Fatty Liver in Pregnancy

NCT ID: NCT00471575

Last Updated: 2007-05-15

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fatty Liver

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ultra sound examination

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

efrat Broide, MD

Role: PRINCIPAL_INVESTIGATOR

Ethic committee of Assaf Harofeh Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assaf Harofeh Medical Center

Ẕerifin, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Efrat Broide, MD

Role: CONTACT

972-8-9779722

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Efrat Broide, MD

Role: primary

972-8-9779722

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

38/07

Identifier Type: -

Identifier Source: org_study_id