Postpartum Low-Dose Aspirin and Preeclampsia
Low-Dose Aspirin in the Postpartum Period and Endothelial Function in Patients With Preeclampsia
Columbia University
100 participants
Jul 22, 2019
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
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
Low dose aspirin, 81mg tablets, PO
Placebo oral capsule, PO
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03667326