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Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation

Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation

Recruiting
18-60 years
Female
Phase N/A

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Overview

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.

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.

Eligibility

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

Study details
    Cholestasis of Pregnancy

NCT05197387

University Hospital, Brest

16 April 2024

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