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NCT Number: NCT04783597

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

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.

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Key information

Conditions

High Risk Pregnancy Arterial Stiffness Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location status: Recruiting

Location contact

Stella S Daskalopoulou, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

Existing predictive tools for preeclampsia (PE), including clinical characteristics, blood pressure, blood biomarkers, and uterine artery Doppler indices, have, at best, moderate predictive properties. While maternal symptoms often resolve with the delivery of the placenta, the burden of PE extends beyond pregnancy; afflicted women are at 3.1-fold increased odds of developing hypertension and 2.3-fold increased odds for cardiovascular disease later in life compared to women with uncomplicated pregnancies. Placental pathogenic changes associated with PE occur weeks to months before clinical manifestations develop, presenting a window of opportunity to identify early those women who will develop PE. The goal of the study investigators is to capitalize on this window and develop strategies for early prediction of PE.

As a composite measure of vascular health, measurement of arterial stiffness and wave reflection could represent a promising non-invasive tool for PE prediction. This multi-national 5-year observational prospective study aims to recruit 2400 participants across 8 sites in Canada, the US, and the UK. Participants will undergo 2 assessments, one in the first trimester (10 - 13 weeks gestation) and one in the second trimester (18 - 21 weeks gestation), which involve vascular measurements (arterial stiffness, blood pressure), blood sample collection, psychosocial and demographic questionnaires, and Uterine Artery Doppler imaging (only at second visit). Post-natal outcome measurements will be collected via medical charts for each participant 6-8 weeks post-partum. The primary objective of the study is to determine if, and to what extent, arterial stiffness and wave reflection parameters improve early prediction of PE beyond that achieved by currently available predictors in high-risk pregnancies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Diagnosis of pre-eclampsia

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Helena Papacostas, PhD

CONTACT

[email protected]

514 934-1934 ext. 42478

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
  • Laval University
  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
  • McGill University
  • University of British Columbia
  • University of Glasgow
  • Université de Montréal

Registry information

Official study title

Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies; a Multinational Study (PULSE)

Acronym: PULSE

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Mar 5, 2021
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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