Early External Cephalic Version (ECV) 2 Trial

Not Applicable

Completed

• Conditions: Breech Presentation
• Interventions: Procedure: Early ECV between 34 0/7 and 35 6/7 weeks; Procedure: Delayed ECV at or after 37 0/7 weeks

• Registration Number: NCT00141687
• Lead Sponsor: McMaster University

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.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1543

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early External Cephalic Version Group	Early ECV between 34 0/7 and 35 6/7 weeks	Early external cephalic version (ECV) procedure performed between 34 weeks and 0/7 days and 35 weeks and 6/7 days of gestation
Delayed External Cephalic Version Group	Delayed ECV at or after 37 0/7 weeks	Delayed external cephalic version (ECV) procedure performed at or after 37 weeks and 0/7 days of gestation

Primary Outcome Measures

Name	Time	Method
Rate of cesarean section	Information not available

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada