Aspirin and 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.
Conditions:
🦠 Preeclampsia Postpartum
🗓️ Study Start (Actual) 15 February 2021
🗓️ Primary Completion (Estimated) 1 October 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 180
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Chicago, Illinois, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 45 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 July 2020
  • First Submitted that Met QC Criteria 18 July 2020
  • First Posted 21 July 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 June 2024
  • Last Update Posted 14 June 2024
  • Last Verified June 2024