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RecruitingNCT06867874PASUpdated Mar 10, 2025

Syncytiotrophoblast-derived Extracellular Vesicles in Placenta Previa and Accreta Spectrum

An interventional study of Blood sample in Placenta Previa and Placenta Accreta Spectrum, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-10.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Placenta Previa
  • Placenta Accreta Spectrum
03

In context

Placenta Previa

80 studies on the registry are indexed under Placenta Previa; 17 are open to participants now.

This study's planned enrollment of 70 is below the median of 109 across 45 interventional studies indexed under Placenta Previa.

Browse Placenta Previa studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • \< 18 years
  • Twin pregnancies
  • Chronic Infections
  • Cancers
  • Unable to give the written consent
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Women with diagnosis of PP and PAS

    Pregnant women with abnormal placentation as placenta previa and accreta spectrum

    Procedure: Blood sample

Interventions

  • ProcedureBlood sample

    Blood sample

06

What researchers measure

Primary outcomes

  1. Concentration of circulating EVs from blood

    Analysis of circulating syncytiotrophoblast-derived extracellular vesicles in the third trimester of pregnancy of women with abnormal placentation (placenta previa and placenta accreta spectrum)

    Time frame: 9 months (three trimester of pregnancy)

  2. Proteomics analysis of circulating EVs

    Multi-omics profiling of circulating EVs cargo isolated from blood of pregnant women with abnormal placentation compared to healthy pregnant women

    Time frame: 9 months (three trimester of pregnancy)

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2023 to primary completion in Mar 2025, 19 months.

Of 23 interventional studies with no phase under Placenta Previa, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's 19 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 10, 2023
First posted
Mar 10, 2025
StartActual
Jul 10, 2023
Primary completionActual
Mar 1, 2025
CompletionEst.
Mar 1, 2026
Last update
Mar 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06867874
Responsible party
Sponsor
First posted
Mar 10, 2025
Start date
Jul 10, 2023
Primary completion
Mar 1, 2025
Completion
Mar 1, 2026 (estimated)
Last update
Mar 10, 2025

Study contacts

Chiara Tersigni
Contact
chiara.tersigni@policlinicogemelli.it
+39 3206557088
Marianna Onori
Contact
mariannaonori@gmail.com
Chiara Tersigni
principal investigator · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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