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NCT Number: NCT06281665

Treatment With Aspirin After Preeclampsia: TAP Trial

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.

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Key information

Conditions

Hypertensive Disorder of Pregnancy Cardiovascular Diseases Eclampsia Female Urogenital Diseases and Pregnancy Complications Gestational Hypertension Hypertension Hypertension, Pregnancy Induced Hypertension, Pregnancy-Induced Hypertension;Pre-Eclamptic Infections Pre-Eclampsia Pregnancy Complications Toxemia Urogenital Diseases Vascular Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Pittsburgh Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Alisse K Hauspurg, MD

PRINCIPAL_INVESTIGATOR

Sila Yavan, MS

CONTACT

[email protected]

4124174981

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Study visit systolic BP

    Time frame: 2 months postpartum

    Mean study visit systolic BP

  2. Study visit diastolic BP

    Time frame: 2 months postpartum

    Mean study visit diastolic BP

  3. Study visit systolic BP

    Time frame: 6 months postpartum

    Mean study visit systolic BP

  4. Study visit diastolic BP

    Time frame: 6 months postpartum

    Mean study visit diastolic BP

  5. Study visit mean arterial pressure

    Time frame: 2 months postpartum

    Mean study visit mean arterial pressure ((2*diastolic BP + systolic BP / 3))

  6. Study visit mean arterial pressure

    Time frame: 6 months postpartum

    Mean study visit mean arterial pressure ((2*diastolic BP + systolic BP / 3))

  7. Anti-hypertensive medication use

    Time frame: 2 months postpartum

    Use of anti-hypertensive medication (percent of participants)

  8. Anti-hypertensive medication use

    Time frame: 6 months postpartum

    Use of anti-hypertensive medication (percent of participants)

  9. 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)

  10. 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)

  11. Mean home systolic blood pressure

    Time frame: delivery through 6 months postpartum

    Mean home systolic blood pressure

  12. Mean home diastolic blood pressure

    Time frame: delivery through 6 months postpartum

    Mean home diastolic blood pressure

  13. Mean home mean arterial pressure

    Time frame: delivery through 6 months postpartum

    Mean home mean arterial pressure

  14. Mean daytime systolic blood pressure

    Time frame: 6 months postpartum

    Mean daytime systolic blood pressure on ambulatory blood pressure monitoring

  15. Mean nocturnal systolic blood pressure

    Time frame: 6 months postpartum

    Mean nocturnal systolic blood pressure on ambulatory blood pressure monitoring

  16. Mean daytime diastolic blood pressure

    Time frame: 6 months postpartum

    Mean daytime diastolic blood pressure on ambulatory blood pressure monitoring

  17. Mean nocturnal diastolic blood pressure

    Time frame: 6 months postpartum

    Mean nocturnal diastolic blood pressure on ambulatory blood pressure monitoring

  18. Mean nocturnal mean arterial pressure

    Time frame: 6 months postpartum

    Mean nocturnal mean arterial pressure on ambulatory blood pressure monitoring

  19. Mean daytime mean arterial pressure

    Time frame: 6 months postpartum

    Mean daytime mean arterial pressure on ambulatory blood pressure monitoring

  20. Mean overall mean arterial pressure

    Time frame: 6 months postpartum

    Mean overall mean arterial pressure on ambulatory blood pressure monitoring

  21. Mean overall systolic blood pressure

    Time frame: 6 months postpartum

    Mean overall systolic blood pressure on ambulatory blood pressure monitoring

  22. Mean overall diastolic blood pressure

    Time frame: 6 months postpartum

    Mean overall diastolic blood pressure on ambulatory blood pressure monitoring

  23. Classification of hypertension

    Time frame: 2 months postpartum

    Stage 1, stage 2 hypertension (percent of participants with each stage)

  24. Classification of hypertension

    Time frame: 6 months postpartum

    Stage 1, stage 2 hypertension (percent of participants with each stage)

  25. Endothelial function EC50%

    Time frame: 2 months postpartum

    EC50% from microiontophoresis

  26. Endothelial function EC50%

    Time frame: 6 months postpartum

    EC50% from microiontophoresis

  27. Endothelial function Emax

    Time frame: 2 months postpartum

    Emax from microiontophoresis

  28. Endothelial function Emax

    Time frame: 6 months postpartum

    Emax from microiontophoresis

  29. Endothelial function change in Emax

    Time frame: 2 to 6 months postpartum

    Change in Emax between visits

  30. Endothelial function change in EC50%

    Time frame: 2 to 6 months postpartum

    Change in EC50% between visits

  31. Change in systolic blood pressure

    Time frame: 2 to 6 months postpartum

    Change in study visit mean systolic blood pressure between visits

  32. Change in diastolic blood pressure

    Time frame: 2 to 6 months postpartum

    Change in study visit mean diastolic blood pressure between visits

  33. Change in mean arterial pressure

    Time frame: 2 to 6 months postpartum

    Change in study visit mean arterial pressure between visits

Study contacts

Contact information is provided by the study sponsor or research team.

Alisse K Hauspurg, MD

CONTACT

[email protected]

412-641-1381

Sila Yavan, MS

CONTACT

[email protected]

4124174981

Sponsors and collaborators

Lead sponsor

Malamo Countouris

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: TAP

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 28, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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