NCT04783597 Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies
| NCT ID | NCT04783597 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | High Risk Pregnancy |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,400 participants |
| Start Date | 2021-07-12 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,400 participants in total. It began in 2021-07-12 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Stella S Daskalopoulou, MD, PhD
PRINCIPAL INVESTIGATOR
Research Institute of the McGill University Health Centre
Frequently Asked Questions
Who can join the NCT04783597 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying High Risk Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04783597 currently recruiting?
Yes, NCT04783597 is actively recruiting participants. Contact the research team at helena.papacostas@rimuhc.ca for enrollment information.
Where is the NCT04783597 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT04783597 clinical trial?
NCT04783597 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The principal investigator is Stella S Daskalopoulou, MD, PhD at Research Institute of the McGill University Health Centre. The trial plans to enroll 2,400 participants.