Inflammatory Signature of Human Chorionic Cells (TROPHY)

February 11, 2026 updated by: Assistance Publique - Hôpitaux de Paris

Inflammatory Signature of Chorionic Cells as Markers of Premature Labor

The purpose of this study is to identify molecules produced specifically by the cells from the chorionic membranes of the materno-fetal interface ("the water bag") sign for the activation of preterm labor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

· Background

During human gestation, fetal membranes (the "water bag") encompass the amnion, facing the amniotic cavity, and the chorion, lining the maternal decidua and comprising trophoblast cells. Membranes usually remain intact until their spontaneous rupture, close to the first stage of labor at term. Often seen as a simple inert shell, with a role of "airbag" for the developing fetus, the membranes provide yet a large surface of interaction between maternal and fetal tissues and function as a transient endocrine organ with immune properties. Indeed human parturition is tightly correlated with hormonal changes at the maternal-fetal interface during pregnancy, that may control cell interactions and chorio-decidua remodeling, the amnion remaining usually intact until the final break. Precocious remodeling may lead to a premature onset of labor, associated or not with premature rupture of membrane whether the cause is infectious or not. A better understanding of this membrane remodeling may thus offer new avenues to define biomarkers of preterm labor.

Hereof, the fact that the mother-to-be accepts and keeps the fetus for months within her womb has long being seen as an enigma, since the fetus is a semi-allograft, half of his genome being of paternal, thus of foreign, origin. This apparent paradox was deciphered by the demonstration of the set-up of an immunotolerance at the site of implantation through the education of maternal immune cells (Natural Killer and T cells) by the fetal trophoblast. This immunotolerance is normally maintained throughout pregnancy, and some recurrent spontaneous miscarriages have been shown to be due to the loss of this immunotolerance, which activates the rejection of the semi-allograft.

In this regard, remodeled fetal membranes overlying the cervix may discharge signals that could be detectable in cervicovaginal fluids and serve as biomarkers of the imminence of delivery. Such information on delivery timing may be of great importance for an adequate prediction that would change drastically the management of threatening preterm delivery.

· Current proposal The objective of this study is to characterize the fetal and maternal cells in the chorio-decidua during the remodeling of the membranes using our well-established cell model (Hervé et al. 2008, J Immunol).

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

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

Study Locations

  • France
      • Paris, France, 75014
        • INSERM

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Normal pregnant women followed for their pregnancy in the maternity

Description

Inclusion Criteria:

  • >18y old
  • Singleton
  • Normal pregnancy without complication
  • >37 weeks of gestation

Exclusion Criteria:

  • Minor
  • Without Health Insurance
  • Inflammatory Disorders (diabetes, twin, autoimmune disesses, etc)
  • Infection HIV, hepatitis

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Caesarean
Normal pregnant women at term without complication during pregnancy and without inflammatory disorders
Other: Caesarean
Collection of tissues and blood
Vaginal Delivery
Normal pregnant women at term without complication during pregnancy and without inflammatory disorders
Other: Vaginal delivery
Collection of tissues and blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protein overexpression
Time Frame: 1 year
Setting of measurements of proteins in the supernatant of chorionic cells
1 year

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Principal Investigator: Céline Méhats, PhD, Institut National de la Santé Et de la Recherche Médicale, France

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

November 1, 2010

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

January 11, 2013

First Submitted That Met QC Criteria

January 11, 2013

First Posted (Estimated)

January 14, 2013

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI10056

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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