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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. | Authors: | Ovadia C.;Lampio L.;Louise J.;Makris A.;Markus C.;Marschall H.-U.;Middleton P.;Mol B.W. ;Morris J.;Newnham J.P.;Khong T.Y.;Peek M.;Shand A.;Stark M.;Thornton J.;Timonen S.;Walker S.;Warrilow D.;Williamson C.;Chambers J.;Chappell L.;Coat S.;de Haan-Jebbink J.;Dekker M.;Dixon P.;Dodd J.;Fuller M.;Gordijn S.;Graham D.;Heikinheimo O.;Hennessy A.;Kaaja R.;Hague W.M.;Callaway L. | Institution: | (Hague, Coat, Dodd, Fuller, Khong, Louise, Middleton, Stark) Robinson Research Institute, The University of Adelaide, 55 King William Road, North Adelaide, SA 5006, Australia (Hague, Stark) Obstetric Medicine, Women's and Babies' Division, Women's and Children's Hospital, 72 King William Road, North Adelaide, SA 5006, Australia (Callaway) Gynaecology, Oncology & Obstetric Medicine, Royal Brisbane and Women's Hospital, Herston, QLD 4029, Australia (Callaway, Dekker) The University of Queensland, Brisbane, QLD 4072, Australia (Chambers, Chappell, Dixon, Ovadia, Williamson) Women and Children's Health, King's College London, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, United Kingdom (de Haan-Jebbink, Gordijn) Dutch Consortium for Healthcare Evaluation in Obstetrics and Gynaecology (NVOG Consortium), Postbus 20075, Utrecht 3502 LB, Netherlands (Fuller, Khong, Markus) SA Pathology, Women's and Children's Hospital, 72 King William Road, North Adelaide, SA 5006, Australia (Graham, Newnham) University of Western Australia Division of Obstetrics and Gynaecology, King Edward Memorial Hospital, PO Box 134, Subiaco, Perth, WA 6904, Australia (Heikinheimo, Makris) Women's Hospital, University of Helsinki and Helsinki University Hospital, P.O. Box 140, Haartmaninkatu 2, Helsinki HUS 00029, Finland (Hennessy, Lampio) School of Medicine, Campbelltown Campus, University of Western Sydney, Narellan Rd, Campbelltown, NSW 2560, Australia (Kaaja, Timonen) Department of Obstetrics and Gynaecology, Turku University Hospital (TYKS), PO Box 52, Turku 20521, Finland (Markus) Flinders University International Centre for Point-of-Care Testing, College of Medicine & Public Health, GPO Box 2100, Sturt Road, Bedford Park, SA 5042, Australia (Marschall) Wallenberg Laboratory, Sahlgrenska University Hospital, Gothenburg SE-413 45, Sweden (Middleton) SAHMRI Women and Kids, South Australian Health and Medical Research Institute, PO Box 11060, Adelaide, SA 5001, Australia (Mol) Obstetrics & Gynaecology Monash Health, Monash University, Clayton, VIC 3800, Australia (Morris, Shand) Paediatrics and Reproductive Medicine, The University of Sydney, Sydney, NSW 2006, Australia (Peek) Obstetrics and Gynaecology, Australian National University Medical School, The Canberra Hospital, PO Box 11, Woden, Australian Capital Territory 2606, Australia (Thornton) Obstetrics and Gynaecology, Nottingham University Hospitals NHS Trust, Queen's Medical Centre, Derby Rd, Nottingham NG7 2UH, United Kingdom (Walker) Department of Obstetrics and Gynaecology, University of Melbourne, Mercy Hospital for Women, 163 Studley Road, Heidelberg, VIC 3084, Australia (Warrilow) Public Health Virology Laboratory, Public and Environmental Health, Forensic and Scientific Services, Health Support Queensland, Department of Health, 39 Kessels Road, Coopers Plains, QLD 4108, Australia | Issue Date: | 1-Feb-2021 | Copyright year: | 2021 | Publisher: | BioMed Central Ltd | Place of publication: | United Kingdom | Publication information: | BMC Pregnancy and Childbirth. 21 (1) (no pagination), 2021. Article Number: 51. Date of Publication: December 2021. | Journal: | BMC Pregnancy and Childbirth | 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. Method(s): 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(s): 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.Copyright © 2021, The Author(s). | DOI: | http://monash.idm.oclc.org/login?url= http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1186/s12884-020-03481-y |
PubMed URL: | 33435904 [http://www.ncbi.nlm.nih.gov/pubmed/?term=33435904] | ISSN: | 1471-2393 (electronic) | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/28481 | Type: | Article | Type of Clinical Study or Trial: | Randomised controlled trial |
Appears in Collections: | Articles |
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