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; 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

doi:10.1186/s12884-020-03481-y

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, Sanne Gordijn, Dorothy Graham, Oskari Heikinheimo, Annemarie Hennessy, Risto Kaaja, Teck Yee Khong, Laura Lampio, Jennie Louise, Angela Makris, Corey MarkusHanns-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

Monash University

Research output: Contribution to journal › Article › peer-review

19 Citations (Scopus)

5 Downloads (Pure)

Abstract

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.

Original language	English
Article number	51
Number of pages	14
Journal	BMC Pregnancy and Childbirth
Volume	21
Issue number	1
Early online date	12 Jan 2021
DOIs	https://doi.org/10.1186/s12884-020-03481-y
Publication status	Published - 2021

Bibliographical note

Funding
The study sponsor and the funder (National Health and Medical Research Council (NHMRC) Medical Research Future Fund (MRFF) Lifting Clinical Trials and Registries Capacity (LCTRC) Grant Opportunity) have had no role in the study design; the collection, management, analysis, and interpretation of the data; the final writing of the report; and the decision to submit the report for publication.

Keywords

Intrahepatic cholestasis of pregnancy
Cholestatic pruritus
Bile acids
Ursodeoxycholic acid
Rifampicin
Maternal and neonatal health outcomes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Hague, W. M., Callaway, L., 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., Khong, T. Y., Lampio, L., Louise, J., Makris, A., ... Williamson, C. (2021). 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, 21(1), Article 51. https://doi.org/10.1186/s12884-020-03481-y

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 et al.
In: BMC Pregnancy and Childbirth, Vol. 21, No. 1, 51, 2021.

Research output: Contribution to journal › Article › peer-review

Hague, WM, Callaway, L, 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, Khong, TY, Lampio, L, Louise, J, Makris, A, Markus, C, Marschall, H-U, Middleton, P, Mol, BW, Morris, J, Newnham, JP, Ovadia, C, Peek, M, Shand, A, Stark, M, Thornton, J, Timonen, S, Walker, S, Warrilow, D & Williamson, C 2021, '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, vol. 21, no. 1, 51. https://doi.org/10.1186/s12884-020-03481-y

Hague WM, Callaway L, Chambers J, Chappell L, Coat S, de Haan-Jebbink J et al. 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. 2021;21(1):51. Epub 2021 Jan 12. doi: 10.1186/s12884-020-03481-y

Hague, William M. ; Callaway, Leonie ; Chambers, Jennifer et al. / 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. In: BMC Pregnancy and Childbirth. 2021 ; Vol. 21, No. 1.

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abstract = "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.",

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AU - Hague, William M.

AU - Callaway, Leonie

AU - Chambers, Jennifer

AU - Chappell, Lucy

AU - Coat, Suzette

AU - de Haan-Jebbink, Jiska

AU - Dekker, Marloes

AU - Dixon, Peter

AU - Dodd, Jodie

AU - Fuller, Maria

AU - Gordijn, Sanne

AU - Graham, Dorothy

AU - Heikinheimo, Oskari

AU - Hennessy, Annemarie

AU - Kaaja, Risto

AU - Khong, Teck Yee

AU - Lampio, Laura

AU - Louise, Jennie

AU - Makris, Angela

AU - Markus, Corey

AU - Marschall, Hanns-Ulrich

AU - Middleton, Philippa

AU - Mol, Ben W.

AU - Morris, Jonathan

AU - Newnham, John P.

AU - Ovadia, Caroline

AU - Peek, Michael

AU - Shand, Antonia

AU - Stark, Michael

AU - Thornton, Jim

AU - Timonen, Susanna

AU - Walker, Susan

AU - Warrilow, David

AU - Williamson, Catherine

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KW - Bile acids

KW - Ursodeoxycholic acid

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