Breech Presentation Clinical Trial
Official 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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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