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

This study is currently recruiting participants.

Verified by Sunnybrook Health Sciences Centre, February 2009

First Received: September 12, 2005 Last Updated: February 6, 2009 History of Changes

Sponsors and Collaborators:	Sunnybrook Health Sciences Centre CIHR
Information provided by:	Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT00187369

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 (CS versus VB)

MedlinePlus related topics: Cesarean Section

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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

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 ]

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 ]

Estimated Enrollment:	2800
Study Start Date:	December 2003
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

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:

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

Exclusion Criteria:

Monoamniotic twins
Lethal fetal anomaly of either fetus
Contraindication to labour or vaginal delivery for either twin
Previous participation in the Twin Birth Study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187369

Contacts

Contact: Jon F Barrett	416-351-2533	jon.barrett@sw.ca
Contact: Dalah C Mason	416-351-2533	tbs@sw.ca

Locations

Canada, Ontario
Data Coordinating Centre/SHSC	Recruiting
Toronto, Ontario, Canada, M5G 1N8
Contact: Dalah C Mason, MPH 416-351-2533 tbs@sw.ca
Contact: Trinh Hoac, BSc 416-351-3779 tbs@sw.ca
Sub-Investigator: Arthur Zaltz

Sponsors and Collaborators

Sunnybrook Health Sciences Centre

CIHR

Investigators

Principal Investigator:

Jon F Barrett

SHSC

More Information

Additional Information:

Twin Birth Study website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sunnybrook Health Sciences Centre ( Jon Barrett )
Study ID Numbers:	MCT-63164, ISRCTN74420086
Study First Received:	September 12, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00187369 History of Changes
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 May 07, 2009