Ursodeoxycholic Acid And Cholestasis Of Pregnancy

Brief Title

Ursodeoxycholic Acid And Cholestasis Of Pregnancy

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.

Study Phase

Phase 3

Study Type


Primary Outcome

Number of participants with preterm delivery (before week 37)

Secondary Outcome

 Pruritus on the Visual Analogue Scale


Intrahepatic Cholestasis of Pregnancy


Ursodeoxycholic Acid

Study Arms / Comparison Groups

Description:  obstetrical monitoring plus placebo


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

November 2010

Completion Date

November 2013

Primary Completion Date

November 2013

Eligibility 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

          -  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




18 Years - N/A

Accepts Healthy Volunteers



Giuseppe Mazzella, Professor, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

University of Bologna

Study Sponsor

Giuseppe Mazzella, Professor, Study Director, University of Bologna

Verification Date

May 2016