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

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,...

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Detalhes bibliográficos
Autores: Cabrera-García, Lourdes, Cruz-Melguizo, Sara, Ruiz-Antorán, Belén, Torres, Ferrán, Velasco, Ana, Martínez-Payo, Cristina, Avendaño Solá, Cristina, Cruz Melguizo, Sara, Cordero, Estefanía, Adiego Burgos, Begoña, Martínez Guisasola, Javier, Martínez Cortés, Luis, García González, Celso, Quesada Segura, Gonzalo, Abarca, Leopoldo, Savirón, Ricardo, Pérez Carbajo, Esther, Rodríguez León, José Alberto, Bartha Rasero, José Luis, Teulón, María, Nogales, Rosa, Rodríguez, Alonso, Gregoria, Álvárez Colomo, Cristina, Anaya Baz, Mángeles, Abeshera Davó, Daniel, Cancelo, Maria Jesús, Díaz dee Teran, Elisa Maria, Mateu Pruñunosa, Joan Carles, Gálvez, Gloria, Torre, Antoniodela, Marqueta Sánchez, José Manuel, Bermejo, Rosa, Lekuona Artola, Arantza, Cabrillo Rodríguez, Eduardo, Dios, Emilia de
Formato: artículo
Fecha de publicación:2015
País:España
Recursos:Universidad Autónoma de Madrid
Repositorio:Biblos-e Archivo. Repositorio Institucional de la UAM
Idioma:inglés
OAI Identifier:oai:repositorio.uam.es:10486/672135
Acesso em linha:http://hdl.handle.net/10486/672135
https://dx.doi.org/10.1186/s13063-015-0964-y
Access Level:acceso abierto
Palavra-chave:Premature birth
Short cervix
Vaginal progesterone
Cervical pessary
Prevention
Medicina
Descrição
Resumo: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

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