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

Not Applicable

Completed

• Conditions: Twin Pregnancy
• Interventions: Procedure: Method of Delivery

• Registration Number: NCT00187369
• Lead Sponsor: Sunnybrook Health Sciences Centre

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)?

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?

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2011-05
• Study Completion: 2011-10
• Results First Submitted: 2019-12-10
• Results First Submitted QC: 2020-04-20
• Status Verified: 2020-05
• Results First Posted: 2020-05-04
• Last Update Submitted: 2020-05-04
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2804

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caesarean Section	Method of Delivery	delivery by CS
Vaginal Birth	Method of Delivery	delivery by VB

Primary Outcome Measures

Name	Time	Method
Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity	until 28 days after delivery	The primary outcome was a composite of fetal or neonatal mortality or serious neonatal morbidity.

Secondary Outcome Measures

Name	Time	Method
Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)	2 years	Neurodevelopmental outcome will be assessed by the Ages and Stages Questionnaire (ASQ). The ASQ is a parent/parental caregiver-administered structured questionnaire that includes questions on 5 domains of development: communication, gross motor skills, fine motor skills, problem-solving skills, and personal-social skills. If the score for any 1 of the 5 domains is below the specific cutoff for the domain, the ASQ was considered abnormal.
Neonatal Morbidity	until 28 days after delivery	Neonatal morbidity, excluding death of either twin
Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum	2 years postpartum	The occurrence of problematic urinary, faecal/flatal incontinence at 2 years following the birth will be determined by structured questionnaire

Trial Locations

Locations (1)

Data Coordinating Centre/SHSC; 🇨🇦 Toronto, Ontario, Canada