Condition category
Pregnancy and Childbirth
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Eileen Hutton


Contact details

Department of Obstetrics and Gynecology
McMaster University
1200 Main Street West
MDCL 3103
L8N 3Z5
+1 (0)905 525 9140 ext. 26654

Additional identifiers

EudraCT number number


Protocol/serial number


Study information

Scientific title

Early External Cephalic Version (ECV) 2 trial



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:

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


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

EECV2 trial information for Parents and Families available on


Pregnancies with a foetus in breech presentation


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



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


Overall trial end date


Reason abandoned


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


Age group




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


Recruitment end date



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
L8N 3Z5

Sponsor information


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
L8S 1B7
+1 (0)905 521 2100

Sponsor type

Hospital/treatment centre



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



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:
2014 results in:

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