NCT06873737

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

March 5, 2025

Last Update Submit

March 11, 2025

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

  • Levels of circulating HLA-DR+ extracellular vesicles

    Levels of circulating HLA-DR+ extracellular vesicles during pregnancy

    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

Study Arms (2)

"High risk"

EXPERIMENTAL

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

Low risk

EXPERIMENTAL

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

Blood samples for inflammatory markersOTHER

Blood sampling in the first, second, trimester of pregnancy

"High risk"Low risk

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant Women
  • Aged \> 18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Chiara Tersigni

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 13, 2025

Study Start

September 1, 2022

Primary Completion

September 30, 2023

Study Completion

January 1, 2026

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations

IT(1)