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dc.contributor.author Schvartzman, Javier A.
dc.contributor.author Krupitzki, Hugo Bernardo
dc.contributor.author Betran, Ana Pilar
dc.contributor.author Requejo, Jennifer
dc.contributor.author Bergel, Eduardo
dc.contributor.author Fiorillo, Angel Eduardo
dc.contributor.author Gadow, Enrique Curt
dc.contributor.author Vizcaino, Francisco M.
dc.contributor.author Von Petery, Felicitas
dc.contributor.author Althabe, Fernando
dc.contributor.author Belizan, Jose
dc.contributor.author Borruto, Franco
dc.contributor.author Boulvain, Michel
dc.contributor.author Di Renzo, Gian Carlo
dc.contributor.author Gülmezoglu , Metin
dc.contributor.author Hofmeyr, Justus
dc.contributor.author Judge, Kevin
dc.contributor.author Leung, Tak Yeung
dc.contributor.author Nguyen, My Huong
dc.contributor.author Saugstad, Ola Didrik
dc.contributor.author Temmerman, Marleen
dc.contributor.author Treisser, Alain
dc.contributor.author 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).
dc.format 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
dc.subject Obstructed labour
dc.subject Intrapartum complications
dc.subject Odón device
dc.subject Maternal mortality
dc.subject Maternal morbidity
dc.subject Fetal mortality
dc.subject.classification Medicina Critica y de Emergencia
dc.subject.classification Medicina Clínica
dc.subject.classification 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
dc.description.fil Fil: Krupitzki, Hugo Bernardo. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina
dc.description.fil Fil: Betran, Ana Pilar. Department of Reproductive Health and Research. Ginebra; Suiza
dc.description.fil Fil: Requejo, Jennifer. Department of Reproductive Health and Research. Ginebra; Suiza
dc.description.fil Fil: Bergel, Eduardo. Instituto de Efectividad Clínica y Sanitaria; Argentina
dc.description.fil Fil: Fiorillo, Angel Eduardo. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina
dc.description.fil 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
dc.description.fil Fil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina
dc.description.fil Fil: Belizan, Jose. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
dc.description.fil Fil: Borruto, Franco. Centre Hospitalier Princesse Grace; Mónaco
dc.description.fil Fil: Boulvain, Michel. Hopitaux Universitaires de Ginebra. Ginebra; Suiza
dc.description.fil Fil: Di Renzo, Gian Carlo. Santa Maria Della Misericordia University Hospital; Italia
dc.description.fil Fil: Gülmezoglu , Metin. World Health Organization. Ginebra; Suiza
dc.description.fil Fil: Hofmeyr, Justus. University of the Witwatersrand; Sudáfrica
dc.description.fil Fil: Judge, Kevin. Becton Dr. Franklin Lakes. New York; Estados Unidos
dc.description.fil Fil: Leung, Tak Yeung. The Chinese University of Hong Kong; Hong Kong
dc.description.fil Fil: Nguyen, My Huong. Department of Reproductive Health and Research. Ginebra; Suiza
dc.description.fil Fil: Saugstad, Ola Didrik. University of Oslo; Noruega
dc.description.fil Fil: Temmerman, Marleen. Department of Reproductive Health and Research. Ginebra; Suiza
dc.description.fil Fil: Treisser, Alain. Centre Hospitalier Princesse Grace; Mónaco
dc.description.fil Fil: Vayena, Effy. Universitat Zurich; Suiza
dc.description.fil 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


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info:eu-repo/semantics/openAccess Excepto donde se diga explícitamente, este item se publica bajo la siguiente descripción: Creative Commons Attribution-NonCommercial-ShareAlike 2.5 Unported (CC BY-NC-SA 2.5)