Ursodeoxycholic Acid And Cholestasis Of Pregnancy (CERTO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of Bologna.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Bologna
ClinicalTrials.gov Identifier:
NCT01226823
First received: October 19, 2010
Last updated: October 21, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Intrahepatic Cholestasis of Pregnancy
Drug: Ursodeoxycholic Acid
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intrahepatic Cholestasis Of Pregnancy: Clinical Impact Of Ursodeoxycholic Acid Treatment

Resource links provided by NLM:


Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • Number of participants with preterm delivery (before week 37) [ Time Frame: at the time of delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pruritus on the Visual Analogue Scale [ Time Frame: from enrollment until delivery ] [ Designated as safety issue: No ]
  • Transaminases [ Time Frame: from enrolment until delivery ] [ Designated as safety issue: No ]
  • Bile Acids [ Time Frame: from enrolment until delivery ] [ Designated as safety issue: No ]
  • Fetal movement count [ Time Frame: from enrolment until delivery ] [ Designated as safety issue: No ]
    mother evaluation

  • Number of pregnancies with cardiotocography suggestive of fetal stress [ Time Frame: from enrolment until delivery ] [ Designated as safety issue: No ]
  • APGAR index [ Time Frame: 1 and 5 minutes after birth ] [ Designated as safety issue: No ]
  • Number of pregnancies with Green stained amniotic fluid [ Time Frame: at delivery ] [ Designated as safety issue: No ]
    obstetrician evaluation


Estimated Enrollment: 118
Study Start Date: November 2010
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
obstetrical monitoring plus placebo
Drug: Placebo
300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery
Experimental: Ursodeoxycholic acid
obstetrical monitoring plus active drug
Drug: Ursodeoxycholic Acid
300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226823

Contacts
Contact: Giuseppe Mazzella, Professor +390516364120 giuseppe.mazzella@unibo.it

Locations
Italy
Divisione di Gastroenterologia, IRCCS Casa Sollievo della Sofferenza Not yet recruiting
San Giovanni Rotondo, Foggia, Italy, 71013
Contact: Alessandra Mangia, MD         
Principal Investigator: Alessandra Mangia, MD         
S.Orsola-Malpighi Hospital Not yet recruiting
Bologna, Italy, 40138
Contact       giuseppe.mazzella@unibo.it   
Contact       francesco.azzaroli@unibo.it   
Principal Investigator: Francesco Azzaroli, Professor         
Sub-Investigator: Andrea Lisotti, MD         
UOC Ostetricia e Ginecologia, Ospedale Maggiore Not yet recruiting
Bologna, Italy, 40100
Contact: Scagliarini Giorgio, Dr.       giorgio.scagliarini@ausl.bo.it   
Principal Investigator: Giorgio Scagliarini, Dr.         
Gastroenterology and Liver Clinic, Azienda Ospedaliero-Universitaria, University of Modena and Reggio Emilia Not yet recruiting
Modena, Italy
Contact: Erica Villa, Professor    +390594222111      
Principal Investigator: Erica Villa, Professor         
Dept. of Surgical and Gastroenterological Sciences, University of Padova Not yet recruiting
Padua, Italy, 34100
Contact: Annarosa Floreani, Professor    +390498212894    annarosa.floreani@unipd.it   
Principal Investigator: Annarosa Floreani, Professor         
Gastroenterology Unit, Policlinic of Palermo Not yet recruiting
Palermo, Italy
Contact: Carlo Cammà, Professor       carlo.cammà@unipa.it   
Principal Investigator: Carlo Cammà, Professor         
Internal Medicine Department, Gemelli Hospital, Catholic University of Sacred Heart Not yet recruiting
Rome, Italy, 00168
Contact: Antonio Gasbarrini, Professor       agasbarrini@rm.unicatt.it   
Principal Investigator: Antonio Gasbarrini, Professor         
Sponsors and Collaborators
University of Bologna
Investigators
Study Director: Giuseppe Mazzella, Professor University of Bologna
Principal Investigator: Francesco Azzaroli, Professor University of Bologna
  More Information

No publications provided

Responsible Party: Prof. Giuseppe Mazzella, S.Orsola-Malpighi Hospital/University of Bologna
ClinicalTrials.gov Identifier: NCT01226823     History of Changes
Other Study ID Numbers: CERTO
Study First Received: October 19, 2010
Last Updated: October 21, 2010
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by University of Bologna:
cholestasis
pregnancy
ursodeoxycholic acid
ICP

Additional relevant MeSH terms:
Cholestasis
Cholestasis, Intrahepatic
Pregnancy Complications
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014