RecruitingNCT04783597

Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies

Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies; a Multinational Study (PULSE)


Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrollment

2,400 participants

Start Date

Jul 12, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

Despite advances in obstetric care, preeclampsia (PE) remains the leading cause of maternal death and disability in both developed and developing countries, contributing to over 70,000 maternal and 500,000 fetal deaths annually worldwide. PULSE was designed using a preventative medicine approach, focusing on improving early detection of PE as opposed to managing symptoms after onset. The study aims to uncover the earliest possible signs of PE using a combination of novel clinical tools and established diagnostic techniques to better identify, track, and manage high risk pregnant women. Specifically, PULSE will be examining the incorporation of a non-invasive test for the measurement of arterial stiffness, which has been shown to be predictive of hypertensive disorders. This test, in combination with a wide range of blood biomarkers, detailed ultrasound imaging, and a comprehensive battery of physical and mental health questionnaires, represents the largest, most comprehensive preventative PE study to date. The results of this work has the potential to revolutionize the way PE and other hypertensive disorders of pregnancy are managed and treated and can serve to inform the design of future preventative clinical research studies.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria2

  • Singleton pregnancy
  • Presence of at least 1 high-risk factor or 2 moderate-risk factors for pre-eclampsia

Exclusion Criteria4

  • \>14 weeks gestation
  • Multiple pregnancy
  • History of heart disease, stroke, or peripheral arterial disease
  • Infectious diseases/conditions, such as Hepatitis B/C, HIV, and COVID19

Interventions

DIAGNOSTIC_TESTArterial Stiffness and Wave Reflection

Arterial stiffness and wave refection, a non-invasive test, will be collected and combined with standard clinical markers (blood biomarkers, ultrasound imaging) as well as medical and psychosocial questionnaires in order to test a comprehensive, multi-marker approach for pre-eclampsia prediction in high risk pregnant women.


Locations(1)

Royal Victoria Hospital

Montreal, Quebec, Canada

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NCT04783597


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