Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 12, 2005
October 8, 2013
December 2003
May 2011   (final data collection date for primary outcome measure)
Perinatal/neonatal mortality and/or serious neonatal morbidity [ Time Frame: 28 days after delivery ] [ Designated as safety issue: Yes ]
Perinatal/neonatal mortality and/or serious neonatal morbidity
Complete list of historical versions of study NCT00187369 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 1) Death or poor neurodevelopmental outcome of the children at 2 yrs of age (corrected for gestational age at birth)
  • 2) Problematic urinary of faecal/flatal incontinence of mothers at 2 years postpartum
Not Provided
Not Provided
 
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

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)?

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?

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Twin Pregnancy
Procedure: Method of Delivery
CS or VB
  • Caesarean Section
    delivery by CS
    Intervention: Procedure: Method of Delivery
  • Vaginal Birth
    delivery by VB
    Intervention: Procedure: Method of Delivery
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; the 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):1295-1305.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2804
June 2011
May 2011   (final data collection date for primary outcome measure)

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
Female
15 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00187369
MCT-63164, ISRCTN74420086
Yes
Dr Jon Barrett, Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Jon F Barrett SHSC
Sunnybrook Health Sciences Centre
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP