ABCB4 Gene Mutations in Intrahepatic Cholestasis of Pregnancy and Controls

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.

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Key information

Conditions

Intrahepatic Cholestasis of Pregnancy Bile Duct Diseases Biliary Tract Diseases Cholestasis Digestive System Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Service de Gynécologie Obstétrique CHRU Tours

Tours, 37044, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

For the control group :

Inclusion criteria

pregnant woman (age > 18 years) during the third trimester
caucasian and born in France
multiparous (with at least 2 full term pregnancies)
with informed written consent

Exclusion criteria

generalized pruritus and/or liver disease during pregnancy
liver disease secondary to oral contraception
Chronic liver disease
disease during current pregnancy

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Mutations and Polymorphisms of Gene ABCB4 Among Women Suffering From Intrahepatic Cholestasis of Pregnancy. A Study With a Control Group.

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2009
First posted: Jun 18, 2008
Registry last updated: Jun 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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