Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy
Status:
Completed
Trial end date:
1998-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to examine the efficacy and safety of ursodeoxycholic acid
(UDCA) in the treatment of patients with intrahepatic cholestasis of pregnancy (ICP).
In the randomised (double-blind, placebo-controlled) study 20 pregnant women with ICP
received (random allocation of) either 450 mg/day UDCA or placebo for 14 days during the
third trimester of pregnancy. The severity of pruritus was registered. Itching scores and
serum levels of alanine aminotransferase, total bile acids, estradiol, progesterone,
prolactin, cholesterol, HDL-cholesterol, triglycerides, activated partial thromboplastin time
(APTT), fibrinogen D-dimers (FIDD) and platelet count were assessed before the treatment and
weekly thereafter. Data on pregnancy and delivery outcome was recorded and analysed.