Postpartum Low-Dose Aspirin and Preeclampsia
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Preeclampsia Postpartum
In brief
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.
Key facts
- Study ID
- NCT03667326
- Run by
- Columbia University
- People needed
- 100
- Starts
- 2019-07-22
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-01-22
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Singleton or Multiple gestation
- Maternal age >= 18 years
- 20 0/7 weeks gestation or greater
- Severe Preeclampsia diagnosed prior to delivery
You may not qualify if…
- 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).
Where it is running
- Columbia University Irving Medical Center — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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