Intrahepatic cholestasis of pregnancy: ursodeoxycholic acid offers no benefit

  • Lancet

  • International Clinical Digest
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Takeaway

  • Ursodeoxycholic acid for intrahepatic cholestasis of pregnancy is not tied to reduced maternal symptoms or reduced perinatal death.

Why this matters

  • Intrahepatic cholestasis of pregnancy, characterized by pruritus and increased serum bile acids, is associated with preterm birth, meconium-stained fluid, neonatal ICU admission, and stillbirth (with levels ≥100 μmol/L).

Key results

  • The primary outcome (perinatal death, preterm delivery, or neonatal unit admission for ≥4 h) did not differ between treatment and placebo groups: 
    • Treatment: 74/322 (23%) infants; vs
    • Placebo: 85/318 (27%) infants;
    • Adjusted risk ratio: 0.85 (95% CI, 0.62-1.15; P=.28).
  • Ursodeoxycholic acid appeared to be safe but had no meaningful clinical effect on maternal itch symptoms.

Study design

  • Parallel-group, double-blind, multicenter randomized placebo-controlled trial.
  • Participants were randomly allocated to receive ursodeoxycholic acid (n=305) vs placebo (n=300).
  • Funding: National Institute for Health Research Efficacy and Mechanism Evaluation Programme.

Limitations

  • The primary outcome is rare; study may not have been adequately powered.