Breech Presentation
Conditions
Keywords
External cephalic version, Cesarean section, pregnancy, labour, Breech pregnancy
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 cesarean section (CS)?
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 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.
Interventions
PROCEDUREEarly 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
PROCEDUREDelayed ECV at or after 37 0/7 weeks
Delayed external cephalic version at or after 37 0/7 weeks of gestation
Sponsors
Canadian Institutes of Health Research (CIHR)
University of British Columbia
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of cesarean section | Information not available |
Secondary
| Measure | 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 |
Countries
Canada
Outcome results
None listed