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Title: Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia.
Authors: 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
metadata.dc.subject.mesh: Adult
Double-Blind Method
Infant, Newborn
Intention to Treat Analysis
Kaplan-Meier Estimate
Pregnancy Complications
Pregnancy Outcome
Issue Date: 28-Jun-2017
Abstract: 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. 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. 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 Results were materially unchanged in a sensitivity analysis that took into account participants who had withdrawn or were lost to follow-up.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. 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 .).
metadata.dc.identifier.doi: 10.1056/NEJMoa1704559
Appears in Collections:Producción 2020

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