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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02276144
Other study ID # Fatty liver in pregnancy
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2014
Est. completion date December 2021

Study information

Verified date April 2019
Source Seoul National University Hospital
Contact JEONGEUN Kwon, MD
Phone 82-02-2072-3085
Email ccoolicoola@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluate the prevalence of metabolic syndrome, liver function abnormality and non-alcoholic fatty liver disease in early pregnancy patients, and the risk of pregnancy complications.


Description:

In cases in which metabolic syndrome and non-alcoholic fatty liver are risk factors of obstetric complications, such as gestational diabetes (GDM) or preeclampsia (PE), we are able to offer systematic clinical results from determining the independent risk factor and developing a predictable model. Recently, obstetric complications, especially GDM and PE, have increased due to the growth of elder pregnancy. In addition, as liver dysfunction has been known to be an independent risk factor of diabetes, cardiovascular disease, high blood pressure and renal dysfunction, its clinical importance has risen. Metabolic syndromes, such as obesity, hypertension, type II diabetes and abnormal lipid profile, have been known for its importance in development of non-alcoholic fatty liver disease. Considering abnormal liver function being an independent risk factor of diabetes, cardiovascular disease, high blood pressure and renal dysfunction in normal adult patients, we are able to predict that liver dysfunction might be a high risk factor of obstetric complications in pregnant women. In previous studies, the frequency of liver dysfunction in normal pregnant women was obtained.

The purpose of this current study was to investigate the prevalence of metabolic syndrome, abnormal liver function and non-alcoholic fatty liver in early pregnancy and the related risks of obstetric complications.


Recruitment information / eligibility

Status Recruiting
Enrollment 2400
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Outpatient clinic patients of Seoul National University Hospital, Seoul Metropolitan Government Boramae Medical Center, Incheon Seoul Woman Hospital

- Agree with this study

- Do not drink excess amount of alcohol for recent 2 years

Exclusion Criteria:

- Do not agree with this study

- Do not perform blood tests

- Have underlying hepatobiliary diseases

- Take medications which can cause liver abnormalities

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Liver ultrasound
For evaluate whether fatty liver is exist or not

Locations

Country Name City State
Korea, Republic of Seoul Women's Hospital Incheon
Korea, Republic of Seoul Metropolitan Goverment Seoul National University Boramae Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compare prevalence of obstetric complications between non-alcoholic fatty liver and normal pregnant women Obstetrical complications include gestational diabetes, preeclampsia, etc Non-alcoholic fatty liver diagnosed by using liver ultrasound result of 1st trimester and blood test (AST, APT) From date of enrollment until the date of delivery, assessed up to 35wks
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