Abstract
The aim was to describe and assess a new late pregnancy point-of-care urinary preeclampsia screening test. Urine samples were collected from a consecutive series of 1,532 pregnant women hospitalized at 20–41 weeks gestation in a Chinese single obstetric unit. A simple disposable Congo red based device was newly developed and employed to prospectively test misfolded proteins in pregnant women’s urine. A total of 140 preeclampsia cases were clinically diagnosed, 101 severe and 87 pre-term. Detection and false positive rates were similar in the training and validation subsets with combined 74% and 3.0%. The detection rate was 83% in severe, 86% in pre-term, 49% and 50% in mild and term cases (P<0.0001) respectively. In conclusion, a simple point-of-care urinary test for misfolded proteins can be used to screen for preeclampsia in late pregnancy with very high screening performance. To the best of our knowledge, this is the first study to screen for preeclampsia using Congo red based device in Chinese pregnant population.
Highlights
Worldwide, 2–8% of pregnant women suffer from preeclampsia, it is a major cause of maternal mortality and accounts for a large proportion of preterm deliveries [1]
Screening in late pregnancy is needed for women not screened earlier, and those not prevented by such screening including term preeclampsia, comprising at least two-thirds of cases
There were highly statistically significant difference between those with preeclampsia and unaffected pregnancies in the gestation at admission, symptoms being included in the reason for admission, specific risk factors for preeclampsia and the initial blood pressure and proteinuria measurements
Summary
2–8% of pregnant women suffer from preeclampsia, it is a major cause of maternal mortality and accounts for a large proportion of preterm deliveries [1]. Primary screening for preeclampsia in early pregnancy and low dose aspirin prophylaxis can prevent about half of preterm cases (i.e. delivering before 37 weeks gestation)—screening detection rate 77% and prevention by aspirin 62% [2]. Screening in late pregnancy is needed for women not screened earlier, and those not prevented by such screening including term preeclampsia, comprising at least two-thirds of cases. Late pregnancy screening is secondary, carried out on women who present with symptoms of preeclampsia or signs of pregnancy related problems. One approach is maternal serum screening using markers such as soluble fms-like tyrosine kinase-1 (sFlt-1) and placental growth factor (PlGF) [3]. Serum PlGF and another biomarker serum pregnancy-associated plasma protein A (PAPP-A) have been
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