Pregnancy Outcomes and Platelet PhenotYpes (POPPY)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Number of Individuals with Overactive Platelets
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(Case Group):
- •Pregnant patients receiving prenatal care prior to 17 weeks at NYU Langone Health- Obstetrics & Gynecology Associates
- •Age 18-50 years
- •Singleton viable gestation
- •Pregnant patients at high risk of preeclampsia: Patients meeting USPSTF recommendation for low-dose aspirin (81 mg/day) prophylaxis for preeclampsia based on clinical risk factors (see below)
- •Inclusion Criteria (Control Group):
- •Pregnant patients receiving prenatal care prior to 17 weeks at NYU Langone Health- Obstetrics & Gynecology Associates
- •Age 18-50 years
- •Singleton viable gestation
- •Pregnant patients at low risk of preeclampsia: Patients who do not meet USPSTF recommendation for low-dose aspirin (81 mg/day) prophylaxis for preeclampsia based on clinical risk factors.
Exclusion Criteria
- •(Case and Control Group):
- •Allergy to aspirin
- •Antithrombotic or antiplatelet therapy
- •Anemia (hemoglobin <10 g/dl) or thrombocytopenia (Platelet count <100,000), or thrombocytosis (Platelet count >600)
- •Known hemorrhagic diathesis
- •Planned delivery outside of NYU
Arms & Interventions
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.
Outcomes
Primary Outcomes
Number of Individuals with Overactive Platelets
Time Frame: Blood Draw 2 (taken between Weeks 24 and 28)
Number of Individuals with Overactive Platelets
Time Frame: Blood Draw 1 (taken between Weeks 6 and 14)
Secondary Outcomes
- Incidence of Adverse Pregnancy Outcomes(Day 30 Post-Delivery (Up to Month 11))