This trial is active, not recruiting.

Condition breech presentation
Treatment external cephalic version
Sponsor McMaster University
Collaborator Canadian Institutes of Health Research (CIHR)
Start date December 2004
End date December 2010
Trial size 1460 participants
Trial identifier NCT00141687, C04-0348, ISRCTN56498577


For women with a fetus in breech presentation, does early ECV (at 340/7-356/7 weeks) versus delayed ECV (not before 370/7 weeks) increase or decrease the likelihood of cesarean section (CS)?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention

Primary Outcomes

Rate of cesarean section
time frame: Information not available

Secondary Outcomes

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.
time frame: Information not available

Eligibility Criteria

Female participants from 14 years up to 45 years old.

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

Additional Information

Official title Early External Cephalic Version 2 Trial
Principal investigator Dr. Eileen Hutton, PhD
Description Primary Outcomes: Rate of cesarean 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2008.
Information provided to ClinicalTrials.gov by McMaster University.