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Syncytiotrophoblast-derived Extracellular Vesicles in Placenta Previa and Accreta Spectrum

Shedding of Syncytiotrophoblast-derived Extracellular Vesicles is Increased in Placenta Previa and Accreta Spectrum: a Case-control Study.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06867874
Acronym
PAS
Enrollment
70
Registered
2025-03-10
Start date
2023-07-10
Completion date
2026-03-01
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Accreta Spectrum, Placenta Previa

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.

Detailed description

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.

Interventions

PROCEDUREBlood sample

Blood sample

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Concentration of circulating EVs from blood9 months (three trimester of pregnancy)Analysis of circulating syncytiotrophoblast-derived extracellular vesicles in the third trimester of pregnancy of women with abnormal placentation (placenta previa and placenta accreta spectrum)
Proteomics analysis of circulating EVs9 months (three trimester of pregnancy)Multi-omics profiling of circulating EVs cargo isolated from blood of pregnant women with abnormal placentation compared to healthy pregnant women

Countries

Italy

Contacts

Primary ContactChiara Tersigni
chiara.tersigni@policlinicogemelli.it+39 3206557088
Backup ContactMarianna Onori
mariannaonori@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026