Ultrasound Obstet Gynecol. 2023 Jun 17. doi: 10.1002/uog.26291. Online ahead of print.
ABSTRACT
OBJECTIVE: To compare the performance at 35+0 to 36+6 weeks’ gestation of screening for delivery with pre-eclampsia (PE) at various time points, using one of three approaches: placental growth factor (PlGF) concentration, the soluble fms-like tyrosine kinase-1 (sFLT-1) to PlGF concentration ratio, or the competing risks model, which combines maternal risk factors with biomarkers to estimate patient-specific risk.
METHODS: This was a prospective observational study in women attending for a routine hospital visit at 35+0 to 36+6 weeks’ gestation in two maternity hospitals in England (2016-22). The visits included recording of maternal demographic characteristics and medical history, and measurement of serum PlGF, serum sFLT-1, and mean arterial pressure (MAP). The detection rates (DRs) were evaluated for delivery with PE (by 2019 American College of Obstetricians and Gynecologists criteria), within 1 week, within 2 weeks, or at any time after screening, using either: (i) low PlGF (<10th percentile), (ii) high sFLT-1/PlGF ratio (>90th percentile), or (iii) the competing risks model, using a combination of maternal factors and multiple of the median (MoM) values of PlGF (‘single’ test), PlGF and sFLT-1 (‘double’ test), or PlGF, sFLT-1 and MAP (‘triple’ test). Risk cut-offs corresponded to a screen-positive rate of 10%. DRs were compared between tests by McNemar’s test, with p<0.05 considered statistically significant.
RESULTS: Of 34,782 pregnancies, 831 (2.4%) developed PE. In screening for delivery with PE at any time from assessment, the DR at 10% screen-positive rate was 47% by low PlGF alone, 54% by the ‘single test’, 55% by high sFLT-1/PlGF, 61% by the ‘double test’, and 68% by the ‘triple test’. In screening for delivery with PE within 2 weeks, the respective values were 67%, 74%, 74%, 80%, and 87%. In screening for delivery with PE within 1 week, the respective values were 77%, 81%, 85%, 88% and 91%. For prediction of PE at any time, the DR difference [95% confidence interval] was significantly higher with the ‘triple test’, compared with PlGF alone (20.1 [16.7-23.0]) or the sFLT-1/PlGF ratio (12.4 [9.7-15.3]). Similar results were seen for prediction of PE within 2 weeks (20.6 [14.9-26.8] and 12.9 [7.7-17.5], respectively) and prediction of PE within 1 week (13.5 [5.4-21.6]) and (5.4 [0.0-10.8]). The double test was superior to the sFLT-1/PlGF ratio and the single test was superior to PlGF alone in the prediction of PE within 2 weeks and at any time from assessment, but not within 1 week of assessment.
CONCLUSION: At 35+0 to 36+6 weeks’ gestation, the performance of screening for PE by the competing risks model ‘triple test’ is superior to that of PlGF alone or the sFLT-1/PlGF ratio for PE within 1 week, within 2 weeks and at any time from screening. This article is protected by copyright. All rights reserved.
PMID:37329494 | DOI:10.1002/uog.26291
