Breech Presentation Clinical Trial
Official title:
Early External Cephalic Version 2 Trial
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)?
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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