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Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

Sponsor
Turku University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01576458
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
11
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: ursodeoxycholic acid
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomised Placebo-controlled Study of Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy
Study Start Date :
Jan 1, 1998
Actual Primary Completion Date :
Dec 1, 1998
Actual Study Completion Date :
Dec 1, 1998

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. pruritus [an average of 5 weeks]

    visual analogy scale (VAS): 0-10

  2. laboratory values [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 Outcome Measures

  1. Obstetrical surveillance [2-12 weeks]

    Data on pregnancy and delivery outcome was recorded and analysed.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Pregnant women with intrahepatic cholestasis of pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Titta Joutsiniemi, MD, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01576458
Other Study ID Numbers:
  • 73/180/2011
  • 73/180/2011
First Posted:
Apr 12, 2012
Last Update Posted:
Apr 12, 2012
Last Verified:
Apr 1, 2012
Keywords provided by Titta Joutsiniemi, MD, Turku University Hospital
ursodeoxycholic acid
intrahepatic cholestasis
pregnancy
Additional relevant MeSH terms:
Cholestasis
Cholestasis, Intrahepatic
Ursodeoxycholic Acid

Study Results

No Results Posted as of Apr 12, 2012