CTRI/2018/10/016128招募中不适用
To investigate correlation between raised serum bile acid levels in pregnancies affected with Intrahepatic Cholestasis of Pregnancy and adverse perinatal outcome.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- To evaluate maternal and neonatal outcomes in Intrahepatic Cholestasis of pregnancy with Serum Bile Acids less than 40 micro mol per litre
研究概览
简要总结
Patients fulfilling the inclusion and exclusion criteria for intrahepatic cholestasis of pregnancy will be recruited in the study followed by monitoring of serum bile acids and liver function tests every fortnightly. The decision for deliver will be taken on the basis of serum bile acid level and maternal , fetal or other complication. The patients will be followed until delivery and maternal and neonatal outcomes would be recorded.
24/11/19
the study is still in the recruiting phase as the desired sample size has not been achieved.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women presenting with pruritis with elevated liver enzymes Primigravida or Multigravida Spontaneous or IVF conception Singleton or Twins.
排除标准
- •History of cholelithiasis Chronic liver disease Hepatitis A,B,C,E Any other cause of raised liver function tests Dermatological cause of pruritis Allergic disorder Pre eclampsia and HELLP Patient refusal Patient with pruritis but no elevation of liver enzymes Pregnancy ending before 24 weeks gestation.
结局指标
主要结局
To evaluate maternal and neonatal outcomes in Intrahepatic Cholestasis of pregnancy with Serum Bile Acids less than 40 micro mol per litre
时间窗: Until delivery
次要结局
- To determine the optimal timing of delivery with close monitoring in these patients(40 weeks gestation)
- To determine the frequency of serum bile acid measurement in these patients(2 weeks)
研究者
研究点 (1)
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