ABCB4 Gene Mutations in Intrahepatic Cholestasis of Pregnancy and Controls

June 16, 2010 updated by: University Hospital, Tours

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tours, France, 37044
        • Service de Gynécologie Obstétrique CHRU TOURS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
Normal multiparous pregnant women without intrahepatic cholestasis of pregnancy (control group)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Study Director: BACQ Yannick, MD, Service d'hépato-gastro-entérologie CHRU Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Estimate)

June 17, 2010

Last Update Submitted That Met QC Criteria

June 16, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOHP06-YB GEN CIG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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