Intrahepatic Cholestasis of Pregnancy
Conditions
Keywords
cholestasis, pregnancy, ursodeoxycholic acid, ICP
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.
Interventions
DRUGUrsodeoxycholic Acid
300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery
DRUGPlacebo
300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery
Sponsors
University of Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with preterm delivery (before week 37) | at the time of delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transaminases | from enrolment until delivery | — |
| Bile Acids | from enrolment until delivery | — |
| Fetal movement count | from enrolment until delivery | mother evaluation |
| Pruritus on the Visual Analogue Scale | from enrollment until delivery | — |
| APGAR index | 1 and 5 minutes after birth | — |
| Number of pregnancies with Green stained amniotic fluid | at delivery | obstetrician evaluation |
| Number of pregnancies with cardiotocography suggestive of fetal stress | from enrolment until delivery | — |
Countries
Italy
Outcome results
None listed