RecruitingPhase 2NCT03667326

Postpartum Low-Dose Aspirin and Preeclampsia

Low-Dose Aspirin in the Postpartum Period and Endothelial Function in Patients With Preeclampsia


Sponsor

Columbia University

Enrollment

100 participants

Start Date

Jul 22, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria10

  • 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)

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Interventions

DRUGAspirin tablet

Low dose aspirin, 81mg tablets, PO

DRUGPlacebo oral capsule

Placebo oral capsule, PO


Locations(1)

Columbia University Irving Medical Center

New York, New York, United States

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NCT03667326


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