PreeclampsiaEarly Phase 1NCT06168461
Daily Aspirin Treatment After Preeclampsia
A Early Phase 1 study testing Aspirin in people with Preeclampsia, run by Anna Stanhewicz, PhD at 1 site in United States.
Trial summary
Women who develop preeclampsia during pregnancy are four times more likely to develop cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs may be related to lasting blood vessel damage after the pregnancy but there are currently no specific treatment strategies to… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to Feb 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- had preeclampsia in the past 5 years,
- 18 years or older
Who cannot join
- current daily aspirin use,
- skin diseases,
- current tobacco or nicotine use (including vaping),
- diagnosed or suspected hepatic or metabolic disease including chronic kidney disease (CKD) defined as reduced eGFR < 60 mL/min/1.73m2,
- statin or other cholesterol-lowering medication,
- current antihypertensive medication,
Show all 13Show fewer
- history of hypertension prior to pregnancy,
- history of gestational diabetes,
- currently pregnancy,
- body mass index <18.5 kg/m2,
- allergy to materials used during the experiment.(e.g. latex),
- known allergies to study drugs,
- bleeding disorders, peptic ulcer disease, gastritis, GI bleeding and gastroesophageal reflux disease (GERD).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aspirin for the Treatment of Vascular Dysfunction After Preeclampsia
Women who develop preeclampsia during pregnancy are four times more likely to develop cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs may be related to lasting blood vessel damage after the pregnancy but there are currently no specific treatment strategies to prevent this disease progression. This study addresses this public health issue by examining whether starting low dose aspirin therapy after pregnancy is an effective treatment for lasting blood vessel damage in order to inform better clinical management of cardiovascular disease risk in women who have had preeclampsia.
- Conditions
- Preeclampsia
- Being tested
- Aspirin, Placebo
- Keywords
- preeclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
162mg aspirin capsule
PlaceboDrug
placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo pill taken once daily at bedtime for 12 weeks Receives: Drug: Placebo |
| aspirin | Experimental | 162mg aspirin taken once daily at bedtime for 12 weeks Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
magnitude of microvascular endothelial function
skin blood flow response to acetylcholine delivered via intradermal microdialysis
Measured: baseline, 12 weeks
magnitude of brachial artery endothelial function
brachial artery flow mediated dilation
Measured: baseline, 12 weeks
magnitude of microvascular endothelin-1 mediated constriction
skin blood flow response to endothelin-1 delivered via intradermal microdialysis
Measured: baseline, 12 weeks
Secondary outcomes (1)
magnitude of microvascular nitric oxide-dependent dilation
skin blood flow response to acetylcholine + L-NAME delivered via intradermal microdialysis
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Nov 2023
- Primary completion30 Jun 2026
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anna Stanhewicz, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Stanhewicz, PhD, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168461
- Sponsor's protocol ID
- 202303799
- Status last verified
- Oct 2026
- First submitted
- 13 Sep 2023
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin for the Treatment of Vascular Dysfunction After Preeclampsia
- ClinicalTrials.gov ID
- NCT06168461
- Acronym / sponsor ID
- 202303799
- Conditions
- Preeclampsia
- Keywords
- preeclampsia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Anna Stanhewicz, PhDUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women who develop preeclampsia during pregnancy are four times more likely to develop cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs may be related to lasting blood vessel damage after the pregnancy but there are currently no specific treatment strategies to prevent this disease progression. This study addresses this public health issue by examining whether starting low dose aspirin therapy after pregnancy is an effective treatment for lasting blood vessel damage in order to inform better clinical management of cardiovascular disease risk in women who have had preeclampsia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placeboplacebo pill taken once daily at bedtime for 12 weeks |
| aspirin | Experimental | Drug: Aspirin162mg aspirin taken once daily at bedtime for 12 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- had preeclampsia in the past 5 years,
- 18 years or older
Key exclusion criteria (13 listed)
- current daily aspirin use,
- skin diseases,
- current tobacco or nicotine use (including vaping),
- diagnosed or suspected hepatic or metabolic disease including chronic kidney disease (CKD) defined as reduced eGFR < 60 mL/min/1.73m2,
- statin or other cholesterol-lowering medication,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin162mg aspirin capsule | Drug | aspirin |
| Placeboplacebo capsule | Drug | placebo |
Primary outcome
magnitude of microvascular endothelial function
Time frame: baseline, 12 weeks
skin blood flow response to acetylcholine delivered via intradermal microdialysis
magnitude of brachial artery endothelial function
Time frame: baseline, 12 weeks
brachial artery flow mediated dilation
magnitude of microvascular endothelin-1 mediated constriction
Time frame: baseline, 12 weeks
skin blood flow response to endothelin-1 delivered via intradermal microdialysis
1 secondary outcome
magnitude of microvascular nitric oxide-dependent dilation
Time frame: baseline, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Related trials for Preeclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Aspirin in people with Preeclampsia, run by Anna Stanhewicz, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
magnitude of microvascular endothelial function (time frame: baseline, 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.