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Recruiting Phase 2 NCT03667326

Postpartum Low-Dose Aspirin and Preeclampsia

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Trial Parameters

Condition Preeclampsia Postpartum
Sponsor Columbia University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 100
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2019-07-22
Completion 2026-06
Interventions
Aspirin tabletPlacebo oral capsule

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Brief 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 Criteria

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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