Interest of HI-RTE Elasticity in Obstetric

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01032564
First received: December 11, 2009
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Premature Birth
Other: The elastography (elasticity imagery)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • The elastography (elasticity imagery) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: December 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: The elastography (elasticity imagery)
    This diagnosis mean use the ultrasonography to measure the tissues answer under pressure
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01032564

Locations
France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Florence BRETELLE Assistance Publique Hopitaux De Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01032564     History of Changes
Other Study ID Numbers: 2009-A00814-53, 2009-22
Study First Received: December 11, 2009
Last Updated: August 28, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique Hopitaux De Marseille:
estimate the interest of the measure of cervix elasticity degree by elastography in prediction of premature birth within a population of pregnant women

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on October 19, 2014