Fatty Liver in Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00471575
First received: May 9, 2007
Last updated: May 13, 2007
Last verified: April 2007
  Purpose

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 Intervention
Fatty Liver
Procedure: ultra sound examination

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: Prospective Observational Study

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Study Start Date: June 2007
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471575

Contacts
Contact: Efrat Broide, MD 972-8-9779722 efibroide@yahoo.com

Locations
Israel
Assaf Harofeh Medical Center Not yet recruiting
Zerifin, Israel, 70300
Contact: Efrat Broide, MD    972-8-9779722    efibroide@yahoo.com   
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: efrat Broide, MD Ethic committee of Assaf Harofeh Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00471575     History of Changes
Other Study ID Numbers: 38/07
Study First Received: May 9, 2007
Last Updated: May 13, 2007
Health Authority: Israel: "The Ethic committee of Assaf Harofeh Medical Center"

Keywords provided by Assaf-Harofeh Medical Center:
fatty liver
pregnancy
ultra sound
Pregnant women at the end of pregnancy or immediately after birth.
controls-women with normal liver
correlation between ultrasonography and nutritional, obsthetric and laboratory data.

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 22, 2014