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NCT01032564 Clinical Trial

Interest of HI-RTE Elasticity in Obstetric

Premature Birth Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01032564
Other study ID # 2009-A00814-53
Secondary ID 2009-22
Status Completed
Phase N/A
First received December 11, 2009
Last updated August 28, 2014
Start date December 2009
Est. completion date July 2013

Study information
Verified date August 2014
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

In obstetric, the investigators can't predict accurately with current means (BISHOP score, traditional cervix ultrasonography and fibronectin) the childbirth time and delay.

If ultrasonography can determine the length, the cervix opening, it can't define its flexibility. Indeed, the conventional cervix ultrasonography can't inform us about the consistency of the uterine cervix.

The elastography (elasticity imagery) is an innovating technology. It is a new technology currently used as part of breast cancer estimate. This diagnosis mean use the ultrasonography to measure the tissues answer under pressure.

Its contribution in obstetric must be estimated to improve patients minimum fare.

The main target of the investigators study is to estimate the interest of the measure of cervix elasticity degree by elastography in prediction of premature birth within a population of pregnant women

Recruitment information / eligibility
Status Completed
Enrollment 73
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Unique(only) or multiple pregnancy about is the term presenting an intra Utérine pregnancy in the 1st quarter ·

- Signed lit(enlightened) consent ·

- Patient of more than 18 years old

Exclusion Criteria:

- Suspicion of pregnancy extra utérine, hémodynamique unstable, important métrorragies, maternal diabetes, arterial high blood pressure

- impossibility to receive the consent lit(enlightened) by the patient · patient old under age 18

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Other:
• The elastography (elasticity imagery)
This diagnosis mean use the ultrasonography to measure the tissues answer under pressure

Locations
Country Name City State
France Assistance Publique Hopitaux de Marseille Marseille

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary The elastography (elasticity imagery) 18 months No
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