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
Coat Suzette; Newnham John P.; Louise Jennie; Markus Corey; Makris Angela; Peek Michael; Kaaja Risto; Callaway Leonie; Chappell Lucy; Chambers Jennifer; Mol Ben W.; Hennessy Annemarie; Lampio Laura; de Haan-Jebbink Jiska; Graham Dorothy; Timonen Susanna; Stark Michael; Fuller Maria; Thornton Jim; Dixon Peter; Williamson Catherine; Hague William M.; Warrilow David; Ovadia Caroline; Khong Teck Yee; Dodd Jodie; Gordijn Sanne; Middleton Philippa; Marschall Hanns-Ulrich; Morris Jonathan; Heikinheimo Oskari; Dekker Marloes; Walker Susan; Shand Antonia
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
Coat Suzette
Newnham John P.
Louise Jennie
Markus Corey
Makris Angela
Peek Michael
Kaaja Risto
Callaway Leonie
Chappell Lucy
Chambers Jennifer
Mol Ben W.
Hennessy Annemarie
Lampio Laura
de Haan-Jebbink Jiska
Graham Dorothy
Timonen Susanna
Stark Michael
Fuller Maria
Thornton Jim
Dixon Peter
Williamson Catherine
Hague William M.
Warrilow David
Ovadia Caroline
Khong Teck Yee
Dodd Jodie
Gordijn Sanne
Middleton Philippa
Marschall Hanns-Ulrich
Morris Jonathan
Heikinheimo Oskari
Dekker Marloes
Walker Susan
Shand Antonia
BMC
Julkaisun pysyvä osoite on:
https://urn.fi/URN:NBN:fi-fe2021042823431
https://urn.fi/URN:NBN:fi-fe2021042823431
Tiivistelmä
BackgroundSevere early onset (less than 34weeks 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.MethodsWe have initiated an international multicentre randomised clinical trial to compare the clinical efficacy of rifampicin tablets (300mg bd) with that of UDCA tablets (up to 2000mg daily) in reducing pruritus in women with ICP, using visual pruritus scores as a measuring tool.DiscussionOur 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 identifiersAustralian 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.
Kokoelmat
- Rinnakkaistallenteet [19207]