Validity of Elastography During Pregnancy

NCT ID: NCT02391467

Last Updated: 2015-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-12-31

Brief Summary

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Non invasive methods are the only available methods to stage liver fibrosis during pregnancy. The safety of elastometry - ultrasound based - is obvious, as medical supervision of pregnancy is based on ultrasonography, both methods using same wavelengths. Therefore, this method is sometimes used in pregnant women with recent diagnosis of chronic viral hepatitis infection, whereas its validity in pregnant women has never been studied. This lack of data justifies our study.

Detailed Description

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One measurement during the third trimester of pregnancy will be compared to a second measurement, 3 months after childbirth.

Conditions

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Hepatitis B Virus Infection; Pregnant Women

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Pregnant women
* Followed in Obstetrics Dpt
* HBV or HCV chronic hepatitis
* After information and written consent

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hopital Lariboisière

OTHER

Sponsor Role lead

Responsible Party

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Stephane Mouly, MD PhD

Professor Paris VII University, Paris, France

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pierre O SELLIER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital Lariboisiere, Paris, France

Locations

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Hopital Lariboisiere

Paris, , France

Site Status

Countries

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France

Other Identifiers

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Liver006

Identifier Type: -

Identifier Source: org_study_id

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