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NCT Number: NCT06867874

Syncytiotrophoblast-derived Extracellular Vesicles in Placenta Previa and Accreta Spectrum

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.

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Key information

Conditions

Placenta Previa Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Accreta Placenta Accreta Spectrum Placenta Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A.Gemelli IRCSS

Roma, 00168, Italy

Location status: Recruiting

Location contact

Chiara Tersigni

CONTACT

[email protected]

+39 3206557088

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Procedure

Blood sample

Primary outcomes

  1. Concentration of circulating EVs from blood

    Time frame: 9 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)

  2. Proteomics analysis of circulating EVs

    Time frame: 9 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara Tersigni

CONTACT

[email protected]

+39 3206557088

Marianna Onori

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: PAS

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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