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
Royal Prince Alfred Hospital
100 participants
Sep 25, 2023
Interventional
Conditions
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
Inclusion Criteria2
- Age > 18 years
- Planned induction of labour using oxytocin
Exclusion Criteria10
- A fetus with a known major anomaly
- “Red-Zone” (abnormal) fetal cardiotocograph according to NSW Health classification
- Fetal breech, brow or face presentation
- Clinical suspicion of cephalopelvic disproportion
- Known or suspected chorioamnionitis
- Intrapartum haemorrhage greater than 50mL
- Intrapartum pyrexia greater than 38C
- Fetal scalp pH less than 7.25 or lactate greater than 4
- Pre-existing maternal diabetes
- Previous caesarean section
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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 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)
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ACTRN12622001342707