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

The Lancet Aug 07, 2019

Chappell LC, Bell JL, Linsell L, et al. - Through a double-blind, multicentre, randomized placebo-controlled trial at 33 hospital maternity units in England and Wales on 605 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 abnormality, researchers assessed if ursodeoxycholic acid decreased adverse perinatal outcomes in women with intrahepatic cholestasis of pregnancy. Women were randomized to receive ursodeoxycholic acid (n = 305) or placebo (n = 300). The primary outcome evaluation involved 304 women and 322 infants and 300 women and 318 infants in the ursodeoxycholic acid group and in the placebo group, respectively. The primary composite outcome happened in 74 of 322 infants and 85 of 318 infants in the ursodeoxycholic acid group and in the placebo group, respectively. In the ursodeoxycholic acid group and in the placebo group, respectively, two and six serious adverse events were noted, although, no serious adverse events were considered as being related to treatment. Therefore, in females with intrahepatic cholestasis of pregnancy, treatment with ursodeoxycholic acid does not decrease adverse perinatal outcomes. Thus, its routine use for this condition should be reviewed.
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