NCT05197387

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
322

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

June 21, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2025

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

3 years

First QC Date

January 5, 2022

Last Update Submit

October 14, 2024

Conditions

Cholestasis of Pregnancy

Keywords

placentacholestasispregnancyinflammation

Outcome Measures

Primary Outcomes (1)

  • Prevalence of placental chronic inflammation

    At delivery

Secondary Outcomes (3)

  • 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

Study Arms (2)

Cases

Women with intrahepatic cholestasis of pregnancy

Controls

Women without intrahepatic cholestasis of pregnancy

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant woman
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women with or without intrahepatic cholestasis of pregnancy included at delivery. Each control will be matched with each case according to gestation age at delivery.

You may qualify if:

  • Adult pregnant woman with singleton
  • For cases: diagnosis of intrahepatic cholestasis of pregnancy For controls: no diagnosis of ICP

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

CHU Angers

Angers, France

NOT YET RECRUITING

Polyclinique KERAUDREN

Brest, 29200, France

RECRUITING

CHU de Brest

Brest, 29609, France

RECRUITING

CHU de Caen

Caen, 14000, France

RECRUITING

CH de Chambery

Chambéry, 75300, France

RECRUITING

CH Bretagne Sud

Lorient, 56100, France

RECRUITING

CHU Nantes

Nantes, France

RECRUITING

CH de Quimper

Quimper, 29000, France

RECRUITING

CHU de Rennes

Rennes, 35000, France

RECRUITING

CH St Brieuc

Saint-Brieuc, France

RECRUITING

CHU de Tours

Tours, 37044, France

RECRUITING

Related 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.

    PMID: 25001852BACKGROUND

  • 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.

    PMID: 24758367BACKGROUND

  • 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.

    PMID: 26469633BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Intrahepatic Cholestasis of PregnancyCholestasisInflammation

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Claire de Moreuil

CONTACT

02 98 14 53 03claire.demoreuil@chu-brest.fr

Philippe Merviel

CONTACT

02-98-22-39-70philippe.merviel@chu-brest.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 19, 2022

Study Start

June 21, 2022

Primary Completion

June 21, 2025

Study Completion

June 22, 2025

Last Updated

October 16, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning two years and ending five years following the publication
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR(11)