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

Interventional


Primary Outcome

Number of participants with preterm delivery (before week 37)

Secondary Outcome

 Pruritus on the Visual Analogue Scale

Condition

Intrahepatic Cholestasis of Pregnancy

Intervention

Ursodeoxycholic Acid

Study Arms / Comparison Groups

 Placebo
Description:  obstetrical monitoring plus placebo

Publications

* 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

Drug

Estimated Enrollment

0

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
             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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Giuseppe Mazzella, Professor, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT01226823

Organization ID

CERTO


Responsible Party

Principal Investigator

Study Sponsor

University of Bologna


Study Sponsor

Giuseppe Mazzella, Professor, Study Director, University of Bologna


Verification Date

May 2016