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Implementation of First-Trimester Screening and Prevention of Preeclampsia: A Stepped Wedge Cluster-Randomized Trial
Long Nguyen-Hoang1, Linh Thuy Dinh2, Angela S T Tai1
1Department of Obstetrics and Gynaecology, Prince of Wales Hospital (L.N.-H., A.S.T.T., H.H.Y.L., N.M.W.L., S.L.L., I.Y.M.W., X.L., D.S.S., L.C.P.), Chinese University of Hong Kong.
Insights
A first-trimester screen-and-prevent strategy for preterm preeclampsia showed high acceptance in Asia. Low-dose aspirin significantly reduced preterm preeclampsia by 41% in high-risk women.
Area of Science:
- Obstetrics and Gynecology
- Maternal-Fetal Medicine
- Clinical Trials
Background:
- Preterm preeclampsia poses significant risks to maternal and infant health.
- Early detection and intervention strategies are crucial for improving pregnancy outcomes.
- Asia presents a diverse population for evaluating obstetric interventions.
Purpose of the Study:
- To evaluate the efficacy, acceptability, and safety of a first-trimester screen-and-prevent strategy for preterm preeclampsia in Asian maternity units.
- To assess the impact of low-dose aspirin prophylaxis in high-risk pregnancies identified through first-trimester screening.
Main Methods:
- A multicenter stepped wedge cluster randomized trial involving 10 regions in Asia.
- Women underwent first-trimester screening for preterm preeclampsia using a Bayes theorem-based triple-test.
- High-risk women (adjusted risk ≥1 in 100) received low-dose aspirin from <16 weeks until 36 weeks.
Main Results:
- Overall acceptance of first-trimester screening was high (88.04%).
- Low-dose aspirin was administered to 82.39% of identified high-risk women.
- While the overall strategy did not significantly reduce preterm preeclampsia incidence, aspirin prophylaxis reduced it by 41% in high-risk women.
- Significant reductions were observed in preeclampsia with delivery at <34 weeks, spontaneous preterm birth <34 weeks, and perinatal death among high-risk women receiving aspirin.
- No significant difference in aspirin-related severe adverse events was noted between groups.
Conclusions:
- The screen-and-prevent strategy for preterm preeclampsia demonstrated high acceptability across diverse ethnic backgrounds.
- Low-dose aspirin is an effective intervention for reducing preterm preeclampsia incidence by 41% in high-risk pregnancies.
- Widespread implementation of this strategy is recommended globally for improved maternal and infant outcomes.
Background:
This trial aimed to assess the efficacy, acceptability, and safety of a first-trimester screen-and-prevent strategy for preterm preeclampsia in Asia.
Methods:
Between August 1, 2019, and February 28, 2022, this multicenter stepped wedge cluster randomized trial included maternity/diagnostic units from 10 regions in Asia. The trial started with a period where all recruiting centers provided routine antenatal care without study-related intervention. At regular 6-week intervals, one cluster was randomized to transit from nonintervention phase to 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 adjusted risk for preterm preeclampsia ≥1 in 100, received low-dose aspirin from <16 weeks until 36 weeks.
Results:
Overall, 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% (2919 of 3543) 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]). In addition, it correlated with 54%, 55%, and 64% reduction 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.
Conclusions:
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 underpin the importance of the widespread implementation of the screen-and-prevent strategy for preterm preeclampsia on a global scale.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03941886.
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