Daily Aspirin Treatment After Preeclampsia

December 8, 2025 updated by: Anna Stanhewicz, PhD

Aspirin for the Treatment of Vascular Dysfunction After Preeclampsia

Women who develop preeclampsia during pregnancy are four times more likely to develop cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs may be related to lasting blood vessel damage after the pregnancy but there are currently no specific treatment strategies to prevent this disease progression. This study addresses this public health issue by examining whether starting low dose aspirin therapy after pregnancy is an effective treatment for lasting blood vessel damage in order to inform better clinical management of cardiovascular disease risk in women who have had preeclampsia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • had preeclampsia in the past 5 years,
  • 18 years or older

Exclusion criteria:

  • current daily aspirin use,
  • skin diseases,
  • current tobacco or nicotine use (including vaping),
  • diagnosed or suspected hepatic or metabolic disease including chronic kidney disease (CKD) defined as reduced eGFR < 60 mL/min/1.73m2,
  • statin or other cholesterol-lowering medication,
  • current antihypertensive medication,
  • history of hypertension prior to pregnancy,
  • history of gestational diabetes,
  • currently pregnancy,
  • body mass index <18.5 kg/m2,
  • allergy to materials used during the experiment.(e.g. latex),
  • known allergies to study drugs,
  • bleeding disorders, peptic ulcer disease, gastritis, GI bleeding and gastroesophageal reflux disease (GERD).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
placebo pill taken once daily at bedtime for 12 weeks
Drug: Placebo
placebo capsule
Experimental: aspirin
162mg aspirin taken once daily at bedtime for 12 weeks
Drug: Aspirin
162mg aspirin capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
magnitude of microvascular endothelial function
Time Frame: baseline, 12 weeks
skin blood flow response to acetylcholine delivered via intradermal microdialysis
baseline, 12 weeks
magnitude of brachial artery endothelial function
Time Frame: baseline, 12 weeks
brachial artery flow mediated dilation
baseline, 12 weeks
magnitude of microvascular endothelin-1 mediated constriction
Time Frame: baseline, 12 weeks
skin blood flow response to endothelin-1 delivered via intradermal microdialysis
baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
magnitude of microvascular nitric oxide-dependent dilation
Time Frame: baseline, 12 weeks
skin blood flow response to acetylcholine + L-NAME delivered via intradermal microdialysis
baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anna Stanhewicz, PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202303799

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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