Skip to main content
OpenTrials
Completed

NCT Number: NCT01576458

Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intrahepatic Cholestasis Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Liver Diseases Pregnancy

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Turku University Hospital

Turku, 20520, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women with intrahepatic cholestasis of pregnancy

Treatment and study plan

Ursodeoxycholic acid

Drug

450 mg/day for 14 days

Placebo

Drug

placebo

Primary outcomes

  1. pruritus

    Time frame: an average of 5 weeks

    visual analogy scale (VAS): 0-10

  2. 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.

Secondary outcomes

  1. Obstetrical surveillance

    Time frame: 2-12 weeks

    Data on pregnancy and delivery outcome was recorded and analysed.

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
1998
Study completion
1998
First posted
Apr 12, 2012
Registry last updated
Apr 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.