Early Prediction of preeclampsia Using arterial Stiffness
Research type
Research Study
Full title
Early Prediction of preeclampsia Using arteriaL Stiffness in high-risk prEgnancies; a multinational study (PULSE)
IRAS ID
299861
Contact name
Christian Delles
Contact email
Sponsor organisation
Research Institute of the McGill University Health Centre
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Despite advances in obstetric care, preeclampsia (PE), a hypertensive syndrome of pregnancy, still represents a leading cause of maternal death. Occurring in 5-8% of pregnancies annually worldwide, PE can implicate multiple organ systems and contributes to 70,000 maternal deaths yearly. PE is associated with fetal risks, including impaired growth, preterm birth, and stillbirth, and accounts for about 500,000 fetal deaths annually worldwide.
Accurate early prediction of PE would lead to better risk stratification, sparing women who are not destined to develop PE from intense monitoring and overtreatment. Improved PE prediction would help design appropriate early care plans, including introduction of aspirin before 16 weeks’ gestation, monitoring, time of delivery, and would allow more efficient allocation of healthcare resources.
Existing predictive tools, including clinical characteristics, blood pressure, blood biomarkers, and uterine artery Doppler (UAD), have at best moderate predictive properties, and currently there are no accurate predictive tools in clinical practice. Herein, we introduce arterial stiffness, a composite indicator of vascular dysfunction, as a potential predictor for PE that may improve the predictive performance of the above existing tools. PULSE’s (early Prediction of preeclampsia Using Arterial Stiffness in high-risk prEgnancies) overarching aim is to evaluate the ability of arterial stiffness to predict the development of PE, alone or in combination with existing tools, in high-risk women with a singleton pregnancy.
This multi-national 3-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 will involve vascular measurements, 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.
REC name
West of Scotland REC 4
REC reference
21/WS/0159
Date of REC Opinion
25 Jan 2022
REC opinion
Further Information Favourable Opinion