About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Singleton pregnancy
Presence of at least 1 high-risk factor or 2 moderate-risk factors for pre-eclampsia
Disqualifiers
>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
Trial population
Pregnant women at high risk of developing preeclampsia
Trial design
Cohort
Prospective
Treatments tested in this trial
Arterial Stiffness and Wave Reflection
Diagnostic testArterial 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.
Treatment groups
Trial outcomes
Primary outcomes
Diagnosis of pre-eclampsia
According to the Society of Obstetricians and Gynaecologists (SOGC) guidelines, upon the presence of 2 criteria: 1) hypertension; chronic (pre-dating pregnancy or diagnosed \<20 weeks' gestation) or de novo/gestational (diagnosed ≥20 weeks') hypertension along with 2) de novo end-organ dysfunction
Sponsors and contacts
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McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead sponsor
Université de Montréal
Collaborator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborator
University of British Columbia
Collaborator
University of Glasgow
Collaborator
Laval University
Collaborator
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Collaborator
McGill University
Collaborator