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Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia
Open accessAbstract
BACKGROUND: Preterm preeclampsia is an important cause of maternal and perinatal death and complications. It is uncertain whether the intake of low-dose aspirin during pregnancy reduces the risk of preterm preeclampsia. METHODS: In this multicenter, double-blind, placebo-controlled trial, we randomly assigned 1776 women with singleton pregnancies who were at high risk for preterm preeclampsia to receive aspirin, at a dose of 150 mg per day, or placebo from 11 to 14 weeks of gestation until 36 weeks of gestation. The primary outcome was delivery with preeclampsia before 37 weeks of gestation. The analysis was performed according to the intention-to-treat principle. RESULTS: A total of 152 women withdrew consent during the trial, and 4 were lost to follow up, which left 798 participants in the aspirin group and 822 in the placebo group. Preterm preeclampsia occurred in 13 participants (1.6%) in the aspirin group, as compared with 35 (4.3%) in the placebo group (odds ratio in the aspirin group, 0.38; 95% confidence interval, 0.20 to 0.74; P=0.004). Results were materially unchanged in a sensitivity analysis that took into account participants who had withdrawn or were lost to follow-up. Adherence was good, with a reported intake of 85% or more of the required number of tablets in 79.9% of the participants. There were no significant between-group differences in the incidence of neonatal adverse outcomes or other adverse events. CONCLUSIONS: Treatment with low-dose aspirin in women at high risk for preterm preeclampsia resulted in a lower incidence of this diagnosis than placebo. (Funded by the European Union Seventh Framework Program and the Fetal Medicine Foundation; EudraCT number, 2013-003778-29 ; Current Controlled Trials number, ISRCTN13633058 .).
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“However, this finding was not confirmed in the Aspirin for Evidence-Based Preeclampsia Prevention (ASPRE) trial, which was primarily designed for preterm preeclampsia prevention.74,75”
From Society for Maternal-Fetal Medicine Consult Series #52: Diagnosis and management of fetal growth restriction (2020) · cites this paper as [74]
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“However, a meta-analysis and an additional trial demonstrate that low-dose aspirin <100 mg is not effective in reducing preeclampsia.Low-dose aspirin >100 mg is required (117-119).”
From 15. Management of Diabetes in Pregnancy: Standards of Care in Diabetes—2024 (2024) · cites this paper as [118]
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“This is based on the ASPRE study, which showed that in women at high-risk of preeclampsia who received low-dose aspirin from 11 to 14 gestational weeks until 36 weeks, the risk of developing preeclampsia was significantly decreased (OR: 0.38; 95% CI: 0.20–0.74; p = 0.004) [78].”
From First-Trimester Ultrasound: A Comparative Review of Guidelines (2026) · cites this paper as [78]
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“The recent ASPRE trial demonstrated that administration of aspirin to a population identified as high risk using a first trimester screening test reduced the incidence of pre-eclampsia compared with placebo [17], but was underpowered to detect an effect on FGR/SGA and stillbirth.”
From Volume and vascularity: Using ultrasound to unlock the secrets of the first trimester placenta (2019) · cites this paper as [17]
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- Van Buuren S, 2011, J Stat Softw, 45, 1
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Metadata
- Authors
- Rolnik, D. L., Wright, D., Poon, L. C., O’Gorman, N., Syngelaki, A., de Paco Matallana, C., Akolekar, R., Cicero, S., Janga, D., Singh, M., Molina, F. S., Persico, N., Jani, J. C., Plasencia, W., Papaioannou, G., Tenenbaum-Gavish, K., Meiri, H., Gizurarson, S., Maclagan, K., & Nicolaides, K. H.
- Affiliations
- Université Libre de Bruxelles (BE)
- King's College Hospital (GB)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2017-08-17
- Volume
- 377
- Issue
- 7
- Pages
- 613-622
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2730504020
- Cited by
- 2,287
- References
- 24
- Citations by year
- 2026: 252 · 2025: 277 · 2024: 231 · 2023: 274 · 2022: 257 · 2021: 249 · 2020: 265 · 2019: 212 · 2018: 196 · 2017: 69
- FWCI
- 238.94
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Research Portal (King's College London) (publishedVersion, other-oa)
- Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion)
- RISalud Institutional Health Repository of Andalucía (submittedVersion, other-oa)
- Funders
- Imperial College London
- Imperial College Healthcare NHS Trust
- University College London
- European Commission (FP7-HEALTH-2013INNOVATION, 601852, HEALTH-2013)
- Fetal Medicine Foundation
- FP7 Health (601852)
- Topics
- Health Sciences › Medicine › Obstetrics and Gynecology › Pregnancy and preeclampsia studies
- Health Sciences › Medicine › Clinical Neurology › Neurological Complications and Syndromes
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Neonatal and fetal brain pathology
- Keywords
- low-dose aspirin, preterm preeclampsia, high-risk pregnancy, preeclampsia prevention, singleton pregnancy, drug safety in pregnancy, adverse neonatal outcomes
- MeSH terms
- Adult, Aspirin, Double-Blind Method, Female, Humans, Infant, Newborn, Pre-Eclampsia, Pregnancy, Pregnancy Complications, Pregnancy Outcome, Risk, Incidence, Kaplan-Meier Estimate, Intention to Treat Analysis
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