Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

• Status: Completed
• Trial end date: 1998-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Turku University Hospital
• Treatments: Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

• Pregnant women with intrahepatic cholestasis of pregnancy