Treatment With Aspirin After Preeclampsia: TAP Trial
- Conditions
- Hypertension;Pre-EclampticHypertensive Disorder of PregnancyPre-EclampsiaGestational HypertensionCardiovascular DiseasesToxemiaPregnancy ComplicationsHypertension, Pregnancy InducedEclampsiaVascular Diseases
- Interventions
- Drug: Placebo
- Registration Number
- NCT06281665
- Lead Sponsor
- Alisse Hauspurg
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- Postpartum individuals ≥18 years old
- Preeclampsia diagnosis
- Fetal anomaly
- Multiple gestation
- Pre-pregnancy hypertension
- Allergy or contraindication to low-dose aspirin
- Pre-pregnancy diabetes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Group Placebo Similar appearing placebo pill daily for 6 months will be given to subjects. Intervention Group Low-dose aspirin Low-dose \[81 mg\] aspirin pill daily for 6 months will be given to subjects
- Primary Outcome Measures
Name Time Method Percent of participants eligible, enrolled and retained (feasibility) 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 Outcome Measures
Name Time Method Mean daytime mean arterial pressure 6 months postpartum Mean daytime mean arterial pressure on ambulatory blood pressure monitoring
Mean overall systolic blood pressure 6 months postpartum Mean overall systolic blood pressure on ambulatory blood pressure monitoring
Mean overall diastolic blood pressure 6 months postpartum Mean overall diastolic blood pressure on ambulatory blood pressure monitoring
Endothelial function Emax 6 months postpartum Emax from microiontophoresis
Endothelial function change in EC50% 2 to 6 months postpartum Change in EC50% between visits
Change in systolic blood pressure 2 to 6 months postpartum Change in study visit mean systolic blood pressure between visits
Study visit diastolic BP 6 months postpartum Mean study visit diastolic BP
Study visit systolic BP 6 months postpartum Mean study visit systolic BP
Endothelial function EC50% 6 months postpartum EC50% from microiontophoresis
Change in diastolic blood pressure 2 to 6 months postpartum Change in study visit mean diastolic blood pressure between visits
Change in mean arterial pressure 2 to 6 months postpartum Change in study visit mean arterial pressure between visits
Anti-hypertensive medication use 6 months postpartum Use of anti-hypertensive medication (percent of participants)
Therapeutic intensity score 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)
Mean home diastolic blood pressure delivery through 6 months postpartum Mean home diastolic blood pressure
Mean home mean arterial pressure delivery through 6 months postpartum Mean home mean arterial pressure
Study visit mean arterial pressure 6 months postpartum Mean study visit mean arterial pressure ((2\*diastolic BP + systolic BP / 3))
Mean nocturnal systolic blood pressure 6 months postpartum Mean nocturnal systolic blood pressure on ambulatory blood pressure monitoring
Mean daytime diastolic blood pressure 6 months postpartum Mean daytime diastolic blood pressure on ambulatory blood pressure monitoring
Classification of hypertension 6 months postpartum Stage 1, stage 2 hypertension (percent of participants with each stage)
Mean home systolic blood pressure delivery through 6 months postpartum Mean home systolic blood pressure
Mean overall mean arterial pressure 6 months postpartum Mean overall mean arterial pressure on ambulatory blood pressure monitoring
Mean daytime systolic blood pressure 6 months postpartum Mean daytime systolic blood pressure on ambulatory blood pressure monitoring
Mean nocturnal diastolic blood pressure 6 months postpartum Mean nocturnal diastolic blood pressure on ambulatory blood pressure monitoring
Mean nocturnal mean arterial pressure 6 months postpartum Mean nocturnal mean arterial pressure on ambulatory blood pressure monitoring
Endothelial function change in Emax 2 to 6 months postpartum Change in Emax between visits
Trial Locations
- Locations (1)
University of Pittsburgh Magee-Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States