Not Yet RecruitingPhase 4ACTRN12626000550303

For women giving birth for the first time and requiring an induction of labour, are we able to reduce duration of labour by giving oxytocin in an intermittent (or pulsatile) manner, as opposed to a continuous oxytocin infusion.

Continuous versus pulsatile oxytocin for nulliparous women undergoing induction of labour: A randomised controlled trial with the primary outcome being mean duration of labour in minutes.

Sponsor

Sydney Local Health District

Enrollment

220 participants

Start Date

Aug 3, 2026

Study Type

Interventional

Conditions

Labour (induction of)Childbirth

Summary

We know from the Australian Institute of Health and Welfare 2021, that almost 1 in 2 (46.5%) of women giving birth for the first time (nulliparous), will require artificial commencement of their labour - known as induction of labour. Of these nulliparous women having an induction of labour, a majority of them (73%) will require an operative birth (forceps, vacuum or emergency caesarean section). We believe that the existing management of induction of labour is contributing to the incidence of operative births and furthermore, it is also resulting in excessively long labours. Our hypothesis is that the use of an intermittent infusion (pulsatile) of oxytocin will reduce the duration of labour when compared to the current use of a continuous infusion of oxytocin. We will test our hypothesis by a randomised controlled trial of 220 nulliparous women who require an induction of labour by randomising them to either a continuous infusion or intermittent infusion of oxytocin, in a blinded fashion.

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 60 Yearss

Inclusion Criteria1

Nulliparous women who have a singleton pregnancy of cehpalic presentation, at least 37 weeks gestation and either requesting or have an obstetric indication, for induction of labour and have already provided written informed consent for induction of labour.

Exclusion Criteria5

Less than 18 years of age
Nulliparous women who do not have the mental and/or legal capacity to consent
All presentations other than cephalic
Multiple pregnancy
Spontaneously labouring post amniotomy

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Interventions

Nulliparous women who either request or have an obstetric indication for induction of labour, will be randomised to either a continuous oxytocin infusion (comparator) or an intermittent (pulsatile) oxytocin infusion (intervention). The stock solution of oxytocin is 30 IU in 500 ml Hartmann's solution. As per Institutional policy and NSW guidelines, obstetric consultation is required if the rate of oxytocin is increased above 20 ml/hr (20 mU/min). For the treatment group, pulsatile oxytocin is initiated by a 0.1 ml infusion of oxytocin every 3 minutes (equivalent to 2 ml/h, with the rate increased every 30 minutes until 4 uterine contractions occur within 10 minutes. The maximum rate of infusion is set at 1.6 ml every 3 minutes (equivalent to 32 ml/h). The oxytocin infusion continues until birth of the neonate. The rate of infusion may be turned down or turned off if uterine tachysystole, uterine hypertonus or uterine hyperstimulation occurs, or if fetal cardiotocographic tracing indicates fetal distress. A review of the electronic medical record documentation will ensure fidelity to the intervention. Women are allowed to eat and drink ad libitum