Defining 'Normal' Liver Function Tests & FibroScan Values in Pregnancy

Study Overview
=================
Brief Summary
-----------------
The main aim of this single-site prospective study is to use serum liver function tests and FibroScan as assessment tools to measure liver disease in pregnant women with or without liver disease at King's College Hospital. This will be assessed during each trimester of pregnancy. FibroScan will assess liver stiffness in these participants and will be used as a surrogate marker for fibrosis.

Detailed Description
-----------------
Approximately 500 pregnant participants above the age of 16 years will be enrolled into this study, which will occur over an 18-month period (February 2019 to August 2020). In this prospective cohort study, pregnant participants with or without liver disease will be identified through clinics at King's College Hospital. Participants attending the antenatal, specialist liver-pregnancy clinic and general liver clinics will be given an information leaflet detailing the study. Participants can be interviewed in a clinic room to answer any queries. The participant is then given the option of consenting and participating in the study during that clinic consultation or to contact us at a future date should they need further time for consideration. Baseline participant details will be collected as well as any preceding liver diagnosis and other comorbidities. Once consented, the assessment visits will be as follows. Trimester 1 visit (at week 12 booking ultrasound scan): - Additional FibroScan after booking scan (ideally 3 hours *fasting will be required before this scan) Trimester 2 visit (at week 20 routine ultrasound scan): Additional FibroScan after ultrasound scan (ideally 3 hours *fasting will be required before this scan) Blood tests to be taken at this point Trimester 3 visit (if occurs, e.g. in participants with diabetes): FibroScan (ideally 3 hours *fasting will be required before this scan) Blood tests (liver function tests) Post-partum visit (if occurs): FibroScan (ideally 3 hours *fasting will be required before this scan) Blood tests (liver function tests) Fasting = nothing to eat or drink (except water) The participants will be followed up during pregnancy and, if required, for 3 months after pregnancy, as per routine Obstetric care. Delivery, maternal and foetal outcomes will also be documented. This information will come from the participant online medical records.

Official Title
-----------------
Defining 'Normal' Liver Function Tests and FibroScan Values in Pregnancies With or Without Liver Disease

Conditions
-----------------
Pregnancy Disease, Liver Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: FibroScan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be female Must be aged 16 years and above and be of childbearing age Must be participants attending clinic at King's College Hospital Must be in the 1st and 2nd trimester of a pregnancy Must be willing and able to provide written informed consent Exclusion Criteria: Non-viable pregnancy Pacemaker in situ Concurrent and/or recent involvement in other research that is likely to interfere with FibroScan results within last 3 months of study enrolment

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal pregnancies<br>Participants who have normal uncomplicated pregnancies | Diagnostic Test: FibroScan<br>* FibroScan will be used to assess liver stiffness<br>|
| Pregnancies with complications<br>Participants who undergo pregnancy with liver disease or develop liver disease or other conditions | Diagnostic Test: FibroScan<br>* FibroScan will be used to assess liver stiffness<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The aim of this study is to evaluate the differences in the range of liver stiffness values measured by the 'FibroScan' machine (the measurement tool) between pregnant women with or without liver disease | The objective of this assessment will be to determine normal and abnormal values of liver stiffness within the pregnant population | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The normal ranges of liver enzyme levels during pregnancy will be extrapolated from blood sample analysis in the laboratory | Blood tests for liver function tests will be performed at different stages of normal and abnormal pregnancies allowing for analysis to determine normal ranges of values | 18 months | 
| To evaluate the normal ranges of Controlled Attenuated Parameter (CAPTM) values in the pregnant population using FibroScan as the tool to assess this parameter | The FibroScan test will allow the assessment of fat content within the liver in normal and abnormal pregnancies, e.g. those with diabetes | 18 months | 
| Clinical information in patient notes will be used to evaluate and correlate between different delivery outcomes and FibroScan results in normal and abnormal pregnancies | Various delivery outcomes will be evaluated and correlated against liver stiffness measurement and CAP values (determined by FibroScan), e.g. caesarean section rates | 18 months | 
| Clinical information in patient notes will be used to evaluate and correlate between different maternal outcomes based on FibroScan results in normal and abnormal pregnancies | Various maternal outcomes will be evaluated and correlated against liver stiffness measurement and CAP values (determined by FibroScan), e.g. hepatic decompensation | 18 months | 
| Clinical information in patient notes will be used to evaluate and correlate between different foetal outcomes and FibroScan results in normal and abnormal pregnancies | Various foetal outcomes will be evaluated and correlated against liver stiffness measurement and CAP values (determined by FibroScan), e.g. live birth rate | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibrosis, FibroScan, Pregnancy, Trimesters, Liver disease