Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04783597
Status:
RECRUITING
Last Update Posted:
2022-06-09
First Post:
2021-02-25
Brief Title:
Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies a Multinational Study PULSE
Status:
RECRUITING
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PULSE
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 70000 maternal and 500000 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 31-fold increased odds of developing hypertension and 23-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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None