NCT01226823

Ursodeoxycholic Acid And Cholestasis Of Pregnancy

Intrahepatic Cholestasis Of Pregnancy: Clinical Impact Of Ursodeoxycholic Acid Treatment

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Bologna · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a multicenter randomized double blind placebo controlled trial. The study will be conducted on pregnant women with a diagnosis of intrahepatic cholestasis of pregnancy (ICP) in third level hospitals (that are also Academic Hospitals). Pregnant women at the time of ICP diagnosis will be randomized in two groups: Group 1 - will receive placebo and obstetrical monitoring until delivery Group 2 - will receive UDCA at the dose of 20 mg/Kg/day and obstetrical monitoring until delivery. The hypotheses are that UDCA treatment will be superior to placebo and effective in: reducing the rate of prematurity; improving maternal biochemical parameters and symptoms.

Conditions

• Intrahepatic Cholestasis of Pregnancy

Interventions

Type	Name	Description
DRUG	Ursodeoxycholic Acid	300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery
DRUG	Placebo	300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2010-10-22
• Last updated: 2016-05-12

Locations

7 sites across 1 country: Italy