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

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

*Corresponding author for this work

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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.

Original languageEnglish
Pages (from-to)89-93
Number of pages5
JournalEuropean Journal of Obstetrics and Gynecology and Reproductive Biology
Publication statusPublished - Mar 2023

Bibliographical note

Funding Information:
The original PROBAAT-2 trial was funded by FondsNutsOhra. For the PROBAAT-1 trial and this follow-up study, no funding was received. MV received a doctoral grant for teachers by the Netherlands Organisation for Scientific Research (023.011.051). BM is supported by a NHMRC Practitioner Fellowship (GNT1082548). Funding sources had no role in design, execution, analyses, interpretation, or decision to submit results.

Publisher Copyright:
© 2023


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