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

Study Overview
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Brief Summary
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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
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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?

Official Title
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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

Conditions
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Twin Pregnancy

Intervention / Treatment
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* Procedure: Method of Delivery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Caesarean Section<br>delivery by CS | Procedure: Method of Delivery<br>* CS or VB<br>|
| Other: Vaginal Birth<br>delivery by VB | Procedure: Method of Delivery<br>* CS or VB<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity | The primary outcome was a composite of fetal or neonatal mortality or serious neonatal morbidity. | until 28 days after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Morbidity | Neonatal morbidity, excluding death of either twin | until 28 days after delivery | 
| Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth) | 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. | 2 years | 
| Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum | The occurrence of problematic urinary, faecal/flatal incontinence at 2 years following the birth will be determined by structured questionnaire | 2 years postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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twins, twin births, multiples