dc.creatorSchvartzman, Javier A.
dc.creatorKrupitzki, Hugo Bernardo
dc.creatorBetran, Ana Pilar
dc.creatorRequejo, Jennifer
dc.creatorBergel, Eduardo
dc.creatorFiorillo, Angel Eduardo
dc.creatorGadow, Enrique Curt
dc.creatorVizcaino, Francisco M.
dc.creatorVon Petery, Felicitas
dc.creatorAlthabe, Fernando
dc.creatorBelizan, Jose
dc.creatorBorruto, Franco
dc.creatorBoulvain, Michel
dc.creatorDi Renzo, Gian Carlo
dc.creatorGülmezoglu , Metin
dc.creatorHofmeyr, Justus
dc.creatorJudge, Kevin
dc.creatorLeung, Tak Yeung
dc.creatorNguyen, My Huong
dc.creatorSaugstad, Ola Didrik
dc.creatorTemmerman, Marleen
dc.creatorTreisser, Alain
dc.creatorVayena, Effy
dc.creatorMerialdi, Mario
dc.date.accessioned2017-11-15T12:09:50Z
dc.date.accessioned2018-11-06T14:58:17Z
dc.date.available2017-11-15T12:09:50Z
dc.date.available2018-11-06T14:58:17Z
dc.date.created2017-11-15T12:09:50Z
dc.date.issued2013-07
dc.identifierSchvartzman, 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.identifier1742-4755
dc.identifierhttp://hdl.handle.net/11336/28198
dc.identifierCONICET Digital
dc.identifierCONICET
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/1892269
dc.description.abstractBackground 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.languageeng
dc.publisherBioMed Central
dc.relationinfo:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.1186/1742-4755-10-33
dc.relationinfo:eu-repo/semantics/altIdentifier/url/https://reproductive-health-journal.biomedcentral.com/articles/10.1186/1742-4755-10-33
dc.rightshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectAssisted vaginal delivery
dc.subjectObstructed labour
dc.subjectIntrapartum complications
dc.subjectOdón device
dc.subjectMaternal mortality
dc.subjectMaternal morbidity
dc.subjectFetal mortality
dc.titleFeasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol
dc.typeArtículos de revistas
dc.typeArtículos de revistas
dc.typeArtículos de revistas


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