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Recruiting NCT07525635

Aspirin Dosing in Pregnancy

Early Phase I Interventional Preeclampsia Possible

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aspirin.
Who it may be relevant to
Registry conditions: Preeclampsia Possible. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Aspirin Dosing and Platelet Phenotype in Pregnancy

Overview

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.

Interventions

  • Drug Aspirin
    81mg twice a day (162mg total)

Primary outcome measures

  • Measures of platelet aggregation assessed by Light Transmission Aggregometry (LTA) [Time frame: Baseline, 4 weeks after initiation of aspirin]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07525635 · 25-01684

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗