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Schvartzman, Javier Alfonso  
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Krupitzki, Hugo Bernardo  
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Merialdi, Mario  
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Betrán, Ana Pilar  
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Requejo, Jennifer  
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Nguyen, My Huong  
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Vayena, Effy  
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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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Marroquin, Victoria  
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Cafferata, María Luisa  
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Mazzoni, Agustina  
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Vannevel, Valerie  
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Pattinson, Robert C.  
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Gülmezoglu, A. Metin  
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Althabe, Fernando  
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Bonet, Mercedes  
dc.date.available
2020-01-30T15:49:51Z  
dc.date.issued
2018-03  
dc.identifier.citation
Schvartzman, Javier Alfonso; Krupitzki, Hugo Bernardo; Merialdi, Mario; Betrán, Ana Pilar; Requejo, Jennifer; et al.; Odon device for instrumental vaginal deliveries: Results of a medical device pilot clinical study; BioMed Central; Reproductive Health; 15; 1; 3-2018; 1-10  
dc.identifier.issn
1742-4755  
dc.identifier.uri
http://hdl.handle.net/11336/96228  
dc.description.abstract
Background: A prolonged and complicated second stage of labour is associated with serious perinatal complications. The Odon device is an innovation intended to perform instrumental vaginal delivery presently under development. We present an evaluation of the feasibility and safety of delivery with early prototypes of this device from an early terminated clinical study. Methods: Hospital-based, multi-phased, open-label, pilot clinical study with no control group in tertiary hospitals in Argentina and South Africa. Multiparous and nulliparous women, with uncomplicated singleton pregnancies, were enrolled during the third trimester of pregnancy. Delivery with Odon device was attempted under non-emergency conditions during the second stage of labour. The feasibility outcome was delivery with the Odon device defined as successful expulsion of the fetal head after one-time application of the device. Results: Of the 49 women enrolled, the Odon device was inserted successfully in 46 (93%), and successful Odon device delivery as defined above was achieved in 35 (71%) women. Vaginal, first and second degree perineal tears occurred in 29 (59%) women. Four women had cervical tears. No third or fourth degree perineal tears were observed. All neonates were born alive and vigorous. No adverse maternal or infant outcomes were observed at 6-weeks follow-up for all dyads, and at 1 year for the first 30 dyads. Conclusions: Delivery using the Odon device is feasible. Observed genital tears could be due to the device or the process of delivery and assessment bias. Evaluating the effectiveness and safety of the further developed prototype of the BD Odon Device™ will require a randomized-controlled trial.  
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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
INSTRUMENTAL VAGINAL DELIVERY  
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ODON DEVICE  
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SECOND STAGE OF LABOUR  
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Obstetricia y Ginecología  
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Medicina Clínica  
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CIENCIAS MÉDICAS Y DE LA SALUD  
dc.title
Odon device for instrumental vaginal deliveries: Results of a medical device pilot clinical study  
dc.type
info:eu-repo/semantics/article  
dc.type
info:ar-repo/semantics/artículo  
dc.type
info:eu-repo/semantics/publishedVersion  
dc.date.updated
2019-10-09T20:44:13Z  
dc.journal.volume
15  
dc.journal.number
1  
dc.journal.pagination
1-10  
dc.journal.pais
Estados Unidos  
dc.description.fil
Fil: Schvartzman, Javier Alfonso. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET; Argentina  
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Fil: Krupitzki, Hugo Bernardo. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET; Argentina  
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Fil: Merialdi, Mario. Organización Mundial de la Salud; Suiza  
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Fil: Betrán, Ana Pilar. Organización Mundial de la Salud; Suiza  
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Fil: Requejo, Jennifer. Organización Mundial de la Salud; Suiza  
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Fil: Nguyen, My Huong. Organización Mundial de la Salud; Suiza  
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Fil: Vayena, Effy. ETH Zurich; Suiza  
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Fil: Fiorillo, Angel Eduardo. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET; Argentina  
dc.description.fil
Fil: Gadow, Enrique Curt. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET; Argentina  
dc.description.fil
Fil: Vizcaino, Francisco M.. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET; Argentina  
dc.description.fil
Fil: Von Petery, Felicitas. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET; Argentina  
dc.description.fil
Fil: Marroquin, Victoria. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET; Argentina  
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Fil: Cafferata, María Luisa. Instituto de Efectividad Clínica y Sanitaria; Argentina  
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Fil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; Argentina  
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Fil: Vannevel, Valerie. University of Pretoria; Sudáfrica  
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Fil: Pattinson, Robert C.. University of Pretoria; Sudáfrica  
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Fil: Gülmezoglu, A. Metin. Organización Mundial de la Salud; Suiza  
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Fil: Althabe, Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; Argentina  
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Fil: Bonet, Mercedes. Organización Mundial de la Salud; Suiza  
dc.journal.title
Reproductive Health  
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.1186/s12978-018-0485-8  
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/https://reproductive-health-journal.biomedcentral.com/articles/10.1186/s12978-018-0485-8