Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation

Recruiting

• Conditions: Cholestasis of Pregnancy

• Registration Number: NCT05197387
• Lead Sponsor: University Hospital, Brest

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.

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.

Study Timeline

• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-19
• Study Start: 2022-06-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-06-21
• Study Completion: 2025-06-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 322

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of placental chronic inflammation	At delivery

Secondary Outcome Measures

Name	Time	Method
Levels of several biological parameters involved in angiogenesis	At delivery
Levels of several biological parameters involved in allograft rejection	At delivery
Levels of several biological parameters involved in inflammation processes	At delivery

Trial Locations

Locations (11)

CHU Angers; 🇫🇷 Angers, France

Polyclinique KERAUDREN; 🇫🇷 Brest, France

CHU de Brest; 🇫🇷 Brest, France

CHU de Caen; 🇫🇷 Caen, France

CH de Chambery; 🇫🇷 Chambéry, France

CH Bretagne Sud; 🇫🇷 Lorient, France

CHU Nantes; 🇫🇷 Nantes, France

CH de Quimper; 🇫🇷 Quimper, France

CHU de Rennes; 🇫🇷 Rennes, France

CH St Brieuc; 🇫🇷 Saint-Brieuc, France

CHU de Tours; 🇫🇷 Tours, France