Participants: Women with ICP (based on pruritis and bile acid above normal limit of local lab)
GA between 20w0d and 40w6d
Singleton or twin pregnancy and no known lethal fetal anomalies
Interventions (from enrollment till birth)
Ursodeoxycholic acid group: 500 mg (1 tablet) twice a day with adjustment based on clinician’s discretion (maximum four tablets | minimum one tablet)
Control group: placebo
Primary outcome: Composite of
Perinatal death: IUFD or neonatal death up to 7 days after birth
Preterm delivery: <37 weeks
NICU admission for at least 4 hours
Primary outcome analysis
Ursodeoxycholic acid group: included 304 women and 322 infants
Control group: 300 women and 318 infants
The primary outcome occurred in
Ursodeoxycholic acid group: 23%
Control group: 27%
Adjusted risk ratio (RR) 0.85 (95% CI, 0.62 to 1.15)
Serious events were recorded but none were attributable to the treatment
Maternal itch score was significantly reduced in the ursodeoxycholic acid group but “had no clinically meaningful effect” (itch score measured as the worst episode of itch over a day on a 100-mm visual analogue scale)
Mean difference −5.7 mm (95% CI, −9.7 to −1.7; p=0·0054)
Bile acid concentration reduction was less in the ursodeoxycholic acid group vs placebo (p=0.030)
Compared to placebo, ursodeoxycholic acid did not impact risk for adverse events related to ICP
The authors of this study suggest that the use of ursodeoxycholic acid for ICP should be reconsidered because
Ursodeoxycholic acid does not seem to have any significant clinical benefit when used routinely for treatment of women with intrahepatic cholestasis of pregnancy
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