Cirrhosis, Liver Clinical Trial
Official title:
EASL: European Registry of Liver Disease in Pregnancy
NCT number | NCT03834285 |
Other study ID # | 238575 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 9, 2019 |
Est. completion date | April 8, 2025 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College Hospital NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
King's College Hospital NHS Trust | European Association for the Study of the Liver |
United Kingdom,
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 |
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