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Postpartum Low-Dose Aspirin and Preeclampsia

RecruitingPhase 2Ages 18 Years - anyFemaleColumbia University
NCT03667326 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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).
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What it tests

  • Aspirin tablet
  • Placebo oral capsule
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Where

1 site
Columbia University Irving Medical Center
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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