An interventional study of Early ECV between 34 0/7 and 35 6/7 weeks and Delayed ECV at or after 37 0/7 weeks in Breech Presentation, sponsored by McMaster University. Completed at 1 site in Canada. Open to female participants aged 14 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-09-15.
Sponsored by McMaster University · Not applicable, Interventional, and Prevention
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.
40 studies on the registry are indexed under Breech Presentation; 10 are open to participants now.
This study's enrollment of 1,543 is above the median of 120 across 29 interventional studies indexed under Breech Presentation.
Browse Breech Presentation studies →McMaster University is the lead sponsor of 738 studies on the registry; 125 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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Exclusion Criteria:
Early external cephalic version (ECV) procedure performed between 34 weeks and 0/7 days and 35 weeks and 6/7 days of gestation
Procedure: Early ECV between 34 0/7 and 35 6/7 weeks
Delayed external cephalic version (ECV) procedure performed at or after 37 weeks and 0/7 days of gestation
Procedure: Delayed ECV at or after 37 0/7 weeks
Early external cephalic version between 34 0/7 and 35 6/7 weeks of gestation
Also known as: Early External Cephalic Version (ECV)
Delayed external cephalic version at or after 37 0/7 weeks of gestation
Also known as: Delayed External Cephalic Version (ECV)
Rate of cesarean section
Time frame: Information not available
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
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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