Actively Recruiting
EV Based Platform for Monitoring Therapeutics Response During Pregnancy (ARISE)
Led by Ohio State University · Updated on 2025-12-29
1000
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
U
University of Texas
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EV Based Platform for Monitoring Therapeutics Response During Pregnancy (ARISE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant individuals aged 18 years or older
- Enrolled by 16 weeks and 6 days of gestation based on best obstetric estimate
- Singleton live intrauterine pregnancy
- Have at least one high-risk factor for hypertensive disorders of pregnancy, such as prior preeclampsia, chronic hypertension, chronic kidney disease, or autoimmune disease
- Or have two or more moderate-risk factors for hypertensive disorders of pregnancy, including nulliparity, obesity (BMI 60 kg/m2), age 35 years or older, Black race, low income, previous adverse pregnancy outcomes, pregnancy after in vitro conception, or family history of preeclampsia
- Or are participating in another clinical trial comparing 81mg versus 162mg aspirin for prevention of hypertensive disorders of pregnancy
You will not qualify if you...
- Younger than 18 years
- Involuntarily confined or detained
- Considered to have diminished decision-making capacity
- Multifetal pregnancy
- Diagnosis of pregestational or gestational diabetes before 20 weeks gestation
- Known or suspected fetal chromosomal abnormalities, major congenital anomalies, fetal demise, or planned pregnancy termination
- Allergy or hypersensitivity to aspirin or medical conditions contraindicating aspirin use (e.g., peptic ulcer disease, nasal polyps, NSAID-induced asthma, gastrointestinal bleeding, G6PD deficiency, severe liver dysfunction, bleeding disorders)
- Plans to deliver at a different center or participation in another intervention study that could affect the primary outcome without prior approval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
M
Maged Costantine, MD, MBA
CONTACT
K
Kara Rood, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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