Platelets in Pregnancy

Pregnancy Outcomes and Platelet PhenotYpes (POPPY)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06194643

Enrollment

Registered

2024-01-08

Start date

2023-01-17

Completion date

2025-07-01

Last updated

2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertensive Disorder of Pregnancy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame
Number of Individuals with Overactive Platelets	Blood Draw 1 (taken between Weeks 6 and 14)

Secondary

Measure	Time frame
Incidence of Adverse Pregnancy Outcomes	Day 30 Post-Delivery (Up to Month 11)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORChristina A. Penfield, MD, MPH

NYU Langone Health

Outcome results