The last innovation in operative vaginal delivery happened centuries ago with the invention of the forceps and the vacuum extractor. The World Health Organization Odon Device Research Group recently published a protocol for a feasibility and safety study for a new device (Odon device) which aims to revolutionize assisted vaginal delivery. This editorial discusses the device and its pathway to global use. Although preliminary results look promising, the rigorous three-phased WHO protocol needs completion before the device can be determined, based on the evidence, to be safe and effective.Fil: Belizan, Jose. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Harris Requejo, Jennifer. Johns Hopkins Bloomberg School of Public Health. Institute for International Programs; Estados Unido

Belizan, Jose

Harris Requejo, Jennifer

Reproductive Health

English

PubMed

Jennifer Harris Requejo

José M Belizán

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Odon device: a promising tool to facilitate vaginal delivery and increase access to emergency care

CONICET Digital

Requejo and Belizán Reproductive Health 2013, 10:42http://www.reproductive-health-journal.com/content/10/1/42EDITORIAL Open AccessOdon device: a promising tool to facilitate vaginaldelivery and increase access to emergency careJennifer Harris Requejo1* and José M Belizán2AbstractThe last innovation in operative vaginal delivery happened centuries ago with the invention of the forceps and thevacuum extractor. The World Health Organization Odon Device Research Group recently published a protocol for afeasibility and safety study for a new device (Odon device) which aims to revolutionize assisted vaginal delivery.This editorial discusses the device and its pathway to global use. Although preliminary results look promising, therigorous three-phased WHO protocol needs completion before the device can be determined, based on theevidence, to be safe and effective.In this journal, the World Health Organization OdonDevice Research Group describes the protocol for afeasibility and safety study of a new device (Odon device)for assisted vaginal deliveries [1]. This device is a low cost,easy to use technological innovation to facilitate operativevaginal delivery when complications occur during thesecond stage of labor. It is designed to minimize traumato the mother and the baby, and may be possible forapplication by mid-level providers. These features com-bined make the Odon device a potentially revolutionarydevelopment in obstetrics. As the article points out, thelast innovation in operative vaginal delivery happenedcenturies ago with the invention of the forceps and thevacuum extractor, both of which require a high level ofskill to use and are associated with certain risks of in-jury to mother and baby. Similarly, caesarean delivery –a third option for clinical management of prolongedsecond stage of labour – is out of reach for manywomen living in low resource settings, making innova-tions like the Odon device essential for increasingwomen’s access to needed obstetrical care.Complications related to prolonged second stage oflabor are responsible for countless women’s and children’sdeaths and long-term disabilities [2,3]. The Odon Devicerepresents a promising novel way to potentially preventthese deaths and improve obstetrical outcomes for bothmother and baby. Given its simplicity and the likelihood* Correspondence: jrequejo@jhsph.edu1Institute for International Programs, Johns Hopkins Bloomberg School ofPublic Health, Baltimore, Maryland, USAFull list of author information is available at the end of the article© 2013 Requejo and Belizán; licensee BioMedCreative Commons Attribution License (http:/distribution, and reproduction in any mediumthat mid-level providers can be trained on its use, the de-vice could increase multi-fold women’s access to qualityemergency obstetrical care – particularly the most vul-nerable populations who struggle to reach tertiary carefacilities when something goes wrong during childbirth.The possibility that use of the device could have add-itional benefits such as counteracting the worrisomerise in caesarean deliveries worldwide, and reducingperinatal infections acquired through the birth canalduring childbirth must also be explored.The seeds of innovation – the Odon device’shumble originsThe story of the development of the Odon Device is atribute to human ingenuity, and gives further credenceto Albert Einstein’s adage, “imagination is more importantthan knowledge”. In 2005, Mr. Jorge Odon, a car mechanicfrom Argentina with no medical training, was inspired todesign the device after thinking carefully about the basicscientific principles underlying a simple trick he used toperform for his friends. This trick involved removing acork from the inside of an empty bottle without breakingit. His eureka moment happened when he realized thatthe solution to the cork challenge could be adapted to amethod for facilitating childbirth.What followed this initial spark was a rapid uptake ofthe idea from Mr. Odon’s first collaboration in 2006 withthe Center for Medical Education and Clinical Investigation(CEMIC) in Buenos Aires, Argentina and professionalsfrom WHO, to the testing of the device in 2008 on asimulator at Des Moines University, Iowa, USA, to theCentral Ltd. This is an Open Access article distributed under the terms of the/creativecommons.org/licenses/by/2.0), which permits unrestricted use,, provided the original work is properly cited.Requejo and Belizán Reproductive Health 2013, 10:42 Page 2 of 2http://www.reproductive-health-journal.com/content/10/1/42approval in 2009 of a World Health Organization studyprotocol to test the device on human beings, and, finally,to the awarding in 2011 of a “Saving Lives at Birth: AGrand Challenge for Development” grant to further testthe potential of the device to save women’s and children’slives at the time of birth when the majority of maternaland newborn deaths occur.Where are we now? The pathway to global useThe World Health Organization Odon Device ResearchGroup’s article in this journal describes in detail the firstphase of the WHO’s three-phased study protocol aimedat bringing the Odon Device from a clever, long-overdueidea into the ‘obstetric arsenal’ – expanding the clinicalmanagement tools available to practitioners for assistedvaginal delivery. The first phase is underway and involvesthe testing of the device under normal delivery conditionsin tertiary hospitals in Argentina and South Africa. Thenext two phases will assess preliminary efficacy in facilitat-ing delivery when women are experiencing prolongedsecond stage of labor with no fetal distress, and comparethe effectiveness of the device to the vacuum extractorand forceps.Although preliminary results look promising, the rigor-ous three-phased WHO protocol needs completion beforethe device can be determined, based on the evidence, tobe safe and effective.Author details1Institute for International Programs, Johns Hopkins Bloomberg School ofPublic Health, Baltimore, Maryland, USA. 2Institute for Clinical Effectivenessand Health Policy, Buenos Aires, Argentina.Received: 13 August 2013 Accepted: 13 August 2013Published: 20 August 2013References1. The World Health Organization Odon Device Research Group: Feasibilityand safety study of a new device (Odón device) for assisted vaginaldeliveries: study protocol. Reprod Health 2013, 10:33.2. AbouZahr C: Global burden of maternal death and disability. In Reducingmaternal death and disability in pregnancy. Edited by Rodeck C. Oxford:Oxford University Press; 2003:1–11.3. Ronsmans C, Graham WJ, on behalf of The Lancet Maternal Survival Seriessteering group: Maternal mortality: who, when, where, and why. Lancet2006, 368:1189–1200.doi:10.1186/1742-4755-10-42Cite this article as: Requejo and Belizán: Odon device: a promising toolto facilitate vaginal delivery and increase access to emergency care.Reproductive Health 2013 10:42.Submit your next manuscript to BioMed Centraland take full advantage of: • Convenient online submission• Thorough peer review• No space constraints or color ﬁgure charges• Immediate publication on acceptance• Inclusion in PubMed, CAS, Scopus and Google Scholar• Research which is freely available for redistributionSubmit your manuscript at www.biomedcentral.com/submit

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Requejo and Belizán Reproductive Health 2013, 10:42http://www.reproductive-health-journal.com/content/10/1/42EDITORIAL Open AccessOdon device: a promising tool to facilitate vaginaldelivery and increase access to emergency careJennifer Harris Requejo1* and José M Belizán2AbstractThe last innovation in operative vaginal delivery happened centuries ago with the invention of the forceps and thevacuum extractor. The World Health Organization Odon Device Research Group recently published a protocol for afeasibility and safety study for a new device (Odon device) which aims to revolutionize assisted vaginal delivery.This editorial discusses the device and its pathway to global use. Although preliminary results look promising, therigorous three-phased WHO protocol needs completion before the device can be determined, based on theevidence, to be safe and effective.In this journal, the World Health Organization OdonDevice Research Group describes the protocol for afeasibility and safety study of a new device (Odon device)for assisted vaginal deliveries [1]. This device is a low cost,easy to use technological innovation to facilitate operativevaginal delivery when complications occur during thesecond stage of labor. It is designed to minimize traumato the mother and the baby, and may be possible forapplication by mid-level providers. These features com-bined make the Odon device a potentially revolutionarydevelopment in obstetrics. As the article points out, thelast innovation in operative vaginal delivery happenedcenturies ago with the invention of the forceps and thevacuum extractor, both of which require a high level ofskill to use and are associated with certain risks of in-jury to mother and baby. Similarly, caesarean delivery –a third option for clinical management of prolongedsecond stage of labour – is out of reach for manywomen living in low resource settings, making innova-tions like the Odon device essential for increasingwomen’s access to needed obstetrical care.Complications related to prolonged second stage oflabor are responsible for countless women’s and children’sdeaths and long-term disabilities [2,3]. The Odon Devicerepresents a promising novel way to potentially preventthese deaths and improve obstetrical outcomes for bothmother and baby. Given its simplicity and the likelihood* Correspondence: jrequejo@jhsph.edu1Institute for International Programs, Johns Hopkins Bloomberg School ofPublic Health, Baltimore, Maryland, USAFull list of author information is available at the end of the article© 2013 Requejo and Belizán; licensee BioMedCreative Commons Attribution License (http:/distribution, and reproduction in any mediumthat mid-level providers can be trained on its use, the de-vice could increase multi-fold women’s access to qualityemergency obstetrical care – particularly the most vul-nerable populations who struggle to reach tertiary carefacilities when something goes wrong during childbirth.The possibility that use of the device could have add-itional benefits such as counteracting the worrisomerise in caesarean deliveries worldwide, and reducingperinatal infections acquired through the birth canalduring childbirth must also be explored.The seeds of innovation – the Odon device’shumble originsThe story of the development of the Odon Device is atribute to human ingenuity, and gives further credenceto Albert Einstein’s adage, “imagination is more importantthan knowledge”. In 2005, Mr. Jorge Odon, a car mechanicfrom Argentina with no medical training, was inspired todesign the device after thinking carefully about the basicscientific principles underlying a simple trick he used toperform for his friends. This trick involved removing acork from the inside of an empty bottle without breakingit. His eureka moment happened when he realized thatthe solution to the cork challenge could be adapted to amethod for facilitating childbirth.What followed this initial spark was a rapid uptake ofthe idea from Mr. Odon’s first collaboration in 2006 withthe Center for Medical Education and Clinical Investigation(CEMIC) in Buenos Aires, Argentina and professionalsfrom WHO, to the testing of the device in 2008 on asimulator at Des Moines University, Iowa, USA, to theCentral Ltd. This is an Open Access article distributed under the terms of the/creativecommons.org/licenses/by/2.0), which permits unrestricted use,, provided the original work is properly cited.Requejo and Belizán Reproductive Health 2013, 10:42 Page 2 of 2http://www.reproductive-health-journal.com/content/10/1/42approval in 2009 of a World Health Organization studyprotocol to test the device on human beings, and, finally,to the awarding in 2011 of a “Saving Lives at Birth: AGrand Challenge for Development” grant to further testthe potential of the device to save women’s and children’slives at the time of birth when the majority of maternaland newborn deaths occur.Where are we now? The pathway to global useThe World Health Organization Odon Device ResearchGroup’s article in this journal describes in detail the firstphase of the WHO’s three-phased study protocol aimedat bringing the Odon Device from a clever, long-overdueidea into the ‘obstetric arsenal’ – expanding the clinicalmanagement tools available to practitioners for assistedvaginal delivery. The first phase is underway and involvesthe testing of the device under normal delivery conditionsin tertiary hospitals in Argentina and South Africa. Thenext two phases will assess preliminary efficacy in facilitat-ing delivery when women are experiencing prolongedsecond stage of labor with no fetal distress, and comparethe effectiveness of the device to the vacuum extractorand forceps.Although preliminary results look promising, the rigor-ous three-phased WHO protocol needs completion beforethe device can be determined, based on the evidence, tobe safe and effective.Author details1Institute for International Programs, Johns Hopkins Bloomberg School ofPublic Health, Baltimore, Maryland, USA. 2Institute for Clinical Effectivenessand Health Policy, Buenos Aires, Argentina.Received: 13 August 2013 Accepted: 13 August 2013Published: 20 August 2013References1. The World Health Organization Odon Device Research Group: Feasibilityand safety study of a new device (Odón device) for assisted vaginaldeliveries: study protocol. Reprod Health 2013, 10:33.2. AbouZahr C: Global burden of maternal death and disability. In Reducingmaternal death and disability in pregnancy. Edited by Rodeck C. Oxford:Oxford University Press; 2003:1–11.3. Ronsmans C, Graham WJ, on behalf of The Lancet Maternal Survival Seriessteering group: Maternal mortality: who, when, where, and why. Lancet2006, 368:1189–1200.doi:10.1186/1742-4755-10-42Cite this article as: Requejo and Belizán: Odon device: a promising toolto facilitate vaginal delivery and increase access to emergency care.Reproductive Health 2013 10:42.Submit your next manuscript to BioMed Centraland take full advantage of: • Convenient online submission• Thorough peer review• No space constraints or color figure charges• Immediate publication on acceptance• Inclusion in PubMed, CAS, Scopus and Google Scholar• Research which is freely available for redistributionSubmit your manuscript at www.biomedcentral.com/submit

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Odon device: a promising tool to facilitate vaginal delivery and increase access to emergency care

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