Effect of Amnioinfusion on External Cephalic Version Successful Rate

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Amnioinfusion on External Cephalic Version After Initial Failure a Prospective Multicentric Randomized Study

Conditions
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Breech Presentation

Intervention / Treatment
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* Procedure: transabdominal amnioinfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Transabdominal amnioinfusion performed before external cephalic version | Procedure: transabdominal amnioinfusion<br>* transabdominal amnioinfusion performed 4 to 24 hours before the second trial of external cephalic version<br>|
| No Intervention: V<br>Without transabdominal amnioinfusion | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cephalic presentation at birth |  | at birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transabdominal amnioinfusion, external cephalic version, breech presentation