Status:
COMPLETED
Early External Cephalic Version (ECV) 2 Trial
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
University of British Columbia
Conditions:
Breech Presentation
Eligibility:
FEMALE
14-45 years
Phase:
NA
Brief Summary
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 cesar...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Women with any breech presentation
- A live singleton fetus
- Gestational age of 33 weeks 0 days to 35 weeks 6 days
Exclusion
- Contraindications to ECV (e.g. fetal heart rate abnormalities, abruptio placenta, major life-threatening fetal anomalies, uterine anomalies, hyper-extended fetal head, rupture of membranes, severe oligohydramnios, severe polyhydramnios)
- 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 \[such as maternal hypertension\])
- Contraindications to labour or vaginal delivery (e.g. placenta previa, previous classical CS)
- Women planning delivery by CS if the fetus turns to cephalic
- Women planning a vaginal delivery if the fetus remains breech
- Women at increased risk of unstable lie (eg. grand multiparity)
- Previous participation in EECV2 Trial
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
1543 Patients enrolled
Trial Details
Trial ID
NCT00141687
Start Date
December 1 2004
End Date
June 1 2008
Last Update
September 15 2016
Active Locations (1)
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1
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5