Status:
UNKNOWN
Liver Disease in Pregnancy
Lead Sponsor:
King's College Hospital NHS Trust
Collaborating Sponsors:
European Association for the Study of the Liver
Conditions:
Pregnancy Disease
Cirrhosis, Liver
Eligibility:
FEMALE
18+ years
Brief 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 ...
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 duri...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 1\. Unable to provide written informed consent
Key Trial Info
Start Date :
May 9 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 8 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03834285
Start Date
May 9 2019
End Date
April 8 2025
Last Update
March 27 2020
Active Locations (1)
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1
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS