NCT01576458

Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Turku University Hospital · Other Government
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Intrahepatic Cholestasis
• Pregnancy

Interventions

Type	Name	Description
DRUG	ursodeoxycholic acid	450 mg/day for 14 days
DRUG	Placebo	placebo

Timeline

• Start date: 1998-01-01
• Primary completion: 1998-12-01
• Completion: 1998-12-01
• First posted: 2012-04-12
• Last updated: 2012-04-12

Locations

1 site across 1 country: Finland