Platelets in Pregnancy
Pregnancy Outcomes and Platelet PhenotYpes (POPPY)
1 other identifier
observational
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 17, 2023
CompletedFirst Submitted
Initial submission to the registry
December 22, 2023
CompletedFirst Posted
Study publicly available on registry
January 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedSeptember 18, 2025
September 1, 2025
2 years
December 22, 2023
September 17, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Individuals with Overactive Platelets
Blood Draw 1 (taken between Weeks 6 and 14)
Number of Individuals with Overactive Platelets
Blood Draw 2 (taken between Weeks 24 and 28)
Secondary Outcomes (1)
Incidence of Adverse Pregnancy Outcomes
Day 30 Post-Delivery (Up to Month 11)
Study Arms (2)
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.
Eligibility Criteria
Pregnant people at high and low risk of preeclampsia and other adverse perinatal outcomes.
You may qualify if:
- 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)
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
Biospecimen
Plasma, serum, whole blood RNA and DNA will be collected.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina A. Penfield, MD, MPH
NYU Langone Health
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2023
First Posted
January 8, 2024
Study Start
January 17, 2023
Primary Completion
January 8, 2025
Study Completion
March 1, 2026
Last Updated
September 18, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- Data will be shared with investigators who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Requests should be directed to christina.penfield@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Individual participant data that underlie the primary results reported in this article, after deidentification (text, tables, figures, and appendices), will be shared with investigators who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Data sharing will begin 9 months and end 36 months following article publication or as required by a condition of awards and agreements supporting the research. Requestors must execute a data use agreement with NYU Langone Health. Requests may be directed to: christina.penfield@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.