Liver Disease in Pregnancy

NCT03834285 | Unknown DMC

• 1 other identifier: 238575
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnancy study, so all participants must be female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Female patients older than 18 years of age, willing and able to sign written informed consent.
• 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
• Able to provide written informed consent
• Willing to provide access to records to necessary data can be collected.
• Willing to complete additional quality of life questionnaires as per protocol.
• Willing to consider donation of optional blood samples as per protocol.

You may not qualify if:

• \. Unable to provide written informed consent

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• European Association for the Study of the Liver: collaborator

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; HELLP Syndrome; Acute fatty liver of pregnancy; Intrahepatic Cholestasis of Pregnancy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Michael Heneghan

  King's College Hospital NHS Trust

  STUDY CHAIR

Central Study Contacts

Joe Montebello

CONTACT

0203 299 5303; j.montebello@nhs.net

Study Design

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

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 7, 2019
• Study Start: May 9, 2019
• Primary Completion: April 8, 2024
• Study Completion: April 8, 2025
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)