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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | 81mg twice a day (162mg total) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measures of platelet aggregation assessed by Light Transmission Aggregometry (LTA) | Baseline, 4 weeks after initiation of aspirin |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina A. Penfield, MD, MPH | Contact | 646-754-2700 | Christina.Penfield@nyulangone.org | |
| Lucia Muzzarelli | Contact | 646-754-2760 | Lucia.Muzzarelli@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Christina A. Penfield, MD, MPH | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| 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 |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |