TerminatedPhase 4ACTRN12619000588190

Does the use of oxytocin in a pulsatile fashion (intermittent boluses), when compared to the use of continuous oxytocin, for the commencement and/or assistance of labour, result in a reduction in the number of caesarean sections that are required?

The pulsatile oxytocin study: A randomised controlled trial comparing pulsatile to continuous oxytocin infusion for the induction and/or augmention of labour and the incidence of unplanned caesarean sections.


Sponsor

Darren Lowen

Enrollment

412 participants

Start Date

Jul 14, 2019

Study Type

Interventional

Conditions

Summary

In 2017, at The Northern Hospital, one in three women required an induction (commencement) and/or augmentation (assistance) of their labour. Induction and/or augmentation is initiated with a medication called oxytocin that is given to you intravenously via a cannula (drip) that is placed on one of the veins on the back of your hand. Oxytocin may be given continuously, or it may be given in a pulsatile fashion (small amounts of the same medicine every 15 minutes). We believe that oxytocin given in a pulsatile fashion is more physiologically normal, which might reduce the incidence of emergency (unplanned caesarean sections) as well as reduce the frequency and severity of post partum haemorrhage (bleeding post the delivery of your baby).


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 60 Yearss

Inclusion Criteria13

  • Any of the indications for induction of labour including the following:
  • Diabetes (Type I, Type II, gestational diabetes, which is poorly controlled)
  • Hypertension
  • Pre-elcampsia
  • Prolonged pregnancy defined as being greater than 41 weeks
  • Term prolonged rupture of membrane
  • Reduced fetal movements +/- non-reassuring CTG
  • Past history of fetal death in utero
  • Chorioamnionitis
  • Low PAPP-A
  • Advanced maternal age (defined as greater than or equal to 40 years of age)
  • Blood group isoimmunisation
  • Suspected intrauterine growth restriction

Exclusion Criteria5

  • Age less than 18 years
  • Women who do not have the mental and/or legal capacity to consent
  • Fetal presentation other than cephalic
  • Gestational age < 37 weeks
  • Multiple pregnancy

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Interventions

Pregnant females who require an induction and or augmentation of their labour will be randomised to either intravenous continuous oxytocin infusion (which is commenced at 12 mls/hour from a stock solu

Pregnant females who require an induction and or augmentation of their labour will be randomised to either intravenous continuous oxytocin infusion (which is commenced at 12 mls/hour from a stock solution of 1000 mls of Hartmann's solution containing 10 IU of oxytocin, with the rate increased every 30 minutes until labour is established, with a rate of four contractions within 10 minutes as per Safer Care Victoria's maternity e-handbook), or in a pulsatile fashion. With regards to the pulsatile oxytocin infusion, from the same stock solution of 10 IU of oxytocin in 1000 mls of Hartmann's solution, a 3 ml bolus is given every 15 minutes. After 4 boluses have been given (ie one hour has elapsed), the rate is increased to the next step (24 mls/hour), which would be given as a 6 ml bolus every 15 minutes. The rate is increased in this stepwise fashion until labour is established with 4 contractions within 10 minutes. As per Institutional policy, the midwives commence the infusion with oxytocin, as directed by the treating obstetrician.


Locations(1)

The Northern Hospital - Epping

VIC, Australia

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ACTRN12619000588190