Clinical Trial: Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomised Placebo-controlled Study of Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

Brief 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.


Detailed Summary:
Sponsor: Turku University Hospital

Current Primary Outcome:

  • pruritus [ Time Frame: an average of 5 weeks ]
    visual analogy scale (VAS): 0-10
  • laboratory values [ Time Frame: an average 5 weeks ]
    Serum levels of alanine aminotransferases and total bile acids were assessed before the treatment and once a week thereafter at least three times or until delivery. Simultaneously serum levels of estradiol, progesterone, prolactin, cholesterol, HDL-cholesterol and triglyserides were assessed. Platelet count activated partial thromboplastin time and fibrinogen D-dimers were measured as well.


Original Primary Outcome: Same as current

Current Secondary Outcome: Obstetrical surveillance [ Time Frame: 2-12 weeks ]

Data on pregnancy and delivery outcome was recorded and analysed.


Original Secondary Outcome: Same as current

Information By: Turku University Hospital

Dates:
Date Received: February 18, 2012
Date Started: January 1998
Date Completion:
Last Updated: April 11, 2012
Last Verified: April 2012