A multi-centre, open label, randomised, parallel-group, superiority Trial to compare the efficacy of URsodeoxycholic acid with RIFampicin in the management of women with severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC randomised trial

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dc.contributor.author Hague, William M
dc.contributor.author Callaway, Leonie
dc.contributor.author Chambers, Jennifer
dc.contributor.author Chappell, Lucy
dc.contributor.author Coat, Suzette
dc.contributor.author de Haan-Jebbink, Jiska
dc.contributor.author Dekker, Marloes
dc.contributor.author Dixon, Peter
dc.contributor.author Dodd, Jodie
dc.contributor.author Fuller, Maria
dc.contributor.author Gordijn, Sanne
dc.contributor.author Graham, Dorothy
dc.contributor.author Heikinheimo, Oskari
dc.contributor.author Hennessy, Annemarie
dc.contributor.author Kaaja, Risto
dc.contributor.author Khong, Teck Y
dc.contributor.author Lampio, Laura
dc.contributor.author Louise, Jennie
dc.contributor.author Makris, Angela
dc.contributor.author Markus, Corey
dc.contributor.author Marschall, Hanns-Ulrich
dc.contributor.author Middleton, Philippa
dc.contributor.author Mol, Ben W
dc.contributor.author Morris, Jonathan
dc.contributor.author Newnham, John P
dc.contributor.author Ovadia, Caroline
dc.contributor.author Peek, Michael
dc.contributor.author Shand, Antonia
dc.contributor.author Stark, Michael
dc.contributor.author Thornton, Jim
dc.contributor.author Timonen, Susanna
dc.contributor.author Walker, Susan
dc.contributor.author Warrilow, David
dc.contributor.author Williamson, Catherine
dc.date.accessioned 2021-01-17T04:10:43Z
dc.date.available 2021-01-17T04:10:43Z
dc.date.issued 2021-01-12
dc.identifier.citation BMC Pregnancy and Childbirth. 2021 Jan 12;21(1):51
dc.identifier.uri http://hdl.handle.net/10138/324753
dc.description.abstract Abstract Background Severe early onset (less than 34 weeks gestation) intrahepatic cholestasis of pregnancy (ICP) affects 0.1% of pregnant women in Australia and is associated with a 3-fold increased risk of stillbirth, fetal hypoxia and compromise, spontaneous preterm birth, as well as increased frequencies of pre-eclampsia and gestational diabetes. ICP is often familial and overlaps with other cholestatic disorders. Treatment options for ICP are not well established, although there are limited data to support the use of ursodeoxycholic acid (UDCA) to relieve pruritus, the main symptom. Rifampicin, a widely used antibiotic including in pregnant women, is effective in reducing pruritus in non-pregnancy cholestasis and has been used as a supplement to UDCA in severe ICP. Many women with ICP are electively delivered preterm, although there are no randomised data to support this approach. Methods We have initiated an international multicentre randomised clinical trial to compare the clinical efficacy of rifampicin tablets (300 mg bd) with that of UDCA tablets (up to 2000 mg daily) in reducing pruritus in women with ICP, using visual pruritus scores as a measuring tool. Discussion Our study will be the first to examine the outcomes of treatment specifically in the severe early onset form of ICP, comparing “standard” UDCA therapy with rifampicin, and so be able to provide for the first-time high-quality evidence for use of rifampicin in severe ICP. It will also allow an assessment of feasibility of a future trial to test whether elective early delivery in severe ICP is beneficial. Trial identifiers Australian New Zealand Clinical Trials Registration Number (ANZCTR): 12618000332224p (29/08/2018). HREC No: HREC/18/WCHN/36. EudraCT number: 2018–004011-44. IRAS: 272398. NHMRC registration: APP1152418 and APP117853.
dc.publisher BioMed Central
dc.subject Intrahepatic cholestasis of pregnancy
dc.subject Cholestatic pruritus
dc.subject Bile acids
dc.subject Ursodeoxycholic acid
dc.subject Rifampicin
dc.subject Maternal and neonatal health outcomes
dc.title A multi-centre, open label, randomised, parallel-group, superiority Trial to compare the efficacy of URsodeoxycholic acid with RIFampicin in the management of women with severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC randomised trial
dc.date.updated 2021-01-17T04:10:43Z
dc.language.rfc3066 en
dc.rights.holder The Author(s)
dc.type.uri http://purl.org/eprint/entityType/ScholarlyWork
dc.type.uri http://purl.org/eprint/entityType/Expression
dc.type.uri http://purl.org/eprint/type/JournalArticle

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