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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

About this trial

This is an interventional treatment trial for Intrahepatic Cholestasis focused on measuring ursodeoxycholic acid, intrahepatic cholestasis, pregnancy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

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

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

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

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Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

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