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临床试验/CTRI/2025/12/098391
CTRI/2025/12/098391招募中不适用

Assessment of liver stiffness by fibroscan in pregnant women of 1st trimester with pre gestational diabetes mellitus without known hepatic pathology for early diagnosis of liver disorders

ICMR1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年12月13日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
ICMR
入组人数
96
试验地点
1

研究概览

简要总结

This is an observational study using convenient sampling technique to observe the results of fibroscan on pre gestational diabetic women of 1st trimester without any known hepatic pathology. This study aims to assess the liver stiffness and its relation with insulin resistance using fibroscan as a non invasive diagnostic tool . The fetal and maternal outcomes will be studied and effects of altered fibroscan results on them.The first change that occurs in pregnant individuals with pre gestational diabetes mellitus is fall in fasting glucose levels , followed by insulin resistance and glucose intolerance potentially causing liver derived metabolic complications , complications like pre eclampsia, preterm birth and affect both fetal and maternal health.

Fibroscan is a diagnostic modality that uses transient elastography which  has 10 times smaller sampling error (3%) and

better inter observer reliability in contrast to liver biopsy.

The study will be conducted on pregnant women with pre gestational diabetes mellitus(PGDM) without known hepatic pathology in the first trimester of pregnancy attending the antenatal opd and wards of a tertiary health care centre. Since there is limited longitudinal data , further research is required to determine the specific contribution of insulin resistance to liver stiffness.

This study aims to study the risk posed by pre gestational diabetes mellitus in development and progression of liver disease in pregnant woman with emphasis on the potential role of fibroscan for early detetction of steatosis/ fibrosis in pregnancies complicated by pregestational diabetes mellitus.

研究设计

研究类型
Observational

入排标准

年龄范围
21.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • All pregnant women in first trimester with pre gestational diabetes mellitus.

排除标准

  • Patients with known hepatic pathology like chronic liver diseases, liver cirrhosis, auto immune hepatitis, hepatocellular carcinoma etc.

研究者

发起方
ICMR
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Aadrita Bishnu

Jawaharlal Nehru Medical College

研究点 (1)

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