Not Yet RecruitingPhase 4ACTRN12624001282572

A comparison between two differing ways of commencing labour and their effect on duration of labour in women giving birth for the first time.

Comparative effectiveness between continuous and pulsatile (intermittent) oxytocin for induction of labour on the duration of labour in nulliparous women: A pilot study.


Sponsor

Northern Health

Enrollment

70 participants

Start Date

Jul 1, 2025

Study Type

Interventional

Conditions

Summary

We are determining, as a pilot study, if we are able to reduce the duration of labour associated with induction of labour, when oxytocin is provided in a pulsatile (intermittent) fashion as opposed to the existing continuous infusion. Furthermore, by the use of paired blood samples, we are determining if restriction, as opposed to a liberal fluid strategy, changes baseline serum osmolality and serum copeptin levels, which may be impacting upon the birth outcomes.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 60 Yearss

Inclusion Criteria13

  • Nulliparous and any of the Safer Care Victoria indications for the requirement for an induction of labour, which include the following:
  • Diabetes (Type I, Type II, gestational diabetes that is poorly controlled)
  • Hypertension
  • Pre-eclampsia
  • Prolonged pregnancy defined as being greater than 41 weeks and 3 days
  • Term prolonged rupture of the membranes
  • 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 Criteria7

  • 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
  • Multiparous
  • Augmentation of labour

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Interventions

Nulliparous women who have an obstetric indication for induction of labour, will be randomised to either a continuous oxytocin infusion and a liberal fluid strategy (comparator), or pulsatile oxytocin

Nulliparous women who have an obstetric indication for induction of labour, will be randomised to either a continuous oxytocin infusion and a liberal fluid strategy (comparator), or pulsatile oxytocin with a restricted fluid strategy (intervention). For pulsatile oxytocin, the stock solution is 6x more concentrated (30 IU oxytocin in 500 ml Hartmann's solution). The equivalent dose of oxytocin, relative to the continuous oxytocin infusion arm is given, which equates to 0.1 ml of the concentrated oxytocin stock solution given every 3 minutes. Similarly, to the continuous oxytocin infusion arm, the dose is increased every 30 minutes, until 4 uterine contractions occur within 10 minutes. The equivalent dose to 192 ml/hr continuous oxytocin is 1.6 ml every 3 minutes. A background infusion of Hartmann's solution is provided at 40 ml/hr and boluses of this IV fluid are contraindicated for the following conditions: 1. Inability to void every 2 hours 2 Presence of ketones in the urine 3. Pre-loading prior to the establishment of epidural analgesia 4. Treatment of hypotension, post establishment of epidural analgesia 5. Treatment of a non-reasuring CTG trace Women are allowed to eat and drink ad libitum


Locations(1)

The Northern Hospital - Epping

VIC, Australia

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