Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Titta Joutsiniemi, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01576458
First received: February 18, 2012
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Intrahepatic Cholestasis
Pregnancy
Drug: ursodeoxycholic acid
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Placebo-controlled Study of Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • pruritus [ Time Frame: an average of 5 weeks ] [ Designated as safety issue: Yes ]
    visual analogy scale (VAS): 0-10

  • laboratory values [ Time Frame: an average 5 weeks ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Obstetrical surveillance [ Time Frame: 2-12 weeks ] [ Designated as safety issue: Yes ]
    Data on pregnancy and delivery outcome was recorded and analysed.


Enrollment: 20
Study Start Date: January 1998
Study Completion Date: December 1998
Primary Completion Date: December 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ursodeoxycholic acid
10 pregant women with intrahepatic cholestasis of pregnancy
Drug: ursodeoxycholic acid
450 mg/day for 14 days
Active Comparator: placebo
10 pregnant women with intrahepatic cholestasis of pregnancy
Drug: Placebo
placebo
Other Name: placebo

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women with intrahepatic cholestasis of pregnancy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01576458

Locations
Finland
Turku University Hospital
Turku, Finland, 20520
Sponsors and Collaborators
Turku University Hospital
Investigators
Study Chair: Susanna Timonen, PhD Turku University Hospital
Study Director: Ulla Ekblad, PhD Turku University Hospital
Principal Investigator: Riitta Leino, MD Turku University Hospital
Principal Investigator: Pertti Palo, PhD Turku University Hospital
  More Information

No publications provided by Turku University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Titta Joutsiniemi, MD, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01576458     History of Changes
Other Study ID Numbers: 73/180/2011, 73/180/2011
Study First Received: February 18, 2012
Last Updated: April 11, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by Turku University Hospital:
ursodeoxycholic acid
intrahepatic cholestasis
pregnancy

Additional relevant MeSH terms:
Cholestasis
Cholestasis, Intrahepatic
Pregnancy Complications
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014