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PreeclampsiaNCT06249178

EV Based Platform for Monitoring Therapeutics Response During Pregnancy (ARISE)

An observational study of Preeclampsia, run by Ohio State University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this prospective observational cohort study of pregnant people at-risk of preeclampsia receiving aspirin as part of clinical care or a planned randomized controlled trial of 81mg vs. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Preeclampsia
How many people
1,000 participants
Where
1 siteUnited States
Study dates
2 Jul 2024to 1 Sep 2028
Phase
Observational
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
  • No healthy volunteers
  • Adult, Older adult

Study population: Pregnant women greater than 18 years of age at risk of preeclampsia (PE), receiving aspirin to prevent PE or a candidate to receive aspirin.

Who may be able to join

  • Participants will be eligible to participate if they meet the following study inclusion criteria:
  • pregnant individuals age ≥18 years
  • enrolled ≤16 6/7 weeks of gestation based on the best obstetric estimate as defined by ACOG criteria
  • singleton live intrauterine gestation
  • Any of the following:
  • At least one of the high-risk criteria for HDP (per US Preventive Services Task Force Recommendation Statement [USPSTF]); i) any prior pregnancy complicated by Preeclampsia ii) current pregnancy complicated by chronic hypertension iii) chronic kidney disease iv) autoimmune disease (e.g., antiphospholipid syndrome, lupus) or
Show all 9Show fewer
  • Two or more moderate-risk criteria for HDP (per USPSTF); i) nulliparity (no prior delivery at or after 20 weeks 0 days of gestation) ii) obesity (body mass index ≥30 kg/m2 at time of enrollment) iii) age ≥35 years (at time of expected estimated due date) iv) Black race v) Low income vi) Personal risk factors (previous pregnancy with low birth weight or SGA infant, previous adverse pregnancy outcome [unexplained stillbirth], placental abruption, interval >10 years between pregnancies).
  • Pregnancy after in vitro conception viii) family history of preeclampsia ( i.e., mother or sister)
  • or participating in another clinical RCT of 81mg vs. 162mg aspirin for prevention of hypertensive disorders of pregnancy

Who cannot join

  • age < 18 years,
  • involuntarily confined or detained
  • considered as having a diminished decision-making capacity
  • multifetal gestation
  • pregestational diabetes mellitus or gestational diabetes diagnosed < 20 weeks due to the impact on exosome response
  • known or suspected fetal aneuploidy or major congenital abnormality, fetal demise, or planned pregnancy termination
  • known allergy or hypersensitivity to aspirin or any medical condition where aspirin is contraindicated (e.g., peptic ulcer disease, nasal polyps, NSAID-induced asthma, gastrointestinal bleeding, G6PD deficiency, severe hepatic dysfunction, bleeding disorders)
  • plan to deliver at another center or participating in another intervention study that influences the primary outcome in this study, without prior approval

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maged Costantine, MD, MBA contact

614-293-2222

Maged.Costantine@osumc.edu

Kara Rood, MD contact

614-293-8045

Kara.Rood@osumc.edu

United States1 site, 1 recruiting

  • The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

    Columbus, Ohio, 43210

    Maged Costantine, MD, MBA, 614-293-2222, Maged.Costantine@osumc.edu

    Kara Rood, MD, 614-293-8045, Kara.Rood@osumc.edu

    Recruiting

Other trials in United States

About this study

Official title: Developing Extracellular Vesicle Based MPRINT Translational Resource Platform for Monitoring Therapeutics Response During Pregnancy

The goal of this prospective observational cohort study of pregnant people at-risk of preeclampsia receiving aspirin as part of clinical care or a planned randomized controlled trial of 81mg vs. 162mg of aspirin is to generate proteomic data to show a distinct maternal and fetal Extracellular Vesicle (EV) proteome profile with aspirin treatment, and develop and validate a multi-marker panel for the monitoring of placental function in people at-risk of Preeclampsia and in response to aspirin treatment. The primary research question is:

  1. Does the maternal and fetal Positive for Placental Alkaline Phosphatase (PLAP+) Extracellular Vesicle (EV) proteome profile in the 2nd and 3rd trimester of pregnancy differ between people who receive aspirin and develop (or not) preeclampsia?

Participants will be asked to give blood samples up to four times during and at the end of their pregnancy.

Read the detailed description

Pregnant and lactating people remain therapeutic orphans as they are excluded from the vast majority of clinical drug development and therapeutic trials. Moreover, current practices in drug evaluation in pregnancy have been hindered by the lack of effective biomarkers and innovative study designs. There is a need to develop novel placental-specific biomarkers in order to assess placental function and response to therapeutics, as a way to inform on their safety and efficacy. An example of these novel biomarkers is placental (fetal) specific extracellular vesicles (EVs). Recent advances in characterizing the cargo content of these EVs demonstrated their potential to be used as placental biomarkers. Fourteen proteins found in EVs significantly correlated with aspirin use (FDR<0.1) in at-risk people, but that more power is needed to confidently assess the relationship with aspirin dosage and pregnancy outcomes. In addition, prior studies showed that aspirin affects endothelial and trophoblast cells, thus potentially modulating exosome derived from these cells and their cargo contents.

The main goal is to develop a novel platform using exosome profiling, as novel biomarkers, to monitor placental mediated adverse pregnancy outcomes and response to therapeutics.

Specific Aim 1: Develop and validate a multi-marker panel/Extracellular Vesicle (EV) proteome profile (maternal and fetal) for monitoring of placental/fetal membrane function in people at-risk of Preeclampsia (PE) and in response to aspirin treatment.

Specific Aim 2: Demonstrate that maternal and fetal Positive for Placental Alkaline Phosphatase (PLAP+) EV proteome profile in the 2nd and 3rd trimester of pregnancy differ between people who develop (or not) preeclampsia and correlate with aspirin dose and salicylic acid concentrations.

Specific Aim 3: Demonstrate that the changes in maternal and fetal EV proteome profiles (baseline to 2nd-3rd trimester) correlate with the changes in inflammatory and angiogenic imbalance profiles associated with PE, and with other clinical outcomes such as Preterm Birth (PTB) and Fetal Growth Restriction (FGR).

Conditions
Preeclampsia
Keywords
Extracellular vesicles proteome profile, Aspirin treatment, Pregnancy, Preeclampsia
Medical subject headings
Pre-Eclampsia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. multi-marker panel

    Multi-marker panel (list of proteins) associated with placental function in people at-risk of PE and in response to aspirin treatment.

    Measured: From enrollment till delivery; up to 29 weeks

Secondary outcomes (9)

  1. Preeclampsia

    Preeclampsia defined according to ACOG guidelines

    Measured: From enrollment to deliver; up to 29 weeks

  2. Preterm birth < 37 weeks gestation

    Delivery before 37 0/7 weeks gestation

    Measured: From enrollment to deliver; up to 25 weeks

  3. Preterm birth < 34 weeks gestation

    Delivery before 34 0/7 weeks gestation

    Measured: From enrollment to deliver; up to 22 weeks

  4. Preeclampsia with severe features

    Preeclampsia with severe features as defined by the ACOG diagnostic criteria

    Measured: From enrollment to deliver; up to 29 weeks

  5. Gestational hypertension

    Gestational hypertension defined as new onset hypertension in the absence of accompanying proteinuria or other features of preeclampsia

    Measured: From enrollment to deliver, up to 29 weeks

  6. Fetal growth restriction

    Estimated fetal weight or abdominal circumference <10%

    Measured: From enrollment to deliver; up to 29 weeks

  7. Birthweight

    weight of newborn at time of birth

    Measured: at delivery

  8. PlGF

    Serum concentration of PlGF in the third trimester

    Measured: 28 to 41 weeks

  9. sFLT-1

    Serum concentration of sFLT-1 in the third trimester

    Measured: 28 to 41 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2024
  2. Study start2 Jul 2024
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06249178
Sponsor's protocol ID
2024H0050
Other IDs
1R24HD113024
Status last verified
Dec 2025
First submitted
31 Jan 2024
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Preeclampsia, run by Ohio State University at 1 site in United States.

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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 29 Dec 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 United States. 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?

Contact Maged Costantine, MD, MBA (614-293-2222, Maged.Costantine@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

multi-marker panel (time frame: From enrollment till delivery; up to 29 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06249178.

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 29 Dec 2025.

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