Investigating the link between pregnancy-related liver issues and placental inflammation
Inflammation in Intrahepatic Cholestasis of Pregnancy
This study is trying to see if inflammation in the placenta is linked to liver problems during pregnancy in women with intrahepatic cholestasis of pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 322 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 11 sites (Angers and 10 other locations) |
| Trial ID | NCT05197387 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore whether an immune response similar to organ rejection is involved in intrahepatic cholestasis of pregnancy (ICP). It will include 322 pregnant women at delivery, with half diagnosed with ICP and half serving as controls. Blood tests will be conducted to measure biological markers related to inflammation and placental analysis will be performed to assess chronic inflammation. The study seeks to compare these parameters between the two groups to better understand the underlying mechanisms of ICP.
Who should consider this trial
Good fit: Ideal candidates are adult pregnant women with a singleton pregnancy, specifically those diagnosed with intrahepatic cholestasis of pregnancy.
Not a fit: Patients with multiple pregnancies, under 18 years old, or those with certain infections or complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new immunomodulatory treatments for women suffering from intrahepatic cholestasis of pregnancy.
How similar studies have performed: While the approach of examining immune processes in pregnancy-related conditions is not widely tested, similar studies have shown promise in understanding placental and inflammatory interactions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Angers and 10 other locations
- CHU Angers — Angers, France (Not_yet_recruiting)
- Polyclinique KERAUDREN — Brest, France (Recruiting)
- CHU de Brest — Brest, France (Recruiting)
- CHU de Caen — Caen, France (Recruiting)
- CH de Chambery — Chambéry, France (Recruiting)
- CH Bretagne Sud — Lorient, France (Recruiting)
- CHU Nantes — Nantes, France (Recruiting)
- CH de Quimper — Quimper, France (Recruiting)
- CHU de Rennes — Rennes, France (Recruiting)
- CH St Brieuc — Saint-Brieuc, France (Recruiting)
- CHU de Tours — Tours, France (Recruiting)
Study contacts
- Study coordinator: Claire de Moreuil
- Email: claire.demoreuil@chu-brest.fr
- Phone: 02 98 14 53 03
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.