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临床试验/CTRI/2024/03/063580
CTRI/2024/03/063580已完成Unknown

Effect of ursodeoxycholic acid on abnormal liver enzymes and their association with maternal and foetal outcomes in intrahepatic cholestasis of pregnancy

SGT MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月20日最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
PRE TEST AND POST TEST OF LIVER ENZYME WILL BE DONE

研究概览

简要总结

Ø Intrahepatic cholestasis of pregnancy (IHCP) is the most common pregnancy-specific liver disease. It classically presents in the late second or early third trimester of pregnancy with pruritis, which typically involves the palms and soles, and is associated with deranged liver functions and elevated serum bile acids.

Ø Altered bile acid metabolism with an accumulation of bile acid is detrimental to the foetus leading to increased perinatal morbidity and mortality in the form of preterm birthsmeconiumfoetal distress, and stillbirths or intra-uterine death.

 Ã˜ A lot of work and research has been done but still, many questions remain unanswered as there is a constant fear of sudden foetal demise nearing term without any alarming signs and critical cut-off level of serum bile acid beyond which pregnancy should be terminated.

As As per the latest data, in Indian Asians, the incidence ranges from 1.2 to 1.5%. It is also seen that more than 70% of IHCP occurs in the third trimester of pregnancy.

Ø Recent studies believed that elevated BA levels can influence lipid and glucose metabolism in women with ICP.

Ø Based on the results of several meta-analyses, it is revealed that women with ICP were more likely to have gestational diabetes mellitus (GDM).

Ø Previous studies reported that ICP was not related to dyslipidaemia but some produces opposite results.

Therefore, this study is aimed to estimate the biochemical parameters associated with adverse foetal and maternal outcome so that we can come to a conclusion that whether this disease has association with liver, glucose and lipid metabolism. This will also help in developing novel targets for its management.

Ø This study is also undertaken to know the current trends of foetal and maternal outcomes associated with intrahepatic cholestasis so that increased attention will be diverted to the important causative factors and foeto-maternal outcomes can be improved.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Singleton pregnant women with ≥20 weeks of gestation and having pruritis and serum bile acid of 10micromol/L or more.

排除标准

  • Multifetal pregnancies
  • Maternal/foetal heart disorders
  • Liver disorder: Hepatitis C, Hepatitis B, Cholelithiasis
  • Medication for any dermatological disease, which can cause itching.

结局指标

主要结局

PRE TEST AND POST TEST OF LIVER ENZYME WILL BE DONE

时间窗: Baseline, 2 weeks and time of delivery

次要结局

  • NA(NA)

研究者

发起方
SGT MEDICAL COLLEGE
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr. Rashmi Ray

SGT University

研究点 (1)

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