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

NCT05675969 | Recruiting

• 1 other identifier: CHUBX 2022/64
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Eclampsia

Keywords

pre-eclampsia; microvesicles

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Concentration of erythrocyte origin microvesicles

  baseline

• Concentration of platelet origin microvesicles

  baseline

• Concentration of placental origin microvesicles

  baseline

• Rate of microvesicles

  baseline

• Number of gravidic hypertension

  baseline

Study Arms (2)

Pre-eclamptic women

EXPERIMENTAL

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

Other: Blood sample

Non pre-eclamptic women

ACTIVE COMPARATOR

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.

Other: Blood sample

Interventions

Blood sample OTHER

Collection of 2 additional tubes of 4.5mL of citrate blood

Non pre-eclamptic women; Pre-eclamptic women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Singleton pregnancy (or spontaneously reduced twin pregnancy before 14 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

You may not qualify if:

• Patient's inability to understand the nature, risks, meaning and implications of the clinical investigation or refusal to give consent
• Patient under legal protection.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• University of Bordeaux: collaborator

Study Sites (1)

CHU Bordeaux

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Loic Sentilhes, MD, PhD

CONTACT

+335 57 82 23 36; loic.sentilhes@chu-bordeaux.fr

Alain Brisson, PhD

CONTACT

a.brisson@cbmn.u-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 9, 2023
• Study Start: May 31, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)