Liver Disease in Pregnancy

Brief Title

Liver Disease in Pregnancy

Official Title

EASL: European Registry of Liver Disease in Pregnancy

Brief Summary

      Liver Diseases in pregnancy represents rare disorders and current data is derived primarily
      from single centres and retrospective cohorts. Moreover, the population prevalence of these
      diseases is low and to-date, it has proven difficult to generate reliable data at a patient
      level.

      This is a multi-center, prospective cohort study that will open at 3 centers within the UK;
      and 4 centers in the European Union. The investigators will aim to collect data and blood
      samples at various time points, for patients presenting with liver disease during pregnancy.
      The main rationale behind this study is to establish a platform that enables detailed review
      of the outcomes of these rare diseases; to help classify and stratify patients according to
      risk and develop interventional studies and care pathways to improve overall outcome.
    

Detailed Description

      The objectives of the study are as follows:

      Primary Objective:

      To determine the characteristic physiological and biological changes exhibited by females who
      develop the following liver diseases during pregnancy.

        -  Acute fatty liver of pregnancy

        -  Severe cholestasis of pregnancy

        -  Severe HELLP syndrome/hypertensive disease

        -  Pre-existing cirrhosis and pregnancy This will be determined through analysis of the
           standard of care imaging (Liver Ultrasound and Transient Elastography) and blood results
           (liver function tests, white blood cells, platelets and scoring systems for assessing
           the severity of liver disease (ALBI, APRI, FIB4 and ELF scores). These results will be
           analysed over the course of the participant's pregnancy and again at delivery, to
           explore any particularly distinguishing parameter changes for each disease group.

      Secondary Objectives

        1. To determine the change in the reported quality of life of these participants either
           from diagnosis of pregnancy-associated liver disease or confirmation of pregnancy for
           pre-existing cirrhotic patients - up to 3 months' post-delivery.

        2. To determine the mitochondrial DNA content of blood from patients with Acute Fatty Liver
           of Pregnancy.

        3. Create an associated pan-European bio-resource (whole blood and serum) collection, which
           will offer an opportunity for ongoing collaborative translational research. Each
           participant will be given the option of donating additional research samples (15ml) of
           blood at each visit under the study for the bio-resource.

      Data from cirrhotic patients will be collected from pre-pregnancy and during the first,
      second and third trimesters as well as at delivery and post-partum. Data from patients with
      AFLP/HELLP/ICP will be collected from pre-diagnosis, at first presentation of liver disease,
      at peak of liver disease, during the recovery period from peak liver disease as well as at
      delivery and post-partum.
    


Study Type

Observational


Primary Outcome

Overall maternal and fetal health during pregnancy and post-delivery in females with liver disease


Condition

Pregnancy Disease


Study Arms / Comparison Groups

 Cirrhosis in pregnancy
Description:  Cirrhotic patients with a confirmed pregnancy will be placed into Cohort 1.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

100

Start Date

May 9, 2019

Completion Date

April 8, 2025

Primary Completion Date

April 8, 2024

Eligibility Criteria

        Inclusion Criteria:

          1. Female patients older than 18 years of age, willing and able to sign written informed
             consent.

          2. Pregnant and presenting with any one of the following conditions (confirmed by local
             diagnosis):

               -  Acute fatty liver of pregnancy

               -  Severe cholestasis of pregnancy

               -  Severe HELLP syndrome /hypertensive disease

               -  Pre-existing cirrhosis and pregnancy

          3. Able to provide written informed consent

          4. Willing to provide access to records to necessary data can be collected.

          5. Willing to complete additional quality of life questionnaires as per protocol.

          6. Willing to consider donation of optional blood samples as per protocol.

        Exclusion Criteria:

        1. Unable to provide written informed consent
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michael Heneghan, 0203 299 5303, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03834285

Organization ID

238575


Responsible Party

Sponsor

Study Sponsor

King's College Hospital NHS Trust

Collaborators

 European Association for the Study of the Liver

Study Sponsor

Michael Heneghan, Study Chair, King's College Hospital NHS Trust


Verification Date

March 2020