Validity of Elastography During Pregnancy

Validity of Non-invasive Liver Fibrosis Assessment by Ultrasound-based Elastography at the Third Trimester of Pregnancy: a Prospective Study

Status

Suspended

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02391467

Enrollment

Registered

2015-03-18

Start date

2014-12-31

Completion date

2015-12-31

Last updated

2015-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B Virus Infection; Pregnant Women

Brief 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.

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
Difference between the fibrosis score during and after pregnancy	3 to 6 months after delivery

Countries

France

Outcome results