ASPRE trial: incidence of preterm preeclampsia in patients fulfilling ACOG and NICE criteria according to risk by the FMF algorithm

NMUH Staff Publications

<h4><span style="font-size: 10pt;">OBJECTIVE: <span style="font-size: 10pt;"><span style="font-weight: normal;">To report the incidence of preterm preeclampsia (PE) in women that fulfil the screening criteria of the National Institute for Health and Clinical Excellence (NICE) and American Congress of Obstetricians and Gynecologists (ACOG) and compare the incidence in those that are screen positive and screen negative by the Fetal Medicine Foundation (FMF) algorithm.</span></span></span></h4><h4><span style="font-size: 10pt;">STUDY DESIGN: <span style="font-size: 10pt;"><span style="font-weight: normal;">This was a secondary analysis of data from the ASPRE study. The study population consisted of women with singleton pregnancies who had prospective screening for preterm-PE by means of the FMF algorithm that combines maternal factors and biomarkers at 11-13 weeks' gestation. We estimated the incidence of preterm-PE in those fulfilling the NICE and ACOG criteria; in these patients we then calculated the incidence of preterm-PE in those that were screen negative relative to those that were screen positive by the FMF algorithm.</span></span></span></h4><h4><span style="font-size: 10pt;">RESULTS: <span style="font-size: 10pt;"><span style="font-weight: normal;">A total of 34,573 women with singleton pregnancies delivering at >24 weeks' gestation underwent prospective screening for preterm-PE, including 239 (0.7%) cases of preterm-PE. At least one of the ACOG criteria was fulfilled in 22,287 (64.5%) of pregnancies and the incidence of preterm-PE was 0.97% (95% CI: 0.85-1.11%); in the subgroup that was FMF screen positive the incidence was 4.80% (95% CI 4.14-5.55%), in those that were screen negative it was 0.25% (95% CI 0.18-0.33%) and the relative incidence in FMF negative to FMF positive was 0.051 (95% CI 0.037-0.071). In 1,392 (4.0%) pregnancies at least one of the NICE high-risk criteria was fulfilled and in this group the incidence of preterm-PE was 5.17% (95% CI: 4.13-6.46%); in the subgroups of screen positive and screen negative by the FMF algorithm the incidence of preterm-PE was 8.71% (95% CI 6.93-10.89%) and 0.65% (95% CI 0.25-1.67%), respectively and the relative incidence was 0.075 (95% CI 0.028-0.205). In 2,360 (6.8%) pregnancies with at least two of the NICE moderate-risk criteria the incidence of preterm-PE was 1.74% (95% CI: 1.28-2.35%); in the subgroups of screen positive and screen negative by the FMF algorithm the incidence was 4.91% (95% CI: 3.54-6.79%) and 0.42% (95% CI 0.20-0.86%), respectively and the relative incidence was 0.085 (95% CI 0.038-0.192).</span></span></span></h4><h4><span style="font-size: 10pt;">CONCLUSION: <span style="font-size: 10pt;"><span style="font-weight: normal;">In ACOG or NICE screen positive women that are screen negative by the FMF algorithm the risk of preterm-PE is reduced to within or below background levels. The results provide further evidence to support risk based screening using biomarkers.</span></span></span></h4><span style="font-size: 10pt;"> </span>