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Randomized Interventional Study on Prediction of Preeclampsia/Eclampsia in Women With Suspected Preeclampsia: INSPIRE.

Cerdeira, AS; O'Sullivan, J; Ohuma, EO; Harrington, D; Szafranski, P; Black, R; Mackillop, L; Impey, L; Greenwood, C; James, T; et al. Cerdeira, AS; O'Sullivan, J; Ohuma, EO; Harrington, D; Szafranski, P; Black, R; Mackillop, L; Impey, L; Greenwood, C; James, T; Smith, I; Papageorghiou, AT; Knight, M; Vatish, M (2019) Randomized Interventional Study on Prediction of Preeclampsia/Eclampsia in Women With Suspected Preeclampsia: INSPIRE. Hypertension, 74 (4). pp. 983-990. ISSN 1524-4563 https://doi.org/10.1161/HYPERTENSIONAHA.119.12739
SGUL Authors: Papageorghiou, Aris

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Abstract

The ratio of maternal serum sFlt-1 (soluble fms-like tyrosine kinase 1) to PlGF (placental growth factor) has been used retrospectively to rule out the occurrence of preeclampsia, a pregnancy hypertensive disorder, within 7 days in women presenting with clinical suspicion of preeclampsia. A prospective, interventional, parallel-group, randomized clinical trial evaluated the use of sFlt-1/PlGF ratio in women presenting with suspected preeclampsia. Women were assigned to reveal (sFlt-1/PlGF result known to clinicians) or nonreveal (result unknown) arms. A ratio cutoff of 38 was used to define low (≤38) and elevated risk (>38) of developing the condition in the subsequent week. The primary end point was hospitalization within 24 hours of the test. Secondary end points were development of preeclampsia and other adverse maternal-fetal outcomes. We recruited 370 women (186 reveal versus 184 nonreveal). Preeclampsia occurred in 85 women (23%). The number of admissions was not significantly different between groups (n=48 nonreveal versus n=60 reveal; P=0.192). The reveal trial arm admitted 100% of the cases that developed preeclampsia within 7 days, whereas the nonreveal admitted 83% (P=0.038). Use of the test yielded a sensitivity of 100% (95% CI, 85.8-100) and a negative predictive value of 100% (95% CI, 97.1-100) compared with a sensitivity of 83.3 (95% CI, 58.6-96.4) and negative predictive value of 97.8 (95% CI, 93.7-99.5) with clinical practice alone. Use of the sFlt-1/PlGF ratio significantly improved clinical precision without changing the admission rate. Clinical Trial Registration- URL: http://www.isrctn.com. Unique identifier: ISRCTN87470468.

Item Type: Article
Additional Information: © 2019 The Authors. Hypertension is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDerivs License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made.
Keywords: biomarkers, hospitalization, prediction, preeclampsia, pregnancy, women, biomarkers, hospitalization, prediction, preeclampsia, pregnancy, women, 1103 Clinical Sciences, 1102 Cardiovascular Medicine And Haematology, Cardiovascular System & Hematology
SGUL Research Institute / Research Centre: Academic Structure > Institute of Medical & Biomedical Education (IMBE)
Academic Structure > Institute of Medical & Biomedical Education (IMBE) > Centre for Clinical Education (INMECE )
Journal or Publication Title: Hypertension
ISSN: 1524-4563
Language: eng
Dates:
DateEvent
October 2019Published
12 August 2019Published Online
12 June 2019Accepted
Publisher License: Creative Commons: Attribution-Noncommercial-No Derivative Works 4.0
Projects:
Project IDFunderFunder ID
UNSPECIFIEDNational Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
PubMed ID: 31401877
Web of Science ID: WOS:000486010100035
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/111291
Publisher's version: https://doi.org/10.1161/HYPERTENSIONAHA.119.12739

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