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Recruiting NCT06281665

Treatment With Aspirin After Preeclampsia: TAP Trial

Phase IV Interventional Hypertensive Disorder of Pregnancy Pre-Eclampsia Hypertension Eclampsia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-dose aspirin, Placebo.
Who it may be relevant to
Registry conditions: Hypertensive Disorder of Pregnancy, Pre-Eclampsia, Hypertension, Eclampsia. Basic parameters: 18 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • Drug Low-dose aspirin
    The intervention group will receive low-dose \[81 mg\] aspirin pill daily for 6 months.
  • Drug Placebo
    The control group will receive similar appearing placebo daily for 6 months.

Primary outcome measures

  • Percent of participants eligible, enrolled and retained (feasibility) [Time frame: Baseline to approximately 6 months postpartum]
Secondary outcome measures (12)
  • Study visit systolic BP [Time frame: 2 months postpartum]
  • Study visit diastolic BP [Time frame: 2 months postpartum]
  • Study visit systolic BP [Time frame: 6 months postpartum]
  • Study visit diastolic BP [Time frame: 6 months postpartum]
  • Study visit mean arterial pressure [Time frame: 2 months postpartum]
  • Study visit mean arterial pressure [Time frame: 6 months postpartum]
  • Anti-hypertensive medication use [Time frame: 2 months postpartum]
  • Anti-hypertensive medication use [Time frame: 6 months postpartum]
  • Therapeutic intensity score [Time frame: 2 months postpartum]
  • Therapeutic intensity score [Time frame: 6 months postpartum]
  • Mean home systolic blood pressure [Time frame: delivery through 6 months postpartum]
  • Mean home diastolic blood pressure [Time frame: delivery through 6 months postpartum]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

United States · 1 center
  • University of Pittsburgh Magee-Womens Hospital — Pittsburgh

Identifiers

NCT: NCT06281665 · STUDY23080099 · K23HL168356

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗