RecruitingPhase 4NCT04479072

Aspirin and Preeclampsia

Aspirin to Prevent Cardiac Dysfunction in Preeclampsia


Sponsor

University of Chicago

Enrollment

180 participants

Start Date

Feb 15, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria3

  • Pregnant Adults between 18 and 45 years of age
  • Diagnosed with preeclampsia
  • Presenting for delivery with a singleton gestation.

Exclusion Criteria9

  • 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

Interventions

DRUGPlacebo

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.

DRUGAspirin 81 mg

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.


Locations(1)

University of Chicago Hospital

Chicago, Illinois, United States

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NCT04479072


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