Treatment With Aspirin After Preeclampsia: TAP Trial

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Malamo Countouris
Study ID
NCT06281665
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cardiovascular Diseases
  • Eclampsia
  • Gestational Hypertension
  • Hypertension
  • Hypertension, Pregnancy Induced
  • Hypertension;Pre-Eclamptic
  • Hypertensive Disorder of Pregnancy
  • Pre-Eclampsia
  • Pregnancy Complications
  • Toxemia
  • Vascular Diseases

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 29, 2024
Status verified
Jun 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Placebo Comparator: Placebo Group
    Similar appearing placebo pill daily for 6 months will be given to subjects.
  • Experimental: Intervention Group
    Low-dose \[81 mg\] aspirin pill daily for 6 months will be given to subjects

Primary Outcome Measure

Percent of participants eligible, enrolled and retained (feasibility) [ Time Frame: Baseline to approximately 6 months postpartum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Magee-Womens HospitalPittsburghPennsylvania15213
Sila Yavan, MS
[email protected]
4124174981
Alisse K Hauspurg, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
University of Pittsburgh Magee-Womens Hospital· Pittsburgh, PA

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