Overview

Ursodeoxycholic Acid And Cholestasis Of Pregnancy

Status:
Withdrawn
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
University of Bologna
Treatments:
Ursodeoxycholic Acid