Effect of Amnioinfusion on External Cephalic Version Successful Rate (AMNIO)

Regional University Hospital Center (CHRU)

Status: Terminated

Conditions: Breech Presentation

Treatments: Procedure: transabdominal amnioinfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00465712

PHRN05-FP/AMNIO2006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

A

Experimental group

Description:

Transabdominal amnioinfusion performed before external cephalic version

Treatment:

Procedure: transabdominal amnioinfusion

V

No Intervention group

Description:

Without transabdominal amnioinfusion