Ursodeoxycholic acid in cholestasis of pregnancy: final report of a randomized, double-blind, placebo controlled study [AASLD abstract]

A double-blind, placebo-controlled study was performed to confirm our previous results with the use of ursodeoxycholic acid (UDCA) in patients with intrahepatic cholestasis of pregnancy (ICP) (Hepatology 1992;15:1043-7) and to determine its effects on the outcome of pregnancy. Hospitalized patients with ICP were randomly assigned to receive either UDCA or a placebo, in identical capsules and in coded boxes. Decisions on pregnancy outcome were taken by obstetricians, independent from this study. Fifteen patients completed 3 weeks of treatment prior to delivery: 7 had received placebo and 8 UDCA (mean daily dose 14 mg/kg). All mothers treated with UDCA had spontaneous deliveries or cesarean sections after week 36 of pregnancy, with normal babies, including one pair of twins. Among patients who received placebo, delivery occurred or cesarean sections were performed before week 34 of pregnancy in 4 of them, and another one had a stillbirth on week 34, without other cause besides ICP. CONCLUSIONS: 1. UDCA attenuates pruritus and ameliorates biochemical abnormalities in patients with ICP; 2. It also appears to improve the outcome of pregnancy and fetal prognosis in these patients; 3. The present data and previous reports in the literature indicate that UDCA can be considered a safe compound when administered during the third trimester of pregnancy.