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Early External Cephalic Version (ECV) 2 Trial

Primary Purpose

Breech Presentation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Early ECV between 34 0/7 and 35 6/7 weeks
Delayed ECV at or after 37 0/7 weeks
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breech Presentation focused on measuring External cephalic version, Cesarean section, pregnancy, labour, Breech pregnancy

Eligibility Criteria

14 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Women with any breech presentation A live singleton fetus Gestational age of 33 weeks 0 days to 35 weeks 6 days Exclusion Criteria: 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) 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]) Contraindications to labour or vaginal delivery (e.g. placenta previa, previous classical CS) Women planning delivery by CS if the fetus turns to cephalic Women planning a vaginal delivery if the fetus remains breech Women at increased risk of unstable lie (eg. grand multiparity) Previous participation in EECV2 Trial

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early External Cephalic Version Group

Delayed External Cephalic Version Group

Arm Description

Early external cephalic version (ECV) procedure performed between 34 weeks and 0/7 days and 35 weeks and 6/7 days of gestation

Delayed external cephalic version (ECV) procedure performed at or after 37 weeks and 0/7 days of gestation

Outcomes

Primary Outcome Measures

Rate of cesarean section

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.

Full Information

First Posted
August 30, 2005
Last Updated
September 14, 2016
Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR), University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT00141687
Brief Title
Early External Cephalic Version (ECV) 2 Trial
Official Title
Early External Cephalic Version 2 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR), University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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)?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breech Presentation
Keywords
External cephalic version, Cesarean section, pregnancy, labour, Breech pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1543 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early External Cephalic Version Group
Arm Type
Experimental
Arm Description
Early external cephalic version (ECV) procedure performed between 34 weeks and 0/7 days and 35 weeks and 6/7 days of gestation
Arm Title
Delayed External Cephalic Version Group
Arm Type
Active Comparator
Arm Description
Delayed external cephalic version (ECV) procedure performed at or after 37 weeks and 0/7 days of gestation
Intervention Type
Procedure
Intervention Name(s)
Early ECV between 34 0/7 and 35 6/7 weeks
Other Intervention Name(s)
Early External Cephalic Version (ECV)
Intervention Description
Early external cephalic version between 34 0/7 and 35 6/7 weeks of gestation
Intervention Type
Procedure
Intervention Name(s)
Delayed ECV at or after 37 0/7 weeks
Other Intervention Name(s)
Delayed External Cephalic Version (ECV)
Intervention Description
Delayed external cephalic version at or after 37 0/7 weeks of gestation
Primary Outcome Measure Information:
Title
Rate of cesarean section
Time Frame
Information not available
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with any breech presentation A live singleton fetus Gestational age of 33 weeks 0 days to 35 weeks 6 days Exclusion Criteria: 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) 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]) Contraindications to labour or vaginal delivery (e.g. placenta previa, previous classical CS) Women planning delivery by CS if the fetus turns to cephalic Women planning a vaginal delivery if the fetus remains breech Women at increased risk of unstable lie (eg. grand multiparity) Previous participation in EECV2 Trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Eileen Hutton, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/21291506
Description
Main results: Hutton EK et al. The Early External Cephalic Version (ECV) 2 Trial: an international multicentre randomised controlled trial of timing of ECV for breech pregnancies. BJOG. 2011 Apr;118(5):564-77.
URL
http://www.ncbi.nlm.nih.gov/pubmed/25257928
Description
Reitsma A et al. Accounting for center in the Early External Cephalic Version trials: an empirical comparison of statistical methods to adjust for center in a multicenter trial with binary outcomes. Trials. 2014 Sep 26;15:377.
URL
http://www.ncbi.nlm.nih.gov/pubmed/22369603
Description
Murray-Davis B. et al. Women's experiences of participating in the early external cephalic version 2 trial. Birth. 2012 Mar;39(1):30-8
URL
http://www.ncbi.nlm.nih.gov/pubmed/27106193
Description
Cost analysis: Ahmed RJ, Gafni A, Hutton EK. The Cost Implications in Ontario, Alberta, and British Columbia of Early Versus Delayed External Cephalic Version in the EECV2 Trial. J Obstet Gynaecol Can. 2016 Mar;38(3):235-245.

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Early External Cephalic Version (ECV) 2 Trial

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