๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-12-24

EV Based Platform for Monitoring Therapeutics Response During Pregnancy (ARISE) (NCT06249178)

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

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Ohio State University

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine โ€” Columbus, Ohio

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine โ€” Columbus, Ohio

๐Ÿ“ž Contact the Study Coordinator

Phone: (614) 293-2222

Email: Maged.Costantine@osumc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Preeclampsia clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—