Pilot Study of Microvesicles in Pre-eclamptic and Non-pre-eclamptic Women With Threatened Preterm Delivery (MICROVES-PE)

February 7, 2025 updated by: University Hospital, Bordeaux

Study of Microvesicles in Pre-eclampsia

A large number of studies on MVs from syncytiotrophoblasts support the hypothesis of their involvement in pre-eclampsia, via their multiple effects, among others as pro-coagulant, immuno-stimulatory and anti-angiogenic factors.

The main objective is to compare the total concentration of the main populations of MVs in the maternal blood of a population of pre-eclamptic patients to those of a population of non-pre-eclamptic patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Activated or apoptotic cells release membrane fragments called microvesicles, microparticles, extracellular vesicles or exosomes into the extracellular environment. The term microvesicle (MV) used in this project encompasses all membrane fragments secreted by cells, regardless of their cellular origin, their size or the membrane compartment from which they originate.

The presence on the surface of MVs and in their reservoir of elements from their parent cell, such as surface receptors, mRNAs or microRNAs, led to the hypothesis that MVs could serve as biomarkers, revealing the existence of tissues in distress in the body.

Under physiological conditions, blood plasma contains mainly MVs from red blood cells and platelets, the main circulating cell populations. During pregnancy, the presence of membrane fragments of placental origin in the maternal circulation has long been established. A large number of studies on syncytiotrophoblast-derived MVs support the hypothesis of their involvement in pre-eclampsia, via their multiple effects, among others as pro-coagulant, immuno-stimulatory, anti-angiogenic factors.

The "Membrane Repair and Extracellular Vesicles" team within the CBMN laboratory of the University of Bordeaux has developed original approaches to characterize and quantify MVs, mainly by cryo-electron microscopy, immunogold labeling and flow cytometry. In addition, recent developments from this team allow the analysis of MVs in whole blood, which is a major advantage.

The main objective is to compare the total concentration of the main populations of MVs in the maternal blood of a population of pre-eclamptic patients to those of a population of non-pre-eclamptic patients.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Singleton pregnancy (or spontaneously reduced twin pregnancy before 14 SA)
  • Gestational age at inclusion between 23 and 31+6 SA
  • Collection of the patient's non-opposition
  • Affiliated or beneficiary of a social security system
  • Specifically for the non-pre-eclampsia group: non-pre-eclamptic patient hospitalized for isolated threat of preterm delivery, whatever the origin, and without clinical (absence of maternal hyperthermia defined by a maternal temperature < 38.0°C) or biological markers of inflammation (CRP<5)
  • Specifically for the pre-eclampsia group : diagnosis of severe pre-eclampsia before 32 weeks' gestation

Exclusion Criteria:

  • Patient's inability to understand the nature, risks, meaning and implications of the clinical investigation or refusal to give consent
  • Patient under legal protection.

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

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pre-eclamptic women
The intervention consists of the collection of 2 additional tubes of 4.5mL of citrate blood. The sample will be collected as close as possible to the diagnosis of pre-eclampsia during a routine care assessment
Other: Blood sample
Collection of 2 additional tubes of 4.5mL of citrate blood
Active Comparator: Non pre-eclamptic women
The intervention consists of the collection of 2 additional tubes of 4.5mL of citrate blood. sampling will be performed during routine care according to the matching.
Other: Blood sample
Collection of 2 additional tubes of 4.5mL of citrate blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total concentration of the main MV
Time Frame: baseline
Total concentration (number of MVs / µL) of the main MV populations, (MVs of erythrocyte, platelet or placental origin, determined by flow cytometry)
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of erythrocyte origin microvesicles
Time Frame: baseline
Concentration (number of MVs / µL) of MVs of erythrocyte origin by flow cytometry
baseline
Concentration of platelet origin microvesicles
Time Frame: baseline
Concentration (number of MVs / µL) of MVs of platelet origin by flow cytometry
baseline
Concentration of placental origin microvesicles
Time Frame: baseline
Concentration (number of MVs / µL) of MVs of placental origin determined by flow cytometry
baseline
Rate of microvesicles
Time Frame: baseline
Rate of MVs
baseline
Number of gravidic hypertension
Time Frame: baseline
Gravidic hypertension (≥ 160/110 mmHg)
baseline

Collaborators and Investigators

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

Sponsor

University Hospital, Bordeaux

Collaborators

Laboratory of Chemistry and Biology of Membranes and Nano-objects (CBMN) of Bordeaux University

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)

May 31, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 28, 2022

First Submitted That Met QC Criteria

December 28, 2022

First Posted (Actual)

January 9, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2022/64

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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