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
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
University of British Columbia
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00141687
First received: August 30, 2005
Last updated: October 28, 2008
Last verified: June 2008
  Purpose

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.

  Eligibility

Ages Eligible for Study:   14 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141687

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

Additional Information:
No publications provided

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
pregnancy
labour
Breech pregnancy

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

ClinicalTrials.gov processed this record on September 16, 2014