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Treatment With Aspirin After Preeclampsia: TAP Trial
The objective of this research project is to conduct a single-site pilot trial to assess the feasibility and effect of low-dose aspirin to augment vascular recovery in the immediate postpartum period after preeclampsia through two specific aims: 1) to pilot test the feasibility of conducting a randomized controlled trial of postpartum low dose aspirin vs. placebo, and 2) to assess the effect of postpartum aspirin on endothelial function and blood pressure. Our central hypothesis is that postpartum administration of low-dose aspirin following preeclampsia will be feasible, improve endothelial function, and lower BP at 6 months postpartum. Subjects will undergo 3 study visits involving BP measurements, blood draws, questionnaires, and/or microiontophoresis. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.
Conditions:
🦠 Hypertensive Disorder of Pregnancy 🦠 Pre-Eclampsia 🦠 Hypertension 🦠 Eclampsia 🦠 Gestational Hypertension 🦠 Cardiovascular Diseases 🦠 Toxemia 🦠 Pregnancy Complications 🦠 Vascular Diseases 🦠 Hypertension, Pregnancy Induced 🦠 Hypertension;Pre-Eclamptic
More conditions available...
🗓️ Study Start (Actual) 29 May 2024
🗓️ Primary Completion (Estimated) 1 June 2025
✅ Study Completion (Estimated) 1 June 2026
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Pittsburgh, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Postpartum individuals ≥18 years old
    • * Preeclampsia diagnosis

    Exclusion Criteria:

    • * Fetal anomaly
    • * Multiple gestation
    • * Pre-pregnancy hypertension
    • * Allergy or contraindication to low-dose aspirin
    • * Pre-pregnancy diabetes
Ages Eligible for Study: 18 Years to 55 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 15 February 2024
  • First Submitted that Met QC Criteria 19 February 2024
  • First Posted 28 February 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 11 June 2024
  • Last Update Posted 13 June 2024
  • Last Verified June 2024
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