Ursodeoxycholic Acid And Cholestasis Of Pregnancy

Study Overview
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Brief Summary
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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.

Official Title
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Intrahepatic Cholestasis Of Pregnancy: Clinical Impact Of Ursodeoxycholic Acid Treatment

Conditions
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Intrahepatic Cholestasis of Pregnancy

Intervention / Treatment
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* Drug: Ursodeoxycholic Acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>obstetrical monitoring plus placebo | Drug: Placebo<br>* 300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery<br>|
| Experimental: Ursodeoxycholic acid<br>obstetrical monitoring plus active drug | Drug: Ursodeoxycholic Acid<br>* 300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with preterm delivery (before week 37) |  | at the time of delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pruritus on the Visual Analogue Scale |  | from enrollment until delivery | 
| Transaminases |  | from enrolment until delivery | 
| Bile Acids |  | from enrolment until delivery | 
| Fetal movement count | mother evaluation | from enrolment until delivery | 
| Number of pregnancies with cardiotocography suggestive of fetal stress |  | from enrolment until delivery | 
| APGAR index |  | 1 and 5 minutes after birth | 
| Number of pregnancies with Green stained amniotic fluid | obstetrician evaluation | at delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholestasis, pregnancy, ursodeoxycholic acid, ICP