Pilot Study of Microvesicles in Pre-eclamptic and Non-pre-eclamptic Women With Threatened Preterm Delivery
NCT ID: NCT05675969
Last Updated: 2025-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-05-31
2025-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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
Blood sample
Collection of 2 additional tubes of 4.5mL of citrate blood
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.
Blood sample
Collection of 2 additional tubes of 4.5mL of citrate blood
Interventions
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Blood sample
Collection of 2 additional tubes of 4.5mL of citrate blood
Eligibility Criteria
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Inclusion Criteria
* 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 under legal protection.
18 Years
FEMALE
Yes
Sponsors
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University of Bordeaux
OTHER
University Hospital, Bordeaux
OTHER
Responsible Party
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Locations
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CHU Bordeaux
Bordeaux, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHUBX 2022/64
Identifier Type: -
Identifier Source: org_study_id
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