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

Pre-Eclampsia Clinical Trial

— MICROVES-PE  

Official title:

Study of Microvesicles in Pre-eclampsia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05675969
• Other study ID #: CHUBX 2022/64
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: May 15, 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Bordeaux
• Contact: Loic Sentilhes, MD, PhD
• Phone: +335 57 82 23 36
• Email: loic.sentilhes[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Other:
• Blood sample
Collection of 2 additional tubes of 4.5mL of citrate blood

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux

Sponsors (2)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total concentration of the main MV	Total concentration (number of MVs / µL) of the main MV populations, (MVs of erythrocyte, platelet or placental origin, determined by flow cytometry)	baseline
Secondary	Concentration of erythrocyte origin microvesicles	Concentration (number of MVs / µL) of MVs of erythrocyte origin by flow cytometry	baseline
Secondary	Concentration of platelet origin microvesicles	Concentration (number of MVs / µL) of MVs of platelet origin by flow cytometry	baseline
Secondary	Concentration of placental origin microvesicles	Concentration (number of MVs / µL) of MVs of placental origin determined by flow cytometry	baseline
Secondary	Rate of microvesicles	Rate of MVs	baseline
Secondary	Number of gravidic hypertension	Gravidic hypertension (= 160/110 mmHg)	baseline