Ursodeoxycholic acid in the treatment of intrahepatic cholestasis of pregnancy. A 12-year experience.

OBJECTIVE: To assess the efficacy of ursodeoxycholic acid (UDCA) in patients with intrahepatic cholestasis of pregnancy (ICP) and in the outcome of pregnancy.

METHODS: Retrospective analysis of our 12-year experience treating ICP patients with UDCA. Thirty-two patients with pruritus starting before week 34 of pregnancy and with increased serum bile salts (BS) and alanine aminotransferase (ALT) received UDCA (15 mg/kg/day) for at least 3 weeks before delivery. They were compared with 16 historical controls who did not receive UDCA. All patients were followed up until delivery and in puerperium. Newborns were followed up during 3 months.

RESULTS: UDCA treatment attenuated pruritus (P < 0.05), serum bilirubin and ALT decreased (P < 0.05) and BS declined. Delivery at term (> or = 37 weeks) occurred in 65.7% of UDCA-treated patients compared with only 12.5% in controls (P < 0.01). Infants born to mothers treated with UDCA weighed a mean of 500 g more than the controls (2882+/-582 vs 2385+/-582; P < 0.01). At 3 months, all infants developed normally. Twenty-six children whose mothers received UDCA were re-examined after 1-12 years and they and their mothers were healthy.

CONCLUSIONS: UDCA improved pruritus and biochemical cholestasis, and facilitated deliveries at term in ICP patients, with a higher birthweight compared with historical controls. The drug was well tolerated and no adverse effects were detected in their infants.