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

Inclusion Criteria2

  • Postpartum individuals ≥18 years old
  • Preeclampsia diagnosis

Exclusion Criteria5

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

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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