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Ursodeoxycholic Acid And Cholestasis Of Pregnancy

NCT01226823 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-05-12

No results posted yet for this 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.

Conditions

  • Intrahepatic Cholestasis of Pregnancy

Interventions

DRUG

Ursodeoxycholic Acid

300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery

DRUG

Placebo

300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery

Sponsors & Collaborators

  • University of Bologna

    lead OTHER

Principal Investigators

  • Giuseppe Mazzella, Professor · University of Bologna

  • Francesco Azzaroli, Professor · University of Bologna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01226823 on ClinicalTrials.gov