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. - TURRIFIC Protocol Version 8

The University Of Adelaide0 个研究点目标入组 108 人开始时间: 2020年5月28日最近更新: 2020年8月18日

试验速览

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•Women will be considered eligible for inclusion into the trial with the following criteria:
•Severe ICP (defined as pruritus with raised total serum BA =40 µmol/L) confirmed
•Viable pregnancy between 14+0 and 33+6 weeks gestation inclusive
•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
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 108
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•A potential participant who meets any of the following criteria will be excluded from participation in this study:
•A decision has already been made for delivery within the next 48 hours
•There is allergy to any component of the UDCA or RIF tablets
•The woman is taking other medication that has a significant interaction with rifampicin treatment
•There is a multi-fetal gestation
•There is laboratory-confirmed active hepatitis A or hepatitis B, or positive serology for hepatitis C
•There is current pre-eclampsia (ISSHP criteria)
•There is a known primary hepatic disorder, including a-1-antitrypsin deficiency and autoimmune hepatitis, including primary biliary cholangitis
•The woman is on current medication causing deranged liver enzymes
•The woman is unwilling for her baby to have standard Vitamin K administration at birth
•The woman has previously participated in TURRIFIC

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