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 (NCT) | NCT00187369 |
| Protocol serial number | MCT-63164 |
| Sponsor | University of Toronto (Canada) |
| Funder | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
The Centre for Mother, Infant, and Child Research
790 Bay St.
7th floor
Toronto
M5G 1N8
Canada
| Phone | +1 (0)416 351 2533 |
|---|---|
| tbs@sw.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
Perinatal or neonatal mortality and/or serious neonatal morbidity (excluding lethal congenital anomalies) |
| Key secondary outcome measure(s) |
1. Death or poor neurodevelopmental outcome of the children at 2 years of age |
| Completion date | 01/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 2800 |
| Total final enrolment | 2804 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 13/12/2003 |
| Date of final enrolment | 04/04/2011 |
Locations
Countries of recruitment
- United Kingdom
- Argentina
- Australia
- Belgium
- Brazil
- Canada
- Chile
- Croatia
- Egypt
- Estonia
- Germany
- Greece
- Hungary
- Israel
- Jamaica
- Jordan
- Netherlands
- Poland
- Romania
- Serbia
- Spain
- United States of America
Study participating centre
M5G 1N8
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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.
