HABIT: Heparin and Aspirin on Birth in Inherited Thrombophilia, an International Multicenter Phase IIb Randomized Triple Blinded Clinical Trial

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dc.contributor.authorCarvalho, Alessandra
dc.contributor.authorAwad, Camila
dc.contributor.authorGallucci, Alessia
dc.contributor.authorFlores, Ana
dc.contributor.authorLa Riva, Anibal
dc.contributor.authorDíaz, Daniel
dc.contributor.authorDa Silva, Deivid
dc.contributor.authorSaraceno, Taylor
dc.contributor.authorRivera, Oswaldo
dc.contributor.authorFricke, Stephan
dc.contributor.authorGarcia, Regina
dc.contributor.authorZhou, Steven
dc.contributor.authorBazan, María
dc.contributor.authorCastellaro, María
dc.contributor.authorAlencar, Luiza
dc.contributor.authorBlanco, Pedro
dc.contributor.authorTeixeira, Eliluane
dc.contributor.authorGonçalves, Roberta
dc.contributor.authorEtchebehere, Priscila
dc.contributor.authorGonzalez, Jessica
dc.contributor.authorAbdallah, Tasneem
dc.contributor.authorHamad, Malaz
dc.contributor.authorAhmed, Shiema
dc.contributor.authorMéndez, Paola
dc.contributor.authorFaisal, Saif
dc.contributor.authorRobladillo, Devy
dc.contributor.authorGutiérrez, Judith
dc.contributor.authorGuidetti, Matteo
dc.contributor.authorAbu, Nebal
dc.date.accessioned2023-03-23T19:10:53Z
dc.date.available2023-03-23T19:10:53Z
dc.date.issued2023
dc.description.abstractIntroduction: In pregnant women with inherited thrombophilia (IT) and recurrent pregnancy loss, there is no higher-level evidence proving the beneficial effects of anticoagulation or platelet inhibition in preventing miscarriages. We hypothesize that anticoagulation with low molecular weight heparin (LMWH) and/or platelet aggregation inhibition with aspirin will increase the proportion of live birth in this population. Methods: In this phase IIb, factorial, randomized, triple blinded, placebo-controlled (double dummy) clinical trial, pregnant women aged 18 to 40 with a history of IT and 2 or more previous miscarriages, will be randomized and stratified by age and number of miscarriages in a 2x2 factorial design will be allocated equally to one of the four arms. The primary outcome of live birth will be analyzed through logistic regression analysis, controlling for strata, and results will be reported as odds ratio (OR) and 95% confidence intervals (CIs). Similarly, the secondary outcomes will include pregnancy loss, maternal mortality, major bleeding events, medication-associated adverse events, placental abruption, preterm birth, and gestational age at delivery. We will perform subgroup analysis for smoking status, weight, age, number of miscarriages, and type of thrombophilia. Discussion: There is lack of evidence for the use of anticoagulants to prevent pregnancy loss in women with inherited thrombophilia, despite the common diverging prescribing practice predominantly extrapolated from observations in acquired thrombophilia. We aim to provide an evidence base to create a standard of care in cases of recurrent pregnancy loss in women with IT.
dc.description.versionVersión publicada
dc.identifier.citationCarvalho, A., Awad, C., Gallucci, A., Flores, A. P., Riva, A. L., Díaz-Gil, D., Silva, D. D., Saraceno, T. J., Rivera, O., Fricke, S., Garcia, R., Zhou, S., Bazan, M., Castellaro, M., Alencar, L., López-Blanco, P., Teixeira, E., Gonçalves, R., Etchebehere, P., . . . Hussein, N. (2022, December 21). The HABIT: Heparin and Aspirin on Birth in Inherited Thrombophilia, an International Multicenter Phase IIb Randomized Triple Blinded Clinical Trial | Principles and Practice of Clinical Research. The HABIT: Heparin and Aspirin on Birth in Inherited Thrombophilia, an International Multicenter Phase IIb Randomized Triple Blinded Clinical Trial | Principles and Practice of Clinical Research. https://doi.org/10.21801/ppcrj.2022.83.8
dc.identifier.doihttps://doi.org/10.21801/ppcrj.2022.83.8
dc.identifier.urihttps://repositorio.udd.cl/handle/11447/7146
dc.language.isoen
dc.subjectHeparin
dc.subjectAspirin
dc.subjectInherited thrombophilia
dc.subjectPregnant
dc.subjectLive birth
dc.titleHABIT: Heparin and Aspirin on Birth in Inherited Thrombophilia, an International Multicenter Phase IIb Randomized Triple Blinded Clinical Trial
dc.typeArticle
dcterms.accessRightsAcceso abierto
dcterms.sourcePrinciples and Practice of Clinical Research

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