Monitoring therapeutic response during pregnancy for preeclampsia
Developing Extracellular Vesicle Based MPRINT Translational Resource Platform for Monitoring Therapeutics Response During Pregnancy
This study is testing if blood samples from pregnant people at risk for preeclampsia can help us understand how well aspirin works in protecting both the mother and baby during pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06249178 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to analyze the extracellular vesicle (EV) proteome profiles of pregnant individuals at risk for preeclampsia who are receiving aspirin treatment. Participants will provide blood samples up to four times during their pregnancy to generate proteomic data that could help identify distinct maternal and fetal EV profiles associated with aspirin use. The study seeks to develop and validate a multi-marker panel to monitor placental function and assess the effectiveness of aspirin in preventing preeclampsia. By focusing on placental-specific biomarkers, the research addresses the gap in therapeutic evaluations for pregnant individuals.
Who should consider this trial
Good fit: Ideal candidates include pregnant individuals aged 18 and older, enrolled before 16 weeks of gestation, who are at high or moderate risk for hypertensive disorders of pregnancy.
Not a fit: Patients who are not pregnant or those with multiple gestations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of preeclampsia in pregnant individuals, enhancing maternal and fetal health outcomes.
How similar studies have performed: While the approach of using extracellular vesicle profiling is innovative, prior studies have shown potential correlations between aspirin use and pregnancy outcomes, indicating a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
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) autoimmune disease (e.g., antiphospholipid syndrome, lupus) or
2. 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)
3. or participating in another clinical RCT of 81mg vs. 162mg aspirin for prevention of hypertensive disorders of pregnancy
Exclusion Criteria:
1. age \< 18 years,
2. involuntarily confined or detained
3. considered as having a diminished decision-making capacity
4. multifetal gestation
5. pregestational diabetes mellitus or gestational diabetes diagnosed \< 20 weeks due to the impact on exosome response
6. known or suspected fetal aneuploidy or major congenital abnormality, fetal demise, or planned pregnancy termination
7. 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)
8. plan to deliver at another center or participating in another intervention study that influences the primary outcome in this study, without prior approval
Where this trial is running
Columbus, Ohio
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Maged Costantine, MD, MBA — Ohio State University
- Study coordinator: Maged Costantine, MD, MBA
- Email: Maged.Costantine@osumc.edu
- Phone: 614-293-2222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.