Abstract

ObjectiveTo evaluate the influence of the soluble fms-like tyrosine kinase 1/placental growth factor ratio in physicians’ decision making in pregnant women with signs and symptoms of preeclampsia in routine clinical practice.MethodsA multicenter, prospective, open, non-interventional study enrolled pregnant women presenting with preeclampsia signs and symptoms in several European perinatal care centers. Before the soluble fms-like tyrosine kinase 1/placental growth factor ratio result was known, physicians documented intended clinical procedures using an iPad® application (data locked/time stamped). After the result was available, clinical decisions were confirmed or revised and documented. An independent adjudication committee evaluated the appropriateness of decisions based on maternal/fetal outcomes. Clinician decision making with regard to hospitalization was the primary outcome.ResultsIn 16.9% of mothers (20/118) the hospitalization decision was changed after knowledge of the ratio. In 13 women (11.0%), the initial decision to hospitalize was changed to no hospitalization. In seven women (5.9%) the revised decision was hospitalization. All revised decisions were considered appropriate by the panel of adjudicators (McNemar test; p < 0.0001).ConclusionsThe use of the soluble fms-like tyrosine kinase 1/placental growth factor test influenced clinical decision making towards appropriate hospitalization in a considerable proportion of women with suspected preeclampsia. This is the first study to demonstrate the impact of angiogenic biomarkers on decision making in a routine clinical practice.

Highlights

  • Preeclampsia is a serious, multi-systemic disorder of pregnancy characterized by endothelial and placental dysfunction [1]

  • The use of the soluble fms-like tyrosine kinase 1/placental growth factor test influenced clinical decision making towards appropriate hospitalization in a considerable proportion of women with suspected preeclampsia

  • This is the first study to demonstrate the impact of angiogenic biomarkers on decision making in a routine clinical practice

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Summary

Introduction

Preeclampsia is a serious, multi-systemic disorder of pregnancy characterized by endothelial and placental dysfunction [1]. Preeclampsia affects 2–5% of all pregnancies, and is associated with maternal and fetal morbidity and mortality [2,3,4,5]. An imbalance of pro-angiogenic and anti-angiogenic factors in the maternal circulation has been demonstrated during preeclampsia, increased levels of the anti-angiogenic soluble fms-like tyrosine kinase 1 (sFlt-1), and reduced levels of proangiogenic placental growth factor (PlGF) [11,12]. A high ratio of sFlt-1/PlGF (a measure that reflects changes in both biomarkers) has been linked with preeclampsia, and has been demonstrated before its clinical onset [11,13,14,15,16]

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