Contributions of authors

Lucy C Chappell (https://orcid.org/0000-0001-6219-3379) (NIHR Research Professor of Obstetrics) conceived the study, was involved in securing study funding, was chief investigator for the trial and wrote the report.

Jennifer L Bell (https://orcid.org/0000-0001-9571-0715) (Statistician) undertook the statistical analyses, and reviewed, contributed to and approved the final version of the report.

Anne Smith (https://orcid.org/0000-0002-2985-9367) (Trial Manager) managed the day-to-day running of the trial, and reviewed, contributed to and approved the final version of the report.

Catherine Rounding (https://orcid.org/0000-0002-1376-7572) (Assistant Trial Manager) assisted with day-to-day running of the trial, and reviewed, contributed to and approved the final version of the report.

Ursula Bowler (https://orcid.org/0000-0002-0100-0155) (Senior Trials Manager) had oversight of the trial management, and reviewed, contributed to and approved the final version of the report.

Louise Linsell (https://orcid.org/0000-0003-3205-6511) (Senior Statistician) had oversight of the statistical analyses, reviewed, contributed to and approved the final version of the report.

Edmund Juszczak (https://orcid.org/0000-0001-5500-2247) (Clinical Trials Unit Director) had oversight of the trial conduct, and reviewed, contributed to and approved the final version of the report.

Sue Tohill (https://orcid.org/0000-0002-2344-4347) (Research Midwife) supported site research midwives and related activities, and reviewed, contributed to and approved the final version of the report.

Amanda Redford (https://orcid.org/0000-0001-5176-4789) (Research Midwife) supported site research midwives and related activities, and reviewed, contributed to and approved the final version of the report.

Peter H Dixon (https://orcid.org/0000-0002-0197-2632) (Senior Research Scientist) was involved in securing study funding, contributed to sample collection management, and reviewed, contributed to and approved the final version of the report.

Jenny Chambers (https://orcid.org/0000-0001-6022-1719) (Chief Executive Officer of ICP Support) was Public and Patient Involvement lead, was involved in securing study funding, and reviewed, contributed to and approved the final version of the report.

Rachael Hunter (https://orcid.org/0000-0002-7447-8934) (Associate Professor of Health Economics) undertook the health economic analyses, was involved in securing study funding, and reviewed, contributed to and approved the final version of the report.

Jon Dorling (https://orcid.org/0000-0002-1691-3221) (Professor of Neonatology) had oversight of neonatology aspects of the trial, and reviewed, contributed to and approved the final version of the report.

Catherine Williamson (https://orcid.org/0000-0002-6226-7611) (Professor of Obstetric Medicine) conceived the study, was involved in securing study funding, led sample collection management, and reviewed, contributed to and approved the final version of the report.

Jim G Thornton (https://orcid.org/0000-0001-9764-6876) (Professor of Obstetrics and Gynaecology) conceived the study, was involved in securing study funding, contributed to trial conduct, and reviewed, contributed to and approved the final version of the report.

Publications

Chappell LC, Chambers J, Dixon PH, Dorling J, Hunter R, Bell JL, et al. Ursodeoxycholic acid versus placebo in treatment of women with intrahepatic cholestasis of pregnancy (ICP) to improve perinatal outcomes: protocol for a randomised controlled trial (PITCHES). Trials 2018;19:657.

Chappell LC, Chambers J, Thornton JG, Williamson C. Does ursodeoxycholic acid improve perinatal outcomes in women with intrahepatic cholestasis of pregnancy? BMJ 2018;360:k104.

Chappell LC, Bell JL, Smith A, Linsell L, Juszczak E, Dixon PH, et al. Ursodeoxycholic acid versus placebo in women with intrahepatic cholestasis of pregnancy (PITCHES): a randomised controlled trial. Lancet 2019;394:849–60.

Fleminger J, Seed PT, Smith A, Juszczak E, Dixon PH, Chambers J, et al. Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a secondary analysis of the PITCHES trial [published online ahead of print 16 October 2020]. BJOG 2020.

Data-sharing statement

All data requests should be submitted to the corresponding author for consideration. Requests must include a study protocol and analysis plan. Access to anonymised data may be granted following review.

Patient data

This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that it is stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.

Disclaimers

This report presents independent research. The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the MRC, NETSCC, the EME programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the EME programme or the Department of Health and Social Care.