Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol

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 majo...

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Autores: Schvartzman, Javier A., Krupitzki, Hugo Bernardo, Betran, Ana Pilar, Requejo, Jennifer, Bergel, Eduardo, Fiorillo, Angel Eduardo, Gadow, Enrique Curt, Vizcaino, Francisco M., Von Petery, Felicitas, Althabe, Fernando, Belizan, Jose, Borruto, Franco, Boulvain, Michel, Di Renzo, Gian Carlo, Gülmezoglu , Metin, Hofmeyr, Justus, Judge, Kevin, Leung, Tak Yeung, Nguyen, My Huong, Saugstad, Ola Didrik, Temmerman, Marleen, Treisser, Alain, Vayena, Effy, Merialdi, Mario
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2013
País:Argentina
Institución:Consejo Nacional de Investigaciones Científicas y Técnicas
Repositorio:CONICET Digital (CONICET)
Idioma:inglés
OAI Identifier:oai:ri.conicet.gov.ar:11336/28198
Acceso en línea:http://hdl.handle.net/11336/28198
Access Level:acceso abierto
Palabra clave:Assisted vaginal delivery
Obstructed labour
Intrapartum complications
Odón device
Maternal mortality
Maternal morbidity
Fetal mortality
https://purl.org/becyt/ford/3.2
https://purl.org/becyt/ford/3
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network_acronym_str AR
network_name_str Argentina
repository_id_str
dc.title.none.fl_str_mv Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol
title Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol
spellingShingle Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol
Schvartzman, Javier A.
Assisted vaginal delivery
Obstructed labour
Intrapartum complications
Odón device
Maternal mortality
Maternal morbidity
Fetal mortality
https://purl.org/becyt/ford/3.2
https://purl.org/becyt/ford/3
title_short Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol
title_full Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol
title_fullStr Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol
title_full_unstemmed Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol
title_sort Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol
dc.creator.none.fl_str_mv Schvartzman, Javier A.
Krupitzki, Hugo Bernardo
Betran, Ana Pilar
Requejo, Jennifer
Bergel, Eduardo
Fiorillo, Angel Eduardo
Gadow, Enrique Curt
Vizcaino, Francisco M.
Von Petery, Felicitas
Althabe, Fernando
Belizan, Jose
Borruto, Franco
Boulvain, Michel
Di Renzo, Gian Carlo
Gülmezoglu , Metin
Hofmeyr, Justus
Judge, Kevin
Leung, Tak Yeung
Nguyen, My Huong
Saugstad, Ola Didrik
Temmerman, Marleen
Treisser, Alain
Vayena, Effy
Merialdi, Mario
author Schvartzman, Javier A.
author_facet Schvartzman, Javier A.
Krupitzki, Hugo Bernardo
Betran, Ana Pilar
Requejo, Jennifer
Bergel, Eduardo
Fiorillo, Angel Eduardo
Gadow, Enrique Curt
Vizcaino, Francisco M.
Von Petery, Felicitas
Althabe, Fernando
Belizan, Jose
Borruto, Franco
Boulvain, Michel
Di Renzo, Gian Carlo
Gülmezoglu , Metin
Hofmeyr, Justus
Judge, Kevin
Leung, Tak Yeung
Nguyen, My Huong
Saugstad, Ola Didrik
Temmerman, Marleen
Treisser, Alain
Vayena, Effy
Merialdi, Mario
author_role author
author2 Krupitzki, Hugo Bernardo
Betran, Ana Pilar
Requejo, Jennifer
Bergel, Eduardo
Fiorillo, Angel Eduardo
Gadow, Enrique Curt
Vizcaino, Francisco M.
Von Petery, Felicitas
Althabe, Fernando
Belizan, Jose
Borruto, Franco
Boulvain, Michel
Di Renzo, Gian Carlo
Gülmezoglu , Metin
Hofmeyr, Justus
Judge, Kevin
Leung, Tak Yeung
Nguyen, My Huong
Saugstad, Ola Didrik
Temmerman, Marleen
Treisser, Alain
Vayena, Effy
Merialdi, Mario
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Assisted vaginal delivery
Obstructed labour
Intrapartum complications
Odón device
Maternal mortality
Maternal morbidity
Fetal mortality
https://purl.org/becyt/ford/3.2
https://purl.org/becyt/ford/3
topic Assisted vaginal delivery
Obstructed labour
Intrapartum complications
Odón device
Maternal mortality
Maternal morbidity
Fetal mortality
https://purl.org/becyt/ford/3.2
https://purl.org/becyt/ford/3
description 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).
publishDate 2013
dc.date.none.fl_str_mv 2013-07
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/28198
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
1742-4755
CONICET Digital
CONICET
url http://hdl.handle.net/11336/28198
identifier_str_mv 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
1742-4755
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.1186/1742-4755-10-33
info:eu-repo/semantics/altIdentifier/url/https://reproductive-health-journal.biomedcentral.com/articles/10.1186/1742-4755-10-33
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv BioMed Central
publisher.none.fl_str_mv BioMed Central
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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spelling Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocolSchvartzman, Javier A.Krupitzki, Hugo BernardoBetran, Ana PilarRequejo, JenniferBergel, EduardoFiorillo, Angel EduardoGadow, Enrique CurtVizcaino, Francisco M.Von Petery, FelicitasAlthabe, FernandoBelizan, JoseBorruto, FrancoBoulvain, MichelDi Renzo, Gian CarloGülmezoglu , MetinHofmeyr, JustusJudge, KevinLeung, Tak YeungNguyen, My HuongSaugstad, Ola DidrikTemmerman, MarleenTreisser, AlainVayena, EffyMerialdi, MarioAssisted vaginal deliveryObstructed labourIntrapartum complicationsOdón deviceMaternal mortalityMaternal morbidityFetal mortalityhttps://purl.org/becyt/ford/3.2https://purl.org/becyt/ford/3Background 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).Fil: Schvartzman, Javier A.. Centro de Educaciones Médicas e Investigación Clínica "Norberto Quirno"; ArgentinaFil: Krupitzki, Hugo Bernardo. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; ArgentinaFil: Betran, Ana Pilar. Department of Reproductive Health and Research. Ginebra; SuizaFil: Requejo, Jennifer. Department of Reproductive Health and Research. Ginebra; SuizaFil: Bergel, Eduardo. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Fiorillo, Angel Eduardo. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; ArgentinaFil: Gadow, Enrique Curt. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; ArgentinaFil: Vizcaino, Francisco M.. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; ArgentinaFil: Von Petery, Felicitas. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; ArgentinaFil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Belizan, Jose. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Borruto, Franco. Centre Hospitalier Princesse Grace; MónacoFil: Boulvain, Michel. Hopitaux Universitaires de Ginebra. Ginebra; SuizaFil: Di Renzo, Gian Carlo. Santa Maria Della Misericordia University Hospital; ItaliaFil: Gülmezoglu , Metin. World Health Organization. Ginebra; SuizaFil: Hofmeyr, Justus. University of the Witwatersrand; SudáfricaFil: Judge, Kevin. Becton Dr. Franklin Lakes. New York; Estados UnidosFil: Leung, Tak Yeung. The Chinese University of Hong Kong; Hong KongFil: Nguyen, My Huong. Department of Reproductive Health and Research. Ginebra; SuizaFil: Saugstad, Ola Didrik. University of Oslo; NoruegaFil: Temmerman, Marleen. Department of Reproductive Health and Research. Ginebra; SuizaFil: Treisser, Alain. Centre Hospitalier Princesse Grace; MónacoFil: Vayena, Effy. Universitat Zurich; SuizaFil: Merialdi, Mario. Department of Reproductive Health and Research. Ginebra; SuizaBioMed Central2013-07info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/28198Schvartzman, 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; 1-81742-4755CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1186/1742-4755-10-33info:eu-repo/semantics/altIdentifier/url/https://reproductive-health-journal.biomedcentral.com/articles/10.1186/1742-4755-10-33info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2024-05-08T14:13:16Zoai:ri.conicet.gov.ar:11336/28198instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982024-05-08 14:13:16.71CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
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