MICROVES-PE: Study of Microvesicles in Pre-eclampsia

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05675969
Collaborator
Laboratory of Chemistry and Biology of Membranes and Nano-objects (CBMN) of Bordeaux University (Other)
20
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2
12
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood sample
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A matching will be performed at inclusion between the two groups on gestational age according to two categories: 23-27+6 and 28-31+6 amenorrhoea weeksA matching will be performed at inclusion between the two groups on gestational age according to two categories: 23-27+6 and 28-31+6 amenorrhoea weeks
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Study of Microvesicles in Pre-eclampsia
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Total concentration of the main MV [baseline]

    Total concentration (number of MVs / µL) of the main MV populations, (MVs of erythrocyte, platelet or placental origin, determined by flow cytometry)

Secondary Outcome Measures

  1. Concentration of erythrocyte origin microvesicles [baseline]

    Concentration (number of MVs / µL) of MVs of erythrocyte origin by flow cytometry

  2. Concentration of platelet origin microvesicles [baseline]

    Concentration (number of MVs / µL) of MVs of platelet origin by flow cytometry

  3. Concentration of placental origin microvesicles [baseline]

    Concentration (number of MVs / µL) of MVs of placental origin determined by flow cytometry

  4. Rate of microvesicles [baseline]

    Rate of MVs

  5. Gravidic hypertension [baseline]

    Gravidic hypertension (≥ 160/110 mmHg)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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 a threat of preterm delivery, whatever the origin, and without clinical or biological markers of inflammation

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Bordeaux Bordeaux France

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT05675969
Other Study ID Numbers:
  • CHUBX 2022/64
First Posted:
Jan 9, 2023
Last Update Posted:
Jan 9, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Bordeaux
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 9, 2023