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

The Lancet Sep 12, 2019

Chappell LC, Bell JL, Smith A, et al. - Researchers examined whether adverse perinatal outcomes in women with intrahepatic cholestasis of pregnancy could be reduced with ursodeoxycholic acid. In this double-blind, multicentre, randomized placebo-controlled trial, which was performed at 33 hospital maternity units in England and Wales, ursodeoxycholic acid or placebo was randomly assigned 1:1 to eligible women, these were given as two oral tablets a day at an equivalent dose of 500 mg twice a day. Eligible women were aged 18 years or older with gestational age between 20 weeks and 40 weeks and 6 days, with a singleton or twin pregnancy and no known lethal fetal anomaly. At the clinician's discretion, the dose could be increased or decreased, to a maximum of four tablets and a minimum of one tablet a day. Continuation of treatment from enrolment until the infant's birth was recommended. Outcomes do not support the utility of treatment with ursodeoxycholic acid in reducing adverse perinatal outcomes in these women. Therefore, reconsideration should be given to its routine use for this condition.
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