None listed
Conditions
Brief 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.
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
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
Sponsors
Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
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 criteria
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
Outcome results
None listed