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

Anna C.M. Kluivers; Rugina I. Neuman; Langeza Saleh; Henk Russcher; Ingrid A. Brussé; Jerome M.J. Cornette; Eric A.P. Steegers; Marijke C. Van Der Weide; Joris Van Drongelen; Ralph R. Scholten; Antonius E. Van Herwaarden; Sanne J. Gordijn; Anneke C. Muller Kobold; Wessel Ganzevoort; Sharon M. Wesselius; Maurits C.F.J. De Rotte; Robert Aardenburg; Maarten Raijmakers; Willy Visser; A. H.Jan Danser

doi:10.1161/HYPERTENSIONAHA.124.24386

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

Anna C.M. Kluivers
, Rugina I. Neuman
, Langeza Saleh
, Henk Russcher
, Ingrid A. Brussé
, Jerome M.J. Cornette
, Eric A.P. Steegers
, Marijke C. Van Der Weide
, Joris Van Drongelen
, Ralph R. Scholten
, Antonius E. Van Herwaarden
, Sanne J. Gordijn
, Anneke C. Muller Kobold
, Wessel Ganzevoort
, Sharon M. Wesselius
, Maurits C.F.J. De Rotte
, Robert Aardenburg
, Maarten Raijmakers
, Willy Visser
, A. H.Jan Danser^*

^*Corresponding author for this work

Reproductive Origins of Adult Health and Disease (ROAHD)

Research output: Contribution to journal › Article › Academic › peer-review

3 Citations (Scopus)

16 Downloads (Pure)

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.

Original language	English
Pages (from-to)	827-838
Number of pages	12
Journal	Hypertension
Volume	82
Issue number	5
DOIs	https://doi.org/10.1161/HYPERTENSIONAHA.124.24386
Publication status	Published - May-2025

Keywords

placental growth factor
pre-eclampsia
pregnancy
risk assessment
soluble fms-like tyrosine kinase-1

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Kluivers, A. C. M., Neuman, R. I., Saleh, L., Russcher, H., Brussé, I. A., Cornette, J. M. J., Steegers, E. A. P., Van Der Weide, M. C., Van Drongelen, J., Scholten, R. R., Van Herwaarden, A. E., Gordijn, S. J., Muller Kobold, A. C., Ganzevoort, W., Wesselius, S. M., De Rotte, M. C. F. J., Aardenburg, R., Raijmakers, M., Visser, W., & Danser, A. H. J. (2025). PRERISK Study: A Randomized Controlled Trial Evaluating a sFlt-1/PlGF-Based Calculator for Preeclampsia Hospitalization. Hypertension, 82(5), 827-838. https://doi.org/10.1161/HYPERTENSIONAHA.124.24386

@article{5c12c5b155cf4a198bfe47f2a891e962,

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

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.",

keywords = "placental growth factor, pre-eclampsia, pregnancy, risk assessment, soluble fms-like tyrosine kinase-1",

author = "Kluivers, \{Anna C.M.\} and Neuman, \{Rugina I.\} and Langeza Saleh and Henk Russcher and Bruss{\'e}, \{Ingrid A.\} and Cornette, \{Jerome M.J.\} and Steegers, \{Eric A.P.\} and \{Van Der Weide\}, \{Marijke C.\} and \{Van Drongelen\}, Joris and Scholten, \{Ralph R.\} and \{Van Herwaarden\}, \{Antonius E.\} and Gordijn, \{Sanne J.\} and \{Muller Kobold\}, \{Anneke C.\} and Wessel Ganzevoort and Wesselius, \{Sharon M.\} and \{De Rotte\}, \{Maurits C.F.J.\} and Robert Aardenburg and Maarten Raijmakers and Willy Visser and Danser, \{A. H.Jan\}",

note = "Publisher Copyright: {\textcopyright} 2025 The Authors. ",

year = "2025",

month = may,

doi = "10.1161/HYPERTENSIONAHA.124.24386",

language = "English",

volume = "82",

pages = "827--838",

journal = "Hypertension",

issn = "0194-911X",

publisher = "Lippincott Williams and Wilkins",

number = "5",

}

Kluivers, ACM, Neuman, RI, Saleh, L, Russcher, H, Brussé, IA, Cornette, JMJ, Steegers, EAP, Van Der Weide, MC, Van Drongelen, J, Scholten, RR, Van Herwaarden, AE, Gordijn, SJ , Muller Kobold, AC , Ganzevoort, W, Wesselius, SM, De Rotte, MCFJ, Aardenburg, R, Raijmakers, M, Visser, W & Danser, AHJ 2025, 'PRERISK Study: A Randomized Controlled Trial Evaluating a sFlt-1/PlGF-Based Calculator for Preeclampsia Hospitalization', Hypertension, vol. 82, no. 5, pp. 827-838. https://doi.org/10.1161/HYPERTENSIONAHA.124.24386

TY - JOUR

T1 - PRERISK Study

T2 - A Randomized Controlled Trial Evaluating a sFlt-1/PlGF-Based Calculator for Preeclampsia Hospitalization

AU - Kluivers, Anna C.M.

AU - Neuman, Rugina I.

AU - Saleh, Langeza

AU - Russcher, Henk

AU - Brussé, Ingrid A.

AU - Cornette, Jerome M.J.

AU - Steegers, Eric A.P.

AU - Van Der Weide, Marijke C.

AU - Van Drongelen, Joris

AU - Scholten, Ralph R.

AU - Van Herwaarden, Antonius E.

AU - Gordijn, Sanne J.

AU - Muller Kobold, Anneke C.

AU - Ganzevoort, Wessel

AU - Wesselius, Sharon M.

AU - De Rotte, Maurits C.F.J.

AU - Aardenburg, Robert

AU - Raijmakers, Maarten

AU - Visser, Willy

AU - Danser, A. H.Jan

PY - 2025/5

Y1 - 2025/5

N2 - 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.

AB - 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.

KW - placental growth factor

KW - pre-eclampsia

KW - pregnancy

KW - risk assessment

KW - soluble fms-like tyrosine kinase-1

UR - https://www.scopus.com/pages/publications/105003281292

U2 - 10.1161/HYPERTENSIONAHA.124.24386

DO - 10.1161/HYPERTENSIONAHA.124.24386

M3 - Article

C2 - 40238908

AN - SCOPUS:105003281292

SN - 0194-911X

VL - 82

SP - 827

EP - 838

JO - Hypertension

JF - Hypertension

IS - 5

ER -

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

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