Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-01-02 @ 2:43 AM
Study NCT ID:
NCT02391467
Status:
SUSPENDED
Last Update Posted:
2015-10-02
First Post:
2015-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity of Elastography During Pregnancy
Sponsor:
Hopital Lariboisière
Organization:
Study Overview
Official Title:
Validity of Non-invasive Liver Fibrosis Assessment by Ultrasound-based Elastography at the Third Trimester of Pregnancy: a Prospective Study
Status:
SUSPENDED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
issue concerning safety of elastography during pregnancy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: