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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT02391467
Other study ID # Liver006
Secondary ID
Status Suspended
Phase N/A
First received March 12, 2015
Last updated September 30, 2015
Start date December 2014
Est. completion date December 2015

Study information

Verified date September 2015
Source Hopital Lariboisière
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

Status Suspended
Enrollment 25
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Pregnant women

- Followed in Obstetrics Dpt

- HBV or HCV chronic hepatitis

- After information and written consent

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France Hopital Lariboisiere Paris

Sponsors (1)

Lead Sponsor Collaborator
Hopital Lariboisière

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference between the fibrosis score during and after pregnancy 3 to 6 months after delivery No