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Interest of HI-RTE Elasticity in Obstetric

Primary Purpose

Premature Birth

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
The elastography (elasticity imagery)
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Premature Birth focused on measuring estimate the interest of the measure of cervix elasticity degree by elastography in prediction of premature birth within a population of pregnant women

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Outcomes

Primary Outcome Measures

The elastography (elasticity imagery)

Secondary Outcome Measures

Full Information

First Posted
December 11, 2009
Last Updated
August 28, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT01032564
Brief Title
Interest of HI-RTE Elasticity in Obstetric
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
estimate the interest of the measure of cervix elasticity degree by elastography in prediction of premature birth within a population of pregnant women

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
The elastography (elasticity imagery)
Intervention Description
This diagnosis mean use the ultrasonography to measure the tissues answer under pressure
Primary Outcome Measure Information:
Title
The elastography (elasticity imagery)
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence BRETELLE
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25666343
Citation
Sabiani L, Haumonte JB, Loundou A, Caro AS, Brunet J, Cocallemen JF, D'ercole C, Bretelle F. Cervical HI-RTE elastography and pregnancy outcome: a prospective study. Eur J Obstet Gynecol Reprod Biol. 2015 Mar;186:80-4. doi: 10.1016/j.ejogrb.2015.01.016. Epub 2015 Jan 23.
Results Reference
derived

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Interest of HI-RTE Elasticity in Obstetric

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