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

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

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.

Study Overview

• Status: Unknown
• Conditions: Liver Diseases; Pregnancy Disease
• Intervention / Treatment: Diagnostic test: FibroScan

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.

1. Trimester 1 visit (at week 12 booking ultrasound scan):

   - Additional FibroScan after booking scan (ideally 3 hours *fasting will be required before this scan)

2. 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

3. 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)

4. 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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Mussarat N Rahim, MBBSBScMRCP; Phone Number: 02032994241; Email: mussaratrahim@nhs.net
• Study Contact Backup: Name: Michael A Heneghan, MDMMedScFRCP; Phone Number: 02032994241; Email: michael.heneghan@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

500 pregnant women above the age of 16 years who will be attending outpatient clinics at King's College Hospital London

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal pregnancies; Participants who have normal uncomplicated pregnancies	Diagnostic test: FibroScan; FibroScan will be used to assess liver stiffness
Pregnancies with complications; Participants who undergo pregnancy with liver disease or develop liver disease or other conditions	Diagnostic test: FibroScan; FibroScan will be used to assess liver stiffness

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

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Investigators: Principal Investigator: Mussarat N Rahim, MBBSBScMRCP, King's College Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: February 5, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 21, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Fibrosis, FibroScan, Pregnancy, Trimesters, Liver disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: IRAS 255412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No