ACTRN12618000332224招募中4 期
A randomised Trial of URsodeoxycholic acid versus RIFampicin in severe early-onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study, comparing their effectiveness in the reduction of pruritus.
niversity of Adelaide0 个研究点目标入组 108 人开始时间: 2018年3月6日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •Pregnant women more than 14 weeks and less than 34 weeks gestation with serum bile acids >=40 umol/L
- •No known lethal fetal anomaly
- •Singleton pregnancy
- •Obstetric care in a consultant-led unit
- •Aged 18 years or over
- •Written informed consent has been obtained
排除标准
- •A decision has already been made for delivery within the next 48 hours
- •Allergy to any component of the UDCA or Rifampicin tablets
- •Multi-fetal gestation
- •Laboratory-confirmed active hepatitis A or hepatitis B or carriage of hepatitis C,
- •Current pre-eclampsia
- •A known primary hepatic disorder, including alpha-1-antitrypsin deficiency and autoimmune liver disease, including primary biliary cholangitis, but NOT any of asymptomatic cholelithiasis, a known genetic disorder of bile acid transport, or gestational diabetes
- •Current medication causing deranged liver enzymes
- •Previous participation in TURRIFIC
研究者
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