Preeclampsia PossibleEarly Phase 1NCT07525635
Aspirin Dosing in Pregnancy
A Early Phase 1 study testing Aspirin in people with Preeclampsia Possible, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is assess platelet phenotypes based on aspirin dosing in pregnant patients at risk for the development preeclampsia who are taking 81mg twice a day aspirin. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preeclampsia Possible
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2026to 20 Feb 2028
- 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
- Pregnant people prior to 17 weeks
- Prenatal care at NYU Langone Health Obstetrics and Gynecology Associates
- Age 18-50 years
- Singleton viable gestation
- Pregnant patients at high risk of preeclampsia: Patients meeting USPSTF recommendation for aspirin prophylaxis for preeclampsia based on clinical risk factors.
Who cannot join
- Undergoing glucose challenge test (GCT) at time of blood draw
- Allergy or intolerance to aspirin
- Antithrombotic or antiplatelet therapy
- Anemia (hemoglobin <10 g/dl) or thrombocytopenia (platelet count <100,000), or thrombocytosis (platelet count >600,000)
- Known hemorrhagic diathesis
- Planned delivery outside of NYU
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Aspirin Dosing and Platelet Phenotype in Pregnancy
The purpose of this study is assess platelet phenotypes based on aspirin dosing in pregnant patients at risk for the development preeclampsia who are taking 81mg twice a day aspirin. Blood samples will be collected approximately 4 weeks after initiation of aspirin to evaluate the platelet phenotype during pregnancy in patients.
- Conditions
- Preeclampsia Possible
- Being tested
- Aspirin
- Keywords
- Asprin, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Acetylsalicylic acid
81mg twice a day (162mg total)
| Study group | Role | What they receive |
|---|---|---|
| Twice daily dosing of Aspirin | Experimental | Participants will take 81mg Aspirin orally, twice daily (162mg total) for 4 weeks and then return to the dosing regimen as prescribed by the discretion of their treating physician. Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of platelet aggregation assessed by Light Transmission Aggregometry (LTA)
Measured: Baseline, 4 weeks after initiation of aspirin
Secondary outcomes (6)
Change in serum thromboxane
Measured: Baseline, 4 weeks after initiation of aspirin
Change in complete blood count
Measured: Baseline, 4 weeks after initiation of aspirin
Change in Mean Platelet Volume (MPV)
Measured: Baseline, 4 weeks after initiation of aspirin
Change in Platelet Distribution Width (PDW)
Measured: Baseline, 4 weeks after initiation of aspirin
Change in Plateletcrit (PCT)
Measured: Baseline, 4 weeks after initiation of aspirin
Change in Life's Essential 8 questionnaire
Life's Essential 8 (LE8) is a cardiovascular health scoring system from the American Heart Association that rates health from 0 to 100 based on diet, activity, smoking, sleep, BMI, cholesterol, blood sugar, and blood pressure. Scores indicate high cardiovascular health, 50-79 is moderate, and below 50 is low. A score of 100 is ideal, while 0 represents the lowest health condition, such as severe, uncontrolled risk factors.
Measured: Baseline, 4 weeks after initiation of aspirin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start27 Apr 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion20 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia PossibleStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina A. Penfield, MD, MPH, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525635
- Sponsor's protocol ID
- 25-01684
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: lucia.muzzarelli@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin Dosing and Platelet Phenotype in Pregnancy
- ClinicalTrials.gov ID
- NCT07525635
- Acronym / sponsor ID
- 25-01684
- Conditions
- Preeclampsia Possible
- Keywords
- Asprin, Pregnancy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 20 Feb 2028 (estimated)
- First posted
- 13 Apr 2026 (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.
The purpose of this study is assess platelet phenotypes based on aspirin dosing in pregnant patients at risk for the development preeclampsia who are taking 81mg twice a day aspirin. Blood samples will be collected approximately 4 weeks after initiation of aspirin to evaluate the platelet phenotype during pregnancy in patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Twice daily dosing of Aspirin | Experimental | Drug: AspirinParticipants will take 81mg Aspirin orally, twice daily (162mg total) for 4 weeks and then return to the dosing regimen as prescribed by the discretion of their treating physician. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant people prior to 17 weeks
- Prenatal care at NYU Langone Health Obstetrics and Gynecology Associates
- Age 18-50 years
- Singleton viable gestation
- Pregnant patients at high risk of preeclampsia: Patients meeting USPSTF recommendation for aspirin prophylaxis for preeclampsia based on clinical risk factors.
Key exclusion criteria (6 listed)
- Undergoing glucose challenge test (GCT) at time of blood draw
- Allergy or intolerance to aspirin
- Antithrombotic or antiplatelet therapy
- Anemia (hemoglobin <10 g/dl) or thrombocytopenia (platelet count <100,000), or thrombocytosis (platelet count >600,000)
- Known hemorrhagic diathesis
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 |
|---|---|---|
| AspirinAlso: Acetylsalicylic acid81mg twice a day (162mg total) | Drug | Twice daily dosing of Aspirin |
Primary outcome
Measures of platelet aggregation assessed by Light Transmission Aggregometry (LTA)
Time frame: Baseline, 4 weeks after initiation of aspirin
6 secondary outcomes
Change in serum thromboxane
Time frame: Baseline, 4 weeks after initiation of aspirin
Change in complete blood count
Time frame: Baseline, 4 weeks after initiation of aspirin
Change in Mean Platelet Volume (MPV)
Time frame: Baseline, 4 weeks after initiation of aspirin
Change in Platelet Distribution Width (PDW)
Time frame: Baseline, 4 weeks after initiation of aspirin
Change in Plateletcrit (PCT)
Time frame: Baseline, 4 weeks after initiation of aspirin
Change in Life's Essential 8 questionnaire
Time frame: Baseline, 4 weeks after initiation of aspirin
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 18 May 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: lucia.muzzarelli@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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.
Christina A. Penfield, MD, MPH principal investigator
NYU Langone Health
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 Possible, run by NYU Langone Health 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 18 May 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. 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?
Contact Christina A. Penfield, MD, MPH (646-754-2700, Christina.Penfield@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measures of platelet aggregation assessed by Light Transmission Aggregometry (LTA) (time frame: Baseline, 4 weeks after initiation of aspirin). 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 18 May 2026.