In pregnant individuals at high risk of preeclampsia and a normal soluble fms-like tyrosine kinase–1 to placental growth factor (sFlt-1:PlGF) ratio between 24 and 28 weeks of gestation, aspirin discontinuation was noninferior to aspirin continuation, a study shows.
The multicenter, open-label, randomized, phase 3, noninferiority trial was conducted in 9 Spanish maternity hospitals. A total of 968 pregnant individuals meeting enrollment criteria were randomly assigned to aspirin discontinuation (intervention group) or aspirin continuation until 36 weeks of gestation (control group). Based on a noninferiority difference of 1.9% for the higher 95% confidence interval in the difference in preterm preeclampsia incidences between groups, the results show: “Among the 936 participants, the mean (SD) age was 32.4 (5.8) years; 3.4% were Black and 93% were White. The incidence of preterm preeclampsia was 1.48% (7/473) in the intervention group and 1.73% (8/463) in the control group (absolute difference, −0.25% [95% CI, −1.86% to 1.36%]), indicating noninferiority.”
Editorial: “By implementing an individualized approach to low-dose aspirin prophylaxis, [these authors] highlight the potential to apply multimodal approaches for risk assessment and management to reduce the burden of major complications of pregnancy,” editorialists write. “This paradigm is poised to capitalize on ongoing efforts, including several in the US, to identify molecular biomarkers with high sensitivity and predictive value for all types of preeclampsia (not just preterm preeclampsia), as well as for other important complications of pregnancy, such as stillbirth, preterm birth, and fetal growth restriction. US practitioners and professional societies should reconsider current risk assessment strategies, which are largely based on maternal factors, and evaluate whether incorporation of molecular biomarkers would improve maternal and fetal/neonatal outcomes.“