Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000550303p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
22/04/2026
Date registered
Help: Date registered
1/05/2026
Date last updated
Help: Date last updated
1/05/2026
Date data sharing statement initially provided
Help: Data sharing statement date
1/05/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Additional trial identifiers [1] 317095 0
Nil
Universal Trial Number (UTN)
Trial acronym
Not applicable
Related trial records
Not applicable

Health condition
Health condition(s) studied:
Labour (induction of) 341629 0
Childbirth 341630 0
Condition category
Condition code
Reproductive Health and Childbirth 337710 337710 0 0
Antenatal care
Reproductive Health and Childbirth 337711 337711 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 337712 337712 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
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
Intervention code [1] 333851 0
Prevention
Intervention code [2] 333852 0
Treatment: Drugs
Description of the comparator or control
For the comparator group, continuous oxytocin is commenced at 2 ml/hr (2 mU/min), with the rate increased every 30 minutes until 4 uterine contractions occur within 10 minutes. The maximum rate of infusion is set at 32 ml/hr (32 mU/min). 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.

Women are allowed to eat and drink ad libitum.
Control group
Active

Outcomes
Primary outcome [1] 345187 0
The primary outcome is the duration of labour as defined by commencement of the oxytocin infusion, post amniotomy, until birth of the neonate. The time of commencement of the oxytocin infusion is documented in the participant's medical record, as is the time of birth of the neonate. The elapsed time between these two time points will be calculated in minutes, thus providing the duration of labour, in minutes.
Timepoint [1] 345187 0
The primary timepoint is birth of the neonate and this timepoint will be used to calculate the elapsed time frm commencement of the oxytocin infusion
Secondary outcome [1] 460779 0
Incidence of unplanned (emergency) caesarean section.
Timepoint [1] 460779 0
Birth of the neonate.
Secondary outcome [2] 460780 0
Incidence of instrumental births (composite of forceps and ventouse births).
Timepoint [2] 460780 0
Birth of the neonate.
Secondary outcome [3] 460781 0
Incidence of operative birth (composite of emergency caesarean section and instrumental birth).
Timepoint [3] 460781 0
Birth of the neonate.
Secondary outcome [4] 460782 0
Incidence of epidural analgesia required.
Timepoint [4] 460782 0
Birth of the neonate.
Secondary outcome [5] 460783 0
Incidence of uterine tachysystole.
Timepoint [5] 460783 0
Birth of the neonate.
Secondary outcome [6] 460784 0
Incidence of uterine hypertonus.
Timepoint [6] 460784 0
Birth of the neonate.
Secondary outcome [7] 460785 0
Incidence of uterine hyperstimulation.
Timepoint [7] 460785 0
Birth of the neonate.
Secondary outcome [8] 460786 0
Total dose of oxytocin received.
Timepoint [8] 460786 0
Birth of the neonate.
Secondary outcome [9] 460787 0
Incidence of postpartum haemorrhage (defined as estimated blood loss >= 500 ml), within the first 24 hours following birth of the neonate.
Timepoint [9] 460787 0
Twenty-four hours, post birth of the neonate.
Secondary outcome [10] 460788 0
Incidence of severe postpartum haemorrhage (defined as estimated blood loss >= 1500 ml), in the first 24 hours following birth of the neonate.
Timepoint [10] 460788 0
Twenty-four hours, post birth of the neonate.
Secondary outcome [11] 460789 0
Umbilical cord arterial pH <= 7.00
Timepoint [11] 460789 0
Birth of the neonate and sampling from the umbilical cord.
Secondary outcome [12] 460790 0
Umbilical cord arterial lactate >= 6.1
Timepoint [12] 460790 0
Birth of the neonate and sampling from the umbilical cord.
Secondary outcome [13] 460791 0
Apgar score <= 7
Timepoint [13] 460791 0
Five minutes post birth of the neonate.
Secondary outcome [14] 460792 0
Incidence of all cause neonatal admission to the special care nursery.
Timepoint [14] 460792 0
Two weeks post birth of the neonate, a retrospective analysis of written documentation in the neonate's medical chart will be undertaken.
Secondary outcome [15] 460793 0
Incidence of neonatal hperbilirubinaemia.
Timepoint [15] 460793 0
Two weeks post birth of the neonate, a retrospective analysis of written documenatation in the neonate's medical chart will be undertaken.
Secondary outcome [16] 460795 0
Birth satisfaction score.
Timepoint [16] 460795 0
Day 1 postpartum.
Secondary outcome [17] 460796 0
Birth satisfaction score.
Timepoint [17] 460796 0
Day 1 postpartum.
Secondary outcome [18] 460797 0
Exclusive breastfeeding.
Timepoint [18] 460797 0
One month post birth of the neonate.
Secondary outcome [19] 460798 0
Exclusive breastfeeding.
Timepoint [19] 460798 0
3 months post birth of the neonate.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Healthy volunteers
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by REDCap
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer generated random numbers in blocks of four and six
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistics will be presented using tables, graphs and descriptive statistics. No loss to follow-up is expected at the time of primary outcome (duration of labour in minutes) and missing data in secondary outcomes collected at birth are expected to be negligible. No crossovers between the randomised interventions are anticipated. Heterogeneity of the treatment effect on duration of labour will be explored for subgroups (e.g. method of cervical ripening), by including subgroup and an interaction term between subgroup and treatment in the model.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/08/2026
Actual
Date of last participant enrolment
Anticipated
31/01/2027
Actual
Date of last data collection
Anticipated
30/04/2027
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 29430 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 45749 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 321683 0
Self funded/Unfunded
Name [1] 321683 0
Country [1] 321683 0
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 324510 0
None
Name [1] 324510 0
Address [1] 324510 0
Country [1] 324510 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 320215 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 320215 0
Ethics committee country [1] 320215 0
Australia
Date submitted for ethics approval [1] 320215 0
24/04/2026
Approval date [1] 320215 0
Ethics approval number [1] 320215 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 149790 0
Dr Darren Lowen
Address 149790 0
Department of Anaesthesia, Perioperative Medicine & Pain, The Northern Hospital, 185 Cooper Street, Epping, VIC, 3076
Country 149790 0
Australia
Phone 149790 0
+61 402 832 336
Fax 149790 0
Email 149790 0
[email protected]
Contact person for public queries
Name 149791 0
Darren Lowen
Address 149791 0
Department of Anaesthesia, Perioperative Medicine & Pain, The Northern Hospital, 185 Cooper Street, Epping, VIC, 3076
Country 149791 0
Australia
Phone 149791 0
+61 402 832 336
Fax 149791 0
Email 149791 0
[email protected]
Contact person for scientific queries
Name 149792 0
Darren Lowen
Address 149792 0
Department of Anaesthesia, Perioperative Medicine & Pain, The Northern Hospital, 185 Cooper Street, Epping, VIC, 3076
Country 149792 0
Australia
Phone 149792 0
+61 402 832 336
Fax 149792 0
Email 149792 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Only to researchers who provide a methodologically sound proposal and at the discretion of the primary sponsor.

Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• In addition to institutional policy with regards to release of data , data will be made available subject to approval by the principal investigator, via e-mail address: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Individual participant data must have approval by the participant for allowing data to be be shared, as described on the participant information sheet and consent form.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.