Overview

Postpartum Low-Dose Aspirin and Preeclampsia

Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Columbia University
Treatments:
Aspirin
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)