Liver Disease in Pregnancy
Acute fatty liver of pregnancy / Posted 2 years ago
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.
Inclusion Criteria :
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Pregnancy study, so all participants must be female.
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
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 : Unable to provide written informed consent
- Study end date : 08/04/2025
- Wales-Based Study Contact : Please speak to your clinician
- Principal Investigator : Michael Heneghan