Liver Disease in Pregnancy
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|ClinicalTrials.gov Identifier: NCT03834285|
Recruitment Status : Recruiting
First Posted : February 7, 2019
Last Update Posted : March 27, 2020
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.
|Condition or disease|
|Pregnancy Disease Cirrhosis, Liver HELLP Syndrome AFLP - Acute Fatty Liver of Pregnancy Intrahepatic Cholestasis of Pregnancy|
The objectives of the study are as follows:
To determine the characteristic physiological and biological changes exhibited by females who develop the following liver diseases during pregnancy.
- Acute fatty liver of pregnancy
- Severe cholestasis of pregnancy
- Severe HELLP syndrome/hypertensive disease
- Pre-existing cirrhosis and pregnancy This will be determined through analysis of the standard of care imaging (Liver Ultrasound and Transient Elastography) and blood results (liver function tests, white blood cells, platelets and scoring systems for assessing the severity of liver disease (ALBI, APRI, FIB4 and ELF scores). These results will be analysed over the course of the participant's pregnancy and again at delivery, to explore any particularly distinguishing parameter changes for each disease group.
- To determine the change in the reported quality of life of these participants either from diagnosis of pregnancy-associated liver disease or confirmation of pregnancy for pre-existing cirrhotic patients - up to 3 months' post-delivery.
- To determine the mitochondrial DNA content of blood from patients with Acute Fatty Liver of Pregnancy.
- Create an associated pan-European bio-resource (whole blood and serum) collection, which will offer an opportunity for ongoing collaborative translational research. Each participant will be given the option of donating additional research samples (15ml) of blood at each visit under the study for the bio-resource.
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||EASL: European Registry of Liver Disease in Pregnancy|
|Actual Study Start Date :||May 9, 2019|
|Estimated Primary Completion Date :||April 8, 2024|
|Estimated Study Completion Date :||April 8, 2025|
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.
- Overall maternal and fetal health during pregnancy and post-delivery in females with liver disease [ Time Frame: Data to be collected from pre-pregnancy to 3 months post-delivery ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834285
|Contact: Joe Montebello||0203 299 5303 ext firstname.lastname@example.org|
|King's College Hospital NHS Foundation Trust||Recruiting|
|London, United Kingdom, SE5 9RS|
|Contact: Michael Heneghan email@example.com|
|Study Chair:||Michael Heneghan||King's College Hospital NHS Trust|