Fatty Liver in Pregnancy

Sponsor
Assaf-Harofeh Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00471575
Collaborator
(none)
1
6

Study Details

Study Description

Brief Summary

Non alcoholic fatty liver disease (NAFLD) is one of the main causes of development of chronic liver disease and cirrhosis. There are no published studies which have investigated the incidence of NAFLD in pregnant women or the correlation between the metabolic changes in pregnancy and this phenomenon.

We aimed in our study to explore the incidence of NAFLD in pregnancy by ultrasonography (US) during the end of the pregnancy or immediately after birth (after 36 weeks) and to look for a correlation between fatty liver and demographic, clinical, nutritional and laboratory data during pregnancy.

Condition or Disease Intervention/Treatment Phase
  • Procedure: ultra sound examination

Detailed Description

Fatty liver in pregnancy-protocol:

Non alcoholic fatty liver disease (NAFLD) is one of the main causes of development of chronic liver disease and cirrhosis. The incidence of NAFLD among the general population is about 17-30%. There are no published studies which have investigated the incidence of NAFLD in pregnant women or the correlation between the metabolic changes in pregnancy and this phenomenon.

We aimed in our study to explore the incidence of NAFLD in pregnancy by ultrasonography (US) during the end of the pregnancy or immediately after birth (after 36 weeks) and to look for a correlation between fatty liver and demographic, clinical, nutritional and laboratory data during pregnancy.

Methods: US examination will be performed by an experienced technician. The liver will be scanned by B mode US using a 2-5 MHZ transducer. In those with fatty liver as seen by US, a repeat examination will be performed after 6 weeks and 24 weeks. For women with the diagnosis of fatty liver, serum lipid profile, glucose, liver function tests and insulin will be done. Homa score as well as BMI will be calculated for each woman with fatty liver. All participants will sign an informed consent which has been approved by the hospital ethical committee.

Study Design

Study Type:
Observational
Observational Model:
Defined Population
Time Perspective:
Other
Official Title:
Prospective Observational Study
Study Start Date :
Jun 1, 2007
Anticipated Study Completion Date :
Dec 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:
    • Pregnant women during the end of the pregnancy or immediately after birth (after 36 weeks)
    Exclusion Criteria:
    • Pregnant women before 36 weeks of pregnancy.

    • Known diabetes or treatment by drugs known to cause fatty liver.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assaf Harofeh Medical Center Zerifin Israel 70300

    Sponsors and Collaborators

    • Assaf-Harofeh Medical Center

    Investigators

    • Principal Investigator: efrat Broide, MD, Ethic committee of Assaf Harofeh Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00471575
    Other Study ID Numbers:
    • 38/07
    First Posted:
    May 10, 2007
    Last Update Posted:
    May 15, 2007
    Last Verified:
    Apr 1, 2007

    Study Results

    No Results Posted as of May 15, 2007