| Abstract: | ![]()
Intrahepatic cholestasis of pregnancy is characterized by maternal itchiness and raised maternal serum bile acids. It affects 0.7% of pregnancies in the UK and is associated with increased risk of adverse perinatal outcomes. The mainstay of treatment has been ursodeoxycholic acid, despite limited evidence for its efficacy. PITCHES is the largest randomized controlled trial to date comparing ursodeoxycholic acid with placebo in women with intrahepatic cholestasis of pregnancy, in which 605 women were randomized to active treatment or placebo. PITCHES demonstrated that although ursodeoxycholic acid appears to be safe in pregnant women, it is not effective in reducing adverse perinatal outcomes. No subgroup was identified, based on characteristics at randomization, that might benefit from targeted treatment. Women taking ursodeoxycholic acid had a small reduction in itch severity, which was not considered clinically significant by women and clinicians. The routine use of ursodeoxycholic acid should be reconsidered. |
