HealthDay News — For women with intrahepatic cholestasis of pregnancy, treatment with ursodeoxycholic acid does not reduce adverse perinatal outcomes, according to a study published online Aug. 1 in The Lancet.
Lucy C. Chappell, Ph.D., from King’s College London, and colleagues conducted a randomized placebo-controlled trial at 33 hospital maternity units involving women with intrahepatic cholestasis of pregnancy aged 18 years or older and with a gestational age between 20 weeks and 40 weeks and six days. Six hundred five women were randomly assigned to either ursodeoxycholic acid or placebo (305 and 300, respectively) given as two oral tablets a day at an equivalent dose of 500 mg twice a day.
The primary outcome analysis included 304 women and 322 infants in the ursodeoxycholic acid group and 300 women and 318 infants in the placebo group. The researchers found that the primary outcome (composite of perinatal death, preterm delivery, or neonatal unit admission for at least four hours) occurred in 23 and 27 percent of infants in the ursodeoxycholic acid and placebo groups, respectively (adjusted risk ratio, 0.85; 95 percent confidence interval, 0.62 to 1.15). Two and six serious adverse events were reported in the ursodeoxycholic acid and placebo groups, respectively; no treatment-related serious adverse events were reported.
“The lack of in-vivo evidence of benefit should preclude further routine clinical use of ursodeoxycholic acid, even in the absence of harm, to avoid women being offered an unproven treatment,” the authors write.