Effect of Amnioinfusion on External Cephalic Version Successful Rate
NCT ID: NCT00465712
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
119 participants
INTERVENTIONAL
2006-07-31
2011-05-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Transabdominal amnioinfusion performed before external cephalic version
transabdominal amnioinfusion
transabdominal amnioinfusion performed 4 to 24 hours before the second trial of external cephalic version
V
Without transabdominal amnioinfusion
No interventions assigned to this group
Interventions
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transabdominal amnioinfusion
transabdominal amnioinfusion performed 4 to 24 hours before the second trial of external cephalic version
Eligibility Criteria
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Inclusion Criteria
* breech presentation
* at term
* initial failure of external cephalic version
* structurally normal foetus
Exclusion Criteria
* anhydramnios
* abnormality of the fetal heart rhythm
* uterine congenital malformation
* cesarian section for a previous birth
* unability to understand study
18 Years
FEMALE
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Franck Perrotin, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
Tours University Hospital
Locations
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Mother Child University Hospital
Nantes, , France
Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Tours, , France
Countries
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References
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Gramellini D, Fieni S, Kaihura C, Piantelli G, Verrotti C. Antepartum amnioinfusion: a review. J Matern Fetal Neonatal Med. 2003 Nov;14(5):291-6. doi: 10.1080/jmf.14.5.291.296.
Benifla JL, Goffinet F, Darai E, Madelenat P. Antepartum transabdominal amnioinfusion to facilitate external cephalic version after initial failure. Obstet Gynecol. 1994 Dec;84(6):1041-2.
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Other Identifiers
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PHRN05-FP/AMNIO2006
Identifier Type: -
Identifier Source: org_study_id