NCT06867874

Brief Summary

The main goal of this case-control study is to quantify the levels of circulating syncytiotrophoblast-derived extracellular vesicles (STBEVs) in maternal blood in a population of women with placenta previa and placenta accreta spectrum.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 10, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 10, 2025

Status Verified

July 1, 2024

Enrollment Period

1.6 years

First QC Date

July 10, 2023

Last Update Submit

March 5, 2025

Conditions

Placenta PreviaPlacenta Accreta Spectrum

Outcome Measures

Primary Outcomes (2)

  • Concentration of circulating EVs from blood

    Analysis of circulating syncytiotrophoblast-derived extracellular vesicles in the third trimester of pregnancy of women with abnormal placentation (placenta previa and placenta accreta spectrum)

    9 months (three trimester of pregnancy)

  • Proteomics analysis of circulating EVs

    Multi-omics profiling of circulating EVs cargo isolated from blood of pregnant women with abnormal placentation compared to healthy pregnant women

    9 months (three trimester of pregnancy)

Study Arms (1)

Women with diagnosis of PP and PAS

EXPERIMENTAL

Pregnant women with abnormal placentation as placenta previa and accreta spectrum

Procedure: Blood sample

Interventions

Blood samplePROCEDURE

Blood sample

Women with diagnosis of PP and PAS

Eligibility Criteria

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

You may qualify if:

  • Pregnant women with diagnosis of placenta previa and accreta spectrum (cases)
  • Healthy pregnant women
  • \> 18 years

You may not qualify if:

  • \< 18 years
  • Twin pregnancies
  • Chronic Infections
  • Cancers
  • Unable to give the written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A.Gemelli IRCSS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Placenta PreviaPlacenta Accreta

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta 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

Central Study Contacts

Chiara Tersigni

CONTACT

+39 3206557088chiara.tersigni@policlinicogemelli.it

Marianna Onori

CONTACT

mariannaonori@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2023

First Posted

March 10, 2025

Study Start

July 10, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2026

Last Updated

March 10, 2025

Record last verified: 2024-07

Locations

IT(1)