An observational study in Pregnancy Disease, Cirrhosis, Liver and HELLP Syndrome, sponsored by King's College Hospital NHS Trust. Recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-27.
Sponsored by King's College Hospital NHS Trust · Observational
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.
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.
Secondary Objectives
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.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's planned enrollment of 100 is below the median of 171 across 526 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →King's College Hospital NHS Trust is the lead sponsor of 171 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pregnant and presenting with any one of the following conditions (confirmed by local diagnosis):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cirrhotic patients with a confirmed pregnancy will be placed into Cohort 1.
Patients who develop Acute Fatty Liver of Pregnancy, HELLP Syndrome / Intrahepatic Cholestasis of pregnancy will be placed into Cohort 2.
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)
Time frame: Data to be collected from pre-pregnancy to 3 months post-delivery
Plan to share: No
No publications or documents are linked to this record.
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