Early External Cephalic Version (ECV) 2 trial

Not Applicable

Completed

Conditions: Pregnancies with a foetus in breech presentation
Pregnancy and Childbirth

Registration Number: ISRCTN56498577

Lead Sponsor: McMaster University Medical Centre (Canada)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 1460

Inclusion Criteria

1. Women with any breech presentation, aged 18 - 49 years old
2. A live singleton foetus
3. Gestational age of 33^0/7 - 35^6/7 weeks

Exclusion Criteria

1. Any contraindication to ECV
2. Previous participation in the EECV2 Trial
3. Any contraindication to early ECV
4. Women who wish a vaginal delivery if the foetus remains breech
5. Any contraindication to labour or vaginal birth
6. Women who wish to deliver by Caesarean Section (CS) if the foetus turns to cephalic
7. Women at increased risk of unstable lie

Please note that the following exclusion criteria was removed from this list on 06/11/2007:
8. Women who plan to move to a non-trial centre prior to delivery

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of CS.<br><br>Outcomes will be measured at two planned interim analyses:<br>1. After 500 participants were recruited (analysis complete 02/2007)<br>2. After 900 participants were recruited (analysis expected to be complete 01/2008) <br>3. After the full sample of 1460 participants have been recruited

Secondary Outcome Measures

Name	Time	Method
1. Rate of preterm birth<br>2. Other outcomes include admission to neonatal intensive care unit more than or equal to 24 hours, perinatal or neonatal mortality or serious neonatal morbidity, serious foetal complications, maternal death or serious maternal morbidity, non-cephalic presentation at birth, women's views, and health care costs<br><br>Outcomes will be measured at two planned interim analyses:<br>1. After 500 participants were recruited (analysis complete 02/2007)<br>2. After 900 participants were recruited (analysis expected to be complete 01/2008) <br>3. After the full sample of 1460 participants have been recruited