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This EBM verdict piece explores the implications of the PITCHES trial, which examined the effect of ursodeoxycholic acid on perinatal outcomes in women with intrahepatic (obstetric) cholestasis of pregnancy. The acronym PITCHES is drawn from the full title of the trial: Phase III trial in IntrahepaTic CHolestasis of pregnancy (ICP) to Evaluate urSodeoxycholic acid (UCDA) in improving perinatal outcomes.
Obstetric cholestasis, also known as intrahepatic cholestasis of pregnancy, is a pregnancy-specific condition characterised by pruritus most commonly but not exclusively, of the hands and soles of the feet, abnormal liver function tests, raised bile acids and resolution in the postpartum period. It affects about 0.7% of pregnant women in the UK and 0.2%–2.0% of pregnant women worldwide with geographical and ethnic variation in incidence that has been speculated to be due to genetic differences.1 Risk factors include Asian ethnicity (Pakistani and Indian), Chilean, indigenous Americans, family history, multifetal pregnancy, assisted reproductive treatment and being of higher maternal age.2
A systematic review and individual patient data meta-analysis published in 2019 examined epidemiological studies for the association of stillbirth and associated outcomes in relation to …
Contributors FGM critically appraised the PITCHES trial and wrote the EBM Verdict manuscript.
Funding The author has not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests The author is a member of the BMJ Evidence-Based Medicine Editorial Board.
Patient consent for publication Not required.
Provenance and peer review Commissioned; internally peer reviewed.
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