- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01032564
Interest of HI-RTE Elasticity in Obstetric
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Marseille, France, 13
- Assistance Publique Hopitaux de Marseille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The elastography (elasticity imagery)
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Florence BRETELLE, Assistance Publique Hopitaux de Marseille
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-A00814-53
- 2009-22
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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