Pre-eclampsia affects approximately 2–5% of pregnancies and can lead to significant maternal and fetal morbidity and mortality. Current clinical practice often results in precautionary hospital admissions and intensive monitoring for women with suspected pre-eclampsia, many of which are ultimately unnecessary. This contributes to substantial healthcare utilization and patient burden.
The PREPARE II study evaluates whether a risk-stratified care approach—based on the angiogenic biomarker ratio sFlt-1/PlGF (from maternal blood) in combination with the urinary protein/creatinine ratio—can safely reduce hospital admissions and outpatient consultations in this population.
Pregnant individuals presenting with clinical suspicion of pre-eclampsia between 20 and 37 weeks of gestation are randomly allocated to either standard care or an intervention arm in which clinical management is guided by test results. In the intervention group, care is stratified based on estimated risk:
Low risk: routine antenatal care without additional surveillance;
Intermediate risk: home blood pressure monitoring and one additional outpatient visit;
High risk: immediate hospital admission for close monitoring.
A total of 470 participants will be enrolled across six Dutch hospitals. In addition to assessing maternal and perinatal outcomes, the study will evaluate health-related quality of life, patient-reported experience measures, and the cost-effectiveness of the risk-based strategy.