Using aspirin to reduce postpartum heart issues in women with preeclampsia
Aspirin to Prevent Cardiac Dysfunction in Preeclampsia
This study is testing if taking aspirin after childbirth can help women with preeclampsia and high Activin A levels have better heart function.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04479072 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of aspirin therapy on postpartum cardiac function in women diagnosed with preeclampsia. It is a single-center, double-blind, randomized, placebo-controlled trial that focuses on patients with elevated Activin A levels, which are associated with increased risk of cardiac dysfunction. Participants will undergo blood tests to measure Activin A levels and will be randomized to receive either aspirin or a placebo after delivery. The goal is to determine if aspirin can effectively lower Activin A levels and improve cardiac function in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 to 45 diagnosed with preeclampsia and presenting for delivery with a singleton gestation.
Not a fit: Patients with preexisting heart conditions, multiple gestations, or those who are in labor will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of cardiac complications in postpartum women with preeclampsia.
How similar studies have performed: While studies on aspirin for various conditions exist, this specific approach targeting postpartum cardiac dysfunction in preeclampsia is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pregnant Adults between 18 and 45 years of age 2. Diagnosed with preeclampsia 3. Presenting for delivery with a singleton gestation. Exclusion Criteria: 1. We will exclude patients in labor 2. Patients with preexisting cardiomyopathy, chronic hypertension, ischemic or valvular heart disease, pulmonary disease, diabetes mellitus, chronic kidney disease, multiple gestation 3. Plan to deliver outside of the participating site 4. Co-enrolled in other trials that might affect the patients taking the study medication, as determined by the PI. 5. Aspirin allergy 6. Clear indication for aspirin therapy or contraindication to aspirin therapy 7. Clinically significant conditions that might limit adherence to trial regimen (e.g., peptic ulcer disease, history of gastrointestinal bleeds, bleeding disorders) 8. Currently or planning on taking any nonsteroidal anti-inflammatory drugs while they are participating in this study. 9. Those who cannot provide consent
Where this trial is running
Chicago, Illinois
- University of Chicago Hospital — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Sajid Shahul, MD, PhD
- Email: sshahul1@dacc.uchicago.edu
- Phone: 773-398-2956
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.