Early External Cephalic Version (ECV) 2 Trial

McMaster University

Status: Completed

Conditions: Breech Presentation

Treatments: Procedure: Early ECV between 34 0/7 and 35 6/7 weeks; Procedure: Delayed ECV at or after 37 0/7 weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT00141687

ISRCTN56498577

C04-0348

Details and patient eligibility

About

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)?

Full 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.

Enrollment: 1,543 patients

Sex: Female

Ages: 14 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,543 participants in 2 patient groups

Early External Cephalic Version Group

Experimental group

Description:

Early external cephalic version (ECV) procedure performed between 34 weeks and 0/7 days and 35 weeks and 6/7 days of gestation

Treatment:

Procedure: Early ECV between 34 0/7 and 35 6/7 weeks

Delayed External Cephalic Version Group

Active Comparator group

Description:

Delayed external cephalic version (ECV) procedure performed at or after 37 weeks and 0/7 days of gestation

Treatment:

Procedure: Delayed ECV at or after 37 0/7 weeks