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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT06249178
Status
Recruiting
Apply to this trial

Conditions

  • Preeclampsia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jul 2, 2024
Status verified
Dec 2025
Primary completion
Sep 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
1,000 participants (estimated)

Primary Outcome Measure

multi-marker panel [ Time Frame: From enrollment till delivery; up to 29 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal MedicineColumbusOhio43210
Maged Costantine, MD, MBA
[email protected]
614-293-2222
Kara Rood, MD
[email protected]
614-293-8045
Kara Rood, MD (SUB_INVESTIGATOR)
Mitch Phelps, PhD (SUB_INVESTIGATOR)
Brian Searle, PhD (SUB_INVESTIGATOR)
Damien Wilburn, PhD (SUB_INVESTIGATOR)

Find similar trials in Columbus, OH

By research site
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine· Columbus, OH

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