Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1543 participants
INTERVENTIONAL
2004-12-31
2008-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Early External Cephalic Version Group
Early external cephalic version (ECV) procedure performed between 34 weeks and 0/7 days and 35 weeks and 6/7 days of gestation
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
Delayed External Cephalic Version Group
Delayed external cephalic version (ECV) procedure performed at or after 37 weeks and 0/7 days of gestation
Delayed ECV at or after 37 0/7 weeks
Delayed external cephalic version at or after 37 0/7 weeks of gestation
Interventions
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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
Delayed ECV at or after 37 0/7 weeks
Delayed external cephalic version at or after 37 0/7 weeks of gestation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. A live singleton fetus
3. Gestational age of 33 weeks 0 days to 35 weeks 6 days
Exclusion Criteria
2. Contraindications to early ECV (e.g. increased risk of preterm labour \[such as past history of preterm labour in this or previous pregnancies\], increased risk of abruptio placenta \[such as maternal hypertension\])
3. Contraindications to labour or vaginal delivery (e.g. placenta previa, previous classical CS)
4. Women planning delivery by CS if the fetus turns to cephalic
5. Women planning a vaginal delivery if the fetus remains breech
6. Women at increased risk of unstable lie (eg. grand multiparity)
7. Previous participation in EECV2 Trial
14 Years
45 Years
FEMALE
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
University of British Columbia
OTHER
McMaster University
OTHER
Responsible Party
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Eileen Hutton
Professor, Department of Obstetrics & Gynecology
Principal Investigators
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Dr. Eileen Hutton, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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McMaster University
Hamilton, Ontario, Canada
Countries
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Related Links
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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.
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.
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
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.
Other Identifiers
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ISRCTN56498577
Identifier Type: -
Identifier Source: secondary_id
C04-0348
Identifier Type: -
Identifier Source: org_study_id
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