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Clinical Trial Details — Status: Recruiting

Administrative data

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

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
Health authority
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:

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Study Design


Related Conditions & MeSH terms


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
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