Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000916842
Ethics application status
Approved
Date submitted
8/06/2021
Date registered
15/07/2021
Date last updated
23/05/2023
Date data sharing statement initially provided
15/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Placental Cord Drainage versus Delayed Cord Clamping at Elective Caesarean Section
Scientific title
Time to Delivery of Placenta in Placental Cord Drainage versus Delayed Cord Clamping at Elective Caesarean Section: a Randomised-Controlled Trial
Secondary ID [1] 304428 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Placental Delivery 322242 0
Postpartum Haemorrhage 322243 0
Condition category
Condition code
Reproductive Health and Childbirth 319934 319934 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Placental Cord Drainage
- ie. immediate clamping and cutting of the placental cord at caesarean section, followed by drainage of the placental side of the cord into a receptacle).
- this will be performed by the operating surgeon (ie. Consultant Obstetrician or Obstetrics Registrar)
- this is a once-off procedure, at the time of elective caesarean section
- this will occur in theatre at an urban hospital, with Obstetrics services
- adherence to the intervention/control will be documented at the time of caesarean, and rationale for deviation will be documented. If not documented at the time, patient medical record will be consulted by study team to determine a possible rationale.
Intervention code [1] 320781 0
Treatment: Surgery
Comparator / control treatment
Delayed Cord Clamping
- ie. clamping and cutting of the placental cord after at least 60 seconds to allow possible perfusion of blood from placenta to neonate
- this will be performed by the operating surgeon (ie. Consultant Obstetrician or Obstetrics Registrar)
- this is a once-off procedure, at the time of elective caesarean section
- this will occur in theatre at an urban hospital, with Obstetrics services
- adherence to the intervention/control will be documented at the time of caesarean, and rationale for deviation will be documented. If not documented at the time, patient medical record will be consulted by study team to determine a possible rationale.
Control group
Active

Outcomes
Primary outcome [1] 327802 0
Time to delivery of placenta
From Data Collection Form and Patient Medical Record
Timepoint [1] 327802 0
At time of delivery of placenta
Secondary outcome [1] 396646 0
Estimated Blood Loss
From Patient Medical Record
Timepoint [1] 396646 0
At End of Caesarean Section
Secondary outcome [2] 396647 0
Change in maternal haemoglobin
From Patient Medical Record
Timepoint [2] 396647 0
Measured 12-36 hours post-operatively (ie. Day 1 Postoperative).
Compared to haemoglobin taken within 72 hours before surgery.
Secondary outcome [3] 396648 0
Proportion of patients with Postpartum Haemorrhage
From Patient Medical Record
Timepoint [3] 396648 0
At the conclusion of study
Secondary outcome [4] 396649 0
Oxytocic medications administered by Anaesthetics
From Patient Medical Record
Timepoint [4] 396649 0
At end of Caesarean section
Secondary outcome [5] 396650 0
Proportion of patients receiving blood transfusion
From Patient Medical Record
Timepoint [5] 396650 0
At the conclusion of study
Secondary outcome [6] 396651 0
Proportion of patients requiring Manual Removal of Placenta at Caesarean Section
From Patient Medical Record
Timepoint [6] 396651 0
At the conclusion of study
Secondary outcome [7] 396652 0
Deviation from Study Protocol or Abandoning Intervention/Control
From Data Collection Form and Patient Medical Record
Timepoint [7] 396652 0
At end of Caesarean section

Eligibility
Key inclusion criteria
Elective Caesarean Section
Singleton Pregnancy
Cephalic Presentation
Gestation 37+0 to 41+6
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Placenta praevia on most recent ultrasound
• Suspected placenta accreta spectrum
• Suspected intrauterine growth restriction
• Oligohydramnios on most recent ultrasound
• Fetal Death in Utero
• Suspected Placental Abruption
• Known fetal anatomical abnormality
• Abnormal fetal dopplers of most recent ultrasound
• Preterm delivery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using online Random Number Generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Cochrane review demonstrated a >40% reduction in time to delivery of placenta at vaginal delivery. Studies have suggested approximately 200 seconds for delivery of placenta at caesarean section. Using a conservative 180 seconds +/- 90 seconds as the baseline time of delivery of placenta at caesarean section, and a conservative 33% reduction (60 seconds), the required power is 35 patients per group.
Using 50 patients per group to allow for uncertainty translating Cochrane findings at vaginal delivery to caesarean section.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/07/2021
Actual
11/10/2021
Date of last participant enrolment
Anticipated
30/06/2022
Actual
4/05/2023
Date of last data collection
Anticipated
29/07/2022
Actual
11/05/2023
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19668 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 19669 0
Angliss Hospital - Upper Ferntree Gully
Recruitment postcode(s) [1] 34301 0
3128 - Box Hill
Recruitment postcode(s) [2] 34302 0
3156 - Upper Ferntree Gully

Funding & Sponsors
Funding source category [1] 308792 0
Hospital
Name [1] 308792 0
Eastern Health
Country [1] 308792 0
Australia
Primary sponsor type
Individual
Name
Michael Fahy
Address
Eastern Health
8 Arnold St
Box Hill
VIC 3128
Country
Australia
Secondary sponsor category [1] 309708 0
None
Name [1] 309708 0
Address [1] 309708 0
Country [1] 309708 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308704 0
Eastern Health Office of Research and Ethics
Ethics committee address [1] 308704 0
Ethics committee country [1] 308704 0
Australia
Date submitted for ethics approval [1] 308704 0
01/06/2021
Approval date [1] 308704 0
04/10/2021
Ethics approval number [1] 308704 0

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

Contacts
Principal investigator
Name 111622 0
Dr Michael Fahy
Address 111622 0
Eastern Health,
8 Arnold St,
Box Hill,
VIC 3128
Country 111622 0
Australia
Phone 111622 0
+61 3 8396 8349
Fax 111622 0
Email 111622 0
[email protected]
Contact person for public queries
Name 111623 0
Michael Fahy
Address 111623 0
Eastern Health,
8 Arnold St,
Box Hill,
VIC 3128
Country 111623 0
Australia
Phone 111623 0
+61 3 8396 8349
Fax 111623 0
Email 111623 0
[email protected]
Contact person for scientific queries
Name 111624 0
Michael Fahy
Address 111624 0
Eastern Health,
8 Arnold St,
Box Hill,
VIC 3128
Country 111624 0
Australia
Phone 111624 0
+61 3 8396 8349
Fax 111624 0
Email 111624 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Any shared data will be de-identified.
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11940Study protocol  [email protected]
11942Informed consent form  [email protected]



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.