Recruiting
Phase 2

Aspirin

Sponsor:

Columbia University

Code:

NCT03667326

Conditions

Preeclampsia Postpartum

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Aspirin tablet

Placebo oral capsule

Study Details

Brief 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.

Conditions

Preeclampsia Postpartum

Study ID

NCT03667326

Start date

Jul 22, 2019

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Low-Dose Aspirin (LDA) Intervention Group

Subjects diagnosed with severe preeclampsia prior to delivery (antepartum or intrapartum) will take 81mg of aspirin daily for up to 3 weeks postpartum, starting within 4 days after delivery.

placebo comparator: Placebo Control Group

Subjects diagnosed with severe preeclampsia prior to delivery (antepartum or intrapartum) will take placebo oral capsule daily for up to 3 weeks postpartum, starting within 4 days after delivery.

no intervention: Healthy Controls Group

Subjects who are healthy volunteers (n = 10) without severe preeclampsia prior to delivery.

Interventions

Aspirin tablet

Low dose aspirin, 81mg tablets, PO

Placebo oral capsule

Placebo oral capsule, PO

Primary outcome measure

  • Change in Flow-Mediated Dilation (FMD) [ Time Frame: Up to 3 weeks postpartum ]

Central Contacts and Locations

Central contacts

Aleha Aziz, MD, MPH

646-678-0289aa4065@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Aleha Aziz, MD, MPH

646-678-0289aa4065@cumc.columbia.edu

Principal Investigator:

Aleha Aziz, MD, MPH

More Information

Sponsor

Columbia University

Last update posted

Jan 22, 2026

Last verified

Dec, 2025

Keywords

  • Aspirin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-01-22.