Ursodeoxycholic Acid And Cholestasis Of Pregnancy

University of Bologna

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Intrahepatic Cholestasis of Pregnancy

Interventions

Ursodeoxycholic AcidDRUG

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

PlaceboDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Divisione di Gastroenterologia, IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy

Dept. of Surgical and Gastroenterological Sciences, University of Padova

Padua, Italy, Italy

UOC Ostetricia e Ginecologia, Ospedale Maggiore

Bologna, Italy

S.Orsola-Malpighi Hospital

Outcomes

Primary Outcomes

Number of participants with preterm delivery (before week 37)

Time frame: at the time of delivery

Secondary Outcomes

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

mother evaluation

Time frame: from enrolment until delivery

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

obstetrician evaluation

Time frame: at delivery

Data from ClinicalTrials.gov

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