Early External Cephalic Version (ECV) 2 trial

ISRCTN	ISRCTN56498577
DOI	https://doi.org/10.1186/ISRCTN56498577
ClinicalTrials.gov (NCT)	NCT00141687
Protocol serial number	MCT-65630
Sponsor	McMaster University Medical Centre (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada), ref: MCT-65630

Submission date: 19/04/2004
Registration date: 22/04/2005
Last edited: 19/06/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Eileen Hutton
Scientific

Department of Obstetrics and Gynecology
McMaster University
1200 Main Street West, MDCL 3103
Hamilton
L8N 3Z5
Canada

Phone	+1 (0)905 525 9140 ext. 26654
Email	huttone@mcmaster.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Early External Cephalic Version (ECV) 2 trial
Study acronym	EECV2
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	1460
Key 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
Key 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
Date of first enrolment	01/12/2004
Date of final enrolment	01/07/2008

Locations

Countries of recruitment

Argentina
Australia
Brazil
Canada
Chile
Egypt
Germany
Hungary
Ireland
Israel
Jordan
Netherlands
Poland
United States of America

Study participating centre

McMaster University

Hamilton
L8N 3Z5
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2011		Yes	No
Results article	results	26/09/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes