Early External Cephalic Version (ECV) 2 Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by McMaster University.
Recruitment status was  Active, not recruiting
Canadian Institutes of Health Research (CIHR)
University of British Columbia
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
First received: August 30, 2005
Last updated: October 28, 2008
Last verified: June 2008
For women with a fetus in breech presentation, does early ECV (at 340/7-356/7 weeks) versus delayed ECV (not before 370/7 weeks) increase or decrease the likelihood of cesarean section (CS)?

Condition Intervention
Breech Presentation
Procedure: External cephalic version

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early External Cephalic Version 2 Trial

Resource links provided by NLM:

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Rate of cesarean section [ Time Frame: Information not available ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of pre-term births. Other outcomes: admission to neonatal intensive care unit ≥ 24 hours, perinatal or neonatal mortality or serious neonatal morbidity, or others. [ Time Frame: Information not available ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1460
Study Start Date: December 2004
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: External cephalic version
    Informaton not available at this time.
Detailed Description:

Primary Outcomes: Rate of cesarean section

Secondary Outcomes: Rate of preterm birth

Other Outcomes: admission to neonatal intensive care unit ≥ 24 hours, perinatal or neonatal mortality or serious neonatal morbidity, serious fetal complications, maternal death or serious maternal morbidity, non-cephalic presentation at birth, women's views, and health care costs.

The Data Coordination for this study is being carried out at the Maternal, Infant Reproductive Health Research Unit at Sunnybrook and Women's College Health Sciences Centre.


Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Women with any breech presentation
  2. A live singleton fetus
  3. Gestational age of 33 weeks 0 days to 35 weeks 6 days

Exclusion Criteria:

  1. Contraindications to ECV (e.g. fetal heart rate abnormalities, abruptio placenta, major life-threatening fetal anomalies, uterine anomalies, hyper-extended fetal head, rupture of membranes, severe oligohydramnios, severe polyhydramnios)
  2. Contraindications to early ECV (e.g. increased risk of preterm labour [such as past history of preterm labour in this or previous pregnancies], increased risk of abruptio placenta [such as maternal hypertension])
  3. Contraindications to labour or vaginal delivery (e.g. placenta previa, previous classical CS)
  4. Women planning delivery by CS if the fetus turns to cephalic
  5. Women planning a vaginal delivery if the fetus remains breech
  6. Women at increased risk of unstable lie (eg. grand multiparity)
  7. Previous participation in EECV2 Trial
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00141687

Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
University of British Columbia
Principal Investigator: Dr. Eileen Hutton, PhD McMaster University
  More Information

Responsible Party: Eileen Hutton, McMaster University
ClinicalTrials.gov Identifier: NCT00141687     History of Changes
Other Study ID Numbers: C04-0348  ISRCTN56498577 
Study First Received: August 30, 2005
Last Updated: October 28, 2008
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
External cephalic versioning
cesarean section
Breech pregnancy

Additional relevant MeSH terms:
Breech Presentation
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on August 29, 2016