Platelets in Pregnancy

Pregnancy Outcomes and Platelet PhenotYpes (POPPY)

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 Overview

• Status: Recruiting
• Conditions: Hypertensive Disorder of Pregnancy

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Christina A. Penfield, MD, MPH; Phone Number: 646-754-2700; Email: Christina.Penfield@nyulangone.org
• Study Contact Backup: Name: Valeryia Avtushka; Phone Number: 646-754-2760; Email: Valeryia.avtushka@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Pregnant people at high and low risk of preeclampsia and other adverse perinatal outcomes.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Christina A. Penfield, MD, MPH, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: December 22, 2023
• First Posted (Estimated): January 8, 2024

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Infections; Toxemia; Hypertension
• Other Study ID Numbers: 22-01439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No