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Randomized Controlled Trial
. 2025 May;82(5):827-838.
doi: 10.1161/HYPERTENSIONAHA.124.24386. Epub 2025 Apr 16.

PRERISK Study: A Randomized Controlled Trial Evaluating a sFlt-1/PlGF-Based Calculator for Preeclampsia Hospitalization

Anna C M Kluivers  1   2 , Rugina I Neuman  1 , Langeza Saleh  2 , Henk Russcher  3 , Ingrid A Brussé  2 , Jerome M J Cornette  2 , Eric A P Steegers  2 , Marijke C van der Weide  4 , Joris van Drongelen  5 , Ralph R Scholten  5 , Antonius E van Herwaarden  6 , Sanne J Gordijn  7 , Anneke C Muller Kobold  8 , Wessel Ganzevoort  4 , Sharon M Wesselius  4 , Maurits C F J de Rotte  9 , Robert Aardenburg  10 , Maarten Raijmakers  11 , Willy Visser  1 , A H Jan Danser  1
Affiliations
Randomized Controlled Trial

PRERISK Study: A Randomized Controlled Trial Evaluating a sFlt-1/PlGF-Based Calculator for Preeclampsia Hospitalization

Anna C M Kluivers et al. Hypertension. 2025 May.

Abstract

Background: A model based on the soluble Fms-like tyrosine kinase-1/placental growth factor ratio, gestational age, and the urinary protein-to-creatinine ratio (PRERISK calculator) has been developed to predict preeclampsia-related maternal-fetal complications. Here, we tested whether this model can reduce hospital admissions without increasing complication rates among women with suspected or confirmed preeclampsia.

Methods: In this multicenter, open-label, randomized controlled trial conducted at 5 Dutch medical centers, women with suspected or confirmed preeclampsia were randomly assigned to the intervention group, where admission was guided by the PRERISK score using a 5% cutoff, or to the control group receiving routine care with a concealed PRERISK score. Two co-primary outcomes were the incidence of maternal-fetal preeclampsia-related complications (noninferiority) and the proportion of women with a hospitalization ratio (=admission days/inclusion days) ≤0.05 (superiority).

Results: The intervention and control groups included 442 and 435 women, respectively. In the intention-to-treat analysis, complications occurred in 41.6% of the intervention group versus 39.5% of the control group (adjusted relative risk 1.06 [95% CI, 0.92-1.22]; P=0.43). The proportion of women achieving a hospitalization ratio ≤0.05 was 23.6% in the intervention group and 26.3% in the control group (adjusted relative risk, 0.89 [95% CI, 0.71-1.13]; P=0.34). The latter was comparable in the per-protocol analysis (adjusted relative risk, 0.87 [95% CI, 0.64-1.19]; P=0.38), while in this analysis, complications occurred in 47.8% of the intervention group (n=251) versus 41.7% of the control group (n=365; adjusted relative risk 1.19 [95% CI, 1.03-1.38]; P=0.02).

Conclusions: Routine screening with the PRERISK score and a 5% cutoff in patients with suspected or confirmed preeclampsia does not decrease hospitalization and is therefore not recommended.

Registration: URL: https://onderzoekmetmensen.nl/nl/trial/48687; Unique identifier: NL63386.078.17, NL-OMON48687.

Keywords: placental growth factor; pre-eclampsia; pregnancy; risk assessment; soluble fms-like tyrosine kinase-1.

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Conflict of interest statement

None.

Figures

Figure 1.
Figure 1.
CONSORT (Consolidated Standards of Reporting Trials) flowchart recruitment of participants.
Figure 2.
Figure 2.
Sensitivity and specificity (area under the curve [AUC]) for PRERISK study compared with soluble Fms-like tyrosine kinase-1 (sFlt-1)/proangiogenic placental growth factor (PlGF) ratio for composite preeclampsia-related complications within 1 week (left) and for the remaining pregnancy (right). The blue line depicts the PRERISK score, the green line depicts the sFlt-1/PlGF ratio, the red line depicts the reference line.
See this image and copyright information in PMC

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