Easing Oxytocin in Early Labour (EASE-OUT) Trial

Phase 1

Recruiting

• Conditions: abour; Labour; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12622001342707
• Lead Sponsor: Royal Prince Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Age > 18 years
2. Planned induction of labour using oxytocin

Exclusion Criteria

1. A fetus with a known major anomaly
2. Red-Zone” (abnormal) fetal cardiotocograph according to NSW Health classification
3. Fetal breech, brow or face presentation
4. Clinical suspicion of cephalopelvic disproportion
5. Known or suspected chorioamnionitis
6. Intrapartum haemorrhage greater than 50mL
7. Intrapartum pyrexia greater than 38C
8. Fetal scalp pH less than 7.25 or lactate greater than 4
9. Pre-existing maternal diabetes
10. Previous caesarean section

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility for a large multicenter trial will be the primary outcome of this pilot study, including:<br>- Any barriers encountered to recruitment - observational<br>- The mean total oxytocin dose per participant (to assess if the two treatment allocations result in a meaningful difference in the received dose of oxytocin) - will be collected from patient's medical records <br>- Number of potential participants assessed for eligibility - will be collected from audits of the study records <br>- Number of potential participants who agree to participate - will be collected from audits of the study records <br>- Number of participants randomised - will be collected from audits of the study records <br>- Final oxytocin infusion rates - will be collected from patient medical records <br>[ We expect the study to be completed in a 2-3 month period ]