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Early External Cephalic Version (ECV) 2 Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00141687
First Posted: September 1, 2005
Last Update Posted: September 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Canadian Institutes of Health Research (CIHR)
University of British Columbia
Information provided by (Responsible Party):
Eileen Hutton, McMaster University
  Purpose
For women with a fetus in breech presentation, does early ECV (at 34 0/7 up to 35 weeks and 6/7 days) versus delayed ECV (not before 37 weeks and 0/7 days) increase or decrease the likelihood of cesarean section (CS)?

Condition Intervention
Breech Presentation Procedure: Early ECV between 34 0/7 and 35 6/7 weeks Procedure: Delayed ECV at or after 37 0/7 weeks

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Early External Cephalic Version 2 Trial

Further study details as provided by Eileen Hutton, McMaster University:

Primary Outcome Measures:
  • Rate of cesarean section [ Time Frame: Information not available ]

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 ]

Enrollment: 1543
Study Start Date: December 2004
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early External Cephalic Version Group
Early external cephalic version (ECV) procedure performed between 34 weeks and 0/7 days and 35 weeks and 6/7 days of gestation
Procedure: Early ECV between 34 0/7 and 35 6/7 weeks
Early external cephalic version between 34 0/7 and 35 6/7 weeks of gestation
Other Name: Early External Cephalic Version (ECV)
Active Comparator: Delayed External Cephalic Version Group
Delayed external cephalic version (ECV) procedure performed at or after 37 weeks and 0/7 days of gestation
Procedure: Delayed ECV at or after 37 0/7 weeks
Delayed external cephalic version at or after 37 0/7 weeks of gestation
Other Name: Delayed External Cephalic Version (ECV)

Detailed Description:

Primary Outcomes: Rate of Caesarean 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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Eileen Hutton, Professor, Department of Obstetrics & Gynecology, McMaster University
ClinicalTrials.gov Identifier: NCT00141687     History of Changes
Other Study ID Numbers: C04-0348
ISRCTN56498577
First Submitted: August 30, 2005
First Posted: September 1, 2005
Last Update Posted: September 15, 2016
Last Verified: September 2016

Keywords provided by Eileen Hutton, McMaster University:
External cephalic version
Cesarean section
pregnancy
labour
Breech pregnancy

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