Early External Cephalic Version (ECV) 2 trial
| ISRCTN | ISRCTN56498577 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56498577 |
| ClinicalTrials.gov number | NCT00141687 |
| Secondary identifying numbers | 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
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 |
|---|---|
| huttone@mcmaster.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Participant information sheet | EECV2 trial information for Parents and Families available on http://www.utoronto.ca/cmicr/eecv2/pat/index.htm |
| 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 | 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 study start date | 01/12/2004 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 1460 women (730 per group) are required. Recruitment complete as of July 2008. |
| 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
L8N 3Z5
Canada
Sponsor information
McMaster University Medical Centre (Canada)
Hospital/treatment centre
Hospital/treatment centre
c/o Sarah Lampson
Clinical Trial Agreements and Contracts Specialist
1057 Main Street West
Suite 1, Room 103
Hamilton
L8S 1B7
Canada
| Phone | +1 (0)905 521 2100 |
|---|---|
| lampson@hhsc.ca | |
"ROR" |
https://ror.org/05jyrng31 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada), ref: MCT-65630
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| 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 |
