Clinical trial NCT01226823: Ursodeoxycholic Acid And Cholestasis Of Pregnancy
Official title: Intrahepatic Cholestasis Of Pregnancy: Clinical Impact Of Ursodeoxycholic Acid Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Intrahepatic Cholestasis of Pregnancy
Keywords: cholestasis
pregnancy
ursodeoxycholic acid
ICP
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2010-10-22
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of participants with preterm delivery (before week 37)
timeFrame: at the time of delivery
Secondary outcomes:
measure: Pruritus on the Visual Analogue Scale
timeFrame: from enrollment until delivery
measure: Transaminases
timeFrame: from enrolment until delivery
measure: Bile Acids
timeFrame: from enrolment until delivery
measure: Fetal movement count
timeFrame: from enrolment until delivery
measure: Number of pregnancies with cardiotocography suggestive of fetal stress
timeFrame: from enrolment until delivery
measure: APGAR index
timeFrame: 1 and 5 minutes after birth
measure: Number of pregnancies with Green stained amniotic fluid
timeFrame: at delivery
Other outcomes:
Locations:
city: San Giovanni Rotondo
country: Italy
facility: Divisione di Gastroenterologia, IRCCS Casa Sollievo della Sofferenza
state: Foggia
city: Bologna
country: Italy
facility: UOC Ostetricia e Ginecologia, Ospedale Maggiore
city: Bologna
country: Italy
facility: S.Orsola-Malpighi Hospital
city: Modena
country: Italy
facility: Gastroenterology and Liver Clinic, Azienda Ospedaliero-Universitaria, University of Modena and Reggio Emilia
city: Padua
country: Italy
facility: Dept. of Surgical and Gastroenterological Sciences, University of Padova
city: Palermo
country: Italy
facility: Gastroenterology Unit, Policlinic of Palermo
city: Rome
country: Italy
facility: Internal Medicine Department, Gemelli Hospital, Catholic University of Sacred Heart
Study officials:
affiliation: University of Bologna
name: Giuseppe Mazzella, Professor
role: STUDY_DIRECTOR
affiliation: University of Bologna
name: Francesco Azzaroli, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walker KF, Chappell LC, Hague WM, Middleton P, Thornton JG. Pharmacological interventions for treating intrahepatic cholestasis of pregnancy. Cochrane Database Syst Rev. 2020 Jul 27;7(7):CD000493. doi: 10.1002/14651858.CD000493.pub3.