Interest of HI-RTE Elasticity in Obstetric

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT01032564

First received: December 11, 2009

Last updated: May 18, 2010

Last verified: May 2010

History of Changes

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 ]

Estimated Enrollment:	200
Study Start Date:	December 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032564

Contacts

Contact: FLORENCE BRETELLE

florence.bretelle@ap-hm.fr

Locations

France
Assistance Publique Hopitaux de Marseille	Recruiting
Marseille, France, 13
Contact: FLORENCE BRETELLE florence.bretelle@ap-hm.fr

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, Direction de la recherche
ClinicalTrials.gov Identifier:	NCT01032564 History of Changes
Other Study ID Numbers:	2009-A00814-53, 2009-22
Study First Received:	December 11, 2009
Last Updated:	May 18, 2010
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 June 17, 2013

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