Preeclampsia Postpartum Clinical Trial
Official title:
Aspirin to Prevent Cardiac Dysfunction in Preeclampsia
This is a single-center, double-blind, randomized, placebo-controlled clinical trial. Peripartum and postpartum Activin A are significantly elevated in women with preeclampsia. Our hypothesis is that elevated Activin A levels reflect a remediable signal and that reducing postpartum Activin A levels with aspirin therapy will improve (GLS) in preeclamptic patients.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | December 31, 2025 |
Est. primary completion date | October 1, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago Hospital | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in Activin A levels | The primary outcome will compare Activin A levels at 6 months between patients randomized to aspirin therapy versus placebo and the observational group. | 6 Months | |
Primary | GLS percentages | The primary outcome will compare GLS levels as a percentage (%) at 6 months between patients randomized to aspirin therapy versus placebo and the observational group. | 6 months | |
Secondary | Mean Arterial Pressure | Difference in mean arterial pressure in subjects, from their baseline to 6 month TTE | 6 Months | |
Secondary | Ejection Fraction % | Comparing the difference in the ejection fraction percentages, from the subjects baseline to 6 month TEE. | 6 Months | |
Secondary | Deceleration Time | Comparing the difference between deceleration time from subjects from their baseline to 6 month TTE. | 6 Months | |
Secondary | Mitral Annular Motion | Comparing the difference between mitral annular motion, in millimeters (mm), from subjects baseline to 6 month TTE. | 6 Months | |
Secondary | Left Atrial Volume Index | Comparing the difference between left atrial volume index, from the subjects baseline to 6 month TTE. | 6 Months |
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