Status:
COMPLETED
The Metabolic Profile in Intrahepatic Cholestasis of Pregnancy and Diabetes Mellitus
Lead Sponsor:
Imperial College London
Conditions:
Intrahepatic Cholestasis of Pregnancy
Gestational Diabetes Mellitus
Eligibility:
FEMALE
16-70 years
Brief Summary
ICP is known to cause abnormal bile acid homeostasis and to be associated with an increased risk of diseases of the biliary system in later life. There have been small studies (Dann et al. 2006; Wójci...
Detailed Description
CLINICAL FEATURES OF INTRAHEPATIC CHOLESTASIS OF PREGNANCY: Intrahepatic cholestasis of pregnancy (ICP), is a pregnancy-specific liver disorder which typically presents with maternal pruritus (itchin...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Women with intrahepatic cholestasis of pregnancy, defined as pruritus in pregnancy in association with raised serum bile acids and in the absence of an alternative cause.
- Women with gestational diabetes mellitus (GDM) according to the diagnostic criteria used at the referring centre
- Non-pregnant parous females with previous ICP or GDM.
- Women who are able to give consent.
- Women \>16 and \<70 years of age. Controls
- Pregnant women not affected by ICP or GDM .
- Non-pregnant parous females with previous uncomplicated pregnancy.
- Women who are able to give consent.
- Women \>16 and \<70 years of age.
- Exclusion Criteria
- Males.
- Non-pregnant females with other medical disorders that can cause liver impairment, abnormal lipid or glucose metabolism in pregnancy, e.g. pre-eclampsia, acute fatty liver of pregnancy, pre-existing diabetes mellitus
- Pregnant females with a history of other medical disorders that can cause liver impairment, abnormal lipid or glucose metabolism in pregnancy, e.g. pre-eclampsia, acute fatty liver of pregnancy, pre-existing diabetes mellitus
- Women who are not able to give consent.
- Women \<16 and \>70 years of age.
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2023
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT01499524
Start Date
November 1 2011
End Date
April 30 2023
Last Update
April 3 2025
Active Locations (2)
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1
Guy's & St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH
2
Imperial College Healthcare NHS Trust Hammersmith
London, United Kingdom