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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00465712
Date of registration: 24/04/2007
Prospective Registration: No
Primary sponsor: University Hospital, Tours
Public title: Effect of Amnioinfusion on External Cephalic Version Successful Rate AMNIO
Scientific title: Effect of Amnioinfusion on External Cephalic Version After Initial Failure a Prospective Multicentric Randomized Study
Date of first enrolment: July 2006
Target sample size: 240
Recruitment status: Terminated
URL:  http://clinicaltrials.gov/show/NCT00465712
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Franck Perrotin, MD-PhD
Address: 
Telephone:
Email:
Affiliation:  Tours University Hospital
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
Breech Presentation
Intervention(s)
Procedure: transabdominal amnioinfusion
Primary Outcome(s)
cephalic presentation at birth [Time Frame: at birth]
Secondary Outcome(s)
Secondary ID(s)
PHRN05-FP/AMNIO2006
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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