NCT03883789

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

March 21, 2019

Status Verified

February 1, 2019

Enrollment Period

1.5 years

First QC Date

February 5, 2019

Last Update Submit

March 18, 2019

Conditions

Pregnancy DiseaseLiver Diseases

Keywords

Fibrosis, FibroScan, Pregnancy, Trimesters, Liver disease

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • The normal ranges of liver enzyme levels during pregnancy will be extrapolated from blood sample analysis in the laboratory

    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

    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

    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

    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

    18 months

Study Arms (2)

Normal pregnancies

Participants who have normal uncomplicated pregnancies

Diagnostic Test: FibroScan

Pregnancies with complications

Participants who undergo pregnancy with liver disease or develop liver disease or other conditions

Diagnostic Test: FibroScan

Interventions

FibroScanDIAGNOSTIC_TEST

FibroScan will be used to assess liver stiffness

Normal pregnanciesPregnancies with complications

Eligibility Criteria

Age16 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women of childbearing age
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver DiseasesFibrosis

Condition Hierarchy (Ancestors)

Digestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mussarat N Rahim, MBBSBScMRCP

    King's College Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mussarat N Rahim, MBBSBScMRCP

CONTACT

02032994241mussaratrahim@nhs.net

Michael A Heneghan, MDMMedScFRCP

CONTACT

02032994241michael.heneghan@nhs.net

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2019

First Posted

March 21, 2019

Study Start

April 1, 2019

Primary Completion

October 1, 2020

Study Completion

November 1, 2020

Last Updated

March 21, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share