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Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a secondary analysis of the PITCHES trial
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  • Jessica Fleminger,
  • Paul Seed,
  • Anne Smith,
  • Ed Juszczak,
  • Peter Dixon,
  • Jenny Chambers,
  • Jon Dorling,
  • Catherine Williamson,
  • James Thornton,
  • Lucy Chappell
Jessica Fleminger
King's College London
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Paul Seed
King's College London
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Anne Smith
University of Oxford
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Ed Juszczak
University of Oxford
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Peter Dixon
King's College London
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Jenny Chambers
ICP Support
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Jon Dorling
Dalhousie University Faculty of Medicine
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Catherine Williamson
King's College London
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James Thornton
University of Nottingham
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Lucy Chappell
King's College London
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Abstract

Objective: To evaluate whether a particular group of women with intrahepatic cholestasis of pregnancy would benefit from treatment with ursodeoxycholic acid. Design: Secondary analysis of the PITCHES trial (ISRCTN91918806). Setting: United Kingdom. Population or Sample: Women with intrahepatic cholestasis of pregnancy. Methods: Subgroup analyses were performed to determine whether baseline bile acid concentrations or baseline itch scores moderated a woman’s response to treatment with ursodeoxycholic acid. Main Outcome Measures: Bile acid concentration and itch score. Results: In women with baseline bile acid concentrations less than 40 μmol/L, treatment with UDCA resulted in increased post-randomisation bile acid concentrations (geometric mean ratio 1.19, 95% CI 1.99 to 1.41, p = 0.048). A test of interaction showed no significance (p = 0.647). A small, clinically insignificant difference was seen in itch response in women with a high baseline itch score (–6.0 mm, 95% CI –11.80 to –0.21, p = 0.042), with a test of interaction not showing significance (p = 0.640). Further subgroup analyses showed no significance. Across all women there was a weak relationship between bile acid concentrations and itch severity. Conclusions: There was no subgroup of women with intrahepatic cholestasis of pregnancy in whom a beneficial effect of treatment with ursodeoxycholic acid on bile acid concentration or itch score could be identified. This confirms that its routine use in women with this condition for improvement of bile acid concentration or itch score should be reconsidered. Funding: NIHR Efficacy and Mechanism Evaluation Programme 12/164/16. Keywords: Cholestasis, Pregnancy, Ursodeoxycholic acid, Perinatal, Stillbirth.

Peer review status:IN REVISION

09 Jul 2020Submitted to BJOG: An International Journal of Obstetrics and Gynaecology
09 Jul 2020Submission Checks Completed
09 Jul 2020Assigned to Editor
10 Jul 2020Reviewer(s) Assigned
07 Aug 2020Review(s) Completed, Editorial Evaluation Pending
02 Sep 2020Editorial Decision: Revise Minor
19 Sep 20201st Revision Received
21 Sep 2020Assigned to Editor
21 Sep 2020Submission Checks Completed