PreeclampsiaNCT06873737
Analysis of the Levels of HLADR+ Extracellular Vesicles in Women With Preeclampsia as a Early Potential Biomarker
A study testing Blood samples for inflammatory markers in people with Preeclampsia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Analysis of the circulating levels of placenta-derived HLA-DR+ extracellular vesicles in the first, second and third trimester of pregnancy of women with high and low risk to develop preeclampsia. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Blood samples for inflammatory markers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2022to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant Women
- Aged > 18 years
Who cannot join
- age < 18 years
- women unable to give informed consent
- infectious diseases
- twin pregnancies
Trial locations and contacts
1 site in 1 country.
About this study
Analysis of the circulating levels of placenta-derived HLA-DR+ extracellular vesicles in the first, second and third trimester of pregnancy of women with high and low risk to develop preeclampsia.
Read the detailed description
The aim of this study is to analyze the levels of circulating placenta-derived HLA-DR+ extracellular vesicles in the first, second and third trimester of pregnancy of women with high and low risk to develop preeclampsia to investigate the potential role of HLA-DR as early biomarker.
- Conditions
- Preeclampsia
- Being tested
- Blood samples for inflammatory markers
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for inflammatory markersOther
Blood sampling in the first, second, trimester of pregnancy
| Study group | Role | What they receive |
|---|---|---|
| "High risk" | Experimental | Blood sampling from women with high risk to develop preeclampsia in the first, second and third trimester of pregnancy Receives: Other: Blood samples for inflammatory markers |
| Low risk | Experimental | Blood sampling from women with low risk to develop preeclampsia in the first, second and third trimester of pregnancy Receives: Other: Blood samples for inflammatory markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of circulating HLA-DR+ extracellular vesicles
Levels of circulating HLA-DR+ extracellular vesicles during pregnancy
Measured: During the first trimester of pregnancy (11-13 weeks +6 days of gestational age), the second trimester (19-22 weeks of gestation) and the third trimester (28-32 weeks of gestation) of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Sep 2022
- Primary completion30 Sep 2023
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiara Tersigni, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873737
- Sponsor's protocol ID
- 4299
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Levels of HLADR+ Extracellular Vesicles in Women With Preeclampsia as a Early Potential Biomarker
- ClinicalTrials.gov ID
- NCT06873737
- Acronym / sponsor ID
- 4299
- Conditions
- Preeclampsia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Analysis of the circulating levels of placenta-derived HLA-DR+ extracellular vesicles in the first, second and third trimester of pregnancy of women with high and low risk to develop preeclampsia.
Detailed description
The aim of this study is to analyze the levels of circulating placenta-derived HLA-DR+ extracellular vesicles in the first, second and third trimester of pregnancy of women with high and low risk to develop preeclampsia to investigate the potential role of HLA-DR as early biomarker.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "High risk" | Experimental | Other: Blood samples for inflammatory markersBlood sampling from women with high risk to develop preeclampsia in the first, second and third trimester of pregnancy |
| Low risk | Experimental | Other: Blood samples for inflammatory markersBlood sampling from women with low risk to develop preeclampsia in the first, second and third trimester of pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant Women
- Aged > 18 years
Key exclusion criteria (4 listed)
- age < 18 years
- women unable to give informed consent
- infectious diseases
- twin pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples for inflammatory markersBlood sampling in the first, second, trimester of pregnancy | Other | "High risk", Low risk |
Primary outcome
Levels of circulating HLA-DR+ extracellular vesicles
Time frame: During the first trimester of pregnancy (11-13 weeks +6 days of gestational age), the second trimester (19-22 weeks of gestation) and the third trimester (28-32 weeks of gestation) of pregnancy
Levels of circulating HLA-DR+ extracellular vesicles during pregnancy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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Furosemide vs Placebo in Severe Preeclampsia Postpartum
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiara Tersigni principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples for inflammatory markers in people with Preeclampsia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of circulating HLA-DR+ extracellular vesicles (time frame: During the first trimester of pregnancy (11-13 weeks +6 days of gestational age), the second trimester (19-22 weeks of gestation) and the third trimester (28-32 weeks of gestation) of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.