Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation

Cholestasis of Pregnancy Clinical Trial

— INTREPIDE  

Official title:

Inflammation in Intrahepatic Cholestasis of Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05197387
• Other study ID #: INTREPIDE (29BRC21.0188)
• Status: Recruiting
• Start date: June 21, 2022
• Est. completion date: June 21, 2025

Study information

• Verified date: April 2024
• Source: University Hospital, Brest
• Contact: Claire de Moreuil
• Phone: 02 98 14 53 03
• Email: claire.demoreuil[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 322
• Est. completion date: June 21, 2025
• Est. primary completion date: June 21, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

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

Related Conditions & MeSH terms

• Cholestasis
• Cholestasis of Pregnancy
• Cholestasis, Intrahepatic
• Inflammation
• Pregnancy Complications

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU de Brest	Brest
France	Polyclinique KERAUDREN	Brest
France	CHU de Caen	Caen
France	CH de Chambery	Chambéry
France	CH Bretagne Sud	Lorient
France	CHU Nantes	Nantes
France	CH de Quimper	Quimper
France	CHU de Rennes	Rennes
France	CH St Brieuc	Saint-Brieuc
France	CHU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & Publications (3)

Du Q, Pan Y, Zhang Y, Zhang H, Zheng Y, Lu L, Wang J, Duan T, Chen J. Placental gene-expression profiles of intrahepatic cholestasis of pregnancy reveal involvement of multiple molecular pathways in blood vessel formation and inflammation. BMC Med Genomics. 2014 Jul 7;7:42. doi: 10.1186/1755-8794-7-42. — View Citation

Larson SP, Kovilam O, Agrawal DK. Immunological basis in the pathogenesis of intrahepatic cholestasis of pregnancy. Expert Rev Clin Immunol. 2016;12(1):39-48. doi: 10.1586/1744666X.2016.1101344. Epub 2015 Oct 15. — View Citation

Patel S, Pinheiro M, Felix JC, Opper N, Ouzounian JG, Lee RH. A case-control review of placentas from patients with intrahepatic cholestasis of pregnancy. Fetal Pediatr Pathol. 2014 Aug;33(4):210-5. doi: 10.3109/15513815.2014.899413. Epub 2014 Apr 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of placental chronic inflammation		At delivery
Secondary	Levels of several biological parameters involved in inflammation processes		At delivery
Secondary	Levels of several biological parameters involved in allograft rejection		At delivery
Secondary	Levels of several biological parameters involved in angiogenesis		At delivery