What this study is
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.
What's being tested
- Aspirin 81 mg
Intervention · DRUG
Subjects in the interventional arm will receive a daily dose of aspirin 81 mg, starting at their baseline visit and to be taken up to their 6-month follow-up visit.
- Placebo
Intervention · DRUG
Subjects in this group will receive a daily dose of a placebo pill, starting at their baseline visit and to be taken up to their 6-month follow-up visit.
Study details
- Official title
- Aspirin to Prevent Cardiac Dysfunction in Preeclampsia
- Sponsor
- University of Chicago
- Conditions
- Preeclampsia Postpartum
- Enrolling
- 180 people
- Starts
- 2021-02-15
- Est. completion
- 2026-12-31
- Design
- Double-blind, randomized, factorial, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 45 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Pregnant Adults between 18 and 45 years of age
- Diagnosed with preeclampsia
- Presenting for delivery with a singleton gestation.
You can't join if
- We will exclude patients in labor
- Patients with preexisting cardiomyopathy, chronic hypertension, ischemic or valvular heart disease, pulmonary disease, diabetes mellitus, chronic kidney disease, multiple gestation
- Plan to deliver outside of the participating site
- Co-enrolled in other trials that might affect the patients taking the study medication, as determined by the PI.
- Aspirin allergy
- Clear indication for aspirin therapy or contraindication to aspirin therapy
- Clinically significant conditions that might limit adherence to trial regimen (e.g., peptic ulcer disease, history of gastrointestinal bleeds, bleeding disorders)
- Currently or planning on taking any nonsteroidal anti-inflammatory drugs while they are participating in this study.
- Those who cannot provide consent
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Chicago Hospital
Chicago, Illinois, United States
- Sajid Shahul, MD, PhD · Contact773-398-2956sshahul1@dacc.uchicago.edu
- John Dreixler, PhD · Contact773-702-6700JDreixle@dacc.uchicago.edu
- Sarosh Rana, MD · Sub-investigator
Recruiting
Study team
Sponsor
University of Chicago
Study ID IRB18-1606
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.