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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.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001282572
Acronym
N/A
Enrollment
70
Registered
2024-10-22
Start date
2025-07-01
Completion date
2025-10-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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 concentra

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

Sponsors

Northern Health
Lead SponsorHospital

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 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 criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026