ABCB4 Gene Mutations in Intrahepatic Cholestasis of Pregnancy and Controls

NCT ID: NCT00700232

Last Updated: 2010-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intrahepatic Cholestasis of Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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University Hospital, Tours

Principal Investigators

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BACQ Yannick, MD

Role: STUDY_DIRECTOR

Service d'hépato-gastro-entérologie CHRU Tours

Locations

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Service de Gynécologie Obstétrique CHRU Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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AOHP06-YB GEN CIG

Identifier Type: -

Identifier Source: org_study_id

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