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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Arterial Stiffness and Wave Reflection

    Diagnostic test

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
up to 6 weeks post-partum (after delivery)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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