RecruitingPhase 4ACTRN12618000332224

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

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.

Sponsor

University of Adelaide

Enrollment

108 participants

Start Date

Oct 30, 2019

Study Type

Interventional

Conditions

Severe early-onset intrahepatic cholestasis of pregnancy

Summary

Severe early-onset intrahepatic cholestasis of pregnancy (ICP), a recognised rare disease of pregnancy, is associated with increased rates of stillbirth, preterm birth and neonatal morbidity. The optimal treatment and management of women who are diagnosed with this condition are not known. We plan to compare a standard treatment used for cholestatic itch outside pregnancy (rifampicin) with a standard treatment of ICP (ursodeoxycholic acid - UDCA) to determine comparative safety and efficacy.

Eligibility

Sex: FemalesMin Age: 18 Yearss

Inclusion Criteria5

Pregnant women more than 14 weeks and less than 35 weeks gestation with serum bile acids >=40 umol/L
No known lethal fetal anomaly
Obstetric care in a consultant-led unit
Aged 18 years or over
Written informed consent has been obtained

Exclusion Criteria7

A decision has already been made for delivery within the next 48 hours
Allergy to any component of the UDCA or Rifampicin tablets
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, carrier status for Hepatitis B and C (normal liver transaminases using local pregnancy-specific ranges) or gestational diabetes
Current medication causing deranged liver enzymes
Previous participation in TURRIFIC

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Interventions

In women with severe (serum Bile Acids >=40 umol/L) early-onset (less than 35 weeks gestation), intrahepatic cholestasis of pregnancy, treatment with rifampicin oral tablets 300 mg twice daily up until delivery. Adherence to treatment will be assessed by the use of a medication dosing card diary, checked at each visit.