Clinical trial NCT04783597: Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies
Official title: Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies; a Multinational Study (PULSE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: High Risk Pregnancy
Arterial Stiffness
Pre-Eclampsia
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Université de Montréal
name: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: University of British Columbia
name: University of Glasgow
name: Laval University
name: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
name: McGill University
First posted: 2021-03-05
Enrollment: 2400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women at high risk of developing preeclampsia

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnosis of pre-eclampsia
timeFrame: up to 6 weeks post-partum (after delivery)
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: Research Institute of the McGill University Health Centre
name: Stella S Daskalopoulou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: