Trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study

Phase 4

Recruiting

• Conditions: Severe early-onset intrahepatic cholestasis of pregnancy; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

• Registration Number: ACTRN12618000332224
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-06
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 108

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in pruritus score, using a 100mm visual analogue scale[One week after trial entry, monthly thereafter, if randomised prior to 24 weeks gestation, and then weekly from 24 weeks gestation until delivery (primary timepoint)]

Secondary Outcome Measures

Name	Time	Method
Change in serum autotaxin[One week after trial entry, monthly thereafter, if randomised prior to 24 weeks gestation, and then weekly from 24 weeks gestation until delivery, and then finally at 6 weeks post partum.];Change in serum progesterone sulphated metabolites[One week after trial entry, monthly thereafter, if randomised prior to 24 weeks gestation, and then weekly from 24 weeks gestation until delivery, and then finally at 6 weeks post partum];Changes in urinary glucuronidated 6a-hydroxylated bile acids[One week after trial entry, monthly thereafter, if randomised prior to 24 weeks gestation, and then weekly from 24 weeks gestation until delivery, and then finally at 6 weeks post partum];Changes in maternal and neonatal stool microbiome/metabolome <br>[One week after trial entry, monthly thereafter, if randomised prior to 24 weeks gestation, and then weekly from 24 weeks gestation until delivery, and then finally at 1 and 6 weeks post partum]