ABCB4 Gene Mutations in Intrahepatic Cholestasis of Pregnancy and Controls

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00700232
First received: June 13, 2008
Last updated: June 16, 2010
Last verified: June 2010
  Purpose

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
Intrahepatic Cholestasis of Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mutations and Polymorphisms of Gene ABCB4 Among Women Suffering From Intrahepatic Cholestasis of Pregnancy. A Study With a Control Group.

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Biospecimen Retention:   Samples With DNA

blood samples


Enrollment: 120
Study Start Date: July 2006
Study Completion Date: July 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Normal multiparous pregnant women without intrahepatic cholestasis of pregnancy (control group)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00700232

Locations
France
Service de Gynécologie Obstétrique CHRU Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
Investigators
Study Director: BACQ Yannick, MD Service d'hépato-gastro-entérologie CHRU Tours
  More Information

No publications provided

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT00700232     History of Changes
Other Study ID Numbers: AOHP06-YB GEN CIG
Study First Received: June 13, 2008
Last Updated: June 16, 2010
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Tours:
genetics
gene expression
MDR3
estrogens
cholestasis
pregnancy
controls

Additional relevant MeSH terms:
Cholestasis
Cholestasis, Intrahepatic
Pregnancy Complications
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on August 19, 2014