RecruitingPhase 4NCT06281665

Treatment With Aspirin After Preeclampsia: TAP Trial


Sponsor

Malamo Countouris

Enrollment

60 participants

Start Date

May 29, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

The TAP Trial is studying whether taking low-dose aspirin after a pregnancy complicated by preeclampsia can reduce the risk of future cardiovascular events (like heart attacks or strokes). Preeclampsia raises long-term heart disease risk, and aspirin may help. **You may be eligible if...** - You are 18 years or older, in the postpartum period (after giving birth) - You were diagnosed with preeclampsia during your recent pregnancy **You may NOT be eligible if...** - Your baby had a fetal abnormality - You had a multiple pregnancy (twins, triplets, etc.) - You had high blood pressure before becoming pregnant - You are allergic to or have a medical reason to avoid low-dose aspirin - You had diabetes before becoming pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLow-dose aspirin

The intervention group will receive low-dose \[81 mg\] aspirin pill daily for 6 months.

DRUGPlacebo

The control group will receive similar appearing placebo daily for 6 months.


Locations(1)

University of Pittsburgh Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

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NCT06281665


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