Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation (INTREPIDE)

Regional University Hospital Center (CHRU)

Status

Enrolling

Conditions

Cholestasis of Pregnancy

Study type

Observational

Funder types

Other

Identifiers

NCT05197387

INTREPIDE (29BRC21.0188)

Details and patient eligibility

About

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.

Full 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.

Enrollment

322 estimated patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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