Aspirin Dosing in Pregnancy

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.

Study Overview

• Status: Recruiting
• Conditions: Preeclampsia Possible
• Intervention / Treatment: Drug: Aspirin

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Christina A. Penfield, MD, MPH; Phone Number: 646-754-2700; Email: Christina.Penfield@nyulangone.org
• Study Contact Backup: Name: Lucia Muzzarelli; Phone Number: 646-754-2760; Email: Lucia.Muzzarelli@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Twice daily dosing of Aspirin; 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.	Drug: Aspirin; 81mg twice a day (162mg total); Other Names: Acetylsalicylic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measures of platelet aggregation assessed by Light Transmission Aggregometry (LTA)	Baseline, 4 weeks after initiation of aspirin

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	Baseline, 4 weeks after initiation of aspirin

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Christina A. Penfield, MD, MPH, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 20, 2028

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Asprin
• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Salicylates; Hydroxybenzoates; Aspirin
• Other Study ID Numbers: 25-01684

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes