Ursodeoxycholic Acid And Cholestasis Of Pregnancy (NCT01226823) | Clinical Trial Compass
WithdrawnPhase 3
Ursodeoxycholic Acid And Cholestasis Of Pregnancy
Stopped: Modified insurance requests by a new law released after its approval.
Italy0Started 2010-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with preterm delivery (before week 37)