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ASPRE trial: performance of screening for preterm pre-eclampsia
D L Rolnik1, D Wright2, L C Y Poon1,3
1King's College Hospital, London, UK.
Insights
This study evaluated a combined screening method for pre-eclampsia (PE) in early pregnancy. The screening demonstrated effective detection rates for both preterm and term pre-eclampsia, supporting its clinical utility.
Area of Science:
- Maternal-fetal medicine
- Obstetrics
- Clinical trial methodology
Background:
- Pre-eclampsia (PE) is a significant cause of maternal and neonatal morbidity.
- Early screening and intervention are crucial for improving pregnancy outcomes.
- The ASPRE (Combined Multimarker Screening and Randomized Patient Treatment with Aspirin for Evidence-Based Preeclampsia Prevention) trial investigated a novel screening algorithm.
Purpose of the Study:
- To assess the performance of a combined first-trimester screening algorithm for preterm and term pre-eclampsia (PE).
- To evaluate the detection rates (DRs) and false-positive rates (FPRs) of the screening algorithm in a large prospective cohort.
- To compare the screening performance with the algorithm's development study.
Main Methods:
- A prospective, first-trimester, multicenter study involving 26,941 singleton pregnancies.
- Screening utilized an algorithm combining maternal factors, mean arterial pressure, uterine artery pulsatility index, and serum PAPP-A and PLGF.
- Women with a preterm PE risk >1 in 100 were invited to a randomized trial of aspirin versus placebo.
Main Results:
- The study included 25,797 pregnancies with 180 (0.7%) preterm PE and 450 (1.7%) term PE cases.
- Combined screening at 11-13 weeks achieved a 76.7% DR for preterm PE and 43.1% DR for term PE.
- The screen-positive rate was 10.5%, with a false-positive rate of 9.2% for the overall population.
Conclusions:
- The performance of the combined screening algorithm in the ASPRE trial was comparable to the development study.
- The screening demonstrated robust detection rates for preterm PE and moderate rates for term PE.
- This multimodal screening approach shows promise for early identification of pregnancies at risk for pre-eclampsia.
Objective:
To examine the performance of screening for preterm and term pre-eclampsia (PE) in the study population participating in the ASPRE (Combined Multimarker Screening and Randomized Patient Treatment with Aspirin for Evidence-Based Preeclampsia Prevention) trial.
Methods:
This was a prospective first-trimester multicenter study on screening for preterm PE in 26 941 singleton pregnancies by means of an algorithm that combines maternal factors, mean arterial pressure, uterine artery pulsatility index and maternal serum pregnancy-associated plasma protein-A and placental growth factor at 11-13 weeks' gestation. Eligible women with an estimated risk for preterm PE of > 1 in 100 were invited to participate in a double-blind trial of aspirin (150 mg per day) vs placebo from 11-14 until 36 weeks' gestation, which showed that, in the aspirin group, the incidence of preterm PE was reduced by 62%. In the screened population, the detection rates (DRs) and false-positive rates (FPRs) for delivery with PE < 37 and ≥ 37 weeks were estimated after adjustment for the effect of aspirin in those receiving this treatment. We excluded 1144 (4.2%) pregnancies because of loss to follow-up or study withdrawal (n = 716), miscarriage (n = 243) or termination (n = 185).
Results:
The study population of 25 797 pregnancies included 180 (0.7%) cases of preterm PE, 450 (1.7%) of term PE and 25 167 (97.6%) without PE. In combined first-trimester screening for preterm PE with a risk cut-off of 1 in 100, the DR was 76.7% (138/180) for preterm PE and 43.1% (194/450) for term PE, at screen-positive rate of 10.5% (2707/25 797) and FPR of 9.2% (2375/25 797).
Conclusion:
The performance of screening in the ASPRE study was comparable with that of a study of approximately 60 000 singleton pregnancies used for development of the algorithm; in that study, combined screening detected 76.6% of cases of preterm PE and 38.3% of term PE at a FPR of 10%. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.
