Recruiting

Preeclampsia Prevention

Sponsor:

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

Code:

NCT04783597

Conditions

High Risk Pregnancy

Arterial Stiffness

Pre-Eclampsia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Arterial Stiffness and Wave Reflection

Study Details

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

Study ID

NCT04783597

Start date

Jul 12, 2021

Status verified date

Apr, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • >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

Study Design

Enrollment

2400 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Diagnosis of pre-eclampsia [ Time Frame: up to 6 weeks post-partum (after delivery) ]

Central Contacts and Locations

Central contacts

Locations

Royal Victoria Hospital

Recruiting

Montreal, Quebec, Canada, H3A 1A1

Principal Investigator:

Stella S Daskalopoulou, MD, PhD

More Information

Sponsor

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

Last update posted

Apr 18, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2025-04-18.