跳至主要内容
临床试验/NCT02276144
NCT02276144Unknown不适用

Investigation on the Frequency and Obstetric Significance of Metabolic Syndrome and Non-alcoholic Fatty Liver During Pregnancy

Seoul National University Hospital3 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,400
试验地点
3
主要终点
Compare prevalence of obstetric complications between non-alcoholic fatty liver and normal pregnant women

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Do not agree with this study
  • Do not perform blood tests
  • Have underlying hepatobiliary diseases
  • Take medications which can cause liver abnormalities

结局指标

主要结局

Compare prevalence of obstetric complications between non-alcoholic fatty liver and normal pregnant women

时间窗: From date of enrollment until the date of delivery, assessed up to 35wks

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)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验