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This is a prospective observational cohort study of platelet phenotype in pregnant patients at high-risk for the development preeclampsia. Blood samples will be collected prior to the initiation of daily aspirin and again in the second trimester to evaluate for platelet changes during pregnancy in patient's as a result of aspirin use and their association with adverse perinatal outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant people at high risk of preeclampsia (case group) | Investigators will collect a sample of blood (up to 50ml) at the time of a previously scheduled visit as part of routine prenatal care. Platelet phenotyping, measuring platelet activity, and the platelet transcriptome will be performed on samples. Plasma, serum, whole blood RNA and DNA will be collected. | ||
| Pregnant people at low risk of preeclampsia (control group) | Investigators will collect a sample of blood (up to 50ml) at the time of a previously scheduled visit as part of routine prenatal care. Platelet phenotyping, measuring platelet activity, and the platelet transcriptome will be performed on samples. Plasma, serum, whole blood RNA and DNA will be collected. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Individuals with Overactive Platelets | Blood Draw 1 (taken between Weeks 6 and 14) | |
| Number of Individuals with Overactive Platelets | Blood Draw 2 (taken between Weeks 24 and 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Pregnancy Outcomes | Day 30 Post-Delivery (Up to Month 11) |
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Inclusion Criteria (Case Group):
Inclusion Criteria (Control Group):
Exclusion Criteria (Case and Control Group):
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Pregnant people at high and low risk of preeclampsia and other adverse perinatal outcomes.
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| Name | Affiliation | Role |
|---|---|---|
| Christina A. Penfield, MD, MPH | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the primary results reported in this article, after deidentification (text, tables, figures, and appendices), will be shared with investigators who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Data sharing will begin 9 months and end 36 months following article publication or as required by a condition of awards and agreements supporting the research. Requestors must execute a data use agreement with NYU Langone Health. Requests may be directed to: christina.penfield@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Data will be shared with investigators who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Requests should be directed to christina.penfield@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D014115 | Toxemia |
| ID | Term |
|---|---|
| D007239 | Infections |
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Plasma, serum, whole blood RNA and DNA will be collected.