Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 1998

Interventions

  • Drug: ursodeoxycholic acid
    • 450 mg/day for 14 days
  • Drug: Placebo
    • placebo

Arms, Groups and Cohorts

  • Active Comparator: ursodeoxycholic acid
    • 10 pregant women with intrahepatic cholestasis of pregnancy
  • Active Comparator: placebo
    • 10 pregnant women with intrahepatic cholestasis of pregnancy

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Obstetrical surveillance
    • Time Frame: 2-12 weeks
    • Data on pregnancy and delivery outcome was recorded and analysed.

Participating in This Clinical Trial

Inclusion Criteria

  • Pregnant women with intrahepatic cholestasis of pregnancy

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Turku University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Titta Joutsiniemi, MD – Turku University Hospital
  • Overall Official(s)
    • Susanna Timonen, PhD, Study Chair, Turku University Hospital
    • Ulla Ekblad, PhD, Study Director, Turku University Hospital
    • Riitta Leino, MD, Principal Investigator, Turku University Hospital
    • Pertti Palo, PhD, Principal Investigator, Turku University Hospital

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