High Risk PregnancyPULSENCT04783597
Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies
An observational study of High Risk Pregnancy and Arterial Stiffness, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High Risk Pregnancy, Arterial Stiffness, Pre-Eclampsia
- What is being tested?
- Arterial Stiffness and Wave Reflection
- How many people
- 2,400 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jul 2021to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women at high risk of developing preeclampsia
Who may be able to join
- Singleton pregnancy
- Presence of at least 1 high-risk factor or 2 moderate-risk factors for pre-eclampsia
Who cannot join
- >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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Stella S Daskalopoulou, MD, PhD
About this study
Official title: Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies; a Multinational Study (PULSE)
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.
Read the 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.
- Conditions
- High Risk Pregnancy, Arterial Stiffness, Pre-Eclampsia
- Being tested
- Arterial Stiffness and Wave Reflection
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial Stiffness and Wave ReflectionDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of pre-eclampsia
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
Measured: up to 6 weeks post-partum (after delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start12 Jul 2021
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk PregnancyStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, University of British Columbia, University of Glasgow, Laval University, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes, McGill University
- Responsible party
- Principal investigator, Dr. Stella Daskalopoulou, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Stella S Daskalopoulou, MD, PhD, Principal investigator, Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783597
- Sponsor's protocol ID
- MP-37-6854
- Acronym
- PULSE
- Status last verified
- Apr 2025
- First submitted
- 25 Feb 2021
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies; a Multinational Study (PULSE)
- ClinicalTrials.gov ID
- NCT04783597
- Acronym / sponsor ID
- PULSE / MP-37-6854
- Conditions
- High Risk Pregnancy, Arterial Stiffness, Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Université de Montréal, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, University of British Columbia, University of Glasgow, Laval University, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes, McGill University
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women at high risk of developing preeclampsia
Key inclusion criteria (2 listed)
- Singleton pregnancy
- Presence of at least 1 high-risk factor or 2 moderate-risk factors for pre-eclampsia
Key exclusion criteria (4 listed)
- >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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial Stiffness and Wave ReflectionArterial 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. | Diagnostic test | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stella S Daskalopoulou, MD, PhD principal investigator
Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Risk Pregnancy and Arterial Stiffness, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helena Papacostas, PhD (514 934-1934 ext. 42478, helena.papacostas@rimuhc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of pre-eclampsia (time frame: up to 6 weeks post-partum (after delivery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.