Ursodeoxycholic Acid And Cholestasis Of Pregnancy

• Status: Withdrawn
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Bologna
• Treatments: Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

• Pregnant state (after week 20 of gestation)

• Total Serum BA elevation (>10 micromol/l)

• Transaminases elevation (ALT>40 UI/L and AST>37 UI/L)

• Occurrence of pruritus

• Informed consent signed

Exclusion Criteria:

• Infectious diseases (HBV, HDV, HCV related liver disease, EBV, CMV, HIV infection)

• Dermatologic diseases

• Metabolic diseases (including alcohol abuse)

• Other causes of cholestasis (i.e. PBC; PSC)

• Autoimmune liver disease

• Obstructive biliary diseases

• Drug related pathologies

• Known or suspected hyper-sensibility to the drug or the pharmacological class under study

• Serious clinical conditions that, according to the judgment of the investigator, contraindicate the participation to the study (heart, kidney and liver disease)

• Use of cholestyramine

• Patients not able or not willing to follow the procedures of the protocol

• Patients not signing the informed consent

• Onset of ICP during of after the 36th week of pregnancy