Liver Disease in Pregnancy

Cirrhosis, Liver Clinical Trial

Official title:

EASL: European Registry of Liver Disease in Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03834285
• Other study ID #: 238575
• Status: Recruiting
• Start date: May 9, 2019
• Est. completion date: April 8, 2025

Study information

• Verified date: March 2020
• Source: King's College Hospital NHS Trust
• Contact: Joe Montebello
• Phone: 0203 299 5303
• Email: j.montebello[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 8, 2025
• Est. primary completion date: April 8, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AFLP - Acute Fatty Liver of Pregnancy
• Cholestasis
• Cholestasis, Intrahepatic
• Cirrhosis, Liver
• Fatty Liver
• HELLP Syndrome
• Intrahepatic Cholestasis of Pregnancy
• Liver Cirrhosis
• Liver Diseases
• Pregnancy Disease

Locations

Country	Name	City	State
United Kingdom	King's College Hospital NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust	European Association for the Study of the Liver

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall maternal and fetal health during pregnancy and post-delivery in females with liver disease	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)	Data to be collected from pre-pregnancy to 3 months post-delivery