Defining 'normal' liver function tests & FibroScan values in pregnancy
Research type
Research Study
Full title
Defining 'normal' liver function tests and FibroScan values in pregnancies with or without liver disease
IRAS ID
255412
Contact name
Michael Heneghan
Contact email
Sponsor organisation
King's College Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Transient elastography (FibroScan) is now a well-established non-invasive method for the assessment of liver fibrosis in patients with chronic liver disease. It does this by measuring liver stiffness. It is a useful way of predicting cirrhosis/fibrosis (and thus prognosis) often abrogating the need for liver biopsy, which has its own complications. It can easily be performed by the bedside and is a well-tolerated procedure which only takes a few minutes to perform. One gets immediate results with good reproducibility. Limitations include the inability to get values in some patients (approximately 5%), particularly those with substantial thoracic fat.
The use of FibroScan is well-validated in several conditions, e.g. viral hepatitis and autoimmune liver diseases. However, there is very little data on the usefulness of this simple non-invasive test in pregnant women. This is partly because manufacturers had initially advised against the use of FibroScan in pregnancy due to limited data of its safety in pregnancy. This changed in 2017 and it is now routinely used in pregnancy throughout the world, although it is not validated in this group. Normal and abnormal results in pregnant patients are based on those validated in non-pregnant patients. FibroScan is CE (certification) marked for use in pregnant women.This study will aim to assess the change in liver stiffness measurements during the three trimesters of pregnancy in healthy and complicated pregnancies. In addition, it will define the normal ranges of liver function tests in blood tests during pregnancy. This data can be compared to normal values in healthy non-pregnant patients. FibroScan has the potential to detect significant liver disease, even when serum liver function tests are normal. Together, defining normal serum liver function and FibroScan values in pregnancy may allow better detection of liver disease in pregnancy and therefore affect the outcome on pregnancy, foetus and mother.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0197
Date of REC Opinion
25 Apr 2019
REC opinion
Further Information Favourable Opinion