Syncytiotrophoblast-derived Extracellular Vesicles in Placenta Previa and Accreta Spectrum

Not Applicable

Recruiting

• Conditions: Placenta Previa; Placenta Accreta Spectrum

• Registration Number: NCT06867874
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Timeline

• Study Start: 2023-07-10
• Study First Submitted: 2023-07-10
• Status Verified: 2024-07
• Primary Completion: 2025-03-01
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Concentration of circulating EVs from blood	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)
Proteomics analysis of circulating EVs	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

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A.Gemelli IRCSS; 🇮🇹 Roma, Italy