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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.
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):
Trimester 3 visit (if occurs, e.g. in participants with diabetes):
Post-partum visit (if occurs):
FibroScan (ideally 3 hours *fasting will be required before this scan)
Blood tests (liver function tests)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal pregnancies | Participants who have normal uncomplicated pregnancies |
| |
| Pregnancies with complications | Participants who undergo pregnancy with liver disease or develop liver disease or other conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FibroScan | Diagnostic Test | FibroScan will be used to assess liver stiffness |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women of childbearing age
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500 pregnant women above the age of 16 years who will be attending outpatient clinics at King's College Hospital London
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mussarat N Rahim, MBBSBScMRCP | Contact | 02032994241 | mussaratrahim@nhs.net | |
| Michael A Heneghan, MDMMedScFRCP | Contact | 02032994241 | michael.heneghan@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Mussarat N Rahim, MBBSBScMRCP | King's College Hospital NHS Trust | Principal Investigator |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |