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The Twin Birth Study: A Trial Comparing Planned Vaginal Birth to Elective Caesarean Section of Twins

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00187369
First Posted: September 16, 2005
Last Update Posted: October 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr Jon Barrett, Sunnybrook Health Sciences Centre
  Purpose
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)?

Condition Intervention
Twin Pregnancy Procedure: Method of Delivery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Dr Jon Barrett, Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Perinatal/neonatal mortality and/or serious neonatal morbidity [ Time Frame: 28 days after delivery ]

Secondary Outcome Measures:
  • Death or poor neurodevelopmental outcome of the children at 2 years of age (corrected for gestational age at birth) [ Time Frame: 2 years ]
  • Problematic urinary or faecal/flatal incontinence of mothers at 2 years postpartum [ Time Frame: 2 years ]

Enrollment: 2804
Study Start Date: December 2003
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Caesarean Section
delivery by CS
Procedure: Method of Delivery
CS or VB
Vaginal Birth
delivery by VB
Procedure: Method of Delivery
CS or VB

Detailed Description:
For twin pregnancies of 32-38 weeks gestation, where twin A is presenting cephalic, does a policy of planned CS decrease the likelihood of perinatal or neonatal mortality or serious neonatal morbidity, during the first 28 days after birth, compared to a policy of planned VB?
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women at 32 0/7 - 38 6/7 weeks gestation
  2. Estimated fetal weight of each fetus 1500 - 4000 g
  3. Both twins alive at time of randomization
  4. Twin A is in cephalic position

Exclusion Criteria:

  1. Monoamniotic twins
  2. Lethal fetal anomaly of either fetus
  3. Contraindication to labour or vaginal delivery for either twin
  4. Previous participation in the Twin Birth Study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187369


Locations
Canada, Ontario
Data Coordinating Centre/SHSC
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Jon F Barrett SHSC