Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation

Inflammation in Intrahepatic Cholestasis of Pregnancy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05197387

Acronym

INTREPIDE

Enrollment

322

Registered

2022-01-19

Start date

2022-06-21

Completion date

2025-06-22

Last updated

2024-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholestasis of Pregnancy

Keywords

placenta, cholestasis, pregnancy, inflammation

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Prevalence of placental chronic inflammation	At delivery

Secondary

Measure	Time frame
Levels of several biological parameters involved in inflammation processes	At delivery
Levels of several biological parameters involved in allograft rejection	At delivery
Levels of several biological parameters involved in angiogenesis	At delivery

Countries

France

Contacts

Primary ContactClaire de Moreuil

claire.demoreuil@chu-brest.fr02 98 14 53 03

Backup ContactPhilippe Merviel

philippe.merviel@chu-brest.fr02-98-22-39-70

Outcome results