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The Twin Birth Study: planned caesarean section versus planned vaginal birth for twins at 32-38 weeks gestation
ISRCTN ISRCTN74420086
DOI 10.1186/ISRCTN74420086
ClinicalTrials.gov identifier NCT00187369
EudraCT number
Public title The Twin Birth Study: planned caesarean section versus planned vaginal birth for twins at 32-38 weeks gestation
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
Serial number at source MCT-63164
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.
Lay summary Not provided at time of registration
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
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
Disease/condition/study domain Twin pregnancies where the first twin is presenting in the cephalic position.
Participants - 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
Participants - 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
Anticipated start date 01/05/2003
Anticipated end date 01/10/2011
Status of trial Completed
Patient information material Patient information material can be found at http://www.sunnybrook.ca/research/?page=sri_proj_cmicr_trial_tbs_info
Target number of participants 2800
Interventions 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
Primary outcome measure(s) Perinatal or neonatal mortality and/or serious neonatal morbidity (excluding lethal congenital anomalies)
Secondary outcome measure(s) 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
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63164)
Trial website http://www.utoronto.ca/cmicr/tbs
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24088091
Contact name Dr  Jon  Barrett
  Address The Centre for Mother, Infant, and Child Research
790 Bay St.
7th floor
  City/town Toronto
  Zip/Postcode M5G 1N8
  Country Canada
  Tel +1 416 351 2533
  Fax +1 416 351 3771
  Email tbs@sw.ca
Sponsor University of Toronto (Canada)
  Address The Centre for Mother, Infant, and Child Research
790 Bay St.
7th floor
  City/town Toronto
  Zip/Postcode M5G 1N8
  Country Canada
  Tel +1 416 351 2533
  Fax +1 416 351 3771
  Email cmicr@sunnybrook.ca
  Sponsor website: http://www.utoronto.ca/
Date applied 31/10/2003
Last edited 07/10/2013
Date ISRCTN assigned 09/12/2003
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