Condition category
Pregnancy and Childbirth
Date applied
19/04/2004
Date assigned
22/04/2005
Last edited
19/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.utoronto.ca/cmicr/eecv2/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes