ABCB4 Gene Mutations in Intrahepatic Cholestasis of Pregnancy and Controls
|ClinicalTrials.gov Identifier: NCT00700232|
Recruitment Status : Completed
First Posted : June 18, 2008
Last Update Posted : June 17, 2010
Mutations of the ATP binding cassette subfamily B member 4 (ABCB4) gene, a gene involved in a subtype of progressive familial intrahepatic cholestasis, have been reported in women suffering from intrahepatic cholestasis of pregnancy. The true incidence and the role of these ABCB4 gene mutations in patients suffering from intrahepatic cholestasis of pregnancy have not been clearly established.
The aim of the present study is to describe the nature and frequency of these mutations in a series of patients with intrahepatic cholestasis of pregnancy and to compare with a control group of pregnant women without intrahepatic cholestasis of pregnancy.
|Condition or disease|
|Intrahepatic Cholestasis of Pregnancy|
Intrahepatic cholestasis of pregnancy was defined by pruritus and elevated serum alanine aminotransferase activity or bile acid concentration, with recovery after delivery. Patients with intercurrent liver disease were excluded.
The entire ABCB4 gene coding sequence and the promoter region were analyzed, during the routine medical management, by single strand conformation polymorphism and/or sequencing in 50 unrelated Caucasian patients with intrahepatic cholestasis of pregnancy.
The genomic variants detected in these patients with intrahepatic cholestasis of pregnancy will be sought in 100 control women from Caucasian origin recruited in the same hospital.
|Study Type :||Observational|
|Actual Enrollment :||120 participants|
|Official Title:||Mutations and Polymorphisms of Gene ABCB4 Among Women Suffering From Intrahepatic Cholestasis of Pregnancy. A Study With a Control Group.|
|Study Start Date :||July 2006|
|Primary Completion Date :||July 2008|
|Study Completion Date :||July 2009|
Normal multiparous pregnant women without intrahepatic cholestasis of pregnancy (control group)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700232
|Service de Gynécologie Obstétrique CHRU Tours|
|Tours, France, 37044|
|Study Director:||BACQ Yannick, MD||Service d'hépato-gastro-entérologie CHRU Tours|