Prospective evaluation of first‐trimester screening strategy for preterm pre‐eclampsia and its clinical applicability in China

Abstract

ABSTRACT Objectives To evaluate, in a Chinese population, the performance of a screening strategy for preterm pre‐eclampsia (PE) using The Fetal Medicine Foundation (FMF)'s competing‐risks model and to explore its clinical applicability in mainland China. Methods This was a prospective, multicenter, observational cohort study including 10 899 women with singleton pregnancy who sought prenatal care at one of 13 hospitals, located in seven cities in mainland China, between 1 December 2017 and 30 December 2019. Mean arterial pressure (MAP), uterine artery pulsatility index (UtA‐PI) and maternal serum levels of placental growth factor (PlGF) and pregnancy‐associated plasma protein‐A (PAPP‐A) at 11 + 0 to 13 + 6 weeks’ gestation were measured and converted into multiples of the median using Chinese reference ranges. Individualized risk for preterm PE was calculated using the FMF algorithm. Prior risk was calculated based on maternal demographic characteristics and obstetric history. We evaluated the efficiency of the screening strategy using various combinations of biomarkers and analyzed its predictive performance for a composite of placenta‐associated adverse pregnancy outcomes, including PE, placental abruption, small‐for‐gestational age (SGA) and preterm birth, at fixed false‐positive rates for preterm PE. Results We identified 312 pregnancies that developed PE, of which 117 cases were diagnosed as preterm PE (< 37 weeks' gestation). There were 386 pregnancies complicated by severe composite placenta‐associated adverse outcome, including preterm PE, 146 cases of severe SGA (birth weight < 3 rd percentile) neonate, 61 cases with placental abruption and 109 cases of early preterm birth < 34 gestational weeks. The triple‐marker model containing biomarkers MAP, UtA‐PI and PAPP‐A achieved, at fixed false‐positive rates of 10%, 15% and 20%, detection rates for preterm PE of 65.0%, 72.7% and 76.1%, respectively, and detection rates for severe composite placenta‐associated adverse outcome of 34.7%, 41.7% and 46.4%, respectively. Replacing PAPP‐A with PlGF or adding PlGF to the model did not improve the performance. Of women screening positive for preterm PE at a fixed 5% false‐positive rate, an estimated 30% developed at least one placenta‐associated adverse pregnancy outcome, including PE, placental abruption, SGA (birth weight < 10 th percentile) and preterm birth < 37 weeks. Conclusions The FMF competing‐risks model for preterm PE was found to be effective in screening a mainland Chinese population. Women who screened positive for preterm PE had increased risk for other placenta‐associated pregnancy complications. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.

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