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临床试验/CTRI/2025/09/095093
CTRI/2025/09/095093尚未招募不适用

Study of Liver Disorders in Pregnancy and Fetomaternal Outcomes

Dr Vangala Uday Kumar1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
To study the Prevalence and Differentiating between common causes of pregnancy related liver diseases.

研究概览

简要总结

Liver disease in pregnancy can have serious consequences and can be a challenge

for health care providers. The cause of liver disease in pregnancy may be difficult to

diagnose and making the correct diagnosis is of paramount importance, as failure to

do so can result in morbidity or mortality for not only the mother but also for her

fetus.

Although there are alterations in normal physiological and hormonal profiles

throughout the pregnancy, there are few alterations in the results of standard liver

tests, however up to 3% of all pregnancies are complicated by liver disorders.

Severe liver disease, although rare, can occur and leads to increased morbidity and

mortality for both mother and newborn infant.The amino-transferases (AST and

ALT), G-glutamyl transpeptidase (GGTP), total bilirubin, and serum bile acid level

remain within the normal range. The alkaline phosphatase rises modestly in the third

trimester. The albumin level is lower than in non pregnant women, and the

cholesterol level is higher.

Liver involvement in pregnancy is of three types, namely liver disease unique to

pregnancy, liver disease coincidental to pregnancy, and pregnancy in patients with

pre-existing liver disease. The liver diseases unique to pregnancy include

hyperemesis gravidarum, acute fatty liver of pregnancy, Intrahepatic cholestasis of

pregnancy (ICP), and pregnancy induced hypertension (PIH) related dysfunction

including pre-eclampsia and HELLP syndrome ( hemolysis, elevated liver enzymes

and low platelets). Liver disease such as acute viral hepatitis can occur in pregnancy,

and pregnancy may occur in a patient with underlying chronic liver disease,including patients with cirrhosis and portal hypertension, and patients who have

undergone liver transplantation.

There are only very few studies available about the frequency, etiological profile,

outcome, and management guidelines for pregnancy related liver disease in India.

We therefore will prospectively study the spectrum of liver disease in pregnancy and

their maternal and fetal outcome

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
Female

入选标准

  • pregnant women attending antenatal clinic.

排除标准

  • women whose foetuses were diagnosed with structural or chromosomal anomaly patients not willing for study.

结局指标

主要结局

To study the Prevalence and Differentiating between common causes of pregnancy related liver diseases.

时间窗: During Antenatal Period and Post Partal period Upto 6 weeks

次要结局

未报告次要终点

研究者

发起方
Dr Vangala Uday Kumar
申办方类型
Other [observational study ]
责任方
Principal Investigator
主要研究者

Dr Vangala uday kumar

Jawaharlal Nehru Medical Collage Wardha

研究点 (1)

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