The Twin Birth Study: A Trial Comparing Planned Vaginal Birth to Elective Caesarean Section of Twins
The Twin Birth Study: A Multicentre Randomised Controlled Trial Comparing Planned Vaginal Birth to Elective Caesarean Section of Twins More Than or Equal to 32 Weeks Gestation
2 other identifiers
interventional
2,804
1 country
1
Brief Summary
For twin pregnancies at 32-38 weeks gestation, where twin A is head down, does a policy of planned caesarean section (CS) lower the likelihood of death or serious illness, during the first 28 days after birth, compared to a plan for vaginal birth (VB)?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
May 4, 2020
CompletedMay 13, 2020
May 1, 2020
7.4 years
September 12, 2005
December 10, 2019
May 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity
The primary outcome was a composite of fetal or neonatal mortality or serious neonatal morbidity.
until 28 days after delivery
Secondary Outcomes (3)
Neonatal Morbidity
until 28 days after delivery
Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)
2 years
Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum
2 years postpartum
Other Outcomes (6)
Baseline Characteristics - Gestational Age at Randomization
Basline
Baseline Characteristics - Estimated Fetal Weight
Basline
Other Maternal Outcomes
2 years postpartum
- +3 more other outcomes
Study Arms (2)
Caesarean Section
OTHERdelivery by CS
Vaginal Birth
OTHERdelivery by VB
Interventions
Eligibility Criteria
You may qualify if:
- Women at 32 0/7 - 38 6/7 weeks gestation
- Estimated fetal weight of each fetus 1500 - 4000 g
- Both twins alive at time of randomization
- Twin A is in cephalic position
You may not qualify if:
- Monoamniotic twins
- Lethal fetal anomaly of either fetus
- Contraindication to labour or vaginal delivery for either twin
- Previous participation in the Twin Birth Study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Data Coordinating Centre/SHSC
Toronto, Ontario, M4N 3M5, Canada
Related Publications (7)
Barrett JF, Hannah ME, Hutton EK, Willan AR, Allen AC, Armson BA, Gafni A, Joseph KS, Mason D, Ohlsson A, Ross S, Sanchez JJ, Asztalos EV; Twin Birth Study Collaborative Group. A randomized trial of planned cesarean or vaginal delivery for twin pregnancy. N Engl J Med. 2013 Oct 3;369(14):1295-305. doi: 10.1056/NEJMoa1214939.
PMID: 24088091BACKGROUNDHochler H, Tevet A, Barg M, Suissa-Cohen Y, Lipschuetz M, Yagel S, Aviram A, Mei-Dan E, Melamed N, Barrett JFR, Fox NS, Walfisch A. Trial of labor of vertex-nonvertex twins following a previous cesarean delivery. Am J Obstet Gynecol MFM. 2022 Jul;4(4):100640. doi: 10.1016/j.ajogmf.2022.100640. Epub 2022 Apr 8.
PMID: 35398584DERIVEDDougan C, Gotha L, Melamed N, Aviram A, Asztalos EV, Anabusi S, Willan AR, Barrett J, Mei-Dan E. Cesarean delivery or induction of labor in pre-labor twin gestations: a secondary analysis of the twin birth study. BMC Pregnancy Childbirth. 2020 Nov 17;20(1):702. doi: 10.1186/s12884-020-03369-x.
PMID: 33203367DERIVEDAviram A, Lipworth H, Asztalos EV, Mei-Dan E, Melamed N, Cao X, Zaltz A, Hvidman L, Barrett JFR. Delivery of monochorionic twins: lessons learned from the Twin Birth Study. Am J Obstet Gynecol. 2020 Dec;223(6):916.e1-916.e9. doi: 10.1016/j.ajog.2020.06.048. Epub 2020 Jun 24.
PMID: 32592694DERIVEDAviram A, Lipworth H, Asztalos EV, Mei-Dan E, Cao X, Melamed N, Zaltz A, Anastasio HB, Berghella V, Barrett JFR. The worst of both worlds-combined deliveries in twin gestations: a subanalysis of the Twin Birth Study, a randomized, controlled, prospective study. Am J Obstet Gynecol. 2019 Oct;221(4):353.e1-353.e7. doi: 10.1016/j.ajog.2019.06.047. Epub 2019 Jun 27.
PMID: 31254526DERIVEDMei-Dan E, Asztalos EV, Willan AR, Barrett JF. The effect of induction method in twin pregnancies: a secondary analysis for the twin birth study. BMC Pregnancy Childbirth. 2017 Jan 6;17(1):9. doi: 10.1186/s12884-016-1201-8.
PMID: 28061767DERIVEDMelamed N, Wong J, Asztalos E, Rosen H, Okby R, Barrett J. The Likelihood of Change in Fetal Presentation During the Third Trimester in Twin Pregnancies. Obstet Gynecol. 2015 Dec;126(6):1231-1236. doi: 10.1097/AOG.0000000000001128.
PMID: 26551181DERIVED
Results Point of Contact
- Title
- Dr Jon Barrett
- Organization
- Sunnybrook Health Sciences Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jon F Barrett
SHSC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Maternal-Fetal Medicine
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 16, 2005
Study Start
December 1, 2003
Primary Completion
May 1, 2011
Study Completion
October 1, 2011
Last Updated
May 13, 2020
Results First Posted
May 4, 2020
Record last verified: 2020-05