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OpenTrials
Completed

NCT Number: NCT06194643

Platelets in Pregnancy

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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Key information

Conditions

Hypertensive Disorder of Pregnancy Infections Toxemia

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Individuals with Overactive Platelets

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

  2. Number of Individuals with Overactive Platelets

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

Secondary outcomes

  1. Incidence of Adverse Pregnancy Outcomes

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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Pregnancy Outcomes and Platelet PhenotYpes (POPPY)

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 8, 2024
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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