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dc.contributor.author
Schvartzman, Javier A.  
dc.contributor.author
Krupitzki, Hugo Bernardo  
dc.contributor.author
Betran, Ana Pilar  
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Requejo, Jennifer  
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Bergel, Eduardo  
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Fiorillo, Angel Eduardo  
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Gadow, Enrique Curt  
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Vizcaino, Francisco M.  
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Von Petery, Felicitas  
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Althabe, Fernando  
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Belizan, Jose  
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Borruto, Franco  
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Boulvain, Michel  
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Di Renzo, Gian Carlo  
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Gülmezoglu , Metin  
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Hofmeyr, Justus  
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Judge, Kevin  
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Leung, Tak Yeung  
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Nguyen, My Huong  
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Saugstad, Ola Didrik  
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Temmerman, Marleen  
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Treisser, Alain  
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Vayena, Effy  
dc.contributor.author
Merialdi, Mario  
dc.date.available
2017-11-15T12:09:50Z  
dc.date.issued
2013-07  
dc.identifier.citation
Schvartzman, Javier A.; Krupitzki, Hugo Bernardo; Betran, Ana Pilar; Requejo, Jennifer; Bergel, Eduardo; et al.; Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol; BioMed Central; Reproductive health; 10; 7-2013; 1-8  
dc.identifier.issn
1742-4755  
dc.identifier.uri
http://hdl.handle.net/11336/28198  
dc.description.abstract
Background Intrapartum complications are responsible for approximately half of all maternal deaths, and two million stillbirth and neonatal deaths per year. Prolonged second stage of labour is associated with potentially fatal maternal complications such as haemorrhage and infection and it is a major cause of stillbirth and newborn morbidity and mortality. Currently, the three main options for managing prolonged second stage of labour are forceps, vacuum extractor and caesarean section. All three clinical practices require relatively expensive equipment (e.g., a surgical theatre for caesarean section) and/or highly trained staff which are often not available in low resource settings. The specific aim of the proposed study is to test the safety and feasibility of a new device (Odón device) to effectively deliver the fetus during prolonged second stage of labour. The Odón device is a low-cost technological innovation to facilitate operative vaginal delivery and designed to minimize trauma to the mother and baby. These features combined make it a potentially revolutionary development in obstetrics, particularly for improving intrapartum care and reducing maternal and perinatal morbidity and mortality in low resource settings. Methods/design This will be a hospital-based, multicenter prospective phase 1 cohort study with no control group. Delivery with the Odón device will be attempted under normal labour and non-emergency conditions on all the women enrolled in the study. One-hundred and thirty pregnant women will be recruited in tertiary care facilities in Argentina. Safety will be assessed by examining maternal and infant outcomes until discharge. Feasibility will be evaluated by observing successful expulsion of the fetal head after one-time application of the device under standardized conditions (full cervical dilation, anterior presentation, +2 station, normal fetal heart rate).  
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application/pdf  
dc.language.iso
eng  
dc.publisher
BioMed Central  
dc.rights
info:eu-repo/semantics/openAccess  
dc.rights.uri
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/  
dc.subject
Assisted Vaginal Delivery  
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Obstructed Labour  
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Intrapartum Complications  
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Odón Device  
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Maternal Mortality  
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Maternal Morbidity  
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Fetal Mortality  
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Medicina Critica y de Emergencia  
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Medicina Clínica  
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CIENCIAS MÉDICAS Y DE LA SALUD  
dc.title
Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol  
dc.type
info:eu-repo/semantics/article  
dc.type
info:ar-repo/semantics/artículo  
dc.type
info:eu-repo/semantics/publishedVersion  
dc.date.updated
2017-11-03T15:50:56Z  
dc.journal.volume
10  
dc.journal.pagination
1-8  
dc.journal.pais
Reino Unido  
dc.journal.ciudad
Londres  
dc.description.fil
Fil: Schvartzman, Javier A.. Centro de Educaciones Médicas e Investigación Clínica "Norberto Quirno"; Argentina  
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Fil: Krupitzki, Hugo Bernardo. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina  
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Fil: Betran, Ana Pilar. Department of Reproductive Health and Research. Ginebra; Suiza  
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Fil: Requejo, Jennifer. Department of Reproductive Health and Research. Ginebra; Suiza  
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Fil: Bergel, Eduardo. Instituto de Efectividad Clínica y Sanitaria; Argentina  
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Fil: Fiorillo, Angel Eduardo. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina  
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Fil: Gadow, Enrique Curt. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina  
dc.description.fil
Fil: Vizcaino, Francisco M.. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina  
dc.description.fil
Fil: Von Petery, Felicitas. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina  
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Fil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina  
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Fil: Belizan, Jose. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina  
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Fil: Borruto, Franco. Centre Hospitalier Princesse Grace; Mónaco  
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Fil: Boulvain, Michel. Hopitaux Universitaires de Ginebra. Ginebra; Suiza  
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Fil: Di Renzo, Gian Carlo. Santa Maria Della Misericordia University Hospital; Italia  
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Fil: Gülmezoglu , Metin. World Health Organization. Ginebra; Suiza  
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Fil: Hofmeyr, Justus. University of the Witwatersrand; Sudáfrica  
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Fil: Judge, Kevin. Becton Dr. Franklin Lakes. New York; Estados Unidos  
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Fil: Leung, Tak Yeung. The Chinese University of Hong Kong; Hong Kong  
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Fil: Nguyen, My Huong. Department of Reproductive Health and Research. Ginebra; Suiza  
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Fil: Saugstad, Ola Didrik. University of Oslo; Noruega  
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Fil: Temmerman, Marleen. Department of Reproductive Health and Research. Ginebra; Suiza  
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Fil: Treisser, Alain. Centre Hospitalier Princesse Grace; Mónaco  
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Fil: Vayena, Effy. Universitat Zurich; Suiza  
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Fil: Merialdi, Mario. Department of Reproductive Health and Research. Ginebra; Suiza  
dc.journal.title
Reproductive health  
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.1186/1742-4755-10-33  
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/https://reproductive-health-journal.biomedcentral.com/articles/10.1186/1742-4755-10-33