Aspirin and Preeclampsia
Sponsored by University of Chicago
About this study
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.
The primary objective of the main part of this trial is to mechanistically compare the effect of postpartum aspirin therapy versus placebo in preeclamptic patients identified as high risk for postpartum cardiac dysfunction using Activin A. The intent is to evaluate the effect of selective treatment based on Activin A status rather than treatment for all postpartum preeclamptic women. After informed consent, 5cc of blood will be collected from the median cubital vein on antepartum admission to labor and delivery for Activin A screening. The patient will be subjected to a total of 2 such blood draws- a single draw at screening, one at their 6 month postpartum visit. The member of the study team carrying out the blood draw will immediately label the specimen in the presence of the subject, a…
Where this study is enrolling
- I'm interested
University of Chicago Hospital
Chicago, Illinois
Who can participate
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
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Trial data sourced from ClinicalTrials.gov.