Completed Research

NCT number: NCT03941886 (click on the NCT number to take you to the clinicaltrials.gov to learn more)

This was a multicentre stepped wedge cluster randomised trial that included maternity and diagnostic units from 10 regions in Asia between 1 August 2019 and 28 February 2022, aimed at assessing the efficacy, acceptability, and safety of a first-trimester screen-and-prevent strategy for preterm preeclampsia in Asia. The trial commenced with a period during which all recruiting centres provided routine antenatal care without study-related intervention. At regular 6-week intervals, one cluster was randomised to transition from the non-intervention phase to the intervention phase. In the intervention phase, women underwent first-trimester screening for preterm preeclampsia using a Bayes theorem-based triple-test. High-risk women, with an adjusted risk for preterm preeclampsia of ≥1 in 100, received low-dose aspirin from before 16 weeks until 36 weeks. We found that 88.04% (42,897 of 48,725) of women agreed to undergo first-trimester screening for preterm preeclampsia. Among those identified as high-risk in the intervention phase, 82.39% (2,919 of 3,543) received aspirin prophylaxis. There was no significant difference in the incidence of preterm preeclampsia between the intervention and non-intervention phases (adjusted odds ratio [aOR], 1.59 [95% CI, 0.91–2.77]). However, among high-risk women in the intervention phase, aspirin prophylaxis was significantly associated with a 41% reduction in the incidence of preterm preeclampsia (aOR, 0.59 [95% CI, 0.37–0.92]). Additionally, it correlated with reductions of 54%, 55%, and 64% in the incidence of preeclampsia with delivery at <34 weeks (aOR, 0.46 [95% CI, 0.23–0.93]), 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 aspirin-related severe adverse events. In conclusion, the implementation of the screen-and-prevent strategy for preterm preeclampsia is not associated with a significant reduction in the incidence of preterm preeclampsia. However, low-dose aspirin effectively reduces the incidence of preterm preeclampsia by 41% among high-risk women. The screen-and-prevent strategy for preterm preeclampsia is highly accepted by a diverse group of women from various ethnic backgrounds, beyond the original population where the strategy was developed. These findings underscore the importance of the widespread implementation of the screen-and-prevent strategy for preterm preeclampsia on a global scale.