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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.
Hague, William M; Callaway, Leonie; Chambers, Jennifer; Chappell, Lucy; Coat, Suzette; de Haan-Jebbink, Jiska; Dekker, Marloes; Dixon, Peter; Dodd, Jodie; Fuller, Maria; Gordijn, Sanne; Graham, Dorothy; Heikinheimo, Oskari; Hennessy, Annemarie; Kaaja, Risto; Khong, Teck Yee; Lampio, Laura; Louise, Jennie; Makris, Angela; Markus, Corey; Marschall, Hanns-Ulrich; Middleton, Philippa; Mol, Ben W; Morris, Jonathan; Newnham, John P; Ovadia, Caroline; Peek, Michael; Shand, Antonia; Stark, Michael; Thornton, Jim; Timonen, Susanna; Walker, Susan; Warrilow, David; Williamson, Catherine.
Afiliación
  • Hague WM; Robinson Research Institute, The University of Adelaide, 55 King William Road, North Adelaide, 5006, South Australia, Australia. bill.hague@adelaide.edu.au.
  • Callaway L; Obstetric Medicine, Women's and Babies' Division, Women's and Children's Hospital, 72 King William Road, North Adelaide, South Australia, 5006, Australia. bill.hague@adelaide.edu.au.
  • Chambers J; Gynaecology, Oncology & Obstetric Medicine, Royal Brisbane and Women's Hospital, Herston, 4029, Queensland, Australia.
  • Chappell L; The University of Queensland, Brisbane, 4072, Queensland, Australia.
  • Coat S; Women and Children's Health, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.
  • de Haan-Jebbink J; Women and Children's Health, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.
  • Dekker M; Robinson Research Institute, The University of Adelaide, 55 King William Road, North Adelaide, 5006, South Australia, Australia.
  • Dixon P; Dutch Consortium for Healthcare Evaluation in Obstetrics and Gynaecology (NVOG Consortium), Postbus 20075, Utrecht, 3502 LB, The Netherlands.
  • Dodd J; The University of Queensland, Brisbane, 4072, Queensland, Australia.
  • Fuller M; Women and Children's Health, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.
  • Gordijn S; Robinson Research Institute, The University of Adelaide, 55 King William Road, North Adelaide, 5006, South Australia, Australia.
  • Graham D; Robinson Research Institute, The University of Adelaide, 55 King William Road, North Adelaide, 5006, South Australia, Australia.
  • Heikinheimo O; SA Pathology, Women's and Children's Hospital, 72 King William Road, North Adelaide, 5006, South Australia, Australia.
  • Hennessy A; Dutch Consortium for Healthcare Evaluation in Obstetrics and Gynaecology (NVOG Consortium), Postbus 20075, Utrecht, 3502 LB, The Netherlands.
  • Kaaja R; University of Western Australia Division of Obstetrics and Gynaecology, King Edward Memorial Hospital, PO Box 134, Subiaco, Perth, 6904, Western Australia, Australia.
  • Khong TY; Women's Hospital, University of Helsinki and Helsinki University Hospital, P.O. Box 140, Haartmaninkatu 2, Helsinki, HUS 00029, Finland.
  • Lampio L; School of Medicine, Campbelltown Campus, University of Western Sydney, Narellan Rd, Campbelltown, 2560, NSW, Australia.
  • Louise J; Department of Obstetrics and Gynaecology, Turku University Hospital (TYKS), PO Box 52, Turku, 20521, Finland.
  • Makris A; Robinson Research Institute, The University of Adelaide, 55 King William Road, North Adelaide, 5006, South Australia, Australia.
  • Markus C; SA Pathology, Women's and Children's Hospital, 72 King William Road, North Adelaide, 5006, South Australia, Australia.
  • Marschall HU; School of Medicine, Campbelltown Campus, University of Western Sydney, Narellan Rd, Campbelltown, 2560, NSW, Australia.
  • Middleton P; Robinson Research Institute, The University of Adelaide, 55 King William Road, North Adelaide, 5006, South Australia, Australia.
  • Mol BW; Women's Hospital, University of Helsinki and Helsinki University Hospital, P.O. Box 140, Haartmaninkatu 2, Helsinki, HUS 00029, Finland.
  • Morris J; SA Pathology, Women's and Children's Hospital, 72 King William Road, North Adelaide, 5006, South Australia, Australia.
  • Newnham JP; Flinders University International Centre for Point-of-Care Testing, College of Medicine & Public Health, GPO Box 2100, Sturt Road, Bedford Park, South Australia, 5042, Australia.
  • Ovadia C; Wallenberg Laboratory, Sahlgrenska University Hospital, Gothenburg, SE-413 45, Sweden.
  • Peek M; Robinson Research Institute, The University of Adelaide, 55 King William Road, North Adelaide, 5006, South Australia, Australia.
  • Shand A; SAHMRI Women and Kids, South Australian Health and Medical Research Institute, PO Box 11060, Adelaide, 5001, South Australia, Australia.
  • Stark M; Obstetrics & Gynaecology Monash Health, Monash University, Clayton, 3800, Victoria, Australia.
  • Thornton J; Paediatrics and Reproductive Medicine, The University of Sydney, Sydney, 2006, New South Wales, Australia.
  • Timonen S; University of Western Australia Division of Obstetrics and Gynaecology, King Edward Memorial Hospital, PO Box 134, Subiaco, Perth, 6904, Western Australia, Australia.
  • Walker S; Women and Children's Health, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.
  • Warrilow D; Obstetrics and Gynaecology, Australian National University Medical School, The Canberra Hospital, PO Box 11, Woden, 2606, Australian Capital Territory, Australia.
  • Williamson C; Paediatrics and Reproductive Medicine, The University of Sydney, Sydney, 2006, New South Wales, Australia.
BMC Pregnancy Childbirth ; 21(1): 51, 2021 Jan 12.
Article en En | MEDLINE | ID: mdl-33435904
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.
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Complicaciones del Embarazo / Rifampin / Ácido Ursodesoxicólico / Colestasis Intrahepática / Antipruriginosos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Female / Humans / Pregnancy País/Región como asunto: Oceania Idioma: En Revista: BMC Pregnancy Childbirth Asunto de la revista: OBSTETRICIA Año: 2021 Tipo del documento: Article País de afiliación: Australia
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Complicaciones del Embarazo / Rifampin / Ácido Ursodesoxicólico / Colestasis Intrahepática / Antipruriginosos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Female / Humans / Pregnancy País/Región como asunto: Oceania Idioma: En Revista: BMC Pregnancy Childbirth Asunto de la revista: OBSTETRICIA Año: 2021 Tipo del documento: Article País de afiliación: Australia