Ursodeoxycholic acid versus placebo in women with intrahepatic cholestasis of pregnancy (PITCHES): a randomised controlled trial

Publication date: Available online 1 August 2019Source: The LancetAuthor(s): Lucy C Chappell, Jennifer L Bell, Anne Smith, Louise Linsell, Edmund Juszczak, Peter H Dixon, Jenny Chambers, Rachael Hunter, Jon Dorling, Catherine Williamson, Jim G Thornton, Irshad Ahmed, Rita Arya, Virginia Beckett, Amarnath Bhide, Heather Brown, George Bugg, Helen Cameron, Nishigandh Deole, Madhuchanda DeySummaryBackgroundIntrahepatic cholestasis of pregnancy, characterised by maternal pruritus and increased serum bile acid concentrations, is associated with increased rates of stillbirth, preterm birth, and neonatal unit admission. Ursodeoxycholic acid is widely used as a treatment without an adequate evidence base. We aimed to evaluate whether ursodeoxycholic acid reduces adverse perinatal outcomes in women with intrahepatic cholestasis of pregnancy.MethodsWe did a double-blind, multicentre, randomised placebo-controlled trial at 33 hospital maternity units in England and Wales. We recruited women with intrahepatic cholestasis of pregnancy, who were aged 18 years or older and with a gestational age between 20 weeks and 40 weeks and 6 days, with a singleton or twin pregnancy and no known lethal fetal anomaly. Participants were randomly assigned 1:1 to ursodeoxycholic acid or placebo, given as two oral tablets a day at an equivalent dose of 500 mg twice a day. The dose could be increased or decreased at the clinician's discretion, to a maximum of four tablets and a minimum of one tablet a day. We...
Source: The Lancet - Category: General Medicine Source Type: research