RecruitingNCT06249178

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

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


Sponsor

Ohio State University

Enrollment

1,000 participants

Start Date

Jul 2, 2024

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a new blood test that measures tiny particles called extracellular vesicles (EVs) to predict and monitor high blood pressure disorders during pregnancy, such as preeclampsia. The goal is to develop a better early-warning tool for pregnant people at risk. **You may be eligible if...** - You are pregnant and at least 18 years old - You are enrolled before 17 weeks of pregnancy - You are carrying a single baby - You have at least one high-risk factor for preeclampsia (such as a prior preeclamptic pregnancy, chronic high blood pressure, kidney disease, or an autoimmune condition), OR you have two moderate-risk factors (such as being a first-time mom, being over 35, being overweight, or having a multiple-pregnancy history) **You may NOT be eligible if...** - You are carrying twins or more - You are under 18 - You do not have risk factors for pregnancy-related blood pressure problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

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

Columbus, Ohio, United States

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NCT06249178


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