ObjectiveTo evaluate the diagnostic accuracy of the Fetal Medicine Foundation (FMF) competing risk model (the triple test) for the prediction of preterm pre‐eclampsia (PE) in a Spanish population.MethodsThis was a prospective cohort study performed in eight fetal‐medicine units in five different regions of Spain between September 2017 and December 2019. All pregnant women with singleton pregnancies and non‐malformed live fetuses attending their routine ultrasound examination at 11+0‐13+6 weeks' gestation were invited to participate in the study. We recorded maternal demographic characteristics and medical history and measured MAP, UtA‐PI, and serum PlGF and PAPP‐A following standardized protocols. We also recorded whether the women were treated with aspirin during pregnancy. The raw values of the biomarkers were converted into multiples of the median (MoM), and audits were periodically performed for the operators and laboratories to receive continuous feedback. Risks for term and preterm PE were calculated according to the FMF competing risks model blinded to outcome. The performance of screening for PE, taking account of aspirin, was assessed by calculating the areas under the receiver‐operating‐characteristics curve (AUROC) and detection rates (DRs) with 95% confidence intervals (CI) at different fixed screen‐positive rates (SPRs). Risk calibration was also assessed.ResultsThe study population comprised 10,110 singleton pregnancies, including 72 (0.7%) that developed preterm PE. Compared to those without PE, the median MAP and UtA‐PI were significantly higher in the preterm PE group, and the median serum PlGF and pregnancy‐associated plasma protein A (PAPP‐A) were significantly lower. In the PE group, the deviation in biomarkers from normal was inversely related to the gestational age at delivery. In screening by a combination of maternal characteristics and medical history with MAP, UtA‐PI, and PlGF, at an SPR of 10%, the DR of preterm PE was 72.7 (95% CI, 62.9–82.6). An alternative strategy of replacing PlGF with PAPP‐A in the triple test was associated with poorer screening performance; the DR was 66.5% (95% CI, 55.8–77.2). Calibration plots showed good agreement between predicted and observed cases of preterm PE, with a slope of 0.983 (0.846–1.120) and an intercept of 0.154 (‐0.091 to 0.397). Our DR of preterm PE at 10% SPR by the triple test was lower than that reported by the FMF (72.7% vs. 74.8%).ConclusionsThe FMF model is effective in predicting preterm PE in the Spanish population. This method of screening is feasible and easy to implement in routine clinical practice, but it must be accompanied by a good audit and monitoring system, which helps ensure the quality of the screening.This article is protected by copyright. All rights reserved.