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

NCT04783597 | Recruiting DMC

• 1 other identifier: MP-37-6854
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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

  up to 6 weeks post-partum (after delivery)

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women at high risk of developing preeclampsia

You may qualify if:

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

You may not qualify if:

• \>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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• 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

Study Sites (1)

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected from participants for serum and plasma biomarker analysis.

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Vascular Stiffness

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Stella S Daskalopoulou, MD, PhD

  Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helena Papacostas, PhD

CONTACT

514 934-1934; helena.papacostas@rimuhc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Department of Medicine, Division of Internal Medicine and Division of Experimental Medicine

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 5, 2021
• Study Start: July 12, 2021
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)