Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

Pregnancy Clinical Trial

Official title:

Randomised Placebo-controlled Study of Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576458
• Other study ID #: 73/180/2011
• Secondary ID: 73/180/2011
• Status: Completed
• Phase: Phase 3
• First received: February 18, 2012
• Last updated: April 11, 2012
• Start date: January 1998
• Est. completion date: December 1998

Study information

• Verified date: April 2012
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 1998
• Est. primary completion date: December 1998
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant women with intrahepatic cholestasis of pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholestasis
• Cholestasis, Intrahepatic
• Intrahepatic Cholestasis
• Pregnancy
• Pregnancy Complications

Intervention

Drug:
• ursodeoxycholic acid
450 mg/day for 14 days
• Placebo
placebo

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pruritus	visual analogy scale (VAS): 0-10	an average of 5 weeks	Yes
Primary	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.	an average 5 weeks	Yes
Secondary	Obstetrical surveillance	Data on pregnancy and delivery outcome was recorded and analysed.	2-12 weeks	Yes