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PITCHES Trial Results

Results of the PITCHES trial have been published.

Intrahepatic cholestasis of pregnancy (ICP) is the commonest pregnancy-specific liver disorder in the UK.  It affects around 5,500 women a year, causing premature birth and, in extreme cases, stillbirth.  The most popular current drug used to treat ICP is called ursodeoxycholic acid (commonly known as 'urso'), but it hasn't been tested in any large clinical trials to show whether it prevents premature birth and stillbirth.

Our trial asked, "If a woman has ICP, what are the effects on the baby if she is treated with ursodeoxycholic acid (or placebo)?"

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PITCHES trial protocol published in BioMedCentral Trials

With no existing evidence to support the use of ursodeoxycholic acid (UDCA) to improve intrahepatic cholestasis of pregnancy (ICP), PITCHES, a Phase III clinical trial proposes to provide definitive evidence to discover if the use of UDCA improves pregnancy outcomes in women with this liver disorder.

For more information, please find the recently published study protocol for the PITCHES trial in the BioMedCentral Trials journal here.

PITCHES trial – end of recruitment phase

The recruitment phase of the PITCHES Trial has ended at midnight on 22nd August 2018, ahead of target and time. Many thanks to the trial participants and the hard working teams at the trial sites including research midwives, nursing staff, doctors and principal investigators.

PITCHES Trial Reaches Recruitment Milestone

A total of 33 PITCHES sites are now live and open to recruitment.  Thanks to great team work at all of the sites, we are delighted to have reached the half-way total of 290 women recruited. Thank you to everyone involved.

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This study is funded by the National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation (EME) Programme (Reference Number 12/164/16). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.