Early External Cephalic Version (ECV) 2 Trial
Recruitment status was Active, not recruiting
For women with a fetus in breech presentation, does early ECV (at 340/7-356/7 weeks) versus delayed ECV (not before 370/7 weeks) increase or decrease the likelihood of cesarean section (CS)?
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Early External Cephalic Version 2 Trial|
- Rate of cesarean section [ Time Frame: Information not available ] [ Designated as safety issue: Yes ]
- Rate of pre-term births. Other outcomes: admission to neonatal intensive care unit ≥ 24 hours, perinatal or neonatal mortality or serious neonatal morbidity, or others. [ Time Frame: Information not available ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2004|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Procedure: External cephalic version
Primary Outcomes: Rate of cesarean 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141687
|Hamilton, Ontario, Canada, L8N 3Z5|
|Principal Investigator:||Dr. Eileen Hutton, PhD||McMaster University|