Clinical trial NCT00465712: Effect of Amnioinfusion on External Cephalic Version Successful Rate
Official title: Effect of Amnioinfusion on External Cephalic Version After Initial Failure a Prospective Multicentric Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breech Presentation
Keywords: transabdominal amnioinfusion
external cephalic version
breech presentation
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2007-04-25
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: cephalic presentation at birth
timeFrame: at birth
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Mother Child University Hospital
city: Tours
country: France
facility: Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Study officials:
affiliation: Tours University Hospital
name: Franck Perrotin, MD-PhD
role: PRINCIPAL_INVESTIGATOR
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