Life sciences · Phase 4 Trial
ClinicalTrials.gov · September 22, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT06281665). This is a study registration, not published results. Lead sponsor: Malamo Countouris. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Hypertensive Disorder of Pregnancy, Pre-Eclampsia, Hypertension, Eclampsia, Gestational Hypertension, Cardiovascular Diseases, Toxemia, Pregnancy Complications, Vascular Diseases, Hypertension, Pregnancy Induced, Hypertension;Pre-Eclamptic. Interventions: DRUG: Low-dose aspirin; DRUG: Placebo. Primary outcome measures: Percent of participants eligible, enrolled and retained (feasibility) , Baseline to approximately 6 months postpartum. Brief 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.