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

NCT04783597 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2400

Last updated 2025-04-18

No results posted yet for this study

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.

Conditions

  • High Risk Pregnancy
  • Arterial Stiffness
  • Pre-Eclampsia

Interventions

DIAGNOSTIC_TEST

Arterial 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.

Sponsors & Collaborators

  • Université de Montréal

    collaborator OTHER
  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    collaborator OTHER
  • University of British Columbia

    collaborator OTHER
  • University of Glasgow

    collaborator OTHER
  • Laval University

    collaborator OTHER
  • Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

    collaborator OTHER_GOV
  • McGill University

    collaborator OTHER
  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Principal Investigators

  • Stella S Daskalopoulou, MD, PhD · Research Institute of the McGill University Health Centre

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2026-01-31
Completion
2027-01-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04783597 on ClinicalTrials.gov