Evidence map›Paper›PMID 33435904›Full record

ArticleBMC pregnancy and childbirth2021

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.

William M Hague, Leonie Callaway, Jennifer Chambers, Lucy Chappell, Suzette Coat, Jiska de Haan-Jebbink, Marloes Dekker, Peter Dixon, Jodie Dodd, Maria Fuller and 24 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC pregnancy and childbirth, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

  1. FIGO guideline on liver disease and pregnancy.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025
    Guideline
  2. Article
  3. Liver Conditions Specific to Pregnancy: Optimizing Management and Outcomes.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2026
    Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Intrahepatic cholestasis of pregnancy.Nature reviews. Disease primers · 2025
    Review
  12. Article
  13. Article
  14. Review
  15. Review
  16. ICP: A midwifery perspective.Obstetric medicine · 2024
    Review
  17. Review
  18. Article
  19. Clinical Management Guidelines for Intrahepatic Cholestasis of Pregnancy.Maternal-fetal medicine (Wolters Kluwer Health, Inc.) · 2024
    Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

34 authors at 18 institutions in 5 countries.

William M HagueRobinson Research Institute, The University of Adelaide, 55 King William Road, North Adelaide, 5006, South Australia, Australia. bill.hague@adelaide.edu.au.ORCID http://orcid.org/0000-0002-5355-2955
Leonie CallawayGynaecology, Oncology & Obstetric Medicine, Royal Brisbane and Women's Hospital, Herston, 4029, Queensland, Australia.
Jennifer ChambersWomen and Children's Health, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.
Lucy ChappellWomen and Children's Health, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.
Suzette CoatRobinson Research Institute, The University of Adelaide, 55 King William Road, North Adelaide, 5006, South Australia, Australia.
Jiska de Haan-JebbinkDutch Consortium for Healthcare Evaluation in Obstetrics and Gynaecology (NVOG Consortium), Postbus 20075, Utrecht, 3502 LB, The Netherlands.
Marloes DekkerThe University of Queensland, Brisbane, 4072, Queensland, Australia.
Peter DixonWomen and Children's Health, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.
Jodie DoddRobinson Research Institute, The University of Adelaide, 55 King William Road, North Adelaide, 5006, South Australia, Australia.
Maria FullerRobinson Research Institute, The University of Adelaide, 55 King William Road, North Adelaide, 5006, South Australia, Australia.
Sanne GordijnDutch Consortium for Healthcare Evaluation in Obstetrics and Gynaecology (NVOG Consortium), Postbus 20075, Utrecht, 3502 LB, The Netherlands.
Dorothy GrahamUniversity of Western Australia Division of Obstetrics and Gynaecology, King Edward Memorial Hospital, PO Box 134, Subiaco, Perth, 6904, Western Australia, Australia.
Oskari HeikinheimoWomen's Hospital, University of Helsinki and Helsinki University Hospital, P.O. Box 140, Haartmaninkatu 2, Helsinki, HUS 00029, Finland.
Annemarie HennessySchool of Medicine, Campbelltown Campus, University of Western Sydney, Narellan Rd, Campbelltown, 2560, NSW, Australia.
Risto KaajaDepartment of Obstetrics and Gynaecology, Turku University Hospital (TYKS), PO Box 52, Turku, 20521, Finland.
Teck Yee KhongRobinson Research Institute, The University of Adelaide, 55 King William Road, North Adelaide, 5006, South Australia, Australia.
Laura LampioSchool of Medicine, Campbelltown Campus, University of Western Sydney, Narellan Rd, Campbelltown, 2560, NSW, Australia.
Jennie LouiseRobinson Research Institute, The University of Adelaide, 55 King William Road, North Adelaide, 5006, South Australia, Australia.
Angela MakrisWomen's Hospital, University of Helsinki and Helsinki University Hospital, P.O. Box 140, Haartmaninkatu 2, Helsinki, HUS 00029, Finland.
Corey MarkusSA Pathology, Women's and Children's Hospital, 72 King William Road, North Adelaide, 5006, South Australia, Australia.
Hanns-Ulrich MarschallWallenberg Laboratory, Sahlgrenska University Hospital, Gothenburg, SE-413 45, Sweden.
Philippa MiddletonRobinson Research Institute, The University of Adelaide, 55 King William Road, North Adelaide, 5006, South Australia, Australia.
Ben W MolObstetrics & Gynaecology Monash Health, Monash University, Clayton, 3800, Victoria, Australia.
Jonathan MorrisPaediatrics and Reproductive Medicine, The University of Sydney, Sydney, 2006, New South Wales, Australia.
John P NewnhamUniversity of Western Australia Division of Obstetrics and Gynaecology, King Edward Memorial Hospital, PO Box 134, Subiaco, Perth, 6904, Western Australia, Australia.
Caroline OvadiaWomen and Children's Health, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.
Michael PeekObstetrics and Gynaecology, Australian National University Medical School, The Canberra Hospital, PO Box 11, Woden, 2606, Australian Capital Territory, Australia.
Antonia ShandPaediatrics and Reproductive Medicine, The University of Sydney, Sydney, 2006, New South Wales, Australia.
Michael StarkRobinson Research Institute, The University of Adelaide, 55 King William Road, North Adelaide, 5006, South Australia, Australia.
Jim ThorntonObstetrics and Gynaecology, Nottingham University Hospitals NHS Trust, Queen's Medical Centre, Derby Rd, Nottingham, NG7 2UH, UK.
Susanna TimonenDepartment of Obstetrics and Gynaecology, Turku University Hospital (TYKS), PO Box 52, Turku, 20521, Finland.
Susan WalkerDepartment of Obstetrics and Gynaecology, University of Melbourne, Mercy Hospital for Women, 163 Studley Road, Heidelberg, 3084, Victoria, Australia.
David WarrilowPublic Health Virology Laboratory, Public and Environmental Health, Forensic and Scientific Services, Health Support Queensland, Department of Health, 39 Kessels Road, Coopers Plains, 4108, Queensland, Australia.
Catherine WilliamsonWomen and Children's Health, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.
St Thomas' Hospital · GBSouth Australia Pathology · AUThe University of Adelaide · AUCamden and Campbelltown Hospitals · AUNederlandse Vereniging voor Obstetrie en Gynaecologie · NLThe University of Queensland · AUThe University of Sydney · AUThe University of Western Australia · AUTurku University Hospital · FIUniversity of Helsinki · FIWomen's and Children's Hospital · AUAustralian National University · AUMonash Health · AUNottingham University Hospitals NHS Trust · GBQueensland Health · AUSahlgrenska University Hospital · SESouth Australian Health and Medical Research Institute · AUThe University of Melbourne · AU

Funding

Department of Health, Australian Government MRFF APP1152418
6 · The paper itself

Abstract

backgroundSevere 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.

methodsWe 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.

Indexed as

AntipruriticsCholestasis, IntrahepaticPregnancy ComplicationsRifampinUrsodeoxycholic AcidAustraliaEquivalence Trials as TopicFemaleHumansMulticenter Studies as TopicPregnancyPregnancy OutcomeRandomized Controlled Trials as TopicTreatment OutcomeAntipruriticsRifampinUrsodeoxycholic AcidBile acidsCholestatic pruritusIntrahepatic cholestasis of pregnancyMaternal and neonatal health outcomesRifampicinUrsodeoxycholic acid

Identifiers

PMID33435904
PMCPMC7802989
OpenAlexW3121027241

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.