Early External Cephalic Version (ECV) 2 Trial

McMaster University1,543 enrolled

Overview

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)?

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,543

Conditions

Breech Presentation

Interventions

Early ECV between 34 0/7 and 35 6/7 weeksPROCEDURE

Early external cephalic version between 34 0/7 and 35 6/7 weeks of gestation

Delayed ECV at or after 37 0/7 weeksPROCEDURE

Delayed external cephalic version at or after 37 0/7 weeks of gestation

Eligibility

Sex: FEMALEMin age: 14 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

McMaster University

Hamilton, Ontario, Canada

Outcomes

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

Data from ClinicalTrials.gov

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