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

Plain Language Summary

Simplified for easier understanding

This trial — called the TURRIFIC study — is comparing two medications used to treat a serious pregnancy liver condition called intrahepatic cholestasis of pregnancy (ICP). ICP causes intense itching and increases the risk of stillbirth and premature birth. The two medications being compared are ursodeoxycholic acid (UDCA), the current standard treatment for ICP, and rifampicin, a medication used for itching in other liver conditions. The study aims to find out which treatment is safer and more effective for ICP. You may be eligible if: - You are a pregnant woman aged 18 or older - You are between 14 and 35 weeks pregnant - Your blood bile acid level is 40 µmol/L or above - You have no known lethal fetal abnormality - You are receiving obstetric care in a consultant-led unit You may NOT be eligible if: - A decision has already been made to deliver your baby within 48 hours - You are allergic to UDCA or rifampicin - You have active hepatitis A, B, or C - You have current pre-eclampsia - You have a known liver disorder (other than uncomplicated gallstones or a genetic bile acid condition) - You have taken medications that impair liver function Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.