Pregnancy DiseaseNCT03834285
Liver Disease in Pregnancy
An observational study of Pregnancy Disease and Cirrhosis, Liver, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Disease, Cirrhosis, Liver, HELLP Syndrome
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 May 2019to 8 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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: * Acute Fatty Liver affects 1:20,000 pregnant women * Severe Cholestasis - 1:3,000 pregnant women * Severe haemolysis, elevated liver enzymes and low platelets (HELLP syndrome) requiring transfer to a liver transplant centre or specialised hepatopancreatobiliary(HPB) centre at best estimate represents less than 0.01% of pregnancies. 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.
Who may be able to join
- Female patients older than 18 years of age, willing and able to sign written informed consent.
- 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
Show all 10Show fewer
- Able to provide written informed consent
- Willing to provide access to records to necessary data can be collected.
- Willing to complete additional quality of life questionnaires as per protocol.
- Willing to consider donation of optional blood samples as per protocol.
Who cannot join
- 1. Unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Michael Heneghan, michael.heneghan@nhs.net
About this study
Official title: EASL: European Registry of Liver Disease in Pregnancy
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.
Read the detailed description
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.
- 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.
Secondary Objectives
- 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.
- Conditions
- Pregnancy Disease, Cirrhosis, Liver, HELLP Syndrome, AFLP - Acute Fatty Liver of Pregnancy, Intrahepatic Cholestasis of Pregnancy
- Medical subject headings
- Liver Cirrhosis, HELLP Syndrome, Acute fatty liver of pregnancy, Intrahepatic Cholestasis of Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Data to be collected from pre-pregnancy to 3 months post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start9 May 2019
- Primary completion8 Apr 2024 (estimated)
- Study completion8 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- European Association for the Study of the Liver
- Responsible party
- Sponsor
- Investigators
- Michael Heneghan, Study chair, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834285
- Sponsor's protocol ID
- 238575
- Status last verified
- Mar 2020
- First submitted
- 5 Feb 2019
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EASL: European Registry of Liver Disease in Pregnancy
- ClinicalTrials.gov ID
- NCT03834285
- Acronym / sponsor ID
- 238575
- Conditions
- Pregnancy Disease, Cirrhosis, Liver, HELLP Syndrome, AFLP - Acute Fatty Liver of Pregnancy, Intrahepatic Cholestasis of Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- European Association for the Study of the Liver
- Study start
- 9 May 2019 (actual)
- Primary completion
- 8 Apr 2024 (estimated)
- Study completion
- 8 Apr 2025 (estimated)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- 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.
Secondary Objectives
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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: * Acute Fatty Liver affects 1:20,000 pregnant women * Severe Cholestasis - 1:3,000 pregnant women * Severe haemolysis, elevated liver enzymes and low platelets (HELLP syndrome) requiring transfer to a liver transplant centre or specialised hepatopancreatobiliary(HPB) centre at best estimate represents less than 0.01% of pregnancies. 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.
Key inclusion criteria (10 listed)
- Female patients older than 18 years of age, willing and able to sign written informed consent.
- Pregnant and presenting with any one of the following conditions (confirmed by local diagnosis):
- Able to provide written informed consent
- Willing to provide access to records to necessary data can be collected.
- Willing to complete additional quality of life questionnaires as per protocol.
Key exclusion criteria (1 listed)
- 1. Unable to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Heneghan study chair
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Disease and Cirrhosis, Liver, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joe Montebello (0203 299 5303 ext. 5303, j.montebello@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.