| Autor: |
Manel Mendoza, Erika Bonacina, Pablo Garcia-Manau, Monica López, Sara Caamiña, Àngels Vives, Eva Lopez-Quesada, Marta Ricart, Anna Maroto, Laura de Mingo, Elena Pintado, Roser Ferrer-Costa, Lourdes Martin, Alicia Rodríguez-Zurita, Esperanza Garcia, Mar Pallarols, Laia Vidal-Sagnier, Mireia Teixidor, Carmen Orizales-Lago, Adela Pérez-Gomez, Vanesa Ocaña, Linda Puerto, Pilar Millán, Mercè Alsius, Sonia Diaz, Nerea Maiz, Elena Carreras, Anna Suy |
| Rok vydání: |
2023 |
| Předmět: |
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| Zdroj: |
JAMA. 329:542 |
| ISSN: |
0098-7484 |
| Popis: |
ImportanceAspirin reduces the incidence of preterm preeclampsia by 62% in pregnant individuals at high risk of preeclampsia. However, aspirin might be associated with an increased risk of peripartum bleeding, which could be mitigated by discontinuing aspirin before term (37 weeks of gestation) and by an accurate selection of individuals at higher risk of preeclampsia in the first trimester of pregnancy.ObjectiveTo determine whether aspirin discontinuation in pregnant individuals with normal soluble fms-like tyrosine kinase–1 to placental growth factor (sFlt-1:PlGF) ratio between 24 and 28 weeks of gestation was noninferior to aspirin continuation to prevent preterm preeclampsia.Design, Setting, and ParticipantsMulticenter, open-label, randomized, phase 3, noninferiority trial conducted in 9 maternity hospitals across Spain. Pregnant individuals (n = 968) at high risk of preeclampsia during the first-trimester screening and an sFlt-1:PlGF ratio of 38 or less at 24 to 28 weeks of gestation were recruited between August 20, 2019, and September 15, 2021; of those, 936 were analyzed (intervention: n = 473; control: n = 463). Follow-up was until delivery for all participants.InterventionsEnrolled patients were randomly assigned in a 1:1 ratio to aspirin discontinuation (intervention group) or aspirin continuation until 36 weeks of gestation (control group).Main Outcomes and MeasuresNoninferiority was met if the higher 95% CI for the difference in preterm preeclampsia incidences between groups was less than 1.9%.ResultsAmong the 936 participants, the mean (SD) age was 32.4 (5.8) years; 3.4% were Black and 93% were White. The incidence of preterm preeclampsia was 1.48% (7/473) in the intervention group and 1.73% (8/463) in the control group (absolute difference, −0.25% [95% CI, −1.86% to 1.36%]), indicating noninferiority.Conclusions and RelevanceAspirin discontinuation at 24 to 28 weeks of gestation was noninferior to aspirin continuation for preventing preterm preeclampsia in pregnant individuals at high risk of preeclampsia and a normal sFlt-1:PlGF ratio.Trial RegistrationClinicalTrials.gov Identifier: NCT03741179 and ClinicalTrialsRegister.eu Identifier: 2018-000811-26 |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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