Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

Ursodeoxycholic Acid And Cholestasis Of Pregnancy (CERTO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01226823
Recruitment Status : Withdrawn (Modified insurance requests by a new law released after its approval.)
First Posted : October 22, 2010
Last Update Posted : May 12, 2016
Information provided by (Responsible Party):
Francesco Azzaroli, University of Bologna

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.

Condition or disease Intervention/treatment Phase
Intrahepatic Cholestasis of Pregnancy Drug: Ursodeoxycholic Acid Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intrahepatic Cholestasis Of Pregnancy: Clinical Impact Of Ursodeoxycholic Acid Treatment
Study Start Date : November 2010
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : November 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Number of participants with preterm delivery (before week 37) [ Time Frame: at the time of delivery ]

Secondary Outcome Measures :
  1. Pruritus on the Visual Analogue Scale [ Time Frame: from enrollment until delivery ]
  2. Transaminases [ Time Frame: from enrolment until delivery ]
  3. Bile Acids [ Time Frame: from enrolment until delivery ]
  4. Fetal movement count [ Time Frame: from enrolment until delivery ]
    mother evaluation

  5. Number of pregnancies with cardiotocography suggestive of fetal stress [ Time Frame: from enrolment until delivery ]
  6. APGAR index [ Time Frame: 1 and 5 minutes after birth ]
  7. Number of pregnancies with Green stained amniotic fluid [ Time Frame: at delivery ]
    obstetrician evaluation

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01226823

Layout table for location information
Divisione di Gastroenterologia, IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy, 71013
UOC Ostetricia e Ginecologia, Ospedale Maggiore
Bologna, Italy, 40100
S.Orsola-Malpighi Hospital
Bologna, Italy, 40138
Gastroenterology and Liver Clinic, Azienda Ospedaliero-Universitaria, University of Modena and Reggio Emilia
Modena, Italy
Dept. of Surgical and Gastroenterological Sciences, University of Padova
Padua, Italy, 34100
Gastroenterology Unit, Policlinic of Palermo
Palermo, Italy
Internal Medicine Department, Gemelli Hospital, Catholic University of Sacred Heart
Rome, Italy, 00168
Sponsors and Collaborators
University of Bologna
Layout table for investigator information
Study Director: Giuseppe Mazzella, Professor University of Bologna
Principal Investigator: Francesco Azzaroli, Professor University of Bologna

Layout table for additonal information
Responsible Party: Francesco Azzaroli, Assistant Professor, University of Bologna Identifier: NCT01226823    
Other Study ID Numbers: CERTO
First Posted: October 22, 2010    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Keywords provided by Francesco Azzaroli, University of Bologna:
ursodeoxycholic acid
Additional relevant MeSH terms:
Layout table for MeSH terms
Cholestasis, Intrahepatic
Pregnancy Complications
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents