RecruitingEarly Phase 1ACTRN12622001342707

Easing Oxytocin in Early Labour (EASE-OUT) Trial

A Randomised Controlled Trial of Easing Oxytocin in Early Labour: Outcomes for Mothers and Babies - a feasibility study

Sponsor

Royal Prince Alfred Hospital

Enrollment

100 participants

Start Date

Sep 25, 2023

Study Type

Interventional

Conditions

Labour

Summary

This research aims to improve outcomes for mothers and babies when a labour is artificially brought on or induced. Inducing the labour can lead to the baby being stressed and make the labour more painful. If the baby is severely stressed this can rarely lead to stillbirth or brain damage to the baby. This research will use lower doses of medications used to bring on labour, aiming to make it safer for mothers and babies. It could also reduce the chances that a woman has a caesarean section

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

When labour is induced (artificially started) with a hormone called oxytocin, the doses used can sometimes be higher than needed, which may cause stress to the baby and increase the chance of a caesarean section. This study is testing whether using lower doses of oxytocin in the early stages of labour can make the process safer for both mothers and babies while still helping labour progress effectively. The trial will compare the standard oxytocin dosing approach with a reduced-dose approach, monitoring both the mother and baby closely throughout. Researchers hope that using lower doses will reduce fetal distress and the rate of caesarean deliveries without slowing down or stopping labour. You may be eligible if you are over 18, are having a planned induction of labour using oxytocin, and do not have certain complications such as known major fetal abnormalities, a breech baby, suspected infection in the womb, pre-existing diabetes, or a previous caesarean section.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Once informed, written consent has been obtained, participants will be entered into the study. Participants will be subsequently randomized into one of two groups to receive the trial intervention or

Once informed, written consent has been obtained, participants will be entered into the study. Participants will be subsequently randomized into one of two groups to receive the trial intervention or routine care, either: Intervention: 5IU oxytocin in 1L of normal saline or Comparator (routine dose, standard care): 10IU oxytocin in 1L of normal saline For both groups, doses be administered intravenously and will be titrated in mLs per hour as per NSW Health protocol by the midwife caring for the patient. The intervention or routine (comparison) oxytocin preparation will be commenced when the active phase of the first stage of labour is first diagnosed (when there are regular uterine contractions and the cervix is 4cm dilated and the cervix is fully effaced). Regular contractions are considered to be contractions that occur at least every 4 minutes for at least one hour and are considered to be adequate by the midwife caring for the woman in labour. The intervention will be ceased upon birth of the fetus or in the event the trial needs to be ceased and unblinded

Locations(2)

Royal Prince Alfred Hospital - Camperdown

NSW, Australia

Canterbury Hospital - Campsie

NSW, Australia

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ACTRN12622001342707

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