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

Sunnybrook Health Sciences Centre

Status: Completed

Conditions: Twin Pregnancy

Treatments: Procedure: Method of Delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT00187369

ISRCTN74420086

MCT-63164

Details and patient eligibility

About

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)?

Full 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?

Enrollment: 2,804 patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,804 participants in 2 patient groups

Caesarean Section

Other group

Description:

delivery by CS

Treatment:

Procedure: Method of Delivery

Vaginal Birth

Other group

Description:

delivery by VB

Treatment:

Procedure: Method of Delivery