A Phase 4 interventional study of Low-dose aspirin and Placebo in Hypertensive Disorder of Pregnancy, Pre-Eclampsia and Hypertension, sponsored by Malamo Countouris. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Malamo Countouris · Phase 4, Interventional, and Other
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.
18 studies on the registry are indexed under Toxemia; 7 are open to participants now.
This study's planned enrollment of 60 is below the median of 81 across 12 interventional studies indexed under Toxemia.
Browse Toxemia studies →This is the only study on the registry with Malamo Countouris as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Similar appearing placebo pill daily for 6 months will be given to subjects.
Drug: Placebo
Low-dose \[81 mg\] aspirin pill daily for 6 months will be given to subjects
Drug: Low-dose aspirin
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.
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
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
Plan to share: Yes — Deidentified data (including data dictionaries) will be shared at the discretion of the primary investigator. Data will include blood pressure, weight, demographics, physical activity, and pregnancy related information. Additional documents (such as the study protocol) will be made available.
Supporting information: Study protocol
Time frame: Within a year after outcomes are published and no later than 3 years after the end of clinical activities.
Access criteria: NHLBI data repository request process
Data sharing details ↗ · biolincc.nhlbi.nih.gov
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for Jan 2027, 31 months after the start.
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Studies of the drug tested here: Aspirin