Effect of Amnioinfusion on External Cephalic Version Successful Rate (AMNIO)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Amnioinfusion on External Cephalic Version After Initial Failure a Prospective Multicentric Randomized Study|
- cephalic presentation at birth [ Time Frame: at birth ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Transabdominal amnioinfusion performed before external cephalic version
Procedure: transabdominal amnioinfusion
transabdominal amnioinfusion performed 4 to 24 hours before the second trial of external cephalic version
No Intervention: V
Without transabdominal amnioinfusion
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465712
|Mother Child University Hospital|
|Nantes, France, 44000|
|Olympe de Gouges Women Health Centre, Bretonneau University Hospital|
|Tours, France, 37000|
|Principal Investigator:||Franck Perrotin, MD-PhD||Tours University Hospital|