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
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 fr...
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2021-01-01
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Series: | BMC Pregnancy and Childbirth |
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Online Access: | https://doi.org/10.1186/s12884-020-03481-y |
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collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
William M. Hague Leonie Callaway Jennifer Chambers Lucy Chappell Suzette Coat Jiska de Haan-Jebbink Marloes Dekker Peter Dixon Jodie Dodd Maria Fuller Sanne Gordijn Dorothy Graham Oskari Heikinheimo Annemarie Hennessy Risto Kaaja Teck Yee Khong Laura Lampio Jennie Louise Angela Makris Corey Markus Hanns-Ulrich Marschall Philippa Middleton Ben W. Mol Jonathan Morris John P. Newnham Caroline Ovadia Michael Peek Antonia Shand Michael Stark Jim Thornton Susanna Timonen Susan Walker David Warrilow Catherine Williamson |
spellingShingle |
William M. Hague Leonie Callaway Jennifer Chambers Lucy Chappell Suzette Coat Jiska de Haan-Jebbink Marloes Dekker Peter Dixon Jodie Dodd Maria Fuller Sanne Gordijn Dorothy Graham Oskari Heikinheimo Annemarie Hennessy Risto Kaaja Teck Yee Khong Laura Lampio Jennie Louise Angela Makris Corey Markus Hanns-Ulrich Marschall Philippa Middleton Ben W. Mol Jonathan Morris John P. Newnham Caroline Ovadia Michael Peek Antonia Shand Michael Stark Jim Thornton Susanna Timonen Susan Walker David Warrilow Catherine Williamson 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 BMC Pregnancy and Childbirth Intrahepatic cholestasis of pregnancy Cholestatic pruritus Bile acids Ursodeoxycholic acid Rifampicin Maternal and neonatal health outcomes |
author_facet |
William M. Hague Leonie Callaway Jennifer Chambers Lucy Chappell Suzette Coat Jiska de Haan-Jebbink Marloes Dekker Peter Dixon Jodie Dodd Maria Fuller Sanne Gordijn Dorothy Graham Oskari Heikinheimo Annemarie Hennessy Risto Kaaja Teck Yee Khong Laura Lampio Jennie Louise Angela Makris Corey Markus Hanns-Ulrich Marschall Philippa Middleton Ben W. Mol Jonathan Morris John P. Newnham Caroline Ovadia Michael Peek Antonia Shand Michael Stark Jim Thornton Susanna Timonen Susan Walker David Warrilow Catherine Williamson |
author_sort |
William M. Hague |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
BMC |
series |
BMC Pregnancy and Childbirth |
issn |
1471-2393 |
publishDate |
2021-01-01 |
description |
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. |
topic |
Intrahepatic cholestasis of pregnancy Cholestatic pruritus Bile acids Ursodeoxycholic acid Rifampicin Maternal and neonatal health outcomes |
url |
https://doi.org/10.1186/s12884-020-03481-y |
work_keys_str_mv |
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doaj-8a92114777df44d2a59f24c463bf44c62021-01-17T12:18:11ZengBMCBMC Pregnancy and Childbirth1471-23932021-01-0121111410.1186/s12884-020-03481-yA 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 trialWilliam M. Hague0Leonie Callaway1Jennifer Chambers2Lucy Chappell3Suzette Coat4Jiska de Haan-Jebbink5Marloes Dekker6Peter Dixon7Jodie Dodd8Maria Fuller9Sanne Gordijn10Dorothy Graham11Oskari Heikinheimo12Annemarie Hennessy13Risto Kaaja14Teck Yee Khong15Laura Lampio16Jennie Louise17Angela Makris18Corey Markus19Hanns-Ulrich Marschall20Philippa Middleton21Ben W. Mol22Jonathan Morris23John P. Newnham24Caroline Ovadia25Michael Peek26Antonia Shand27Michael Stark28Jim Thornton29Susanna Timonen30Susan Walker31David Warrilow32Catherine Williamson33Robinson Research Institute, The University of AdelaideGynaecology, Oncology & Obstetric Medicine, Royal Brisbane and Women’s HospitalWomen and Children’s Health, King’s College LondonWomen and Children’s Health, King’s College LondonRobinson Research Institute, The University of AdelaideDutch Consortium for Healthcare Evaluation in Obstetrics and Gynaecology (NVOG Consortium)The University of QueenslandWomen and Children’s Health, King’s College LondonRobinson Research Institute, The University of AdelaideRobinson Research Institute, The University of AdelaideDutch Consortium for Healthcare Evaluation in Obstetrics and Gynaecology (NVOG Consortium)University of Western Australia Division of Obstetrics and Gynaecology, King Edward Memorial HospitalWomen’s Hospital, University of Helsinki and Helsinki University HospitalSchool of Medicine, Campbelltown Campus, University of Western SydneyDepartment of Obstetrics and Gynaecology, Turku University Hospital (TYKS)Robinson Research Institute, The University of AdelaideSchool of Medicine, Campbelltown Campus, University of Western SydneyRobinson Research Institute, The University of AdelaideWomen’s Hospital, University of Helsinki and Helsinki University HospitalSA Pathology, Women’s and Children’s HospitalWallenberg Laboratory, Sahlgrenska University HospitalRobinson Research Institute, The University of AdelaideObstetrics & Gynaecology Monash Health, Monash UniversityPaediatrics and Reproductive Medicine, The University of SydneyUniversity of Western Australia Division of Obstetrics and Gynaecology, King Edward Memorial HospitalWomen and Children’s Health, King’s College LondonObstetrics and Gynaecology, Australian National University Medical School, The Canberra HospitalPaediatrics and Reproductive Medicine, The University of SydneyRobinson Research Institute, The University of AdelaideObstetrics and Gynaecology, Nottingham University Hospitals NHS TrustDepartment of Obstetrics and Gynaecology, Turku University Hospital (TYKS)Department of Obstetrics and Gynaecology, University of Melbourne, Mercy Hospital for WomenPublic Health Virology Laboratory, Public and Environmental Health, Forensic and Scientific Services, Health Support Queensland, Department of HealthWomen and Children’s Health, King’s College LondonAbstract 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.https://doi.org/10.1186/s12884-020-03481-yIntrahepatic cholestasis of pregnancyCholestatic pruritusBile acidsUrsodeoxycholic acidRifampicinMaternal and neonatal health outcomes |