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Trial registered on ANZCTR


Registration number
ACTRN12619000588190
Ethics application status
Approved
Date submitted
9/04/2019
Date registered
16/04/2019
Date last updated
17/12/2019
Date data sharing statement initially provided
16/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
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?
Scientific title
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.
Secondary ID [1] 297927 0
Nil
Universal Trial Number (UTN)
U1111-1231-4592
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Labour (induction of) 312359 0
Condition category
Condition code
Reproductive Health and Childbirth 310883 310883 0 0
Antenatal care
Reproductive Health and Childbirth 310952 310952 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 310953 310953 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 314155 0
Prevention
Intervention code [2] 314181 0
Treatment: Drugs
Comparator / control treatment
The comparator is intravenous oxytocin given in a pulsatile fashion, compared to the active control of giving inrtravenous oxytocin as a continuous infusion.
Control group
Active

Outcomes
Primary outcome [1] 319708 0
The primary outcome is the incidence of emergency (unplanned) caesarean sections, as determined from the patient's medical record and as described by the treating obstetrician
Timepoint [1] 319708 0
The primary timepoint is the birth of the fetus.
Secondary outcome [1] 369239 0
Uterine hyperstimulation, as determined from the partogram, which is scanned into the patient's medical record
Timepoint [1] 369239 0
During labour, defined as > 4 four contractions per 10 minutes
Secondary outcome [2] 369240 0
Total dose of oxytocin required, as determined from the partogram, which is scanned into the patient's medical record
Timepoint [2] 369240 0
At the end of labour after the birth of the fetus.
Secondary outcome [3] 369241 0
Total length of labour from the beginning of induction and/or augmentation to the end of the third stage of labour, as determined from the partogram, which is scanned into the patient's medical record
Timepoint [3] 369241 0
The secondary timepoint is the delivery of the placenta
Secondary outcome [4] 369242 0
Abnormal CTG traces
Timepoint [4] 369242 0
The secondary timepoint is the birth of the fetus
Secondary outcome [5] 369243 0
Primary postpartum haemorrhage (defined as an estimated blood loss of 500 mls or greater)
Timepoint [5] 369243 0
24 hours post birth
Secondary outcome [6] 369244 0
Primary severe postpartum haemorrhage (defined as estimated blood loss of 1500 mls or greater)
Timepoint [6] 369244 0
24 hours post birth
Secondary outcome [7] 369246 0
Apgar scores < 7 at 5 minutes
Timepoint [7] 369246 0
5 minutes post birth
Secondary outcome [8] 369247 0
Neonatal hyperbilirubinaemia necessitating the use of phototherapy, Neonatal hyberbilirubinaemia being defined as a total serum bilirubin level above 86 micromol per litre
Timepoint [8] 369247 0
The secondary timepoint would be from birth, up until discharge from the hospital post birth (usually within 72 hours, but occasionally up to 5 days).
Secondary outcome [9] 369248 0
Admission to the neonatal intensive care unit (NICU).
Timepoint [9] 369248 0
The secondary timepoint would be from birth, up until discharge from the hospital post partum (which is usually 3 - 5 days).
Secondary outcome [10] 369349 0
Use of any ergometrine (Yes/No)
Timepoint [10] 369349 0
Within 24 hours from the time of delivery of the placenta
Secondary outcome [11] 369350 0
Use of any carboprost (Yes/No)
Timepoint [11] 369350 0
Within 24 hours of the delivery of the placenta

Eligibility
Key inclusion criteria
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

Minimum age
18 Years
Maximum age
60 Years
Gender
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

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
Based upon an analysis of all of the birthing outcomes for 2017 at The Northern Hospital and a clinically significant difference in emergency (unplanned) caesarean section rates of 50%, with an alpha of 0.05 and a power of 80%, we calculate that we will need 412 participants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13584 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 26245 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 302443 0
Hospital
Name [1] 302443 0
The Northern Hospital through the Departments of Anaesthesia and Obstetrics
Address [1] 302443 0
The Departments of Anaesthesia & Perioperative Medicine and Obstetrics & Gynaecology
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country [1] 302443 0
Australia
Primary sponsor type
Individual
Name
Darren Lowen
Address
Department of Anaesthesia & Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country
Australia
Secondary sponsor category [1] 302345 0
None
Name [1] 302345 0
Address [1] 302345 0
Country [1] 302345 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303112 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 303112 0
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Ethics committee country [1] 303112 0
Australia
Date submitted for ethics approval [1] 303112 0
27/02/2019
Approval date [1] 303112 0
08/04/2019
Ethics approval number [1] 303112 0
HREC/51071/Austin-2019

Summary
Brief 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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92518 0
Dr Darren Lowen
Address 92518 0
Department of Anaesthesia & Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 92518 0
Australia
Phone 92518 0
+61 402-832-336
Fax 92518 0
Email 92518 0
dlowen@gmp.usyd.edu.au
Contact person for public queries
Name 92519 0
Dr Darren Lowen
Address 92519 0
Department of Anaesthesia & Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 92519 0
Australia
Phone 92519 0
+61-402-832-336
Fax 92519 0
Email 92519 0
dlowen@gmp.usyd.edu.au
Contact person for scientific queries
Name 92520 0
Dr Darren Lowen
Address 92520 0
Department of Anaesthesia & Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 92520 0
Australia
Phone 92520 0
+61-402-832-336
Fax 92520 0
Email 92520 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 trial, after it has been de-identified.
When will data be available (start and end dates)?
Data will be made available immediately following 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 the release of data, data will be made available subject to approval by the principal investigator, via email address: dlowen@gmp.usyd.edu.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results