Low-dose aspirin for women with severe preeclampsia after delivery
Low-Dose Aspirin in the Postpartum Period and Endothelial Function in Patients With Preeclampsia
This study is testing if giving low-dose aspirin to women with severe preeclampsia after childbirth can help improve their blood vessel function and make their condition better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03667326 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether administering low-dose aspirin to women diagnosed with severe preeclampsia for three weeks postpartum can improve their endothelial function and reduce the severity of their condition. Participants will be randomly assigned to receive either low-dose aspirin or a placebo, with the primary outcome measured through flow-mediated dilation. The study also includes a comparison group of healthy postpartum women without preeclampsia. The goal is to gather data on the potential benefits of low-dose aspirin in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older who have been diagnosed with severe preeclampsia prior to delivery.
Not a fit: Patients who are currently using aspirin for other medical reasons or have certain contraindications, such as allergies to aspirin or NSAIDs, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved cardiovascular health and reduced long-term complications for women who have experienced severe preeclampsia.
How similar studies have performed: While there is limited data on the use of low-dose aspirin postpartum in preeclamptic patients, previous studies have shown some success with aspirin in reducing risks during pregnancy, making this a novel exploration in the postpartum context.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Aleha Aziz, MD, MPH — Columbia University
- Study coordinator: Aleha Aziz, MD, MPH
- Email: aa4065@cumc.columbia.edu
- Phone: 646-678-0289
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.