Early External Cephalic Version (ECV) 2 Trial

Breech Presentation Clinical Trial

Official title:

Early External Cephalic Version 2 Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141687
• Other study ID #: C04-0348
• Secondary ID: ISRCTN56498577
• Status: Completed
• Phase: N/A
• First received: August 30, 2005
• Last updated: September 14, 2016
• Start date: December 2004
• Est. completion date: June 2008

Study information

• Verified date: September 2016
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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)?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1543
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breech Presentation

Intervention

Procedure:
• Early 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
• Delayed ECV at or after 37 0/7 weeks
Delayed external cephalic version at or after 37 0/7 weeks of gestation

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR), University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of cesarean section		Information not available	Yes
Secondary	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	Yes

External Links

•   Cost analysis: Ahmed RJ, Gafni A, Hutton EK. The Cost Implications in Ontario, Alberta, and British Columbia of Early Versus Delayed External Cephalic Version in the EECV2 Trial. J Obstet Gynaecol Can. 2016 Mar;38(3):235-245.
•   Main results: Hutton EK et al. The Early External Cephalic Version (ECV) 2 Trial: an international multicentre randomised controlled trial of timing of ECV for breech pregnancies. BJOG. 2011 Apr;118(5):564-77.
•   Murray-Davis B. et al. Women's experiences of participating in the early external cephalic version 2 trial. Birth. 2012 Mar;39(1):30-8
•   Reitsma A et al. Accounting for center in the Early External Cephalic Version trials: an empirical comparison of statistical methods to adjust for center in a multicenter trial with binary outcomes. Trials. 2014 Sep 26;15:377.