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.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000332224

Acronym

TURRIFIC

Enrollment

Registered

2018-03-06

Start date

2019-10-30

Completion date

2026-06-30

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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 criteria

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

Outcome results