Defining 'Normal' Liver Function Tests & FibroScan Values in Pregnancy
NCT ID: NCT03883789
Last Updated: 2019-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2019-04-01
2020-11-01
Brief Summary
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Detailed Description
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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
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Normal pregnancies
Participants who have normal uncomplicated pregnancies
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
FibroScan
FibroScan will be used to assess liver stiffness
Interventions
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FibroScan
FibroScan will be used to assess liver stiffness
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
FEMALE
Yes
Sponsors
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King's College Hospital NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Mussarat N Rahim, MBBSBScMRCP
Role: PRINCIPAL_INVESTIGATOR
King's College Hospital NHS Trust
Central Contacts
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Other Identifiers
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IRAS 255412
Identifier Type: -
Identifier Source: org_study_id
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