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 volunteersQualifiers
Postpartum individuals ≥18 years old
Preeclampsia diagnosis
Disqualifiers
Fetal anomaly
Multiple gestation
Pre-pregnancy hypertension
Allergy or contraindication to low-dose aspirin
Trial design
Parallel
Treatments tested in this trial
Low-dose aspirin
DrugThe intervention group will receive low-dose \[81 mg\] aspirin pill daily for 6 months.
Placebo
DrugThe control group will receive similar appearing placebo daily for 6 months.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Study visit systolic BP
Mean study visit systolic BP
Study visit diastolic BP
Mean study visit diastolic BP
Study visit systolic BP
Mean study visit systolic BP
Study visit diastolic BP
Mean study visit diastolic BP
Sponsors and contacts
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Malamo Countouris
Lead sponsor
University of Pittsburgh
Sponsor institution
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator