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Liver Disease in Pregnancy

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ClinicalTrials.gov Identifier: NCT03834285
Recruitment Status : Recruiting
First Posted : February 7, 2019
Last Update Posted : March 27, 2020
Sponsor:
Collaborator:
European Association for the Study of the Liver
Information provided by (Responsible Party):
King's College Hospital NHS Trust

Study Description
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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.


Condition or disease
Pregnancy Disease Cirrhosis, Liver HELLP Syndrome AFLP - Acute Fatty Liver of Pregnancy Intrahepatic Cholestasis of Pregnancy

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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: EASL: European Registry of Liver Disease in Pregnancy
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : April 8, 2024
Estimated Study Completion Date : April 8, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Cirrhosis in pregnancy
Cirrhotic patients with a confirmed pregnancy will be placed into Cohort 1.
Pregnancy-associated liver diseases
Patients who develop Acute Fatty Liver of Pregnancy, HELLP Syndrome / Intrahepatic Cholestasis of pregnancy will be placed into Cohort 2.


Outcome Measures
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Primary Outcome Measures :
  1. Overall maternal and fetal health during pregnancy and post-delivery in females with liver disease [ Time Frame: Data to be collected from pre-pregnancy to 3 months post-delivery ]
    Data from 100 patients will be collected across the EU who have either pre-exisiting cirrhosis or one of the three pregnancy-associated liver diseases that are to be studied in this protocol (AFLP, HELLP, ICP)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnancy study, so all participants must be female.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Liver Diseases in pregnancy represent rare disorders and the numbers of patients affected in the overall population is low and therefore, it has proven difficult to generate reliable data. For example, the numbers of patients affected with these conditions in Europe are as follows:

  • Acute Fatty Liver affects 1:20,000 pregnant women
  • Severe Cholestasis - 1:3,000 pregnant women
  • Severe haemolysis, elevated liver enzymes and low platelets (HELLP syndrome) requiring transfer to a liver transplant centre or specialised hepatopancreatobiliary(HPB) centre at best estimate represents less than 0.01% of pregnancies.

Patients with pre-existing cirrhosis and pregnancy represent approximately 0.003% of pregnancies, yet, to-date, less than 5 reliable publications exist in the literature to inform patient management.

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834285


Contacts
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Contact: Joe Montebello 0203 299 5303 ext 5303 j.montebello@nhs.net

Locations
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United Kingdom
King's College Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SE5 9RS
Contact: Michael Heneghan       michael.heneghan@nhs.net   
Sponsors and Collaborators
King's College Hospital NHS Trust
European Association for the Study of the Liver
Investigators
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Study Chair: Michael Heneghan King's College Hospital NHS Trust
More Information
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Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT03834285    
Other Study ID Numbers: 238575
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Cholestasis
Liver Cirrhosis
Cholestasis, Intrahepatic
HELLP Syndrome
Fibrosis
 Pathologic Processes
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Pregnancy Complications
Hypertension, Pregnancy-Induced