RecruitingNot Applicable

Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation

France322 participantsStarted 2022-06-21

Plain-language summary

This observational prospective study will help to determine if an immune process similar to allograft rejection is responsible for the occurrence of an intrahepatic cholestasis of pregnancy (ICP). If so, it would suggest the potential benefit of immunomodulatory therapeutics.

Who can participate

Age range

18 Years – 60 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: * Adult pregnant woman with singleton For cases: diagnosis of intrahepatic cholestasis of pregnancy For controls: no diagnosis of ICP Exclusion Criteria: * Women under 18 years old * Women under legal protection * Gemellar pregnancies * Delivery before 22 Weeks of gestation * Medical termination of pregnancy * Acute chorioamniotitis, in particular those due to the following pathogens: toxoplasmosis, rubella, CMV, herpes virus * Premature rupture of membranes \<37SA * Women infected by covid-19 in the month before delivery

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

Prevalence of placental chronic inflammation

Timeframe: At delivery

Trial details

NCT IDNCT05197387

SponsorUniversity Hospital, Brest

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-21

Contact for this trial

Claire de Moreuil

02 98 14 53 03 claire.demoreuil@chu-brest.fr

View on ClinicalTrials.gov More Cholestasis of Pregnancy trials