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Early External Cephalic Version (ECV) 2 Trial

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
University of British Columbia
Information provided by (Responsible Party):
Eileen Hutton, McMaster University
ClinicalTrials.gov Identifier:
NCT00141687
First received: August 30, 2005
Last updated: September 14, 2016
Last verified: September 2016
  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
Endpoint Classification: Safety/Efficacy Study
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 ]

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

Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
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:
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 
Study First Received: August 30, 2005
Last Updated: September 14, 2016
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on September 29, 2016