Syncytiotrophoblast-derived Extracellular Vesicles in Placenta Previa and Accreta Spectrum

NCT ID: NCT06867874

Last Updated: 2025-03-10

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

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2026-03-01

Brief Summary

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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.

Detailed Description

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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 ultrasound diagnosis of PP with and without postpartum histopathologic diagnosis of PAS, compared to pregnant women with normal placentation.

The secondary aim of this case-control study is to characterize the multi-omics profiling of STBEVs cargo's (proteins, gene and transcripts) isolated from patients diagnosed with PP and PAS compared to the control population.

Conditions

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Placenta Previa Placenta Accreta Spectrum

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Women with diagnosis of PP and PAS

Pregnant women with abnormal placentation as placenta previa and accreta spectrum

Group Type EXPERIMENTAL

Blood sample

Intervention Type PROCEDURE

Blood sample

Interventions

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Blood sample

Blood sample

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* \< 18 years
* Twin pregnancies
* Chronic Infections
* Cancers
* Unable to give the written consent
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 A.Gemelli IRCSS

Roma, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Chiara Tersigni

Role: CONTACT

+39 3206557088

Marianna Onori

Role: CONTACT

Facility Contacts

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Chiara Tersigni

Role: primary

+39 3206557088

Other Identifiers

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5606

Identifier Type: -

Identifier Source: org_study_id

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