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Postpartum Low-Dose Aspirin and Preeclampsia
The purpose of this research study is to find out whether women with severe preeclampsia taking low-dose aspirin (LDA) for 3 weeks post-delivery will experience an improvement in endothelial function (measured as flow-mediated dilation - FMD) and severity of disease, as the effects of preeclampsia can persist postpartum. Women diagnosed with severe preeclampsia prior to delivery will be enrolled and randomized to receive either low-dose aspirin (81mg) or placebo to take daily for up to 3 weeks post-delivery. Exploratory objective includes healthy control postpartum patients without preeclampsia and not on LDA during pregnancy or postpartum in comparison with the primary study population affected by preeclampsia with severe features.
Conditions:
🦠 Preeclampsia Postpartum
🗓️ Study Start (Actual) 22 July 2019
🗓️ Primary Completion (Estimated) June 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Singleton or Multiple gestation
    • * Maternal age \>= 18 years
    • * 20 0/7 weeks gestation or greater
    • * Severe Preeclampsia diagnosed prior to delivery

    Exclusion Criteria:

    • * Aspirin use postpartum for other medical indication
    • * Lovenox, unfractionated heparin, or other anticoagulant use postpartum for an indication other than postoperative (in-house)
    • * Aspirin use within 7 days of planned initial FMD testing postpartum
    • * Hypersensitivity or allergy to Aspirin or other salicylates
    • * Hypersensitivity or allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) - exception if taking LDA in pregnancy
    • * Nasal polyps
    • * Gastric or Duodenal ulcers, history of GI bleeding
    • * Severe hepatic dysfunction
    • * Bleeding disorders and diathesis
    • * Breastfeeding a newborn with low platelets (NAIT)
    • For sub-study patients, inclusion and exclusion criteria will be the same, with the exception of diagnosis of severe preeclampsia prior to delivery (exclusion criterion for healthy controls group).
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ 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 27 August 2018
  • First Submitted that Met QC Criteria 10 September 2018
  • First Posted 12 September 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 June 2024
  • Last Update Posted 28 June 2024
  • Last Verified June 2024
I'm interested ...!!