Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465712
Status:
TERMINATED
Last Update Posted:
2011-06-01
First Post:
2007-04-24
Brief Title:
Effect of Amnioinfusion on External Cephalic Version Successful Rate
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
Effect of Amnioinfusion on External Cephalic Version After Initial Failure a Prospective Multicentric Randomized Study
Status:
TERMINATED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMNIO
Brief Summary:
The aim of the study is to evaluate the effect of transabdominal amnioinfusion before second external cephalic version after initial failurePatient 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 efficacys evaluation is based on rate of cephalic presentation at birthSuccess rate of cephalic version with or without transabdominal amnioinfusion rates of cesarian section in the two groupsmaternal 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
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 versions technique is the same
Efficacys 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
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 versions technique is the same
Efficacys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None