Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Eileen Hutton
ORCID ID
Contact details
Department of Obstetrics and Gynecology
McMaster University
1200 Main Street West
MDCL 3103
Hamilton
L8N 3Z5
Canada
+1 (0)905 525 9140 ext. 26654
huttone@mcmaster.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00141687
Protocol/serial number
MCT-65630
Study information
Scientific title
Early External Cephalic Version (ECV) 2 trial
Acronym
EECV2
Study hypothesis
1. For women with a foetus in breech presentation, does early External Cephalic Version (ECV) (at 34^0/7 - 35^6/7 weeks) versus delayed ECV (not before 37^0/7 weeks) increase or decrease the likelihood of Caesarean Section (CS)?
2. Is the risk of preterm birth (less than 37^0/7 weeks) lower or higher with early versus delayed ECV?
Protocol can be found at: http://sunnybrook.ca/uploads/sri_cmicr_eecv2_protocol_en.pdf
Ethics approval
1. The University of British Columbia Clinical Research Ethics Board, 18/08/2004, ref. no.: C04-0348, amendment 06/10/2004
2. Research Ethics Board of Hamilton Health Sciences Research Ethics Board, 20/03/2007, ref: 07-122
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
EECV2 trial information for Parents and Families available on http://www.utoronto.ca/cmicr/eecv2/pat/index.htm
Condition
Pregnancies with a foetus in breech presentation
Intervention
Women will be randomised to have either an early ECV at 34 - 35 weeks gestation, or a delayed ECV at or after 37 weeks gestation
On 01/01/2007 the sponsor changed from the Canadian Institutes of Health Research (CIHR) to the current sponsor, the McMaster University Medical Centre (see below).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Rate of CS.
Outcomes will be measured at two planned interim analyses:
1. After 500 participants were recruited (analysis complete 02/2007)
2. After 900 participants were recruited (analysis expected to be complete 01/2008)
3. After the full sample of 1460 participants have been recruited
Secondary outcome measures
1. Rate of preterm birth
2. Other outcomes include admission to neonatal intensive care unit more than or equal to 24 hours, perinatal or neonatal mortality or serious neonatal morbidity, serious foetal complications, maternal death or serious maternal morbidity, non-cephalic presentation at birth, women's views, and health care costs
Outcomes will be measured at two planned interim analyses:
1. After 500 participants were recruited (analysis complete 02/2007)
2. After 900 participants were recruited (analysis expected to be complete 01/2008)
3. After the full sample of 1460 participants have been recruited
Overall trial start date
01/12/2004
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women with any breech presentation, aged 18 - 49 years old
2. A live singleton foetus
3. Gestational age of 33^0/7 - 35^6/7 weeks
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1460 women (730 per group) are required. Recruitment complete as of July 2008.
Participant exclusion criteria
1. Any contraindication to ECV
2. Previous participation in the EECV2 Trial
3. Any contraindication to early ECV
4. Women who wish a vaginal delivery if the foetus remains breech
5. Any contraindication to labour or vaginal birth
6. Women who wish to deliver by Caesarean Section (CS) if the foetus turns to cephalic
7. Women at increased risk of unstable lie
Please note that the following exclusion criteria was removed from this list on 06/11/2007:
8. Women who plan to move to a non-trial centre prior to delivery
Recruitment start date
01/12/2004
Recruitment end date
01/07/2008
Locations
Countries of recruitment
Argentina, Australia, Brazil, Canada, Chile, Egypt, Germany, Hungary, Ireland, Israel, Jordan, Netherlands, Poland, United States of America
Trial participating centre
McMaster University
Hamilton
L8N 3Z5
Canada
Sponsor information
Organisation
McMaster University Medical Centre (Canada)
Sponsor details
c/o Sarah Lampson
Clinical Trial Agreements and Contracts Specialist
1057 Main Street West
Suite 1
Room 103
Hamilton
L8S 1B7
Canada
+1 (0)905 521 2100
lampson@hhsc.ca
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada), ref: MCT-65630
Alternative name(s)
Instituts de Recherche en Santé du Canada, CIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Canada
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21291506
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25257928
Publication citations
-
Results
Hutton EK, Hannah ME, Ross SJ, Delisle MF, Carson GD, Windrim R, Ohlsson A, Willan AR, Gafni A, Sylvestre G, Natale R, Barrett Y, Pollard JK, Dunn MS, Turtle P, , The Early External Cephalic Version (ECV) 2 Trial: an international multicentre randomised controlled trial of timing of ECV for breech pregnancies., BJOG, 2011, 118, 5, 564-577, doi: 10.1111/j.1471-0528.2010.02837.x.
-
Results
Reitsma A, Chu R, Thorpe J, McDonald S, Thabane L, Hutton E, 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, 15, 377, doi: 10.1186/1745-6215-15-377.