NCT00141687

Early External Cephalic Version (ECV) 2 Trial

Early External Cephalic Version 2 Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,543 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: Female
• Age: 14 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

For women with a fetus in breech presentation, does early ECV (at 34 0/7 up to 35 weeks and 6/7 days) versus delayed ECV (not before 37 weeks and 0/7 days) increase or decrease the likelihood of cesarean section (CS)?

Detailed description

Primary Outcomes: Rate of Caesarean section Secondary Outcomes: Rate of preterm birth Other Outcomes: admission to neonatal intensive care unit ≥ 24 hours, perinatal or neonatal mortality or serious neonatal morbidity, serious fetal complications, maternal death or serious maternal morbidity, non-cephalic presentation at birth, women's views, and health care costs. The Data Coordination for this study is being carried out at the Maternal, Infant Reproductive Health Research Unit at Sunnybrook and Women's College Health Sciences Centre.

Conditions

• Breech Presentation

Interventions

Type	Name	Description
PROCEDURE	Early ECV between 34 0/7 and 35 6/7 weeks	Early external cephalic version between 34 0/7 and 35 6/7 weeks of gestation
PROCEDURE	Delayed ECV at or after 37 0/7 weeks	Delayed external cephalic version at or after 37 0/7 weeks of gestation

Timeline

• Start date: 2004-12-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2005-09-01
• Last updated: 2016-09-15

Locations

1 site across 1 country: Canada