Treatment With Aspirin After Preeclampsia: TAP Trial (TAP)

June 3, 2026 updated by: Malamo Countouris
The objective of this research project is to conduct a single-site pilot trial to assess the feasibility and effect of low-dose aspirin to augment vascular recovery in the immediate postpartum period after preeclampsia through two specific aims: 1) to pilot test the feasibility of conducting a randomized controlled trial of postpartum low dose aspirin vs. placebo, and 2) to assess the effect of postpartum aspirin on endothelial function and blood pressure. Our central hypothesis is that postpartum administration of low-dose aspirin following preeclampsia will be feasible, improve endothelial function, and lower BP at 6 months postpartum. Subjects will undergo 3 study visits involving BP measurements, blood draws, questionnaires, and/or microiontophoresis. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a pilot randomized, single-center, double-blind placebo-control study of low dose aspirin in postpartum individuals with preeclampsia. Individuals will be randomized at the time of delivery 1:1 to 81mg of low-dose aspirin or identical appearing placebo daily for six months postpartum. Treatment and control groups will monitor home blood pressure throughout the study period and undergo two study visits. At each study visit, participants will undergo a blood draw, blood pressure measurement and assessment of endothelial function with microiontophoresis. Participant adherence will be monitored through pill counts, text message check-ins, patient diary and biochemical monitoring.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Magee-Womens Hospital
        • Contact:
        • Principal Investigator:
          • Alisse K Hauspurg, MD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Postpartum individuals ≥18 years old
  • Preeclampsia diagnosis

Exclusion Criteria:

  • Fetal anomaly
  • Multiple gestation
  • Pre-pregnancy hypertension
  • Allergy or contraindication to low-dose aspirin
  • Pre-pregnancy diabetes

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo Group
Similar appearing placebo pill daily for 6 months will be given to subjects.
Drug: Placebo
The control group will receive similar appearing placebo daily for 6 months.
Experimental: Intervention Group
Low-dose [81 mg] aspirin pill daily for 6 months will be given to subjects
Drug: Low-dose aspirin
The intervention group will receive low-dose [81 mg] aspirin pill daily for 6 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent of participants eligible, enrolled and retained (feasibility)
Time Frame: Baseline to approximately 6 months postpartum
To determine the feasibility of conducting a single-site randomized controlled trial of 6 months of postpartum low-dose aspirin vs. placebo in women with preeclampsia.
Baseline to approximately 6 months postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Study visit systolic BP
Time Frame: 2 months postpartum
Mean study visit systolic BP
2 months postpartum
Study visit diastolic BP
Time Frame: 2 months postpartum
Mean study visit diastolic BP
2 months postpartum
Study visit systolic BP
Time Frame: 6 months postpartum
Mean study visit systolic BP
6 months postpartum
Study visit diastolic BP
Time Frame: 6 months postpartum
Mean study visit diastolic BP
6 months postpartum
Study visit mean arterial pressure
Time Frame: 2 months postpartum
Mean study visit mean arterial pressure ((2*diastolic BP + systolic BP / 3))
2 months postpartum
Study visit mean arterial pressure
Time Frame: 6 months postpartum
Mean study visit mean arterial pressure ((2*diastolic BP + systolic BP / 3))
6 months postpartum
Anti-hypertensive medication use
Time Frame: 2 months postpartum
Use of anti-hypertensive medication (percent of participants)
2 months postpartum
Anti-hypertensive medication use
Time Frame: 6 months postpartum
Use of anti-hypertensive medication (percent of participants)
6 months postpartum
Therapeutic intensity score
Time Frame: 2 months postpartum
Therapeutic intensity score for those on anti-hypertensive medications. Range of scores 0 to 5 (higher number indicates higher doses and number of anti-hypertensive medications; worse outcome)
2 months postpartum
Therapeutic intensity score
Time Frame: 6 months postpartum
Therapeutic intensity score for those on anti-hypertensive medications. Range of scores 0 to 5 (higher number indicates higher doses and number of anti-hypertensive medications; worse outcome)
6 months postpartum
Mean home systolic blood pressure
Time Frame: delivery through 6 months postpartum
Mean home systolic blood pressure
delivery through 6 months postpartum
Mean home diastolic blood pressure
Time Frame: delivery through 6 months postpartum
Mean home diastolic blood pressure
delivery through 6 months postpartum
Mean home mean arterial pressure
Time Frame: delivery through 6 months postpartum
Mean home mean arterial pressure
delivery through 6 months postpartum
Mean daytime systolic blood pressure
Time Frame: 6 months postpartum
Mean daytime systolic blood pressure on ambulatory blood pressure monitoring
6 months postpartum
Mean nocturnal systolic blood pressure
Time Frame: 6 months postpartum
Mean nocturnal systolic blood pressure on ambulatory blood pressure monitoring
6 months postpartum
Mean daytime diastolic blood pressure
Time Frame: 6 months postpartum
Mean daytime diastolic blood pressure on ambulatory blood pressure monitoring
6 months postpartum
Mean nocturnal diastolic blood pressure
Time Frame: 6 months postpartum
Mean nocturnal diastolic blood pressure on ambulatory blood pressure monitoring
6 months postpartum
Mean nocturnal mean arterial pressure
Time Frame: 6 months postpartum
Mean nocturnal mean arterial pressure on ambulatory blood pressure monitoring
6 months postpartum
Mean daytime mean arterial pressure
Time Frame: 6 months postpartum
Mean daytime mean arterial pressure on ambulatory blood pressure monitoring
6 months postpartum
Mean overall mean arterial pressure
Time Frame: 6 months postpartum
Mean overall mean arterial pressure on ambulatory blood pressure monitoring
6 months postpartum
Mean overall systolic blood pressure
Time Frame: 6 months postpartum
Mean overall systolic blood pressure on ambulatory blood pressure monitoring
6 months postpartum
Mean overall diastolic blood pressure
Time Frame: 6 months postpartum
Mean overall diastolic blood pressure on ambulatory blood pressure monitoring
6 months postpartum
Classification of hypertension
Time Frame: 2 months postpartum
Stage 1, stage 2 hypertension (percent of participants with each stage)
2 months postpartum
Classification of hypertension
Time Frame: 6 months postpartum
Stage 1, stage 2 hypertension (percent of participants with each stage)
6 months postpartum
Endothelial function EC50%
Time Frame: 2 months postpartum
EC50% from microiontophoresis
2 months postpartum
Endothelial function EC50%
Time Frame: 6 months postpartum
EC50% from microiontophoresis
6 months postpartum
Endothelial function Emax
Time Frame: 2 months postpartum
Emax from microiontophoresis
2 months postpartum
Endothelial function Emax
Time Frame: 6 months postpartum
Emax from microiontophoresis
6 months postpartum
Endothelial function change in Emax
Time Frame: 2 to 6 months postpartum
Change in Emax between visits
2 to 6 months postpartum
Endothelial function change in EC50%
Time Frame: 2 to 6 months postpartum
Change in EC50% between visits
2 to 6 months postpartum
Change in systolic blood pressure
Time Frame: 2 to 6 months postpartum
Change in study visit mean systolic blood pressure between visits
2 to 6 months postpartum
Change in diastolic blood pressure
Time Frame: 2 to 6 months postpartum
Change in study visit mean diastolic blood pressure between visits
2 to 6 months postpartum
Change in mean arterial pressure
Time Frame: 2 to 6 months postpartum
Change in study visit mean arterial pressure between visits
2 to 6 months postpartum

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Malamo Countouris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alisse K Hauspurg, MD, UPMC Magee Women's Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY23080099
  • K23HL168356 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data (including data dictionaries) will be shared at the discretion of the primary investigator. Data will include blood pressure, weight, demographics, physical activity, and pregnancy related information. Additional documents (such as the study protocol) will be made available.

IPD Sharing Time Frame

Within a year after outcomes are published and no later than 3 years after the end of clinical activities.

IPD Sharing Access Criteria

NHLBI data repository request process

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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.

Yes

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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