Condition category
Pregnancy and Childbirth
Date applied
31/10/2003
Date assigned
09/12/2003
Last edited
07/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.utoronto.ca/cmicr/tbs

Contact information

Type

Scientific

Primary contact

Dr Jon Barrett

ORCID ID

Contact details

The Centre for Mother
Infant
and Child Research
790 Bay St.
7th floor
Toronto
M5G 1N8
Canada
+1 416 351 2533
tbs@sw.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00187369

Protocol/serial number

MCT-63164

Study information

Scientific title

The Twin Birth Study: a multicentre randomised controlled trial comparing planned caesarean section with planned vaginal birth for twins at 32-38 weeks gestation

Acronym

TBS

Study hypothesis

Twins complicate approximately 2 - 3% of all births. Twin fetuses that are greater than 2500 g at birth are at higher risk of death and neonatal morbidity than singletons of the same birth weight. In addition, the second twin is at higher risk of death and/or serious neonatal morbidity compared with twin A if delivery is vaginal but not if delivery is by caesarean section (CS). There has been one randomised controlled trial (RCT) of planned CS versus planned vaginal birth (VB) for twins: the sample size was too small to answer the question of the better approach to delivery. A Cochrane review has recommended that a larger RCT be undertaken.

As of 04/03/2009 this record has been updated to include an extra country of recruitment: Serbia. All other changes can be found under the relevant fields with the above update date.

Ethics approval

Added 04/03/2009: Sunnybrook Health Sciences Centre Research Ethics Board gave approval on the 31/10/2008 (ref: 244-2003)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information material can be found at http://www.sunnybrook.ca/research/?page=sri_proj_cmicr_trial_tbs_info

Condition

Twin pregnancies where the first twin is presenting in the cephalic position.

Intervention

Women will be randomised to either a planned vaginal birth group or to a planned caesarean section group.

Randomisation will be carried out at 32 weeks, allowing for planning of the delivery and birth. Eligible consenting women presenting in labour or with an indication for urgent delivery may also be randomised at 32 - 38 weeks.

Timing and Method of Delivery:
Because there is an increase in stillbirth rate after 38 weeks gestation, trial participants will be delivered by the planned method of delivery at 38 weeks. Vaginal delivery will be conducted by experienced personnel: if twin B is non-vertex the initial options for delivery are:
1. Spontaneous or assisted vaginal breech delivery (if breech)
2. Total breech extraction with or without internal podalic version
3. External cephalic version and vaginal delivery of the fetus as a vertex

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Perinatal or neonatal mortality and/or serious neonatal morbidity (excluding lethal congenital anomalies)

Secondary outcome measures

1. Death or poor neurodevelopmental outcome of the children at 2 years of age
2. Problematic urinary or faecal/flatal incontinence for the mother at 2 years postpartum

Other outcome measures:
1. Maternal death or serious maternal morbidity within 28 days following delivery
2. Maternal satisfaction with method of delivery (3 months)
3. Breast feeding (3 months)
4. Maternal quality of life (3 months and 2 years)
5. Problematic urinary or faecal/flatal incontinence at 3 months
6. Costs

Overall trial start date

01/05/2003

Overall trial end date

01/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women at 32 - 38 weeks gestation
2. Aged 18 - 49 years old, female
3. Carrying live twins that each weigh 1500 - 4000 g
4. First twin is presenting in the cephalic position

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

2800

Participant exclusion criteria

1. Monoamniotic twins
2. Lethal anomaly of either twin
3. Contraindication to labour or VB

Added 04/03/2009:
4. Previous participation in the Twin Birth Study

Recruitment start date

01/05/2003

Recruitment end date

01/10/2011

Locations

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Canada, Chile, Croatia, Egypt, Estonia, Germany, Greece, Hungary, Israel, Jamaica, Jordan, Netherlands, Poland, Romania, Serbia, Spain, United Kingdom, United States of America

Trial participating centre

The Centre for Mother, Infant, and Child Research
Toronto
M5G 1N8
Canada

Sponsor information

Organisation

University of Toronto (Canada)

Sponsor details

The Centre for Mother
Infant
and Child Research
790 Bay St.
7th floor
Toronto
M5G 1N8
Canada
+1 416 351 2533
cmicr@sunnybrook.ca

Sponsor type

University/education

Website

http://www.utoronto.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63164)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24088091

Publication citations

  1. Results

    Barrett JF, Hannah ME, Hutton EK, Willan AR, Allen AC, Armson BA, Gafni A, Joseph KS, Mason D, Ohlsson A, Ross S, Sanchez JJ, Asztalos EV, , A randomized trial of planned cesarean or vaginal delivery for twin pregnancy., N. Engl. J. Med., 2013, 369, 14, 1295-1305, doi: 10.1056/NEJMoa1214939.

Additional files

Editorial Notes