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Trial registered on ANZCTR


Registration number
ACTRN12624001282572p
Ethics application status
Submitted, not yet approved
Date submitted
3/10/2024
Date registered
22/10/2024
Date last updated
22/10/2024
Date data sharing statement initially provided
22/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison between two differing ways of commencing labour and their effect on duration of labour in women giving birth for the first time.
Scientific title
Comparative effectiveness between continuous and pulsatile (intermittent) oxytocin for induction of labour on the duration of labour in nulliparous women: A pilot study.
Secondary ID [1] 313100 0
Nil
Universal Trial Number (UTN)
U1111-1314-0878
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Induction of labour 335347 0
Childbirth 335348 0
Condition category
Condition code
Reproductive Health and Childbirth 331935 331935 0 0
Antenatal care
Reproductive Health and Childbirth 331936 331936 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 331937 331937 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 329664 0
Prevention
Intervention code [2] 329665 0
Treatment: Drugs
Comparator / control treatment
For the continuous oxytocin infusion, the concentration of oxytocin is 10 IU in 1000 ml Hartmann's solution, which is commenced at 12 ml/hr, with the rate increased every 30 minutes, until there are 4 uterine contractions within 10 minutes, as per Safer Care Victoria's maternity e-handbook. The maximum infusion rate is 192 ml/hr. A background infusion of Hartmann's solution is provided at 125 ml/hr and boluses of this IV fluid are allowed, if deemed necessary, by either the midwife caring for the participant, or the obstetrician. There is no pre-determined amount of IV fluid bolus that may be provided 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-reassuring CTG trace

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

Outcomes
Primary outcome [1] 339537 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 wil be calculated in minutes, thus providing the duration of labour, in minutes
Timepoint [1] 339537 0
The primary timepoint is birth of the neonate and this timepoint will be used to calculate the elapsed time, from commencement of the oxytocin infusion.
Secondary outcome [1] 440369 0
Incidence of unplanned (emergency) caesarean section
Timepoint [1] 440369 0
Birth of the neonate
Secondary outcome [2] 440370 0
Incidence of instrumental births (composite of forceps and ventouse births).
Timepoint [2] 440370 0
Birth of the neonate.
Secondary outcome [3] 440371 0
Incidence of operative birth (composite of emergency caesarean section and instrumental birth).
Timepoint [3] 440371 0
Birth of the neonate.
Secondary outcome [4] 440372 0
Incidence of epidural analgesia required.
Timepoint [4] 440372 0
Birth of the neonate.
Secondary outcome [5] 440373 0
Incidence of uterine tachysystole.
Timepoint [5] 440373 0
Birth of the neonate.
Secondary outcome [6] 440374 0
Incidence of uterine hypertonus
Timepoint [6] 440374 0
Birth of the neonate.
Secondary outcome [7] 440375 0
Incidence of uterine hyperstimulation.
Timepoint [7] 440375 0
Birth of the neonate.
Secondary outcome [8] 440376 0
Total dose of oxytocin received
Timepoint [8] 440376 0
Birth of the neonate
Secondary outcome [9] 440377 0
Incidence of postpartum haemorrhage (defined as estimated blood loss >= 500 ml), within the first 24 hours following birth of the neonate.
Timepoint [9] 440377 0
Twenty-four hours, following birth of the neoate.
Secondary outcome [10] 440378 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] 440378 0
Twenty-four hours, post birth of the neonate.
Secondary outcome [11] 440379 0
Change in maternal serum osmolality from baseline.
Timepoint [11] 440379 0
Baseline and at time of birth of the neonate.
Secondary outcome [12] 440380 0
Change in maternal serum copeptin from baseline.
Timepoint [12] 440380 0
Baseline and at the time of birth of the neonate.
Secondary outcome [13] 440382 0
Umbilical cord arterial pH <= 7.00.
Timepoint [13] 440382 0
Birth of the neonate and sampling from the umbilical cord.
Secondary outcome [14] 440383 0
Umbilical cord arterial lactate >= 6.1.
Timepoint [14] 440383 0
Birth of the neonate and sampling from the umbilical cord.
Secondary outcome [15] 440384 0
Umbilical cord arterial copeptin.
Timepoint [15] 440384 0
Birth of the neonate and sampling from the umbilical cord.
Secondary outcome [16] 440385 0
Apgar score <= 7
Timepoint [16] 440385 0
Five minutes post birth of the neonate.
Secondary outcome [17] 440388 0
Incidence of all cause neonatal admission to the special care nursery.
Timepoint [17] 440388 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 [18] 440392 0
Incidence of neonatal hyperbilirubinaemia.
Timepoint [18] 440392 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 [19] 440393 0
Exclusive breastfeeding.
Timepoint [19] 440393 0
One month post birth of the neonate.
Secondary outcome [20] 440394 0
Exclusive breastfeeding.
Timepoint [20] 440394 0
3 months post birth of the neonate.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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

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)
Sealed, sequentially numbered, opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
As guided by a statistician, appropriate statisitical analyses will be peformed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27181 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 43264 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 317546 0
Commercial sector/Industry
Name [1] 317546 0
LTR Medical
Country [1] 317546 0
Australia
Primary sponsor type
Hospital
Name
Northern Health
Address
Country
Australia
Secondary sponsor category [1] 319851 0
None
Name [1] 319851 0
Address [1] 319851 0
Country [1] 319851 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316257 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 316257 0
Ethics committee country [1] 316257 0
Australia
Date submitted for ethics approval [1] 316257 0
14/10/2024
Approval date [1] 316257 0
Ethics approval number [1] 316257 0

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

Contacts
Principal investigator
Name 137306 0
Dr Darren Lowen
Address 137306 0
Department of Anaesthesia, Perioperative Medicine & Pain, The Northern Hospital, 185 Cooper Street, Epping, VIC 3076
Country 137306 0
Australia
Phone 137306 0
+61 402 832 336
Fax 137306 0
Email 137306 0
dlowen@gmp.usyd.edu.au
Contact person for public queries
Name 137307 0
Darren Lowen
Address 137307 0
Department of Anaesthesia, Perioperative Medicine & Pain, The Northern Hospital, 185 Cooper Street, Epping, VIC 3076
Country 137307 0
Australia
Phone 137307 0
+61 402 832 336
Fax 137307 0
Email 137307 0
dlowen@gmp.usyd.edu.au
Contact person for scientific queries
Name 137308 0
Darren Lowen
Address 137308 0
Department of Anaesthesia, Perioperative Medicine & Pain, The Northern Hospital, 185 Cooper Street, Epping, VIC 3076
Country 137308 0
Australia
Phone 137308 0
+61 402 832 336
Fax 137308 0
Email 137308 0
dlowen@gmp.usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the pilot study, after it has been de-identified.
When will data be available (start and end dates)?
Data will be made available immediately post publication, with no end date
Available to whom?
Only to researchers who provide a methodologically sound proposal and at the discretion of the primary sponsor
Available for what types of analyses?
Data will be available for any purpose, provided that the data achieves the aims in the approved proposal, at the discretion of the primary sponsor. Data will be made available for meta-analyses.
How or where can data be obtained?
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 dlowen@gmp.usyd.edu.au


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.