Fatty LiverNCT00471575
Fatty Liver in Pregnancy
An observational study of Fatty Liver, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fatty Liver
- What is being tested?
- ultra sound examination
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Jun 2007to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Who may be able to join
- Pregnant women during the end of the pregnancy or immediately after birth (after 36 weeks)
Who cannot join
- Pregnant women before 36 weeks of pregnancy.
- Known diabetes or treatment by drugs known to cause fatty liver.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Assaf Harofeh Medical Center
Tsrifin, 70300
Efrat Broide, MD, 972-8-9779722, efibroide@yahoo.com
About this study
Official title: Prospective Observational Study
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.
Read the 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.
- Conditions
- Fatty Liver
- Being tested
- ultra sound examination
- Keywords
- 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.
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultra sound examinationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2007 (estimated)
- Study startJun 2007
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- efrat Broide, MD, Principal investigator, Ethic committee of Assaf Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471575
- Sponsor's protocol ID
- 38/07
- Status last verified
- Apr 2007
- First submitted
- 9 May 2007
- Last updated
- 15 May 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study
- ClinicalTrials.gov ID
- NCT00471575
- Acronym / sponsor ID
- 38/07
- Conditions
- Fatty Liver
- Keywords
- 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.
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jun 2007
- Study completion
- Dec 2007 (estimated)
- First posted
- 10 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women during the end of the pregnancy or immediately after birth (after 36 weeks)
Key exclusion criteria (2 listed)
- Pregnant women before 36 weeks of pregnancy.
- Known diabetes or treatment by drugs known to cause fatty liver.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultra sound examination | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
efrat Broide, MD principal investigator
Ethic committee of Assaf Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Liver, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Efrat Broide, MD (972-8-9779722, efibroide@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2007.