Randomized controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with intrauterine infection: study protocol

Detalhes bibliográficos
Autor(a) principal: Krauss-Silva, Leticia
Data de Publicação: 2010
Outros Autores: Moreira, Maria Elisabeth Lopes, Alves, Mariane B., Rezende, Maria R., Braga, Alcione, Camacho, Karla G., Batista, Maria Rosa R., Savastano, Clarisse, Almada-Horta, Antonio, Guerra, Fernando
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/8415
Resumo: Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Unidade de Avaliação de Tecnologias em Saúde. Rio de Janeiro, RJ, Brasil
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spelling Krauss-Silva, LeticiaMoreira, Maria Elisabeth LopesAlves, Mariane B.Rezende, Maria R.Braga, AlcioneCamacho, Karla G.Batista, Maria Rosa R.Savastano, ClarisseAlmada-Horta, AntonioGuerra, Fernando2014-09-22T12:40:39Z2014-09-22T12:40:39Z2010KRAUSS-SILVA, Leticia et al. Randomized controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with intrauterine infection: study protocol. Reprod. health., v. 7, n. 14, 2010.1742-4755https://www.arca.fiocruz.br/handle/icict/8415engBioMed CentralRandomized controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with intrauterine infection: study protocolinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Unidade de Avaliação de Tecnologias em Saúde. Rio de Janeiro, RJ, BrasilFundação Oswaldo Cruz. Instituto Nacional de Saúde da Mulher, da Criança e do Adolescente Fernandes Figueira. Unidade de Pesquisa Clínica. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Unidade de Avaliação de Tecnologias em Saúde. Rio de Janeiro, RJ, Brasil / Universidade Federal do Rio de Janeiro. Centro de Ciências Matemáticas e da Natureza. Instituto de Matemática. Rio de Janeiro, RJ. Brasil.Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Unidade de Avaliação de Tecnologias em Saúde. Rio de Janeiro, RJ, BrasilPROCEP. Pró-Cardíaco. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Unidade de Avaliação de Tecnologias em Saúde. Rio de Janeiro, RJ, BrasilFundação Oswaldo Cruz. Instituto Nacional de Saúde da Mulher, da Criança e do Adolescente Fernandes Figueira. Departamento de Obstetrícia e Ginecologia. Rio de Janeiro, RJ, Brasil.Background: Spontaneous preterm deliveries that occur before the 34th week of gestation, and particularly before the 32nd week of gestation, have been strongly associated to intrauterine infection, ascending from vagina, and represent the largest portion of neonatal deaths and neurological problems. Bacterial vaginosis, characterized by a diminished or absent flora of lactobacilli and increased colonization of several anaerobic or facultative microorganisms, increases two times the risk of preterm delivery before the 34th week. Trials of antibiotics failed to show efficacy and effectiveness against spontaneous preterm birth related to bacterial vaginosis. Some studies indicate benefit from selected probiotics to treat genitourinary infections, including bacterial vaginosis. Objective: The purpose of this study is to evaluate the effectiveness of the early administration of selected probiotics to pregnant women with asymptomatic bacterial vaginosis/intermediate degree infection to reduce the occurrence of spontaneous preterm delivery and related neonatal mortality and morbidity. Methods/Design: Women attending public prenatal care services in Rio de Janeiro will be screened to select asymptomatic pregnant women, less than 20 weeks' gestation, with no indication of elective preterm delivery. Those with vaginal pH > = 4.5 and a Nugent score between 4 and 10 (intermediate degree infection or bacterial vaginosis) will be randomized to either the placebo or the intervention group, after written informed consent. Intervention consists in the use of probiotics, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14, 2 capsules a day, each capsule containing more than one million bacilli of each strain, for 6-12 weeks, up to the 24th-25th wk of gestation. Ancillary analyses include quantification of selected cervicovaginal cytokines and genotyping of selected polymorphisms. The randomization process is stratified for history of preterm delivery and blocked. Allocation concealment was designed as well as blinding of women, caregivers and outcome evaluators. The study will be supervised by an independent monitoring committee. Outcomes under study are preterm delivery (< 34- < 32 weeks of gestation) and associated neonatal complications: early neonatal sepsis, bronchopulmonary dysplasia, periventricular leukomalacia, necrotizing enterocolitis, and prematurity-related retinopathy; definitions were adapted from those recommended by the 2002 version of the Vermont-Oxford Network. Trial registration at NIH register: NCT00303082.Trabalho de Parto PrematuroVaginose BacterianaUnidades de Terapia Intensiva NeonatalGestantesDistribuição Aleatóriainfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZORIGINALSRtuadyn pdrotoocmol ized controlled trial of probiotics for the.pdfapplication/pdf743339https://www.arca.fiocruz.br/bitstream/icict/8415/1/SRtuadyn%20pdrotoocmol%20ized%20controlled%20trial%20of%20probiotics%20for%20the.pdf58b88e07abed5bd6df3d23afed754d79MD51LICENSElicense.txttext/plain1914https://www.arca.fiocruz.br/bitstream/icict/8415/2/license.txt7d48279ffeed55da8dfe2f8e81f3b81fMD52TEXTSRtuadyn pdrotoocmol ized controlled trial of probiotics for the.pdf.txtSRtuadyn pdrotoocmol ized controlled trial of probiotics for the.pdf.txtExtracted texttext/plain68055https://www.arca.fiocruz.br/bitstream/icict/8415/3/SRtuadyn%20pdrotoocmol%20ized%20controlled%20trial%20of%20probiotics%20for%20the.pdf.txt4cd608499125fdbaa46a64bed97c4118MD53icict/84152023-01-13 10:23:52.631oai:www.arca.fiocruz.br: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ório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352023-01-13T13:23:52Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.pt_BR.fl_str_mv Randomized controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with intrauterine infection: study protocol
title Randomized controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with intrauterine infection: study protocol
spellingShingle Randomized controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with intrauterine infection: study protocol
Krauss-Silva, Leticia
Trabalho de Parto Prematuro
Vaginose Bacteriana
Unidades de Terapia Intensiva Neonatal
Gestantes
Distribuição Aleatória
title_short Randomized controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with intrauterine infection: study protocol
title_full Randomized controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with intrauterine infection: study protocol
title_fullStr Randomized controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with intrauterine infection: study protocol
title_full_unstemmed Randomized controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with intrauterine infection: study protocol
title_sort Randomized controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with intrauterine infection: study protocol
author Krauss-Silva, Leticia
author_facet Krauss-Silva, Leticia
Moreira, Maria Elisabeth Lopes
Alves, Mariane B.
Rezende, Maria R.
Braga, Alcione
Camacho, Karla G.
Batista, Maria Rosa R.
Savastano, Clarisse
Almada-Horta, Antonio
Guerra, Fernando
author_role author
author2 Moreira, Maria Elisabeth Lopes
Alves, Mariane B.
Rezende, Maria R.
Braga, Alcione
Camacho, Karla G.
Batista, Maria Rosa R.
Savastano, Clarisse
Almada-Horta, Antonio
Guerra, Fernando
author2_role author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Krauss-Silva, Leticia
Moreira, Maria Elisabeth Lopes
Alves, Mariane B.
Rezende, Maria R.
Braga, Alcione
Camacho, Karla G.
Batista, Maria Rosa R.
Savastano, Clarisse
Almada-Horta, Antonio
Guerra, Fernando
dc.subject.decs.pt_BR.fl_str_mv Trabalho de Parto Prematuro
Vaginose Bacteriana
Unidades de Terapia Intensiva Neonatal
Gestantes
Distribuição Aleatória
topic Trabalho de Parto Prematuro
Vaginose Bacteriana
Unidades de Terapia Intensiva Neonatal
Gestantes
Distribuição Aleatória
description Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Unidade de Avaliação de Tecnologias em Saúde. Rio de Janeiro, RJ, Brasil
publishDate 2010
dc.date.issued.fl_str_mv 2010
dc.date.accessioned.fl_str_mv 2014-09-22T12:40:39Z
dc.date.available.fl_str_mv 2014-09-22T12:40:39Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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status_str publishedVersion
dc.identifier.citation.fl_str_mv KRAUSS-SILVA, Leticia et al. Randomized controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with intrauterine infection: study protocol. Reprod. health., v. 7, n. 14, 2010.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/8415
dc.identifier.issn.pt_BR.fl_str_mv 1742-4755
identifier_str_mv KRAUSS-SILVA, Leticia et al. Randomized controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with intrauterine infection: study protocol. Reprod. health., v. 7, n. 14, 2010.
1742-4755
url https://www.arca.fiocruz.br/handle/icict/8415
dc.language.iso.fl_str_mv eng
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dc.publisher.none.fl_str_mv BioMed Central
publisher.none.fl_str_mv BioMed Central
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