European Registry for Liver Disease in Pregnancy
Research type
Research Study
Full title
European Registry for Liver Disease in Pregnancy
IRAS ID
238575
Contact name
Michael Heneghan
Contact email
Sponsor organisation
Kings College Hospital NHSFT
Duration of Study in the UK
5 years, 0 months, 1 days
Research 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 5 centers in the European Union. We will aim to collect data and blood samples at various time points, for patients presenting with liver disease during pregnancy and for patients with pre-existing cirrhosis (scarring) of the liver who become pregnant. The main rationale behind this study is to determine the characteristic physiological and biological changes of these rare conditions and establish a registry of data collected throughout pregnancy and delivery.
Each participant will be given the opportunity of donating an additional 15ml of blood at each visit, for storage in an ethics-approved biobank pending future ethics-approved research. It is hoped this future research, combined with the platform established in this study, will enable detailed review of the outcomes of these rare diseases. This will help classify and stratify patients according to risk and develop interventional studies and care pathways to improve overall outcome.
Additionally, this study will measure the mitochondrial DNA content of pregnant females with acute fatty liver of pregnancy. Mitochondrial DNA is a useful biological marker of disease and this aspect of the study will explore whether mitochondrial DNA content in the blood is related to the maternal disease state of acute fatty liver of pregnancy. This will be done by collecting additional 200uL blood samples at first presentation of liver disease and again at 3 months post-delivery.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
19/WM/0145
Date of REC Opinion
3 May 2019
REC opinion
Further Information Favourable Opinion