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Ursodeoxycholic Acid And Cholestasis Of Pregnancy (CERTO)

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ClinicalTrials.gov 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Recruitment Status : Withdrawn (Modified insurance requests by a new law released after its approval.)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
Sponsor:
Information provided by (Responsible Party):
Francesco Azzaroli, University of Bologna

October 19, 2010
October 22, 2010
May 12, 2016
November 2010
November 2013   (Final data collection date for primary outcome measure)
Number of participants with preterm delivery (before week 37) [ Time Frame: at the time of delivery ]
Same as current
Complete list of historical versions of study NCT01226823 on ClinicalTrials.gov Archive Site
  • Pruritus on the Visual Analogue Scale [ Time Frame: from enrollment until delivery ]
  • Transaminases [ Time Frame: from enrolment until delivery ]
  • Bile Acids [ Time Frame: from enrolment until delivery ]
  • Fetal movement count [ Time Frame: from enrolment until delivery ]
    mother evaluation
  • Number of pregnancies with cardiotocography suggestive of fetal stress [ Time Frame: from enrolment until delivery ]
  • APGAR index [ Time Frame: 1 and 5 minutes after birth ]
  • Number of pregnancies with Green stained amniotic fluid [ Time Frame: at delivery ]
    obstetrician evaluation
Same as current
Not Provided
Not Provided
 
Ursodeoxycholic Acid And Cholestasis Of Pregnancy
Intrahepatic Cholestasis Of Pregnancy: Clinical Impact Of Ursodeoxycholic Acid Treatment

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Intrahepatic Cholestasis of Pregnancy
  • 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
  • Placebo Comparator: Placebo
    obstetrical monitoring plus placebo
    Intervention: Drug: Placebo
  • Experimental: Ursodeoxycholic acid
    obstetrical monitoring plus active drug
    Intervention: Drug: Ursodeoxycholic Acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
118
November 2013
November 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01226823
CERTO
No
Not Provided
Not Provided
Francesco Azzaroli, University of Bologna
University of Bologna
Not Provided
Study Director: Giuseppe Mazzella, Professor University of Bologna
Principal Investigator: Francesco Azzaroli, Professor University of Bologna
University of Bologna
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP