Analysis of the Levels of HLADR+ Extracellular Vesicles in Women With Preeclampsia as a Early Potential Biomarker

NCT ID: NCT06873737

Last Updated: 2025-03-13

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2026-01-01

Brief Summary

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Analysis of the circulating levels of placenta-derived HLA-DR+ extracellular vesicles in the first, second and third trimester of pregnancy of women with high and low risk to develop preeclampsia.

Detailed Description

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The aim of this study is to analyze the levels of circulating placenta-derived HLA-DR+ extracellular vesicles in the first, second and third trimester of pregnancy of women with high and low risk to develop preeclampsia to investigate the potential role of HLA-DR as early biomarker.

Conditions

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Preeclampsia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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"High risk"

Blood sampling from women with high risk to develop preeclampsia in the first, second and third trimester of pregnancy

Group Type EXPERIMENTAL

Blood samples for inflammatory markers

Intervention Type OTHER

Blood sampling in the first, second, trimester of pregnancy

Low risk

Blood sampling from women with low risk to develop preeclampsia in the first, second and third trimester of pregnancy

Group Type EXPERIMENTAL

Blood samples for inflammatory markers

Intervention Type OTHER

Blood sampling in the first, second, trimester of pregnancy

Interventions

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Blood samples for inflammatory markers

Blood sampling in the first, second, trimester of pregnancy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant Women
* Aged \> 18 years

Exclusion Criteria

* age \< 18 years
* women unable to give informed consent
* infectious diseases
* twin pregnancies
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chiara Tersigni

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Locations

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Fondazione Policlinico Universitario Agostino Gemelli

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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4299

Identifier Type: -

Identifier Source: org_study_id

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