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

Autor: Catherine Williamson, Peter H. Dixon, Jennifer Chambers, Jonathan M. Morris, Laura Lampio, Leonie K. Callaway, John P. Newnham, Jodie M Dodd, David Warrilow, Susan P. Walker, Oskari Heikinheimo, Risto Kaaja, William M. Hague, Jennie Louise, Michael Stark, Jiska de Haan-Jebbink, Dorothy Graham, T. Y. Khong, Sanne J. Gordijn, Jim G Thornton, Corey Markus, Ben W.J. Mol, Caroline Ovadia, Susanna Timonen, Lucy C Chappell, Maria Fuller, Angela Makris, Antonia W. Shand, Michael J. Peek, Marloes Nitert Dekker, Philippa Middleton, Suzette Coat, Annemarie Hennessy, Hanns-Ulrich Marschall
Přispěvatelé: HUS Gynecology and Obstetrics, Clinicum, Department of Obstetrics and Gynecology, University of Helsinki, Helsinki University Hospital Area
Rok vydání: 2021
Předmět:
medicine.medical_specialty
Maternal and neonatal health outcomes
Cholestatic pruritus
Cholestasis
Intrahepatic
lcsh:Gynecology and obstetrics
Study Protocol
03 medical and health sciences
0302 clinical medicine
Superiority Trial
Cholestasis
Pregnancy
3123 Gynaecology and paediatrics
Intrahepatic cholestasis of pregnancy
Internal medicine
medicine
Humans
030212 general & internal medicine
lcsh:RG1-991
Rifampicin
030219 obstetrics & reproductive medicine
integumentary system
business.industry
musculoskeletal
neural
and ocular physiology
Australia
Pregnancy Outcome
Obstetrics and Gynecology
Antipruritics
medicine.disease
Bile acids
Ursodeoxycholic acid
3. Good health
Pregnancy Complications
Clinical trial
Gestational diabetes
Treatment Outcome
Gestation
Female
Rifampin
business
Cholestasis of pregnancy
medicine.drug
Zdroj: BMC Pregnancy and Childbirth
BMC Pregnancy and Childbirth, Vol 21, Iss 1, Pp 1-14 (2021)
ISSN: 1471-2393
Popis: 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.
Databáze: OpenAIRE
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