Breech Presentation Clinical Trial
Official title:
Early External Cephalic Version 2 Trial
Verified date | September 2016 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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)?
Status | Completed |
Enrollment | 1543 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 14 Years to 45 Years |
Eligibility |
Inclusion Criteria: 1. Women with any breech presentation 2. A live singleton fetus 3. Gestational age of 33 weeks 0 days to 35 weeks 6 days Exclusion Criteria: 1. 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) 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | McMaster University | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Canadian Institutes of Health Research (CIHR), University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of cesarean section | Information not available | Yes | |
Secondary | 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 | Yes |
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