Breech Presentation Clinical Trial
— AMNIOOfficial title:
Effect of Amnioinfusion on External Cephalic Version After Initial Failure a Prospective Multicentric Randomized Study
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.
Status | Terminated |
Enrollment | 240 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Mother Child University Hospital | Nantes | |
France | Olympe de Gouges Women Health Centre, Bretonneau University Hospital | Tours |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Tours |
France,
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* Note: There are 41 references in all — Click here to view all references
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