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