Postpartum Low-Dose Aspirin and Preeclampsia
Columbia University · NCT03667326
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · Women only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 2
- Target enrollment
- 100
- US sites recruiting
- 1
- Study start
- July 22, 2019
- Record last updated
- January 22, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Aspirin tablet; Placebo oral capsule
Conditions: Preeclampsia Postpartum
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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).
Recruiting US locations
Columbia University Irving Medical Center
New York, NY 10032
Site contact: Aleha Aziz, MD, MPH · 646-678-0289 · aa4065@cumc.columbia.edu
Study contacts (from the official record)
- Aleha Aziz, MD, MPH · 646-678-0289 · aa4065@cumc.columbia.edu
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