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NCT06194643 Clinical Trial

Platelets in Pregnancy

Hypertensive Disorder of Pregnancy Clinical Trial

Official title:
Pregnancy Outcomes and Platelet PhenotYpes (POPPY)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06194643
Other study ID # 22-01439
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 17, 2023
Est. completion date June 2025

Study information
Verified date December 2023
Source NYU Langone Health
Contact Christina A. Penfield, MD, MPH
Phone 646-754-2700
Email Christina.Penfield@nyulangone.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States NYU Langone Health New York New York

Sponsors (1)
Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Individuals with Overactive Platelets Blood Draw 1 (taken between Weeks 6 and 14)
Primary Number of Individuals with Overactive Platelets Blood Draw 2 (taken between Weeks 24 and 28)
Secondary Incidence of Adverse Pregnancy Outcomes Day 30 Post-Delivery (Up to Month 11)
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