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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

August 30, 2005
September 14, 2016
December 2004
June 2008   (final data collection date for primary outcome measure)
Rate of cesarean section [ Time Frame: Information not available ] [ Designated as safety issue: Yes ]
Lower rates of non-cephalic presentation at birth and CS. The Early ECV 2 Trial will be adequately sized to assess the effect of early versus delayed ECV in terms of the need
Complete list of historical versions of study NCT00141687 on ClinicalTrials.gov Archive Site
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 ]
Preterm birth impacts on neonatal morbidity50 and health care utilisation, and is therefore an important surrogate outcome for serious perinatal or neonatal morbidity.
Not Provided
Not Provided
 
Early External Cephalic Version (ECV) 2 Trial
Early External Cephalic Version 2 Trial
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)?

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Breech Presentation
  • 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)
  • 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)
  • 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
    Intervention: Procedure: Early ECV between 34 0/7 and 35 6/7 weeks
  • 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
    Intervention: Procedure: Delayed ECV at or after 37 0/7 weeks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1543
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Female
14 Years to 45 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
Argentina,   Australia,   Brazil,   Chile,   Egypt,   Germany,   Hungary,   Ireland,   Israel,   Jordan,   Netherlands,   Poland,   Portugal,   United States
 
NCT00141687
C04-0348, ISRCTN56498577
No
Not Provided
Not Provided
Eileen Hutton, McMaster University
McMaster University
  • Canadian Institutes of Health Research (CIHR)
  • University of British Columbia
Principal Investigator: Dr. Eileen Hutton, PhD McMaster University
McMaster University
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP