Treatment With Aspirin After Preeclampsia: TAP Trial

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorMalamo Countouris

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Postpartum individuals ≥18 years old

Preeclampsia diagnosis

Disqualifiers

Fetal anomaly

Multiple gestation

Pre-pregnancy hypertension

Allergy or contraindication to low-dose aspirin

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Placebo GroupPlacebo comparator 1 intervention
Group B: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percent of participants eligible, enrolled and retained (feasibility)

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.

Time frame
Baseline to approximately 6 months postpartum

Secondary outcomes

1

Study visit systolic BP

Mean study visit systolic BP

Time frame
2 months postpartum
2

Study visit diastolic BP

Mean study visit diastolic BP

Time frame
2 months postpartum
3

Study visit systolic BP

Mean study visit systolic BP

Time frame
6 months postpartum
4

Study visit diastolic BP

Mean study visit diastolic BP

Time frame
6 months postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Malamo Countouris

Lead sponsor

University of Pittsburgh

Sponsor institution

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator