Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

Phase 3

Completed

• Conditions: Intrahepatic Cholestasis; Pregnancy
• Interventions: Drug: Placebo; Drug: ursodeoxycholic acid

• Registration Number: NCT01576458
• Lead Sponsor: Turku University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-01
• Primary Completion: 1998-12
• Study Completion: 1998-12
• Study First Submitted: 2012-02-18
• Status Verified: 2012-04
• Study First Submitted QC: 2012-04-11
• Last Update Submitted: 2012-04-11
• Study First Posted: 2012-04-12
• Last Update Posted: 2012-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Pregnant women with intrahepatic cholestasis of pregnancy

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	10 pregnant women with intrahepatic cholestasis of pregnancy
ursodeoxycholic acid	ursodeoxycholic acid	10 pregant women with intrahepatic cholestasis of pregnancy

Primary Outcome Measures

Name	Time	Method
pruritus	an average of 5 weeks	visual analogy scale (VAS): 0-10
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

Name	Time	Method
Obstetrical surveillance	2-12 weeks	Data on pregnancy and delivery outcome was recorded and analysed.

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland