Postpartum Low-Dose Aspirin and Preeclampsia

NCT03667326 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AAAR9439
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Aspirin

Outcome Measures

Primary Outcomes (1)

• Change in Flow-Mediated Dilation (FMD)

  This is designed to measure if patients with preeclampsia with severe features diagnosed antepartum or intrapartum, will experience an increase in Flow-Mediated Dilation (FMD) - a measure of endothelial function - within 3 weeks after delivery when taking daily LDA in the postpartum period.

  Up to 3 weeks postpartum

Secondary Outcomes (6)

• Change in Systolic blood pressure

  Within 3 weeks postpartum

• Change in Diastolic blood pressure

  Within 3 weeks postpartum

• Number of subjects with presentation of disease postpartum (symptoms, severe range BPs, lab abnormalities)

  Up to 3 weeks postpartum

• Magnesium sulfate re-administration

  Up to 3 weeks postpartum

• Number of subjects with initiation of, increase in or addition of blood pressure medication

  Up to 3 weeks postpartum

Study Arms (3)

Low-Dose Aspirin (LDA) Intervention Group

ACTIVE COMPARATOR

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.

Drug: Aspirin tablet

Placebo Control Group

PLACEBO COMPARATOR

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.

Drug: Placebo oral capsule

Healthy Controls Group

NO INTERVENTION

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

Interventions

Aspirin tablet DRUG

Low dose aspirin, 81mg tablets, PO

Also known as: Aspirin

Low-Dose Aspirin (LDA) Intervention Group

Placebo oral capsule DRUG

Placebo oral capsule, PO

Also known as: Placebo

Placebo Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton or Multiple gestation
• Maternal age \>= 18 years
• /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)

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Related Publications (2)

• The American College of Obstetricians and Gynecologists. Practice Advisory on Low-Dose Aspirin and Prevention of Preeclampsia: Updated Recommendations [Internet]. 2016. Available from: https://www.acog.org/Clinical-Guidance-and-Publications/Practice-Advisories/Practice-Advisory-Low-Dose-Aspirin-and-Prevention-of-Preeclampsia-Updated-Recommendations

  BACKGROUND

• Costa AC, Reina-Couto M, Albino-Teixeira A, Sousa T. Aspirin and blood pressure: Effects when used alone or in combination with antihypertensive drugs. Rev Port Cardiol. 2017 Jul-Aug;36(7-8):551-567. doi: 10.1016/j.repc.2017.05.008. Epub 2017 Jul 3. English, Portuguese.

  PMID: 28684123 BACKGROUND

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Aleha Aziz, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleha Aziz, MD, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Model Details: Preeclampsia patients will be recruited and randomized to receive either Aspirin or Placebo (n = 90). Additionally, there will be healthy patients (n = 10) recruited to collect the same set of data for comparison with no intervention.

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: September 12, 2018
• Study Start: July 22, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)