Status:

RECRUITING

Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation

Lead Sponsor:

University Hospital, Brest

Conditions:

Cholestasis of Pregnancy

Eligibility:

FEMALE

18-60 years

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...

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 deliv...

Eligibility Criteria

Inclusion

  • Adult pregnant woman with singleton
  • For cases: diagnosis of intrahepatic cholestasis of pregnancy For controls: no diagnosis of ICP

Exclusion

  • 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

Key Trial Info

Start Date :

June 21 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 22 2025

Estimated Enrollment :

322 Patients enrolled

Trial Details

Trial ID

NCT05197387

Start Date

June 21 2022

End Date

June 22 2025

Last Update

October 16 2024

Active Locations (11)

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Page 1 of 3 (11 locations)

1

CHU Angers

Angers, France

2

Polyclinique KERAUDREN

Brest, France, 29200

3

CHU de Brest

Brest, France, 29609

4

CHU de Caen

Caen, France, 14000