| Title: |
Induction of labour versus standard care to prevent shoulder dystocia in fetuses suspected to be large for gestational age in the UK (the Big Baby trial): a multicentre, open-label, randomised controlled trial |
| Authors: |
Gardosi, J; Ewington, LJ; Booth, K; Bick, D; Bouliotis, G; Butler, E; Deshpande, S; Ellson, H; Fisher, J; Gornall, A; Lall, R; Mistry, H; Naghdi, S; Petrou, S; Slowther, A-M; Wood, S; Underwood, M; Quenby, S |
| Publisher Information: |
Elsevier |
| Publication Year: |
2026 |
| Collection: |
Oxford University Research Archive (ORA) |
| Description: |
Background: The benefits and harms of early induction of labour to reduce shoulder dystocia in fetuses suspected to be large for gestational age (LGA) are uncertain. We aimed to investigate whether early induction of labour is associated with a reduced risk of shoulder dystocia compared with standard care. Methods: In this open-label, randomised controlled phase 3 trial, women aged ≥18 years with a suspected LGA fetus (estimated fetal weight >90th customised percentile) as identified by ultrasound scan between 35 weeks and 0 days (35+0 weeks) of gestation and 38+0 weeks' gestation, recruited from 106 hospitals across England, Scotland, and Wales in the UK, were randomly assigned (1:1) by web app to standard care or induction of labour between 38+0 weeks' gestation and 38+4 weeks' gestation using minimisation, balancing site, estimated fetal weight percentile (≤95th EFW percentile or >95th EFW percentile), and maternal age (≤35 years or >35 years). Key exclusion criteria included drug-treated diabetes, gestational diabetes, and elective caesarean section or induction already planned or indicated for any reason. Our primary outcome was incidence of shoulder dystocia, assessed by a masked independent expert adjudication panel who reviewed participants' delivery notes. Induction of labour was anticipated to result in birth 10·5 days earlier with a 300 g lower birthweight on average than standard care. We did an intention-to-treat (ITT) analysis in all participants for whom we had primary outcome data, and a per-protocol analysis in participants in the induction group who went into labour or were induced at 38+0 to 38+4 weeks' gestation versus participants in the standard care group who had not started labour, been induced, or had an elective caesarean section before 38+4 weeks' gestation. This study was registered with ISRCTN (18229892) and is no longer recruiting. Findings: Between June 8, 2018, and Oct 25, 2022, 2893 women were randomly assigned to induction of labour (n=1447) or standard care (n=1446); ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1016/s0140-6736(25)00162-x |
| Availability: |
https://doi.org/10.1016/s0140-6736(25)00162-x; https://ora.ox.ac.uk/objects/uuid:0f1f2f7c-d4d6-4885-b723-2b0f5074bdb4 |
| Rights: |
info:eu-repo/semantics/openAccess ; CC Attribution-NonCommercial (CC BY-NC) |
| Accession Number: |
edsbas.78AF2EF5 |
| Database: |
BASE |