EV Based Platform for Monitoring Therapeutics Response During Pregnancy (ARISE)
Developing Extracellular Vesicle Based MPRINT Translational Resource Platform for Monitoring Therapeutics Response During Pregnancy
Ohio State University
1,000 participants
Jul 2, 2024
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
Inclusion Criteria8
- pregnant individuals age ≥18 years
- enrolled ≤16 6/7 weeks of gestation based on the best obstetric estimate as defined by ACOG criteria
- singleton live intrauterine gestation
- Any of the following:
- 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) autoimmune disease (e.g., antiphospholipid syndrome, lupus) or
- Two or more moderate-risk criteria for HDP (per USPSTF); i) nulliparity (no prior delivery at or after 20 weeks 0 days of gestation) ii) obesity (body mass index ≥30 kg/m2 at time of enrollment) iii) age ≥35 years (at time of expected estimated due date) iv) Black race v) Low income vi) Personal risk factors (previous pregnancy with low birth weight or SGA infant, previous adverse pregnancy outcome \[unexplained stillbirth\], placental abruption, interval \>10 years between pregnancies).
- vii) Pregnancy after in vitro conception viii) family history of preeclampsia ( i.e., mother or sister)
- or participating in another clinical RCT of 81mg vs. 162mg aspirin for prevention of hypertensive disorders of pregnancy
Exclusion Criteria8
- age \< 18 years,
- involuntarily confined or detained
- considered as having a diminished decision-making capacity
- multifetal gestation
- pregestational diabetes mellitus or gestational diabetes diagnosed \< 20 weeks due to the impact on exosome response
- known or suspected fetal aneuploidy or major congenital abnormality, fetal demise, or planned pregnancy termination
- known allergy or hypersensitivity to aspirin or any medical condition where aspirin is contraindicated (e.g., peptic ulcer disease, nasal polyps, NSAID-induced asthma, gastrointestinal bleeding, G6PD deficiency, severe hepatic dysfunction, bleeding disorders)
- plan to deliver at another center or participating in another intervention study that influences the primary outcome in this study, without prior approval
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06249178