• The Microbiome Composition in Women With Recurring Intrahepatic Cholestasis of Pregnancy (ICP)

  NCT05151913

  CompletedObservationalUpdated Dec 9, 2021
• Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy

  NCT07428226

  RecruitingObservationalUpdated Feb 23, 2026
• Il-17 Levels in Intrahepatic Cholestasis of Pregnancy

  NCT01898832

  Unknown statusObservationalUpdated Mar 18, 2014
• Bile Acids Metabolism and Genetic Mutation Profile in the Intrahepatic Cholestasis of Pregnacy in Indian Population

  NCT05691036

  RecruitingObservationalUpdated May 18, 2026
• Placental Inflammation in Prenatal Care

  NCT02476656

  CompletedObservationalUpdated Aug 2, 2018
• Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies

  NCT00456118

  CompletedObservationalUpdated Aug 13, 2018

ClinicalTrials.gov ID

NCT05197387

Lead Sponsor

University Hospital, BrestOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

322Estimated

Last Update Posted

Oct 16, 2024Actual

Start Date

Jun 21, 2022Actual

Primary Completion Date

Jun 21, 2025Estimated

Completion Date

Jun 22, 2025Estimated

Official Title

Inflammation in Intrahepatic Cholestasis of Pregnancy

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.

• Cholestasis of Pregnancy

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

Yes

Eligibility Criteria

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

Observational Model

Case-Control

Time Perspective

Prospective

Lead Sponsor

University Hospital, BrestOTHER

norbert.winer@chu-nantes.fr