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NCT00471575 Clinical Trial

Fatty Liver in Pregnancy

Fatty Liver Clinical Trial

Official title:
Prospective Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00471575
Other study ID # 38/07
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 9, 2007
Last updated May 13, 2007
Start date June 2007
Est. completion date December 2007

Study information
Verified date April 2007
Source Assaf-Harofeh Medical Center
Contact Efrat Broide, MD
Phone 972-8-9779722
Email efibroide@yahoo.com
Is FDA regulated No
Health authority Israel: "The Ethic committee of Assaf Harofeh Medical Center"
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 0
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Procedure:
• ultra sound examination

Locations
Country Name City State
Israel Assaf Harofeh Medical Center Zerifin

Sponsors (1)
Lead Sponsor Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

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