NCT06249178 EV Based Platform for Monitoring Therapeutics Response During Pregnancy (ARISE)
| NCT ID | NCT06249178 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | Preeclampsia |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-07-02 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-07-02 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: Participants will be eligible to participate if they meet the following study inclusion criteria: 1. pregnant individuals age ≥18 years 2. enrolled ≤16 6/7 weeks of gestation based on the best obstetric estimate as defined by ACOG criteria 3. singleton live intrauterine gestation 4. Any of the following: 1. 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 2. 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). vii) Pregnancy after in vitro conception viii) family history of preeclampsia ( i.e., mother or sister) 3. or participating in another clinical RCT of 81mg vs. 162mg aspirin for prevention of hypertensive disorders of pregnancy Exclusion Criteria: 1. age \< 18 years, 2. involuntarily confined or detained 3. considered as having a diminished decision-making capacity 4. multifetal gestation 5. pregestational diabetes mellitus or gestational diabetes diagnosed \< 20 weeks due to the impact on exosome response 6. known or suspected fetal aneuploidy or major congenital abnormality, fetal demise, or planned pregnancy termination 7. 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) 8. plan to deliver at another center or participating in another intervention study that influences the primary outcome in this study, without prior approval
Contact & Investigator
Maged Costantine, MD, MBA
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT06249178 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preeclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06249178 currently recruiting?
Yes, NCT06249178 is actively recruiting participants. Contact the research team at Maged.Costantine@osumc.edu for enrollment information.
Where is the NCT06249178 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT06249178 clinical trial?
NCT06249178 is sponsored by Ohio State University. The principal investigator is Maged Costantine, MD, MBA at Ohio State University. The trial plans to enroll 1,000 participants.