NCT03883789

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: King's College Hospital NHS Trust · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Pregnancy Disease
• Liver Diseases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	FibroScan	FibroScan will be used to assess liver stiffness

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-10-01
• Completion: 2020-11-01
• First posted: 2019-03-21
• Last updated: 2019-03-21

Regulatory

• FDA-regulated device study