OC13.02: Implementation of first trimester screening and prevention of pre‐eclampsia: a stepped wedge cluster‐randomised trial in Asia

Le résumé fourni par la source

This trial aimed to assess the efficacy, acceptability and safety of a first trimester screen-and-prevent strategy for preterm pre-eclampsia (PE). This was a multicentre cluster stepped wedge randomised trial (SWT) involving 48,725 pregnant women in ten regions across Asia from 2019 to 2022. The SWT started with a period where all recruiting centres provided routine antenatal care without any study-related intervention. At regular six-week intervals, one cluster was randomised to transit from non-intervention phase to intervention phase. In the intervention phase, women underwent first trimester FMF screening for preterm PE. Women who were identified as high-risk, with adjusted risk for preterm PE ≥ 1 in 100, received low-dose aspirin (LDA). Overall, 88.04% (42,897/48,725) of women agreed to undergo first trimester screening for preterm PE. Among those who were identified as high-risk in the intervention phase, 82.39% (2,919/3,543) received LDA. The use of LDA was significantly associated with a 41% reduction in the incidence of preterm PE (aOR 0.59; 95%CI 0.37-0.92). In additional, it correlated with 54%, 54%, 55% and 64% reduction in the incidence of PE <34 weeks (aOR 0.46; 95%CI 0.23-0.93), maternal composite adverse outcomes <34 weeks (aOR 0.46; 95%CI 0.27 to 0.81), spontaneous preterm birth <34 weeks (aOR 0.45; 95%CI 0.22-0.92) and perinatal death (aOR 0.34; 95%CI 0.12-0.91), respectively. There was no significant between-group difference in the incidence of severe adverse events due to LDA. The screen-and-prevent strategy for preterm PE is highly accepted among women from diverse ethnic backgrounds, beyond the original population where the strategy was developed. In the intervention phase, LDA effectively reduces the incidence of preterm PE and great obstetrical syndromes <34 weeks by approximately 50% among high-risk women. LDA is considered a safe intervention during pregnancy.

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