Ursodeoxycholic Acid And Cholestasis Of Pregnancy

Last updated: May 10, 2016
Sponsor: University of Bologna
Overall Status: Trial Not Available

Phase

3

Condition

Pregnancy Complications

Primary Biliary Cholangitis

Treatment

N/A

Clinical Study ID

NCT01226823
CERTO
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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 understudy

  • 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

Study Design

Study Start date:
November 01, 2010
Estimated Completion Date:
November 30, 2013

Connect with a study center

  • Divisione di Gastroenterologia, IRCCS Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia 71013
    Italy

    Site Not Available

  • S.Orsola-Malpighi Hospital

    Bologna, 40138
    Italy

    Site Not Available

  • UOC Ostetricia e Ginecologia, Ospedale Maggiore

    Bologna, 40100
    Italy

    Site Not Available

  • Gastroenterology and Liver Clinic, Azienda Ospedaliero-Universitaria, University of Modena and Reggio Emilia

    Modena,
    Italy

    Site Not Available

  • Dept. of Surgical and Gastroenterological Sciences, University of Padova

    Padua, 34100
    Italy

    Site Not Available

  • Gastroenterology Unit, Policlinic of Palermo

    Palermo,
    Italy

    Site Not Available

  • Internal Medicine Department, Gemelli Hospital, Catholic University of Sacred Heart

    Rome, 00168
    Italy

    Site Not Available

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