Predicting preeclampsia early using arterial stiffness in high-risk pregnancies
Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies; a Multinational Study (PULSE)
This study is testing a new way to spot early signs of preeclampsia in high-risk pregnancies by measuring how stiff blood vessels are, along with other tests, to help improve care for moms and babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2400 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT04783597 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve early detection of preeclampsia (PE) in high-risk pregnancies by utilizing a non-invasive test to measure arterial stiffness, alongside blood biomarkers and ultrasound imaging. The study will recruit 2400 participants across multiple sites in Canada, the US, and the UK, conducting assessments in both the first and second trimesters of pregnancy. By identifying early signs of PE, the study seeks to develop strategies for better management and prevention of this serious condition. The findings could lead to significant advancements in maternal health care.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women with singleton pregnancies who have at least one high-risk factor or two moderate-risk factors for preeclampsia.
Not a fit: Patients who are beyond 14 weeks gestation, have multiple pregnancies, or have a history of heart disease or infectious diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier identification and management of preeclampsia, potentially reducing maternal and fetal morbidity and mortality.
How similar studies have performed: Other studies have shown promise in using non-invasive measures for predicting preeclampsia, but this approach is among the most comprehensive and multi-national efforts to date.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montreal, Quebec
- Royal Victoria Hospital — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Stella S Daskalopoulou, MD, PhD — Research Institute of the McGill University Health Centre
- Study coordinator: Helena Papacostas, PhD
- Email: helena.papacostas@rimuhc.ca
- Phone: 514 934-1934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.