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N Engl J Med. 2016 Jan 7;374(1):13-22. doi: 10.1056/NEJMoa1414838.

Predictive Value of the sFlt-1:PlGF Ratio in Women with Suspected Preeclampsia.

Author information

1
From the Department of Obstetrics and Gynecology, Medical University Vienna, Vienna (H.Z.); the Department of Obstetrics, Maternal-Fetal Medicine Unit, Hospital Universitari Vall d'Hebron, Barcelona, and the Maternal and Child Health and Development Network, Instituto de Salud Carlos III, Madrid (E.L.); the Department of Obstetrics and Gynecology, University of Liege, Liege, Belgium (F.C.); Nuffield Department of Obstetrics and Gynaecology, University of Oxford, Oxford, United Kingdom (M.V.); the Departments of Gynecology and Obstetrics, Oslo University Hospital, and University of Oslo, Oslo (A.C.S.); the Department of Women's and Children's Health, Karolinska University Hospital, and Karolinska Institute, Stockholm (M. Sennström), and the Department of Women's and Children's Health, Uppsala University, Uppsala (M.O.) - both in Sweden; Pregnancy Research Centre, Department of Perinatal Medicine, Royal Women's Hospital and Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, VIC, Australia (S.P.B.); the Department of Obstetrics, University of Leipzig, Leipzig (H.S.), Roche Diagnostics, Penzberg (P.D., M. Schoedl), and the Department of Obstetrics, Campus Virchow-Klinikum Charité, Berlin (S.V.) - all in Germany; and Roche Diagnostics International, Rotkreuz, Switzerland (D.A., M.H.).

Abstract

BACKGROUND:

The ratio of soluble fms-like tyrosine kinase 1 (sFlt-1) to placental growth factor (PlGF) is elevated in pregnant women before the clinical onset of preeclampsia, but its predictive value in women with suspected preeclampsia is unclear.

METHODS:

We performed a prospective, multicenter, observational study to derive and validate a ratio of serum sFlt-1 to PlGF that would be predictive of the absence or presence of preeclampsia in the short term in women with singleton pregnancies in whom preeclampsia was suspected (24 weeks 0 days to 36 weeks 6 days of gestation). Primary objectives were to assess whether low sFlt-1:PlGF ratios (at or below a derived cutoff) predict the absence of preeclampsia within 1 week after the first visit and whether high ratios (above the cutoff) predict the presence of preeclampsia within 4 weeks.

RESULTS:

In the development cohort (500 women), we identified an sFlt-1:PlGF ratio cutoff of 38 as having important predictive value. In a subsequent validation study among an additional 550 women, an sFlt-1:PlGF ratio of 38 or lower had a negative predictive value (i.e., no preeclampsia in the subsequent week) of 99.3% (95% confidence interval [CI], 97.9 to 99.9), with 80.0% sensitivity (95% CI, 51.9 to 95.7) and 78.3% specificity (95% CI, 74.6 to 81.7). The positive predictive value of an sFlt-1:PlGF ratio above 38 for a diagnosis of preeclampsia within 4 weeks was 36.7% (95% CI, 28.4 to 45.7), with 66.2% sensitivity (95% CI, 54.0 to 77.0) and 83.1% specificity (95% CI, 79.4 to 86.3).

CONCLUSIONS:

An sFlt-1:PlGF ratio of 38 or lower can be used to predict the short-term absence of preeclampsia in women in whom the syndrome is suspected clinically. (Funded by Roche Diagnostics.).

PMID:
26735990
DOI:
10.1056/NEJMoa1414838
[Indexed for MEDLINE]
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