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NCT Number: NCT05675969

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sample

Other

Collection of 2 additional tubes of 4.5mL of citrate blood

Primary outcomes

  1. 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)

Secondary outcomes

  1. Concentration of erythrocyte origin microvesicles

    Time frame: baseline

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

  2. Concentration of platelet origin microvesicles

    Time frame: baseline

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

  3. Concentration of placental origin microvesicles

    Time frame: baseline

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

  4. Rate of microvesicles

    Time frame: baseline

    Rate of MVs

  5. Number of gravidic hypertension

    Time frame: baseline

    Gravidic hypertension (≥ 160/110 mmHg)

Study contacts

Contact information is provided by the study sponsor or research team.

Alain Brisson, PhD

CONTACT

[email protected]

Loic Sentilhes, MD, PhD

CONTACT

[email protected]

+335 57 82 23 36

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • University of Bordeaux

Registry information

Official study title

Study of Microvesicles in Pre-eclampsia

Acronym: MICROVES-PE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2023
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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