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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN56498577 |
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| University of British Columbia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early External Cephalic Version Group | Experimental | Early external cephalic version (ECV) procedure performed between 34 weeks and 0/7 days and 35 weeks and 6/7 days of gestation |
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| Delayed External Cephalic Version Group | Active Comparator | Delayed external cephalic version (ECV) procedure performed at or after 37 weeks and 0/7 days of gestation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early ECV between 34 0/7 and 35 6/7 weeks | Procedure | Early external cephalic version between 34 0/7 and 35 6/7 weeks of gestation |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of cesarean section | Information not available |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Information not available |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Eileen Hutton, PhD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | L8N 3Z5 | Canada |
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| Label | URL |
|---|---|
| Main results: Hutton EK et al. The Early External Cephalic Version (ECV) 2 Trial: an international multicentre randomised controlled trial of timing of ECV for breech pregnancies. BJOG. 2011 Apr;118(5):564-77. | View source |
| Reitsma A et al. Accounting for center in the Early External Cephalic Version trials: an empirical comparison of statistical methods to adjust for center in a multicenter trial with binary outcomes. Trials. 2014 Sep 26;15:377. | View source |
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| ID | Term |
|---|---|
| D001946 | Breech Presentation |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Delayed ECV at or after 37 0/7 weeks | Procedure | Delayed external cephalic version at or after 37 0/7 weeks of gestation |
|
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| Murray-Davis B. et al. Women's experiences of participating in the early external cephalic version 2 trial. Birth. 2012 Mar;39(1):30-8 | View source |
| Cost analysis: Ahmed RJ, Gafni A, Hutton EK. The Cost Implications in Ontario, Alberta, and British Columbia of Early Versus Delayed External Cephalic Version in the EECV2 Trial. J Obstet Gynaecol Can. 2016 Mar;38(3):235-245. | View source |