An observational study in Cholestasis of Pregnancy, sponsored by Alexandra Hospital, Athens, Greece. Status unknown at 1 site in Greece. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-02.
Sponsored by Alexandra Hospital, Athens, Greece · Observational
To assess the occurrence of 11 SNP's in ABCB11 and ABCB4 genes in Greek women with ICP compared with healthy pregnant women. Moreover, these genetic polymorphisms will be examined in their first-degree relatives.
Introduction: ICP is commolnly manifested in the 2nd and especially in the 3rd trimester of pregnancy. Pathogenesis of ICP is multifactorial implicating genetic, environmental and hormonologic factors. Prevalence of ICP varies. In certain populations in latin America occurrence of ICP is up to 15% of pregnancies. In Caucasian populations incidence of ICP is approximately 1% of pregnancies. Data for the Greek population are scarce. Genes ABCB4 and ABCB11 that are encoding transport proteins in the hepatocyte are implicated in the pathogenesis of ICP.
Aim of the Study: To study the genetic polymorphisms in pregnant women with ICP and in their first degree relatives Patients and Methods: To recruit 100 women with ICP. Analyze the occurrence of 11 SNP's in ABCB11 and ABCB4 genes in women with ICP. As control group will be used pregnant women without ICP or known hepatic disease. In these women the same analysis for SNP's as in women with ICP will be performed. Exclusion criteria: women with known hepatic disease ( HBV, HCV, HIV, HEV, Autoimmune Hepatitis, Drug induced liver injury, cirrhosis) and women with pregnancy related liver disease (pre-eclampsia, acute fatty liver of pregnancy or HELLP syndrome) Inclusion criteria: pregnant women with ICP. Detailed report of medical history, laboratory and clinical data regarding women and the pregnancy. Follow up of laboratory values before and after the begging of treatment with UDCA.
220 studies on the registry are indexed under Cholestasis; 37 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 65 observational studies indexed under Cholestasis.
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pregnant women with ICP. Detailed report of medical history, laboratory and clinical data regarding women and the pregnancy. Follow up of laboratory values before and after the begging of treatment with UDCA.
Exclusion Criteria:
To study the genetic polymorphisms in pregnant women with ICP and in their first degree relatives
Drug: ursofalk
To study the genetic polymorphisms in pregnant women with ICP treated with ursoflak and in their first degree relatives
genetic polymorphisms in pregnant women with ICP and in their first degree relatives
Time frame: 01/01/2018-31/01/2021
Plan to share: Undecided
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Alexandra Hospital, Athens, Greece