Skip to content

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

Study of Microvesicles in Pre-eclampsia

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05675969
Acronym
MICROVES-PE
Enrollment
20
Registered
2023-01-09
Start date
2023-05-31
Completion date
2025-12-31
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-Eclampsia

Keywords

pre-eclampsia, microvesicles

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.

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.

Interventions

OTHERBlood sample

Collection of 2 additional tubes of 4.5mL of citrate blood

Sponsors

University of Bordeaux
CollaboratorOTHER
University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

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 weeks

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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 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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Concentration of erythrocyte origin microvesiclesbaselineConcentration (number of MVs / µL) of MVs of erythrocyte origin by flow cytometry
Concentration of platelet origin microvesiclesbaselineConcentration (number of MVs / µL) of MVs of platelet origin by flow cytometry
Concentration of placental origin microvesiclesbaselineConcentration (number of MVs / µL) of MVs of placental origin determined by flow cytometry
Rate of microvesiclesbaselineRate of MVs
Number of gravidic hypertensionbaselineGravidic hypertension (≥ 160/110 mmHg)

Countries

France

Contacts

Primary ContactLoic Sentilhes, MD, PhD
loic.sentilhes@chu-bordeaux.fr+335 57 82 23 36
Backup ContactAlain Brisson, PhD
a.brisson@cbmn.u-bordeaux.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026