The Twin Birth Study: planned caesarean section versus planned vaginal birth for twins at 32-38 weeks gestation

ISRCTN	ISRCTN74420086
DOI	https://doi.org/10.1186/ISRCTN74420086
ClinicalTrials.gov number	NCT00187369
Secondary identifying numbers	MCT-63164

Submission date: 31/10/2003
Registration date: 09/12/2003
Last edited: 12/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Study website

Contact information

Dr Jon Barrett
Scientific

The Centre for Mother, Infant, and Child Research
790 Bay St.
7th floor
Toronto
M5G 1N8
Canada

Phone	+1 (0)416 351 2533
Email	tbs@sw.ca

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Patient information material can be found at http://www.sunnybrook.ca/research/?page=sri_proj_cmicr_trial_tbs_info
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
Study 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.
Ethics approval(s)	Sunnybrook Health Sciences Centre Research Ethics Board, 31/10/2008, ref: 244-2003
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	Procedure/Surgery
Primary outcome measure	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 study start date	01/05/2003
Overall study end date	01/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	2800
Total final enrolment	2804
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 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	13/12/2003
Recruitment end date	04/04/2011

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

Study participating centre

The Centre for Mother, Infant, and Child Research

Toronto
M5G 1N8
Canada

Sponsor information

University of Toronto (Canada)
University/education

The Centre for Mother, Infant, and Child Research
790 Bay St.
7th floor
Toronto
M5G 1N8
Canada

Phone	+1 (0)416 351 2533
Email	cmicr@sunnybrook.ca
Website	http://www.utoronto.ca/
"ROR"	https://ror.org/03dbr7087

Funders

Funder type

Research organisation

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

Alternative name(s): Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Location: Canada

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/10/2013		Yes	No
Other publications	secondary analysis	06/01/2017		Yes	No
Other publications	secondary analysis	01/04/2021	04/11/2019	Yes	No
Other publications	secondary analysis	01/10/2019	12/03/2020	Yes	No

Editorial Notes

12/03/2020: Publication reference added.
04/11/2019: The following changes were made:
1. Publication reference added.
2. The final enrolment number was added from the reference.
30/08/2017: Recruitment dates have been updated from 01/05/2003-01/10/2011 to 13/12/2003-04/04/2011.
09/01/2017: Publication reference added.
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.