EASing Oxytocin in Early Labour - OUTcomes for Mothers and Babies (EASE-OUT): a feasibility randomised controlled trial
A randomized controlled trial comparing different oxytocin concentrations during labor induction is feasible, but further studies are needed to assess clinical effectiveness.
Where it sits
this study against the rest of the oxytocin corpusSummary and findings
This study assessed the feasibility of a randomized controlled trial comparing halved versus routine-concentration oxytocin infusion during the active phase of labor in women undergoing induction. A total of 293 women consented to participate, with 101 being randomized. No significant differences in maternal or neonatal outcomes were reported.
Abstract
Objective To assess the feasibility of a definitive randomised controlled trial comparing halved versus routine-concentration oxytocin infusion during active phase of the first stage of labour in women undergoing induction of labour. Design Multicentre, double-blind, randomised feasibility trial with 1:1 allocation. Participants Women & birthing people aged 18 years or older undergoing planned induction of labour in two public maternity hospitals in Sydney, Australia, between September 2023 and September 2025 were eligible. Key exclusions included previous caesarean delivery, pre-existing diabetes, major fetal anomaly, abnormal fetal cardiotocography, malpresentation, suspected cephalopelvic disproportion, suspected chorioamnionitis, intrapartum pyrexia, and other predefined maternal or fetal safety concerns. Interventions All participants commenced induction with standard oxytocin during the latent phase (10 IU in 1 L crystalloid). At established active labour, participants were randomised to receive either halved-concentration oxytocin (5 IU in 1 L crystalloid) or routine-concentration oxytocin (10 IU in 1 L normal saline), titrated according to the New South Wales (NSW) Health oxytocin protocol between one and 40 mIUmin -1 . Main outcome measures Feasibility outcomes were recruitment, consent, randomisation, retention, protocol adherence, unblinding, and treatment separation, assessed by total oxytocin dose and infusion rates. Secondary outcomes included maternal, neonatal, and participant-reported outcomes. Results Of 771 women assessed for eligibility in two centres, 572 were approached and 293 (51%) consented to participate, of whom 101 (34%) were randomised. During active recruitment, randomised participants represented 9.2% of all births. Baseline characteristics were similar between groups. No between-group differences were observed in maternal, neonatal, or participant-reported outcomes, although the trial was not powered to assess clinical effectiveness. Satisfaction outcomes were ascertained for 69% (70/101) participants. There was 100% ascertainment for short-term clinical outcomes and for readmissions to the hospital of delivery. Twenty-nine participants were interested in providing feedback and in being involved in developing a larger study across multiple hospitals. Conclusions A blinded randomised controlled trial of oxytocin dose reduction in active labour is feasible in a real-world labour ward. Trial registration This trial was registered on the ANZCTR (ACTRN12622001342707) Funding This trial was supported through seed funding from the Sydney Institute for Women, Children and their Families, Sydney Local Health District and the NHMRC Clinical Trials Centre, University of Sydney.