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

October 14, 2024 updated by: University Hospital, Brest

Inflammation in Intrahepatic Cholestasis of Pregnancy

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

322

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cases
Women with intrahepatic cholestasis of pregnancy
Controls
Women without intrahepatic cholestasis of pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of placental chronic inflammation
Time Frame: At delivery
At delivery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2022

Primary Completion (Estimated)

June 21, 2025

Study Completion (Estimated)

June 22, 2025

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 14, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INTREPIDE (29BRC21.0188)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning two years and ending five years following the publication

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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