Aspirin Dosing in Pregnancy
Aspirin Dosing and Platelet Phenotype in Pregnancy
1 other identifier
interventional
30
1 country
1
Brief 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. Blood samples will be collected approximately 4 weeks after initiation of aspirin to evaluate the platelet phenotype during pregnancy in patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2026
CompletedFirst Posted
Study publicly available on registry
April 13, 2026
CompletedStudy Start
First participant enrolled
April 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 20, 2028
April 13, 2026
April 1, 2026
1.3 years
April 1, 2026
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measures of platelet aggregation assessed by Light Transmission Aggregometry (LTA)
Baseline, 4 weeks after initiation of aspirin
Secondary Outcomes (6)
Change in serum thromboxane
Baseline, 4 weeks after initiation of aspirin
Change in complete blood count
Baseline, 4 weeks after initiation of aspirin
Change in Mean Platelet Volume (MPV)
Baseline, 4 weeks after initiation of aspirin
Change in Platelet Distribution Width (PDW)
Baseline, 4 weeks after initiation of aspirin
Change in Plateletcrit (PCT)
Baseline, 4 weeks after initiation of aspirin
- +1 more secondary outcomes
Study Arms (1)
Twice daily dosing of Aspirin
EXPERIMENTALParticipants 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.
Interventions
81mg twice a day (162mg total)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina A. Penfield, MD, MPH
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2026
First Posted
April 13, 2026
Study Start
April 15, 2026
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
February 20, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to lucia.muzzarelli@nyulangone.org To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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.