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

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr Jon Barrett, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00187369
First received: September 12, 2005
Last updated: October 8, 2013
Last verified: October 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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 Sunnybrook Health Sciences Centre:

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

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 ] [ Designated as safety issue: No ]
  • Problematic urinary or faecal/flatal incontinence of mothers at 2 years postpartum [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   15 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Dr Jon Barrett, Chief, Maternal-Fetal Medicine, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00187369     History of Changes
Other Study ID Numbers: MCT-63164, ISRCTN74420086
Study First Received: September 12, 2005
Last Updated: October 8, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Sunnybrook Health Sciences Centre:
twins
twin births
multiples

ClinicalTrials.gov processed this record on July 20, 2014