ABCB4 Gene Mutations in Intrahepatic Cholestasis of Pregnancy and Controls

NCT00700232 | Completed

• 1 other identifier: AOHP06-YB GEN CIG
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intrahepatic Cholestasis of Pregnancy

Keywords

genetics; gene expression; MDR3; estrogens; cholestasis; pregnancy; controls

Study Arms (1)

1

Normal multiparous pregnant women without intrahepatic cholestasis of pregnancy (control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

multiparous normal pregnant women (control group)from a single University center

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

Service de Gynécologie Obstétrique CHRU Tours

Tours, 37044, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Intrahepatic Cholestasis of Pregnancy; Cholestasis

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• BACQ Yannick, MD

  Service d'hépato-gastro-entérologie CHRU Tours

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 18, 2008
• Study Start: July 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2009
• Last Updated: June 17, 2010

Record last verified: 2010-06

Locations

FR (1)