Evaluation of two treatment strategies for the prevention of preterm birth in women identified as at risk by ultrasound (PESAPRO Trial): Study protocol for a randomized controlled trial

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dc.contributor.author Cabrera-García, Lourdes
dc.contributor.author Cruz-Melguizo, Sara
dc.contributor.author Ruiz-Antorán, Belén
dc.contributor.author Torres, Ferrán
dc.contributor.author Velasco, Ana
dc.contributor.author Martínez-Payo, Cristina
dc.contributor.author Avendaño, Cristina
dc.contributor.author Cruz Melguizo, Sara
dc.contributor.author Cordero, Estefanía
dc.contributor.author Adiego Burgos, Begoña
dc.contributor.author Martínez Guisasola, Javier
dc.contributor.author Martínez Cortés, Luis
dc.contributor.author García González, Celso
dc.contributor.author Quesada Segura, Gonzalo
dc.contributor.author Abarca, Leopoldo
dc.contributor.author Savirón, Ricardo
dc.contributor.author Pérez Carbajo, Esther
dc.contributor.author Rodríguez León, José Alberto
dc.contributor.author Bartha, José Luis
dc.contributor.author Teulón, María
dc.contributor.author Nogales, Rosa
dc.contributor.author Rodríguez
dc.contributor.author Alonso, Gregoria
dc.contributor.author Álvbarez Colomo, Cristina
dc.contributor.author Anaya Baz, Mángeles
dc.contributor.author Abeshera Davó, Daniel
dc.contributor.author Cancelo, Maria Jesús
dc.contributor.author Díaz dee Teran, Elisa Maria
dc.contributor.author Mateu Pruñunosa, Joan Carles
dc.contributor.author Gálvez, Gloria
dc.contributor.author Torre, Antoniodela
dc.contributor.author Marqueta Sánchez, José Manuel
dc.contributor.author Bermejo, Rosa
dc.contributor.author Lekuona Artola, Arantza
dc.contributor.author Cabrillo Rodríguez, Eduardo
dc.contributor.author Dios, Emilia de
dc.contributor.other UAM. Departamento de Obstetricia y Ginecología es_ES
dc.contributor.other UAM. Departamento de Farmacología es_ES
dc.date.accessioned 2016-07-18T12:44:23Z
dc.date.available 2016-07-18T12:44:23Z
dc.date.issued 2015-09-25
dc.identifier.citation Trials 16.1 (2015): 427 es_ES
dc.identifier.issn 1745-6215 es_ES
dc.identifier.uri http://hdl.handle.net/10486/672135
dc.description.abstract Background: Premature birth is considered one of the main problems in modern Obstetrics. It causes more than 50 % of neonatal mortality; it is responsible for a large proportion of infant morbidity and incurs very high economic costs. Cervical length, which can be accurately measured by ultrasound, has an inverse relationship with the risk of preterm birth. As a result, having an effective intervention for asymptomatic patients with short cervix could reduce the prematurity. Although recently published data demonstrates the effectiveness of vaginal progesterone and cervical pessary, these treatments have never been compared to one another. Methods/Design: The PESAPRO study is a noncommercial, multicenter, open-label, randomized clinical trial (RCT) in pregnant women with a short cervix as identified by transvaginal ultrasonography at 19 to 22 weeks of gestation. Patients are randomized (1:1) to either daily vaginal progesterone or cervical pessary until the 37th week of gestation or delivery; whichever comes first. During the trial, women visit every 4 weeks for routine questions and tests. The primary outcome is the proportion of spontaneous preterm deliveries before 34 weeks of gestation. A sample size of 254 pregnant women will be included at 29 participating hospitals in order to demonstrate noninferiority of placing a pessary versus vaginal progesterone. The first patient was randomized in August 2012, and recruitment of study subjects will continue until the end of December 2015. Discussion: This trial assesses the comparative efficacy and safety between two accepted treatments, cervical pessary versus vaginal progesterone, and it will provide evidence in order to establish clinical recommendations en_US
dc.description.sponsorship The study has been funded by two national grants from the Spanish Ministry of Health and ISCIII. es_ES
dc.format.extent 10 pag. es_ES
dc.format.mimetype application/pdf en
dc.language.iso eng en
dc.publisher BioMed Central en_US
dc.relation.ispartof Trials en_US
dc.rights © 2015 Cabrera-García et al. es_ES
dc.subject.other Premature birth en_US
dc.subject.other Short cervix en_US
dc.subject.other Vaginal progesterone en_US
dc.subject.other Cervical pessary en_US
dc.subject.other Prevention en_US
dc.title Evaluation of two treatment strategies for the prevention of preterm birth in women identified as at risk by ultrasound (PESAPRO Trial): Study protocol for a randomized controlled trial en_US
dc.type article en
dc.subject.eciencia Medicina es_ES
dc.relation.publisherversion http://dx.doi.org/10.s13063-015-0964-y es_ES
dc.identifier.doi 10.1186/s13063-015-0964-y es_ES
dc.identifier.publicationfirstpage 427 es_ES
dc.identifier.publicationissue 1 es_ES
dc.identifier.publicationlastpage 427 es_ES
dc.identifier.publicationvolume 16 es_ES
dc.type.version info:eu-repo/semantics/publishedVersion en_US
dc.rights.cc Reconocimiento es_ES
dc.rights.accessRights openAccess en
dc.authorUAM Avendaño Sola, Cristina (259513)

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