Platelets in Pregnancy

N/AActive Not RecruitingNCT06194643

NYU Langone Health66 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hypertensive Disorder of Pregnancy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

Number of Individuals with Overactive Platelets

Time frame: Blood Draw 1 (taken between Weeks 6 and 14)

Number of Individuals with Overactive Platelets

Time frame: Blood Draw 2 (taken between Weeks 24 and 28)

Secondary Outcomes

Incidence of Adverse Pregnancy Outcomes

Time frame: Day 30 Post-Delivery (Up to Month 11)

Data from ClinicalTrials.gov

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