Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001299594
Ethics application status
Approved
Date submitted
25/11/2015
Date registered
30/11/2015
Date last updated
17/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of timing of oxytocin administration during delayed cord clamping in term infants
Scientific title
The effect of timing of intramuscular oxytocin administration on neonatal arterial oxygen saturation during delayed cord clamping in vaginal births. at term
Secondary ID [1] 287988 0
None
Universal Trial Number (UTN)
U1111-1176-9406
Trial acronym
OACC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delayed Cord Clamping 296866 0
Condition category
Condition code
Reproductive Health and Childbirth 297098 297098 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 297099 297099 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Delayed cord clamping (90 seconds) with delayed maternal intramuscular injection of 10IU oxytocin within 2 minutes after cord clamping.

All procedure and drug administration times logged by study staff on data collection sheet.
Intervention code [1] 293329 0
Treatment: Drugs
Comparator / control treatment
Delayed cord clamping (90 seconds) with maternal intramuscular injection of 10IU oxytocin at delivery of the anterior shoulder of the fetus.
Control group
Active

Outcomes
Primary outcome [1] 296707 0
Neonatal arterial oxygen saturation in the 30 minutes immediately following birth as measured by pulse oximetry.
Timepoint [1] 296707 0
30 minute duration following vaginal birth.
Measured every 1 minute from time of birth until 10 minutes after birth, then every 5 minutes from 10 minutes until 30 minutes after birth.
Secondary outcome [1] 319145 0
Rates of PPH (> 500 mL) as recorded in hospital notes following assessment by treating team.
Timepoint [1] 319145 0
Within first 24 hours after birth
Secondary outcome [2] 319146 0
Proportion of participants with retained placenta as diagnosed by treating obstetrician and recorded in hospital notes.
Timepoint [2] 319146 0
Within 24 hours of birth
Secondary outcome [3] 319147 0
Neonatal APGAR score
Timepoint [3] 319147 0
1, 5 and 10 minutes after birth
Secondary outcome [4] 319148 0
Neonatal birth weight as recorded in hospital notes
Timepoint [4] 319148 0
Within 24 hours after birth
Secondary outcome [5] 319149 0
Admission to NICU or Special Care Baby Unit (SCBU) as recorded in hospital records
Timepoint [5] 319149 0
Within 24 hours of birth
Secondary outcome [6] 319150 0
Duration of admission to NICU or SCBU by review of hospital records
Timepoint [6] 319150 0
From birth to time of discharge from hospital
Secondary outcome [7] 319151 0
Requirement for respiratory support as recorded in hospital records
Timepoint [7] 319151 0
From birth to time of discharge from hospital
Secondary outcome [8] 319152 0
Proportion of babies with necrotising enterocolitis, assessed by review of hospital records
Timepoint [8] 319152 0
From birth to time of discharge from hospital
Secondary outcome [9] 319153 0
Proporition of babies with jaundice requiring phototherapy, assessed by review of hospital records
Timepoint [9] 319153 0
From birth to time of discharge from hospital
Secondary outcome [10] 319154 0
Proportion of babies with intraventricular haemorrhage, assess by review of hospital records
Timepoint [10] 319154 0
From birth to time of discharge from hospital
Secondary outcome [11] 319197 0
Rate of severe PPH (>1,000 mL) as recorded in hospital notes following assessment by treating team.
Timepoint [11] 319197 0
Within 24 hours after birth
Secondary outcome [12] 319200 0
Duration of respiratory support
Timepoint [12] 319200 0
From initiation till infant weaned off respiratory support
Secondary outcome [13] 319201 0
Neonatal heart rate in the 30 minutes immediately following birth as measured using pulse oximetry
Timepoint [13] 319201 0
30 minute duration following vaginal birth.
Measured every 1 minute from time of birth until 10 minutes after birth, then every 5 minutes from 10 minutes until 30 minutes after birth.

Eligibility
Key inclusion criteria
To be eligible to participate in the trial, women must:
1) Over the age of 18
2) Under the age of 50
3) 37 weeks pregnant or more
4) Singleton pregnancy
5) Vaginal birth at term
6) Be capable of understanding the information provided
7) Give written informed consent
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who meet any of the following criteria at any point during the trial will not be eligible to participate:
1) Multiple gestation
2) Previous post partum haemorrhage (blood loss of >500 mL following vaginal birth or > 750 mL following caesarean section)
3) Detected congenital disorders or intrauterine growth restriction
4) Possession of contraindicating factors for the use of oxytocin
5) Possession of significant risk factors for post partum haemorrhage (e.g. macrosomia >4.5kg, polyhydramnios, abnormal placentation, emergency caesarean section)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2016
Actual
4/03/2016
Date of last participant enrolment
Anticipated
27/01/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
192
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4745 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 4746 0
Jessie McPherson Private Hospital - Clayton
Recruitment hospital [3] 7544 0
Casey Hospital - Berwick
Recruitment postcode(s) [1] 15432 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 292452 0
Government body
Name [1] 292452 0
Monash Health
Country [1] 292452 0
Australia
Primary sponsor type
Government body
Name
Monash Health
Address
246 Clayton Road
Clayton
VIC 3168
Country
Australia
Secondary sponsor category [1] 291148 0
University
Name [1] 291148 0
Monash University
Address [1] 291148 0
Wellington Road and Blackburn Road
Clayton
VIC 3168
Country [1] 291148 0
Australia
Secondary sponsor category [2] 291149 0
Other
Name [2] 291149 0
The Hudson Institute of Medical Research
Address [2] 291149 0
27-31 Wright Street
Clayton
VIC 3168
Country [2] 291149 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293911 0
Monash Health Human Research Ethics Committee B (EC00383)
Ethics committee address [1] 293911 0
246 Clayton Road
Clayton
VIC 3168
Ethics committee country [1] 293911 0
Australia
Date submitted for ethics approval [1] 293911 0
25/11/2015
Approval date [1] 293911 0
03/02/2016
Ethics approval number [1] 293911 0
15522A
Ethics committee name [2] 293912 0
Monash University Research Ethics Committee (EC00234)
Ethics committee address [2] 293912 0
Wellington Road & Blackburn Road
Clayton
VIC 3168
Ethics committee country [2] 293912 0
Australia
Date submitted for ethics approval [2] 293912 0
25/11/2015
Approval date [2] 293912 0
10/02/2016
Ethics approval number [2] 293912 0
CF16/408 - 2016000189

Summary
Brief summary
Delayed cord clamping (DCC) is slowly becoming common practice in the management of uncomplicated births in Australia, however it is unclear how the administration of maternal uterotonics such as oxytocin as part of the active management of the third stage of labour have on the newborn DCC. Oxytocin is administered prophylactically as it has been shown to significantly decrease the risk or post partum haemorrhage (PPH). PPH occurs in more than 5% of births and is most commonly caused by uterine atony, the failure of the uterus to adequately contract after birth. Oxytocin causes contractions of the uterus, which helps to reduce this risk. In Australia and New Zealand, an intramuscular (IM) or intravenous (IV) injection of Syntocinon ('Registered Trademark'), a synthetic form of the hormone, oxytocin, is administered as the anterior shoulder of the fetus is delivered. There are currently no guidelines indicating how to prophylactically treat PPH during delayed cord clamping. Current standard practice of care allows for the provision of early or delayed cord clamping. however, if cord clamping is delayed a maternal IM injection of 10IU oxytocin is routinely administered with delivery of the anterior shoulder of the fetus. Therefore DCC is currently being performed under the influence of oxytocin without an understanding of the potential effects of uterotonic administration prior to cord clamping on the newborn.
This clinical trial aims to determine the effect of maternal IM Syntocinon ('Registered Trademark') administration during delayed umbilical cord clamping on neonatal arterial oxygen saturation (SpO2) and heart rate (HR) at vaginal birth.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61798 0
Prof Euan M Wallace
Address 61798 0
The Ritchie Centre
Level 5
Monash Medical Centre
246 Clayton Road
Clayton
VIC 3168
Country 61798 0
Australia
Phone 61798 0
+613 9594 5145
Fax 61798 0
Email 61798 0
euan.wallace@monash.edu
Contact person for public queries
Name 61799 0
Ms Fiona Stenning
Address 61799 0
The Ritchie Centre
Level 5
Monash Medical Centre
246 Clayton Road
Clayton
VIC 3168
Country 61799 0
Australia
Phone 61799 0
+613 85722828
Fax 61799 0
Email 61799 0
fiona.stenning@monash.edu
Contact person for scientific queries
Name 61800 0
Dr Graeme Polglase
Address 61800 0
The Ritchie Centre
Level 5
Monash Medical Centre
246 Clayton Road
Clayton
VIC 3168
Country 61800 0
Australia
Phone 61800 0
+613 85722822
Fax 61800 0
Email 61800 0
graeme.polglase@monash.edu

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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