NCT05197387

Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation

Inflammation in Intrahepatic Cholestasis of Pregnancy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 322 (estimated)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

This observational study will include 322 pregnant women at delivery: 161 women diagnosed with an intrahepatic cholestasis of pregnancy, and 161 control women. A blood test will be performed at delivery for each woman and each newborn, in order to measure several biological parameters involved in inflammation processes, allograft rejection and angiogenesis. Placenta will also be analysed. In particular, we will look for chronic inflammation in placenta. Biological parameters and placental parameters will be compared between the two groups: cases with ICP and controls.

Conditions

• Cholestasis of Pregnancy

Timeline

• Start date: 2022-06-21
• Primary completion: 2025-06-21
• Completion: 2025-06-22
• First posted: 2022-01-19
• Last updated: 2024-10-16

Locations

11 sites across 1 country: France