Pregnancy DiseaseNCT03883789
Defining 'Normal' Liver Function Tests & FibroScan Values in Pregnancy
An observational study of Pregnancy Disease and Liver Diseases, run by King's College Hospital NHS Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Disease, Liver Diseases
- What is being tested?
- FibroScan
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 500 pregnant women above the age of 16 years who will be attending outpatient clinics at King's College Hospital London
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy Disease, Liver Diseases
- Being tested
- FibroScan
- Keywords
- Fibrosis, FibroScan, Pregnancy, Trimesters, Liver disease
- Medical subject headings
- Liver Diseases, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroScanDiagnostic test
FibroScan will be used to assess liver stiffness
| Study group | Role | What they receive |
|---|---|---|
| Normal pregnancies | Participants who have normal uncomplicated pregnancies Receives: Diagnostic Test: FibroScan | |
| Pregnancies with complications | Participants who undergo pregnancy with liver disease or develop liver disease or other conditions Receives: Diagnostic Test: FibroScan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mussarat N Rahim, MBBSBScMRCP, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883789
- Sponsor's protocol ID
- IRAS 255412
- Status last verified
- Feb 2019
- First submitted
- 5 Feb 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining 'Normal' Liver Function Tests and FibroScan Values in Pregnancies With or Without Liver Disease
- ClinicalTrials.gov ID
- NCT03883789
- Acronym / sponsor ID
- IRAS 255412
- Conditions
- Pregnancy Disease, Liver Diseases
- Keywords
- Fibrosis, FibroScan, Pregnancy, Trimesters, Liver disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal pregnancies | – | Diagnostic Test: FibroScanParticipants who have normal uncomplicated pregnancies |
| Pregnancies with complications | – | Diagnostic Test: FibroScanParticipants who undergo pregnancy with liver disease or develop liver disease or other conditions |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 500 pregnant women above the age of 16 years who will be attending outpatient clinics at King's College Hospital London
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibroScanFibroScan will be used to assess liver stiffness | Diagnostic test | Normal pregnancies, Pregnancies with complications |
Primary outcome
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
Time frame: 18 months
The objective of this assessment will be to determine normal and abnormal values of liver stiffness within the pregnant population
5 secondary outcomes
The normal ranges of liver enzyme levels during pregnancy will be extrapolated from blood sample analysis in the laboratory
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mussarat N Rahim, MBBSBScMRCP principal investigator
King's College Hospital NHS Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Disease and Liver Diseases, run by King's College Hospital NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mussarat N Rahim, MBBSBScMRCP (02032994241, mussaratrahim@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019; AzTrials last refreshed its copy on 29 Oct 2026.