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Interest of HI-RTE Elasticity in Obstetric

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ClinicalTrials.gov Identifier: NCT01032564
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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


Condition or disease Intervention/treatment Phase
Premature Birth Other: The elastography (elasticity imagery) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : December 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

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


Primary Outcome Measures :
  1. The elastography (elasticity imagery) [ Time Frame: 18 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01032564     History of Changes
Other Study ID Numbers: 2009-A00814-53
2009-22
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: August 2014

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