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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
60
The intervention group will receive low-dose \[81 mg\] aspirin pill daily for 6 months.
The control group will receive similar appearing placebo daily for 6 months.
University of Pittsburgh Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
RECRUITINGPercent 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
Study visit systolic BP
Mean study visit systolic BP
Time frame: 2 months postpartum
Study visit diastolic BP
Mean study visit diastolic BP
Time frame: 2 months postpartum
Study visit systolic BP
Mean study visit systolic BP
Time frame: 6 months postpartum
Study visit diastolic BP
Mean study visit diastolic BP
Time frame: 6 months postpartum
Study visit mean arterial pressure
Mean study visit mean arterial pressure ((2\*diastolic BP + systolic BP / 3))
Time frame: 2 months postpartum
Study visit mean arterial pressure
Mean study visit mean arterial pressure ((2\*diastolic BP + systolic BP / 3))
Time frame: 6 months postpartum
Anti-hypertensive medication use
Use of anti-hypertensive medication (percent of participants)
Time frame: 2 months postpartum
Anti-hypertensive medication use
Use of anti-hypertensive medication (percent of participants)
Time frame: 6 months postpartum
Therapeutic intensity score
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)
Time frame: 2 months postpartum
Therapeutic intensity score
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)
Time frame: 6 months postpartum
Mean home systolic blood pressure
Mean home systolic blood pressure
Time frame: delivery through 6 months postpartum
Mean home diastolic blood pressure
Mean home diastolic blood pressure
Time frame: delivery through 6 months postpartum
Mean home mean arterial pressure
Mean home mean arterial pressure
Time frame: delivery through 6 months postpartum
Mean daytime systolic blood pressure
Mean daytime systolic blood pressure on ambulatory blood pressure monitoring
Time frame: 6 months postpartum
Mean nocturnal systolic blood pressure
Mean nocturnal systolic blood pressure on ambulatory blood pressure monitoring
Time frame: 6 months postpartum
Mean daytime diastolic blood pressure
Mean daytime diastolic blood pressure on ambulatory blood pressure monitoring
Time frame: 6 months postpartum
Mean nocturnal diastolic blood pressure
Mean nocturnal diastolic blood pressure on ambulatory blood pressure monitoring
Time frame: 6 months postpartum
Mean nocturnal mean arterial pressure
Mean nocturnal mean arterial pressure on ambulatory blood pressure monitoring
Time frame: 6 months postpartum
Mean daytime mean arterial pressure
Mean daytime mean arterial pressure on ambulatory blood pressure monitoring
Time frame: 6 months postpartum
Mean overall mean arterial pressure
Mean overall mean arterial pressure on ambulatory blood pressure monitoring
Time frame: 6 months postpartum
Mean overall systolic blood pressure
Mean overall systolic blood pressure on ambulatory blood pressure monitoring
Time frame: 6 months postpartum
Mean overall diastolic blood pressure
Mean overall diastolic blood pressure on ambulatory blood pressure monitoring
Time frame: 6 months postpartum
Classification of hypertension
Stage 1, stage 2 hypertension (percent of participants with each stage)
Time frame: 2 months postpartum
Classification of hypertension
Stage 1, stage 2 hypertension (percent of participants with each stage)
Time frame: 6 months postpartum
Endothelial function EC50%
EC50% from microiontophoresis
Time frame: 2 months postpartum
Endothelial function EC50%
EC50% from microiontophoresis
Time frame: 6 months postpartum
Endothelial function Emax
Emax from microiontophoresis
Time frame: 2 months postpartum
Endothelial function Emax
Emax from microiontophoresis
Time frame: 6 months postpartum
Endothelial function change in Emax
Change in Emax between visits
Time frame: 2 to 6 months postpartum
Endothelial function change in EC50%
Change in EC50% between visits
Time frame: 2 to 6 months postpartum
Change in systolic blood pressure
Change in study visit mean systolic blood pressure between visits
Time frame: 2 to 6 months postpartum
Change in diastolic blood pressure
Change in study visit mean diastolic blood pressure between visits
Time frame: 2 to 6 months postpartum
Change in mean arterial pressure
Change in study visit mean arterial pressure between visits
Time frame: 2 to 6 months postpartum
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