Cited by 2,287Pregnancy and preeclampsia studiesNeurological Complications and SyndromesNeonatal and fetal brain pathology

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Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia

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Rolnik, Daniel L., Wright, David, Poon, Liona C., O’Gorman, Neil, Syngelaki, Argyro, de Paco Matallana, Catalina, Akolekar, Ranjit, Cicero, Simona, Janga, Deepa, Singh, Mandeep, Molina, Francisca S., Persico, Nicola, Jani, Jacques C., Plasencia, Walter, Papaioannou, George, Tenenbaum-Gavish, Kinneret, Meiri, Hamutal, Gizurarson, Sveinbjorn, Maclagan, Kate, Nicolaides, Kypros H.·2017·New England Journal of Medicine

DOI 10.1056/nejmoa1704559

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Abstract

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 Results were materially unchanged in a sensitivity analysis that took into account participants who had withdrawn or were lost to follow-up.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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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: Rolnik, Daniel L.
Wright, David
Poon, Liona C.
O’Gorman, Neil
Syngelaki, Argyro
Akolekar, Ranjit
Singh, Mandeep
Molina, Francisca S.
Persico, Nicola
Jani, Jacques C.
Plasencia, Walter
Papaioannou, George
Meiri, Hamutal
Maclagan, Kate
Nicolaides, Kypros H.
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
DOI: 10.1056/nejmoa1704559
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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Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia

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