Twin Birth Study
The objective of the study was to compare the risk of fetal or neonatal death or serious neonatal morbidity with two delivery strategies, planned cesarean delivery or planned vaginal delivery with cesarean delivery only if indicated, for twin pregnancies between 32 weeks and 38 weeks of gestation, if the leading twin was in the cephalic presentation.
Overview
- Acronym
- TBS
- Website
- TBS
- Investigators
-
- Contacts
-
General Design
- Study design
- Clinical trial
- Start - End Year
- 2003 - 2014
- General Information on Follow Up (profile, frequency)
-
Mothers were followed-up at 32-38 weeks of gestation, from birth to 28 days postpartum, 3 months postpartum and 2 years postpartum. Children were followed-up 7 days prior the randomization, at birth and at 2 years of age.
- Recruitment Target
-
- Families
- Number of Participants
- 8,411
- Number of Participants with Biological Samples
- 8,393
- Supplementary information about number of participants
-
Mothers: 2804 participants
Children: 5607 participants - Supplementary Information
-
Mothers were randomly assigned to planned cesarean or planned vaginal delivery.
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
|
- By contacting the study representative: Dr. Jon Barrett (Sunnybrook Health Sciences Centre)
Sector of research
| Possible Access to Data | Possible Access to Biosamples | |
| Investigators from the public sector | ||
| Investigators from the private sector | ||
| Investigators from not-for-profit organization |
Transfer
| Possible Access to Data | Possible Access to Biosamples | |
| Can leave the study facility | ||
| Can leave the country |
A data transfer agreement will be needed and data will be transferred by password protected files.
Cost
| Possible Access to Data | Not yet defined |
| Possible Access to Biosamples | N/A |
Cost reduction for co-analyses
| Possible Access to Data | |
| Possible Access to Biosamples |
Costs will be based on time needed to extract data
Marker Paper
Barrett JFR, Hannah ME, Hutton EK, Willan AR, Allen AC, Armson BA, Gafni A, Joseph KS, Mason D, Ohlsson A, Ross S, Sanchez JJ, Asztalos EV, for the Twin Birth Study Collaborative Group. 2013. A Randomized Trial of Planned Cesarean or Vaginal Delivery for Twin Pregnancy. The New England Journal of Medicine; 369 (14):1295–1305.
PUBMED 24088091Timeline
Populations
TBS - Mothers - Planned cesarean delivery group
The population was composed of women who were pregnant with twins and were taken in charge by international participating centres. The women in this group were randomly assigned to the planned cesarean delivery group.
Selection Criteria
- Gender
-
Women only
- Minimum age
-
15
- Maximum age
-
45
- Pregnant Women
-
- Third trimester
- Countries
-
- Argentina
- Australia
- Belgium
- Brazil
- Canada
- Chile
- Croatia
- Egypt
- Estonia
- Germany
- Greece
- Hungary
- Israel
- Jamaica
- Jordan
- Netherlands
- Oman
- Poland
- Qatar
- Romania
- Serbia
- Spain
- United Kingdom
- Uruguay
- United States of America
- Canadian Provinces
-
- Ontario
- Other Criteria
- Women had to be pregnant from 32 weeks and 0 days to 38 weeks and 6 days, had living fetuses with an estimated weight between 1,500g to 4,000g and the twin A has to be in cephalic presentation. Women were excluded of the study if they had monoamniotic twins, lethal fetal anomaly of either fetus and had contraindication to labour or vaginal delivery of either twin.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Women were recruited via their primary care centre, which had to be a participating centre in the study that complied with all aspects of the study protocol.
Sample Size
- Number of Participants
- 1,398
- Number of Participants with Biological Samples
- 1,393
- Supplementary information about number of participants
-
32-38 weeks of pregnancy: 1398 participants
Birth: 1393 participants
3 months postpartum follow-up: 1285 participants
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | TBS - Mothers - 32-36 weeks of gestation |
|
2003 (December) | 2011 (April) | |
| 1 | TBS - Mothers - 28 days postpartum |
|
|
2003 (December) | 2011 (May) |
| 2 | TBS - Mothers - 3 months postpartum |
|
2004 (March) | 2011 (July) | |
| 3 | TBS - Mothers - 2 years postpartum |
|
2005 (December) | 2013 (April) |
TBS - Mothers - Planned vaginal delivery group
The population was composed of women who were pregnant with twins and were taken in charge by international participating centres. The women in this group were randomly assigned to the planned vaginal delivery group.
Selection Criteria
- Gender
-
Women only
- Minimum age
-
15
- Maximum age
-
45
- Pregnant Women
-
- Third trimester
- Countries
-
- Argentina
- Australia
- Belgium
- Brazil
- Canada
- Chile
- Croatia
- Egypt
- Estonia
- Germany
- Greece
- Hungary
- Israel
- Jamaica
- Jordan
- Netherlands
- Oman
- Poland
- Qatar
- Romania
- Serbia
- Spain
- United Kingdom
- Uruguay
- United States of America
- Canadian Provinces
-
- Ontario
- Other Criteria
- Women had to be pregnant from 32 weeks and 0 days to 38 weeks and 6 days, had living fetuses with an estimated weight between 1,500g to 4,000g and the twin A has to be in cephalic presentation. Women were excluded of the study if they had monoamniotic twins, lethal fetal anomaly of either fetus and had contraindication to labour or vaginal delivery of either twin.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Women were recruited via their primary care centre, which had to be a participating centre in the study that complied with all aspects of the study protocol.
Sample Size
- Number of Participants
- 1,406
- Number of Participants with Biological Samples
- 1,393
- Supplementary information about number of participants
-
32-38 weeks of pregnancy: 1406 participants
Birth: 1393 participants
3 months postpartum follow-up: 1285 participants
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | TBS - Mothers - 32-36 weeks of gestation |
|
2003 (December) | 2011 (April) | |
| 1 | TBS - Mothers - 28 days postpartum |
|
|
2003 (December) | 2011 (May) |
| 2 | TBS - Mothers - 3 months postpartum |
|
2004 (March) | 2011 (July) | |
| 3 | TBS - Mothers - 2 years postpartum |
|
2005 (December) | 2013 (April) |
TBS - Children
The population is composed of children of the women who were enrolled in the study.
Selection Criteria
- Newborns
- Twins
- Countries
-
- Argentina
- Australia
- Belgium
- Brazil
- Canada
- Chile
- Croatia
- Egypt
- Estonia
- Germany
- Greece
- Hungary
- Israel
- Jamaica
- Jordan
- Netherlands
- Oman
- Poland
- Qatar
- Romania
- Serbia
- Spain
- United Kingdom
- Uruguay
- United States of America
- Canadian Provinces
-
- Ontario
Sources of Recruitment
- Specific Population
-
- Other specific population : Children of the women already included in the study.
Sample Size
- Number of Participants
- 5,607
- Number of Participants with Biological Samples
- 5,607
- Supplementary information about number of participants
-
Birth: 5607 participants
2 years follow-up: 4603 participants
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | TBS - Children - 32-36 weeks of gestation |
|
2003 (December) | 2011 (April) | |
| 1 | TBS - Children - 28 days postpartum |
|
|
2003 (December) | 2011 (May) |
| 2 | TBS - Children - 2 years postpartum |
|
2005 (December) | 2013 (April) |
Participating Studies
| Acronym | Name | Study design | Countries |
|---|
Harmonization Initiatives Included
| Acronym | Name |
|---|
Datasets
| Name | Data Collection Events | Variables |
|---|
Areas of Information Collected
- Socio-demographic and economic characteristics
- Death
- Lifestyle and behaviours
- Physical measures and assessments
- Birth, pregnancy and reproductive health history
- Laboratory measures
- Perception of health, quality of life, development and functional limitations
- Cognition, personality and psychological measures and assessments
- Diseases
- Life events, life plans, beliefs and values
- Symptoms and signs
- Preschool, school and work life
- Medication and supplements
- Social environment and relationships
- Non-pharmacological interventions
- Physical environment
- Health and community care services utilization
- Administrative information
Variables Content Summary
Areas of Information Collected
No Areas of Information Collected
No Scales Collected
Areas of Information Collected per per Population and Data Collection Event
No Areas of Information Collected
No Scales Collected
Networks
| Acronym | Name | Harmonization Initiatives | Individual Studies |
|---|
Last Update: 2022-12-05T10:54:39.608