Early External Cephalic Version (ECV) 2 trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN56498577

Enrollment

1460

Registered

2005-04-22

Start date

2004-12-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancies with a foetus in breech presentation Pregnancy and Childbirth

Interventions

Women will be randomised to have either an early ECV at 34 - 35 weeks gestation, or a delayed ECV at or after 37 weeks gestation On 01/01/2007 the sponsor changed from the Canadian Institutes of Heal

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
1. Rate of preterm birth 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 Outcomes will be measured at two planned interim analyses: 1. After 500 participants were recruited (analysis complete 02/2007) 2. After 900 participants were recruited (analysis expected to be complete 01/2008) 3. After the full sample of 1460 participants have been recruited	—

Measure

Time frame

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

—

Countries

Argentina, Australia, Brazil, Canada, Chile, Egypt, Germany, Hungary, Ireland, Israel, Jordan, Netherlands, Poland, United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026