NCT05197387 Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation
| NCT ID | NCT05197387 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Brest |
| Condition | Cholestasis of Pregnancy |
| Study Type | OBSERVATIONAL |
| Enrollment | 322 participants |
| Start Date | 2022-06-21 |
| Primary Completion | 2025-06-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 322 participants in total. It began in 2022-06-21 with a primary completion date of 2025-06-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05197387 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 60 Years, studying Cholestasis of Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05197387 currently recruiting?
Yes, NCT05197387 is actively recruiting participants. Contact the research team at claire.demoreuil@chu-brest.fr for enrollment information.
Where is the NCT05197387 trial being conducted?
This trial is being conducted at Angers, France, Brest, France, Brest, France, Caen, France and 7 additional locations.
Who is sponsoring the NCT05197387 clinical trial?
NCT05197387 is sponsored by University Hospital, Brest. The trial plans to enroll 322 participants.