Effect of ursodeoxycholic acid on abnormal liver enzymes and their association with maternal and foetal outcomes in intrahepatic cholestasis of pregnancy
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 births, meconium, foetal distress, and stillbirths or intra-uterine death.
Ø 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
Dr. Rashmi Ray
SGT University
