Effect of Amnioinfusion on External Cephalic Version Successful Rate (AMNIO)
Primary Purpose
Breech Presentation
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transabdominal amnioinfusion
Sponsored by
About this trial
This is an interventional treatment trial for Breech Presentation focused on measuring transabdominal amnioinfusion, external cephalic version, breech presentation
Eligibility Criteria
Inclusion Criteria:
- single fetal pregnancy
- breech presentation
- at term
- initial failure of external cephalic version
- structurally normal foetus
Exclusion Criteria:
- polyhydramnios
- anhydramnios
- abnormality of the fetal heart rhythm
- uterine congenital malformation
- cesarian section for a previous birth
- unability to understand study
Sites / Locations
- Mother Child University Hospital
- Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A
V
Arm Description
Transabdominal amnioinfusion performed before external cephalic version
Without transabdominal amnioinfusion
Outcomes
Primary Outcome Measures
cephalic presentation at birth
Secondary Outcome Measures
Full Information
NCT ID
NCT00465712
First Posted
April 24, 2007
Last Updated
May 31, 2011
Sponsor
University Hospital, Tours
1. Study Identification
Unique Protocol Identification Number
NCT00465712
Brief Title
Effect of Amnioinfusion on External Cephalic Version Successful Rate
Acronym
AMNIO
Official Title
Effect of Amnioinfusion on External Cephalic Version After Initial Failure a Prospective Multicentric Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Terminated
Study Start Date
July 2006 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Tours
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study is to evaluate the effect of transabdominal amnioinfusion before second external cephalic version after initial failure.Patient with a single foetus, at term, in breech presentation and after a first cephalic version are included. The randomisation determines whether the patient is included in the group with amnioinfusion before second cephalic version or with usual second cephalic version only; The efficacy's evaluation is based on rate of cephalic presentation at birth.Success rate of cephalic version with or without transabdominal amnioinfusion, rates of cesarian section in the two groups,maternal and fetal morbidity, time between second cephalic version and birth will be studied.
Prospective interventional randomized sequential comparative multicentric study. A maximum of 240 patients will be included (120 in each group). As the study is sequential it will be over as soon as a significative difference is shown.
Detailed Description
The purpose of the study is to evaluate the effect of transabdominal amnioinfusion before a second external cephalic version after initial failure. In case of success it could be an alternative to cesarian section. Without any other technique the foetus is in cephalic presentation after a first external cephalic version in 50%.
Patients with a single fetus, at term, in breech presentation are proposed to participate. The randomization is done at the inclusion and determines whether the patient is included in the group with amnioinfusion before second cephalic version or usual second cephalic version only. The only difference between the two groups is the realisation of an amnioinfusion, the cephalic version's technique is the same.
Efficacy's evaluation is based on rate of cephalic presentation at birth. Success rate of cephalic version, rates of cesarian section, maternal and fetal morbidity in the two groups, time between second cephalic version and birth will be studied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breech Presentation
Keywords
transabdominal amnioinfusion, external cephalic version, breech presentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Transabdominal amnioinfusion performed before external cephalic version
Arm Title
V
Arm Type
No Intervention
Arm Description
Without transabdominal amnioinfusion
Intervention Type
Procedure
Intervention Name(s)
transabdominal amnioinfusion
Intervention Description
transabdominal amnioinfusion performed 4 to 24 hours before the second trial of external cephalic version
Primary Outcome Measure Information:
Title
cephalic presentation at birth
Time Frame
at birth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
single fetal pregnancy
breech presentation
at term
initial failure of external cephalic version
structurally normal foetus
Exclusion Criteria:
polyhydramnios
anhydramnios
abnormality of the fetal heart rhythm
uterine congenital malformation
cesarian section for a previous birth
unability to understand study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck Perrotin, MD-PhD
Organizational Affiliation
Tours University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mother Child University Hospital
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Olympe de Gouges Women Health Centre, Bretonneau University Hospital
City
Tours
ZIP/Postal Code
37000
Country
France
12. IPD Sharing Statement
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Effect of Amnioinfusion on External Cephalic Version Successful Rate
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