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

Primary Purpose

Pre-Eclampsia

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pre-Eclampsia focused on measuring pre-eclampsia, microvesicles

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • CHU Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pre-eclamptic women

Non pre-eclamptic women

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Concentration of erythrocyte origin microvesicles
Concentration (number of MVs / µL) of MVs of erythrocyte origin by flow cytometry
Concentration of platelet origin microvesicles
Concentration (number of MVs / µL) of MVs of platelet origin by flow cytometry
Concentration of placental origin microvesicles
Concentration (number of MVs / µL) of MVs of placental origin determined by flow cytometry
Rate of microvesicles
Rate of MVs
Number of gravidic hypertension
Gravidic hypertension (≥ 160/110 mmHg)

Full Information

First Posted
December 28, 2022
Last Updated
April 21, 2023
Sponsor
University Hospital, Bordeaux
Collaborators
Laboratory of Chemistry and Biology of Membranes and Nano-objects (CBMN) of Bordeaux University
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1. Study Identification

Unique Protocol Identification Number
NCT05675969
Brief Title
Pilot Study of Microvesicles in Pre-eclamptic and Non-pre-eclamptic Women With Threatened Preterm Delivery
Acronym
MICROVES-PE
Official Title
Study of Microvesicles in Pre-eclampsia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2, 2023 (Anticipated)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
May 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Laboratory of Chemistry and Biology of Membranes and Nano-objects (CBMN) of Bordeaux University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia
Keywords
pre-eclampsia, microvesicles

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-eclamptic women
Arm Type
Experimental
Arm Description
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
Arm Title
Non pre-eclamptic women
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
Collection of 2 additional tubes of 4.5mL of citrate blood
Primary Outcome Measure Information:
Title
Total concentration of the main MV
Description
Total concentration (number of MVs / µL) of the main MV populations, (MVs of erythrocyte, platelet or placental origin, determined by flow cytometry)
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Concentration of erythrocyte origin microvesicles
Description
Concentration (number of MVs / µL) of MVs of erythrocyte origin by flow cytometry
Time Frame
baseline
Title
Concentration of platelet origin microvesicles
Description
Concentration (number of MVs / µL) of MVs of platelet origin by flow cytometry
Time Frame
baseline
Title
Concentration of placental origin microvesicles
Description
Concentration (number of MVs / µL) of MVs of placental origin determined by flow cytometry
Time Frame
baseline
Title
Rate of microvesicles
Description
Rate of MVs
Time Frame
baseline
Title
Number of gravidic hypertension
Description
Gravidic hypertension (≥ 160/110 mmHg)
Time Frame
baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Loic Sentilhes, MD, PhD
Phone
+335 57 82 23 36
Email
loic.sentilhes@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alain Brisson, PhD
Email
a.brisson@cbmn.u-bordeaux.fr
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loic Sentilhes, MD, PhD
Phone
+335 56 79 55 79
Email
loic.sentilhes@chu-bordeaux.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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