Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Intrahepatic Cholestasis Of Pregnancy: Clinical Impact Of Ursodeoxycholic Acid Treatment
Brief 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.