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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2804 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2011-10-31

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)?

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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?

Conditions

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Twin Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Caesarean Section

delivery by CS

Group Type OTHER

Method of Delivery

Intervention Type PROCEDURE

CS or VB

Vaginal Birth

delivery by VB

Group Type OTHER

Method of Delivery

Intervention Type PROCEDURE

CS or VB

Interventions

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Method of Delivery

CS or VB

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No