Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy
Primary Purpose
Intrahepatic Cholestasis, Pregnancy
Status
Completed
Phase
Phase 3
Locations
Finland
Study Type
Interventional
Intervention
ursodeoxycholic acid
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Intrahepatic Cholestasis focused on measuring ursodeoxycholic acid, intrahepatic cholestasis, pregnancy
Eligibility Criteria
Inclusion Criteria:
- Pregnant women with intrahepatic cholestasis of pregnancy
Sites / Locations
- Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ursodeoxycholic acid
placebo
Arm Description
10 pregant women with intrahepatic cholestasis of pregnancy
10 pregnant women with intrahepatic cholestasis of pregnancy
Outcomes
Primary Outcome Measures
pruritus
visual analogy scale (VAS): 0-10
laboratory values
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
Data on pregnancy and delivery outcome was recorded and analysed.
Full Information
NCT ID
NCT01576458
First Posted
February 18, 2012
Last Updated
April 11, 2012
Sponsor
Turku University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01576458
Brief Title
Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy
Official Title
Randomised Placebo-controlled Study of Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
December 1998 (Actual)
Study Completion Date
December 1998 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrahepatic Cholestasis, Pregnancy
Keywords
ursodeoxycholic acid, intrahepatic cholestasis, pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ursodeoxycholic acid
Arm Type
Active Comparator
Arm Description
10 pregant women with intrahepatic cholestasis of pregnancy
Arm Title
placebo
Arm Type
Active Comparator
Arm Description
10 pregnant women with intrahepatic cholestasis of pregnancy
Intervention Type
Drug
Intervention Name(s)
ursodeoxycholic acid
Intervention Description
450 mg/day for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
pruritus
Description
visual analogy scale (VAS): 0-10
Time Frame
an average of 5 weeks
Title
laboratory values
Description
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.
Time Frame
an average 5 weeks
Secondary Outcome Measure Information:
Title
Obstetrical surveillance
Description
Data on pregnancy and delivery outcome was recorded and analysed.
Time Frame
2-12 weeks
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant women with intrahepatic cholestasis of pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanna Timonen, PhD
Organizational Affiliation
Turku University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ulla Ekblad, PhD
Organizational Affiliation
Turku University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Riitta Leino, MD
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pertti Palo, PhD
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20520
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
23978872
Citation
Joutsiniemi T, Timonen S, Leino R, Palo P, Ekblad U. Ursodeoxycholic acid in the treatment of intrahepatic cholestasis of pregnancy: a randomized controlled trial. Arch Gynecol Obstet. 2014 Mar;289(3):541-7. doi: 10.1007/s00404-013-2995-5. Epub 2013 Aug 27.
Results Reference
derived
Learn more about this trial
Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy
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