Twin Birth Study
- Start Year
- 2003
- End Year
- 2014
Visit TBS
| Investigators | Contacts |
|---|---|
|
|
Design
- Study design
- Clinical trial
- Follow Up
- 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.
- Supplementary Information
- Mothers were randomly assigned to planned cesarean or planned vaginal delivery.
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 24088091
Recruitment
- Recruitment Target
-
- Families
Number of Participants
- Number of Participants
- 8,411
- Number of Participants with Biological Samples
- 8,393
- Supplementary Information
-
Mothers: 2804 participants
Children: 5607 participants
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
Availability of access information
By contacting the study representative
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
Timeline
Populations
Selection Criteria
- Sex
-
Women
- Minimum age
-
15
- Maximum age
-
45
- Pregnant Women
-
- Third trimester
- 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
- Territory
- Ethnic Origin
-
- Health Status
-
- 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.
Recruitment
- Sources of recruitment
-
- Specific population
- 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.
Number of Participants
- Number of Participants
- 1,398
- Number of Participants with Biological Samples
- 1,393
- Supplementary Information about selection criteria
-
32-38 weeks of pregnancy: 1398 participants
Birth: 1393 participants
3 months postpartum follow-up: 1285 participants
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
TBS - Mothers - 32-36 weeks of gestation
|
Physical measures were taken seven days before randomization. The life status, fetal weight estimation, fetuses’ presentation, presence of contraindications to labour or vaginal delivery and ... |
2003-12 | 2011-04 |
| 1 |
TBS - Mothers - 28 days postpartum
|
Information was collected about the primary outcomes, which concerned maternal death or serious maternal morbidity from delivery to 28 days postpartum. Physical examinations were carried ... |
2003-12 | 2011-05 |
| 2 |
TBS - Mothers - 3 months postpartum
|
The questionnaires at 3 months postpartum collected information about breastfeeding, quality of life, sleep, depression, fatigue, urinary or fecal/flatal incontinence, relationship with the ... |
2004-03 | 2011-07 |
| 3 |
TBS - Mothers - 2 years postpartum
|
The questionnaires at 2 years postpartum collected information about breastfeeding, quality of life, depression, fatigue, urinary or fecal/flatal incontinence and satisfaction with the planned ... |
2005-12 | 2013-04 |
Selection Criteria
- Sex
-
Women
- Minimum age
-
15
- Maximum age
-
45
- Pregnant Women
-
- Third trimester
- 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
- Territory
- Ethnic Origin
-
- Health Status
-
- 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.
Recruitment
- Sources of recruitment
-
- Specific population
- 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.
Number of Participants
- Number of Participants
- 1,406
- Number of Participants with Biological Samples
- 1,393
- Supplementary Information about selection criteria
-
32-38 weeks of pregnancy: 1406 participants
Birth: 1393 participants
3 months postpartum follow-up: 1285 participants
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
TBS - Mothers - 32-36 weeks of gestation
|
Physical measures were taken seven days before randomization. The life status, fetal weight estimation, fetuses’ presentation, presence of contraindications to labour or vaginal delivery and ... |
2003-12 | 2011-04 |
| 1 |
TBS - Mothers - 28 days postpartum
|
Information was collected about the primary outcomes, which concerned maternal death or serious maternal morbidity from delivery to 28 days postpartum. Physical examinations were carried ... |
2003-12 | 2011-05 |
| 2 |
TBS - Mothers - 3 months postpartum
|
The questionnaires at 3 months postpartum collected information about breastfeeding, quality of life, sleep, depression, fatigue, urinary or fecal/flatal incontinence, relationship with the ... |
2004-03 | 2011-07 |
| 3 |
TBS - Mothers - 2 years postpartum
|
The questionnaires at 2 years postpartum collected information about breastfeeding, quality of life, depression, fatigue, urinary or fecal/flatal incontinence and satisfaction with the planned ... |
2005-12 | 2013-04 |
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
- Territory
- Ethnic Origin
-
- Health Status
-
- Other Criteria
- Supplementary Information about selection criteria
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Other specific population : Children of the women already included in the study.
Number of Participants
- Number of Participants
- 5,607
- Number of Participants with Biological Samples
- 5,607
- Supplementary Information about selection criteria
-
Birth: 5607 participants
2 years follow-up: 4603 participants
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
TBS - Children - 32-36 weeks of gestation
|
Physical measures were taken seven days before randomization. The life status, fetal weight estimation, fetuses’ presentation, presence of contraindications to labour or vaginal delivery and ... |
2003-12 | 2011-04 |
| 1 |
TBS - Children - 28 days postpartum
|
Information was collected about the primary outcomes which concerned fetal or neonatal mortality or serious neonatal morbidity.Neonatal mortality was assessed for the period from 0 to 27 days ... |
2003-12 | 2011-05 |
| 2 |
TBS - Children - 2 years postpartum
|
A questionnaire was filled by the mother at 2 years postpartum to assess the child's neurodevelopment. If the questionnaire’s score was in the abnormal range, a formal neurodevelopmental ... |
2005-12 | 2013-04 |
Classifications
- Socio-demographic and economic characteristics
- Lifestyle and behaviours
- Birth, pregnancy and reproductive health history
- Perception of health, quality of life, development and functional limitations
- Diseases
- Symptoms and signs
- Medication and supplements
- Non-pharmacological interventions
- Health and community care services utilization
- Death
- Physical measures and assessments
- Laboratory measures
- Cognition, personality and psychological measures and assessments
- Life events, life plans, beliefs and values
- Preschool, school and work life
- Social environment and relationships
- Physical environment
- Administrative information
- Cognitive functioning
- Personality
- Psychological distress and emotions
- Other psychological measures and assessments
- Perception of health
- Quality of life
- Life course development
- Functional limitations
- Other perception of health, quality of life and functional limitation-related information
Socio-demographic and economic characteristics
Lifestyle and behaviours
Birth, pregnancy and reproductive health history
Perception of health, quality of life, development and functional limitations
Diseases
Symptoms and signs
Medication and supplements
Non-pharmacological interventions
Health and community care services utilization
Death
Physical measures and assessments
Laboratory measures
Cognition, personality and psychological measures and assessments
Social environment and relationships
Administrative information
Psychological distress and emotions
Quality of life
Life course development