Clinical trial NCT03883789: Defining 'Normal' Liver Function Tests & FibroScan Values in Pregnancy
Official title: Defining 'Normal' Liver Function Tests and FibroScan Values in Pregnancies With or Without Liver Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Disease
Liver Diseases
Keywords: Fibrosis, FibroScan, Pregnancy, Trimesters, Liver disease
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 500
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

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.

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

Primary outcomes:
measure: 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
timeFrame: 18 months
Secondary outcomes:
measure: The normal ranges of liver enzyme levels during pregnancy will be extrapolated from blood sample analysis in the laboratory
timeFrame: 18 months
measure: To evaluate the normal ranges of "Controlled Attenuated Parameter (CAPTM)" values in the pregnant population using FibroScan as the tool to assess this parameter
timeFrame: 18 months
measure: Clinical information in patient notes will be used to evaluate and correlate between different delivery outcomes and FibroScan results in normal and abnormal pregnancies
timeFrame: 18 months
measure: 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
timeFrame: 18 months
measure: Clinical information in patient notes will be used to evaluate and correlate between different foetal outcomes and FibroScan results in normal and abnormal pregnancies
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: King's College Hospital NHS Trust
name: Mussarat N Rahim, MBBSBScMRCP
role: PRINCIPAL_INVESTIGATOR
References: