Burnet Institute will be a trial implementing partner in the world’s largest trial study on the use of aspirin to prevent pre-eclampsia.
The PEARLS (Preventing pre-eclampsia: Evaluating AspiRin Low-dose regimens following risk Screening) trial is led by the international NGO Concept Foundation, funded by the Bill & Melinda Gates Foundation, and will be held in three African countries — Ghana, Kenya and South Africa — in collaboration with principal investigators from the University of Ghana, University of Nairobi, and University of Cape Town.
The study will strengthen pre-eclampsia screening for at-risk women and will also be the first study investigating blood loss quantitatively in pregnancy related to aspirin intake.
Pre-eclampsia is a leading cause of maternal and neonatal morbidity and mortality worldwide.
It can lead to high blood pressure, protein in the urine, and problems with the kidneys or liver which results from problems with the placenta. In turn, this can affect the blood supply to the pregnancy.
Ninety-nine per cent of all maternal deaths caused by hypertensive disorders, such as pre-eclampsia, occur in low- and middle- income countries (LMICs), and aspirin is a simple and cost-effective intervention to prevent this condition.
However, there are uncertainties about the optimal dose and whether doses in the upper range put pregnant women at risk of excessive bleeding.
Concept Foundation will work with Burnet and other top clinical and research institutions, comparing the effects of daily intake of two different doses of aspirin during pregnancy — 75 mg and 150mg.
A screening app developed by Tommy’s National Centre for Maternity Improvement, UK, is being adapted to identify eligible women at high risk of pre-eclampsia, using an algorithm that has been proven to be more specific and more sensitive than any existing screening checklists.
The existing algorithm and app user interface are being adjusted for use in the three LMICs, with varying health systems and levels of resources.
In addition, Concept Foundation is partnering with Intelligent Ultrasound to provide clinical sites with ultrasound devices that are equipped with software that uses artificial intelligence (AI) to estimate gestational age.
The study aims to advance evidence on pre-eclampsia prevention and inform policies so that women who are treated with aspirin to prevent pre-eclampsia receive a dose that is both effective and safe.
Results from the formative phase research are expected in early 2025, and results from the main trial are expected in early 2027.
This landmark trial is the first multi-country study of systematic pre-eclampsia risk screening in Africa, and will impact global recommendations on the dosage of aspirin for pre-eclampsia prevention.
This project is conducted in collaboration between Concept Foundation, Burnet Institute, University of Ghana, University of Nairobi, University of Cape Town, Nossal Institute for Global Health - University of Melbourne, Tommy’s National Centre for Maternity Improvement, and Intelligent Ultrasound, with the generous financial support of Bill & Melinda Gates Foundation.