Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000267550
Ethics application status
Approved
Date submitted
6/04/2005
Date registered
6/04/2005
Date last updated
6/04/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Twin Birth Study
Scientific title
The Twin birth study: A multicentre randomised controlled trial comparing planned vaginal birth to planned Caesarean Section of twins more than or equal to 32 weeks gestation to assess neonatal mortality and/or serious neonatal morbidity during the first 28 days after birth.
Secondary ID [1] 62 0
Perinatal Trials Registry: PTR540
Universal Trial Number (UTN)
Trial acronym
TBS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Twin pregnancy where twin A is cephalic and the gestational age is between 32-38 weeks. 58 0
Condition category
Condition code
Reproductive Health and Childbirth 67 67 0 0
Normal pregnancy
Reproductive Health and Childbirth 68 68 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Planned vaginal birth vs caesarean section planned
Intervention code [1] 1118 0
Other interventions
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 98 0
Perinatal/neonatal mortality and/or serious neonatal morbidity
Timepoint [1] 98 0
Within the first 28 days after delivery
Secondary outcome [1] 195 0
Death or poor neurodevelopemental outcome for children.
Timepoint [1] 195 0
Collected at 2 years.

Eligibility
Key inclusion criteria
Twins where twin A is cephalic, gestational age 32-38 weeks, estimated fetal weight 1500-4000g, both twins alive.
Minimum age
32 Weeks
Maximum age
38 Weeks
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
monoamniotic twins, lethal fetal anomaly, contraindication to labour or vaginal birth.

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)
3. Central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
5. Stratified allocation by centre
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2800
Accrual to date
Final
Recruitment outside Australia
Country [1] 329 0
Canada
State/province [1] 329 0

Funding & Sponsors
Funding source category [1] 97 0
Government body
Name [1] 97 0
Canadian Institutes of Health Research
Country [1] 97 0
Canada
Primary sponsor type
Hospital
Name
Maternal, Infant and Reproductive Health Research Unit
Address
Country
Canada
Secondary sponsor category [1] 74 0
None
Name [1] 74 0
Nil
Address [1] 74 0
Country [1] 74 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 663 0
Mater Mothers'
Ethics committee address [1] 663 0
Ethics committee country [1] 663 0
Australia
Date submitted for ethics approval [1] 663 0
Approval date [1] 663 0
25/05/2004
Ethics approval number [1] 663 0
690M
Ethics committee name [2] 664 0
Monash
Ethics committee address [2] 664 0
Ethics committee country [2] 664 0
Australia
Date submitted for ethics approval [2] 664 0
Approval date [2] 664 0
16/11/2004
Ethics approval number [2] 664 0
04053C
Ethics committee name [3] 665 0
Ipswich
Ethics committee address [3] 665 0
Ethics committee country [3] 665 0
Australia
Date submitted for ethics approval [3] 665 0
Approval date [3] 665 0
24/02/2006
Ethics approval number [3] 665 0
12/05N
Ethics committee name [4] 666 0
Logan
Ethics committee address [4] 666 0
Ethics committee country [4] 666 0
Australia
Date submitted for ethics approval [4] 666 0
Approval date [4] 666 0
27/08/2004
Ethics approval number [4] 666 0
2004/015
Ethics committee name [5] 667 0
St George
Ethics committee address [5] 667 0
Ethics committee country [5] 667 0
Australia
Date submitted for ethics approval [5] 667 0
Approval date [5] 667 0
19/05/2004
Ethics approval number [5] 667 0
Davis 04/05
Ethics committee name [6] 668 0
Toowoomba Base
Ethics committee address [6] 668 0
Ethics committee country [6] 668 0
Australia
Date submitted for ethics approval [6] 668 0
Approval date [6] 668 0
20/05/2004
Ethics approval number [6] 668 0
017/2004
Ethics committee name [7] 669 0
Townsville
Ethics committee address [7] 669 0
Ethics committee country [7] 669 0
Australia
Date submitted for ethics approval [7] 669 0
Approval date [7] 669 0
06/04/2004
Ethics approval number [7] 669 0
07/04

Summary
Brief summary
To conduct a multicentre international RCT comparing planned vaginal birth for twins, when twin A is cephalic and 32-38 weeks gestation, to planned caesarean section.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36262 0
Address 36262 0
Country 36262 0
Phone 36262 0
Fax 36262 0
Email 36262 0
Contact person for public queries
Name 10307 0
Dalah Mason
Address 10307 0
790 Bay Street
7th Floor
Toronto ON M5G 1N8
Country 10307 0
Canada
Phone 10307 0
1-416-351-2533
Fax 10307 0
1-416-351-3771
Email 10307 0
[email protected]
Contact person for scientific queries
Name 1235 0
Dr Jon Barrett
Address 1235 0
790 Bay Street, 7th floor
Toronto, ON CANADA
M5G 1N8
Country 1235 0
Canada
Phone 1235 0
1-416-351-2533
Fax 1235 0
Email 1235 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.