Developing Extracellular Vesicle Based MPRINT Translational Resource Platform for Monitoring Therapeutics Response During Pregnancy
Ohio State University
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.
Description
Pregnant and lactating people remain therapeutic orphans as they are excluded from the vast majority of clinical drug development and therapeutic trials. Moreover, current practices in drug evaluation in pregnancy have been hindered by the lack of effective biomarkers and innovative study designs. There is a need to develop novel placental-specific biomarkers in order to assess placental function and response to therapeutics, as a way to inform on their safety and efficacy. An example of these novel biomarkers is placental (fetal) specific extracellular vesicles (EVs). Recent advances in chara…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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)…
Location
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal MedicineColumbus, Ohio