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Active, not recruitingNCT06873737Updated Mar 13, 2025

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

An interventional study of Blood samples for inflammatory markers in Preeclampsia, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Active, not recruiting at 1 site in Italy. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-13.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Sep 2022, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Preeclampsia

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03

In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's planned enrollment of 300 is above the median of 110 across 468 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Pregnant Women
  • Aged > 18 years

Exclusion criteria

Exclusion Criteria:

  • age \< 18 years
  • women unable to give informed consent
  • infectious diseases
  • twin pregnancies
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    "High risk"

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

    Other: Blood samples for inflammatory markers

  • Experimental
    Low risk

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

    Other: Blood samples for inflammatory markers

Interventions

  • OtherBlood samples for inflammatory markers

    Blood sampling in the first, second, trimester of pregnancy

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What researchers measure

Primary outcomes

  1. Levels of circulating HLA-DR+ extracellular vesicles

    Levels of circulating HLA-DR+ extracellular vesicles during pregnancy

    Time frame: During the first trimester of pregnancy (11-13 weeks +6 days of gestational age), the second trimester (19-22 weeks of gestation) and the third trimester (28-32 weeks of gestation) of pregnancy

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Study locations

1 site
  • Fondazione Policlinico Universitario Agostino Gemelli
    Rome, 00168, Italy
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06873737
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Sponsor
First posted
Mar 13, 2025
Start date
Sep 1, 2022
Primary completion
Sep 30, 2023
Completion
Jan 1, 2026 (estimated)
Last update
Mar 13, 2025

Study contacts

Chiara Tersigni
principal investigator · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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