Low-Dose Aspirin in the Postpartum Period and Endothelial Function in Patients With Preeclampsia
Columbia University
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.
Description
Preeclampsia is a serious disease of pregnancy that manifests with increased blood pressure and can affect all the organs in a woman's body. It usually develops after 20 weeks of pregnancy. There is an abnormal amount of protein in the urine and with worsening disease known as "severe features," patients can have pain in the upper abdomen, changes in vision, fluid in the lungs, an intense headache, low number of platelets in the blood, and abnormal liver or kidney function. Very high blood pressure is also considered a severe feature. The exact cause of preeclampsia is unknown but women with t…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- Yes
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 ta…
Interventions
- DrugAspirin tablet
Low dose aspirin, 81mg tablets, PO
- DrugPlacebo oral capsule
Placebo oral capsule, PO
Location
- Columbia University Irving Medical CenterNew York, New York