Syncytiotrophoblast-derived Extracellular Vesicles in Placenta Previa and Accreta Spectrum (PAS)

March 5, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Women with diagnosis of PP and PAS
Pregnant women with abnormal placentation as placenta previa and accreta spectrum
Procedure: Blood sample
Blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
9 months (three trimester of pregnancy)
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
9 months (three trimester of pregnancy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Chiara Tersigni, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2023

Primary Completion (Actual)

March 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

July 10, 2023

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5606

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe