Dorothée M.R.; Verhoeven, Corine J.M.; de Boer, Marjon A.; Jozwiak, Marta; ten Eikelder, Mieke L.G.; Mol, Ben Willem; Bloemenkamp, Kitty W.M.; de Heus, Roel

Abstract

Objective: To evaluate the safety aspects of different induction methods in pregnancies with small-for-gestational-age neonates. Study design: This was a secondary analysis of two previously reported multicenter, randomized controlled trials conducted in the Netherlands. In the original trials, women were randomized to either a 30 cc Foley catheter, vaginal prostaglandin E2 (PROBAAT-1) or oral misoprostol (PROBAAT-2). A total of 425 patients with a term, singleton pregnancy in cephalic presentation with an indication for labor induction and a small-for-gestational-age neonate were included in this secondary analysis. Our primary outcome was a composed adverse neonatal outcome of Apgar score < 7 after 5 min and/or a pH in the umbilical artery < 7.05 and/or NICU admission. Secondary outcomes were mode of birth, operative birth for fetal distress and pH < 7.10 in the umbilical artery. For these outcome measures, multivariate as well as bivariate analyses were performed. Results: An adverse neonatal outcome occurred in 4.7 % (10/214) induction with a Foley catheter, versus 12.8 % (19/149) after misoprostol (RR 0.36; 95 % CI 0.17–0.76) and 4.7 % (3/64) after Prostaglandin E2 (RR 0.98; 95 %CI 0.28–3.51). For individual components of the composed outcome of adverse events, a difference was found between a Foley catheter and misoprostol for Apgar score < 7 at 5 min (0.5 % versus 3.4; RR 0.14; 95 %CI 0.02–1.16) and NICU admission (1.9 % versus 6.1 %; RR 0.31; 0.10–0.97). No differences were found for mode of birth. Conclusions: For women who gave birth to a small-for-gestational-age neonate, a Foley catheter is probably a safer induction method compared to oral misoprostol.

Citation

de Vaan, M. D., Croll, D. M., Verhoeven, C. J., de Boer, M. A., Jozwiak, M., ten Eikelder, M. L., Mol, B. W., Bloemenkamp, K. W., & de Heus, R. (2023). The influence of various induction methods on adverse outcomes in small for gestational age neonates: A secondary analysis of the PROBAAT 1 and 2 trials. European Journal of Obstetrics and Gynecology and Reproductive Biology, 282, 89-93. https://doi.org/10.1016/j.ejogrb.2023.01.003

• Journal Article Type: Article
• Acceptance Date: Jan 3, 2023
• Online Publication Date: Jan 5, 2023
• Publication Date: 2023-03
• Deposit Date: Jun 8, 2023
• Publicly Available Date: Jun 8, 2023
• Journal: European Journal of Obstetrics and Gynecology and Reproductive Biology
• Print ISSN: 0301-2115
• Electronic ISSN: 1872-7654
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 282
• Pages: 89-93
• DOI: https://doi.org/10.1016/j.ejogrb.2023.01.003
• Keywords: Prostaglandin, Foley catheter, Balloon, Cervical ripening, Induction of labor, SGA, PGE1, Misoprostol, FGR, PGE2
• Public URL: https://nottingham-repository.worktribe.com/output/17372818
• Publisher URL: https://www.sciencedirect.com/science/article/pii/S0301211523000039?via%3Dihub
• Additional Information: This article is maintained by: Elsevier; Article Title: The influence of various induction methods on adverse outcomes in small for gestational age neonates: A secondary analysis of the PROBAAT 1 and 2 trials; Journal Title: European Journal of Obstetrics & Gynecology and Reproductive Biology; CrossRef DOI link to publisher maintained version: https://doi.org/10.1016/j.ejogrb.2023.01.003; Content Type: article; Copyright: © 2023 The Authors. Published by Elsevier B.V.