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Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

NCT01576458 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-04-12

No results posted yet for this study

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.

Conditions

  • Intrahepatic Cholestasis
  • Pregnancy

Interventions

DRUG

ursodeoxycholic acid

450 mg/day for 14 days

DRUG

Placebo

placebo

Sponsors & Collaborators

  • Turku University Hospital

    lead OTHER_GOV

Principal Investigators

  • Susanna Timonen, PhD · Turku University Hospital

  • Ulla Ekblad, PhD · Turku University Hospital

  • Riitta Leino, MD · Turku University Hospital

  • Pertti Palo, PhD · Turku University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-01-31
Primary Completion
1998-12-31
Completion
1998-12-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01576458 on ClinicalTrials.gov