Odon device for instrumental vaginal deliveries: Results of a medical device pilot clinical study

Autores
Schvartzman, Javier Alfonso; Krupitzki, Hugo Bernardo; Merialdi, Mario; Betrán, Ana Pilar; Requejo, Jennifer; Nguyen, My Huong; Vayena, Effy; Fiorillo, Angel Eduardo; Gadow, Enrique Curt; Vizcaino, Francisco M.; Von Petery, Felicitas; Marroquin, Victoria; Cafferata, María Luisa; Mazzoni, Agustina; Vannevel, Valerie; Pattinson, Robert C.; Gülmezoglu, A. Metin; Althabe, Fernando; Bonet, Mercedes
Año de publicación
2018
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
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.
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
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
Fil: Merialdi, Mario. Organización Mundial de la Salud; Suiza
Fil: Betrán, Ana Pilar. Organización Mundial de la Salud; Suiza
Fil: Requejo, Jennifer. Organización Mundial de la Salud; Suiza
Fil: Nguyen, My Huong. Organización Mundial de la Salud; Suiza
Fil: Vayena, Effy. ETH Zurich; Suiza
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
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
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
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
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
Fil: Cafferata, María Luisa. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Vannevel, Valerie. University of Pretoria; Sudáfrica
Fil: Pattinson, Robert C.. University of Pretoria; Sudáfrica
Fil: Gülmezoglu, A. Metin. Organización Mundial de la Salud; Suiza
Fil: Althabe, Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Bonet, Mercedes. Organización Mundial de la Salud; Suiza
Materia
INSTRUMENTAL VAGINAL DELIVERY
ODON DEVICE
SECOND STAGE OF LABOUR
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/96228
Acceder
id CONICETDig_b1a094122889a7d8e1325a4566f9653d
oai_identifier_str oai:ri.conicet.gov.ar:11336/96228
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Odon device for instrumental vaginal deliveries: Results of a medical device pilot clinical studySchvartzman, Javier AlfonsoKrupitzki, Hugo BernardoMerialdi, MarioBetrán, Ana PilarRequejo, JenniferNguyen, My HuongVayena, EffyFiorillo, Angel EduardoGadow, Enrique CurtVizcaino, Francisco M.Von Petery, FelicitasMarroquin, VictoriaCafferata, María LuisaMazzoni, AgustinaVannevel, ValeriePattinson, Robert C.Gülmezoglu, A. MetinAlthabe, FernandoBonet, MercedesINSTRUMENTAL VAGINAL DELIVERYODON DEVICESECOND STAGE OF LABOURhttps://purl.org/becyt/ford/3.2https://purl.org/becyt/ford/3Background: 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.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; ArgentinaFil: 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; ArgentinaFil: Merialdi, Mario. Organización Mundial de la Salud; SuizaFil: Betrán, Ana Pilar. Organización Mundial de la Salud; SuizaFil: Requejo, Jennifer. Organización Mundial de la Salud; SuizaFil: Nguyen, My Huong. Organización Mundial de la Salud; SuizaFil: Vayena, Effy. ETH Zurich; SuizaFil: 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; ArgentinaFil: 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; ArgentinaFil: 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; ArgentinaFil: 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; ArgentinaFil: 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; ArgentinaFil: Cafferata, María Luisa. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Vannevel, Valerie. University of Pretoria; SudáfricaFil: Pattinson, Robert C.. University of Pretoria; SudáfricaFil: Gülmezoglu, A. Metin. Organización Mundial de la Salud; SuizaFil: Althabe, Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Bonet, Mercedes. Organización Mundial de la Salud; SuizaBioMed Central2018-03info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/96228Schvartzman, 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; 1-101742-4755CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1186/s12978-018-0485-8info:eu-repo/semantics/altIdentifier/url/https://reproductive-health-journal.biomedcentral.com/articles/10.1186/s12978-018-0485-8info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T10:08:14Zoai:ri.conicet.gov.ar:11336/96228instacron: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:34982025-09-03 10:08:14.861CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Odon device for instrumental vaginal deliveries: Results of a medical device pilot clinical study
title Odon device for instrumental vaginal deliveries: Results of a medical device pilot clinical study
spellingShingle Odon device for instrumental vaginal deliveries: Results of a medical device pilot clinical study
Schvartzman, Javier Alfonso
INSTRUMENTAL VAGINAL DELIVERY
ODON DEVICE
SECOND STAGE OF LABOUR
title_short Odon device for instrumental vaginal deliveries: Results of a medical device pilot clinical study
title_full Odon device for instrumental vaginal deliveries: Results of a medical device pilot clinical study
title_fullStr Odon device for instrumental vaginal deliveries: Results of a medical device pilot clinical study
title_full_unstemmed Odon device for instrumental vaginal deliveries: Results of a medical device pilot clinical study
title_sort Odon device for instrumental vaginal deliveries: Results of a medical device pilot clinical study
dc.creator.none.fl_str_mv Schvartzman, Javier Alfonso
Krupitzki, Hugo Bernardo
Merialdi, Mario
Betrán, Ana Pilar
Requejo, Jennifer
Nguyen, My Huong
Vayena, Effy
Fiorillo, Angel Eduardo
Gadow, Enrique Curt
Vizcaino, Francisco M.
Von Petery, Felicitas
Marroquin, Victoria
Cafferata, María Luisa
Mazzoni, Agustina
Vannevel, Valerie
Pattinson, Robert C.
Gülmezoglu, A. Metin
Althabe, Fernando
Bonet, Mercedes
author Schvartzman, Javier Alfonso
author_facet Schvartzman, Javier Alfonso
Krupitzki, Hugo Bernardo
Merialdi, Mario
Betrán, Ana Pilar
Requejo, Jennifer
Nguyen, My Huong
Vayena, Effy
Fiorillo, Angel Eduardo
Gadow, Enrique Curt
Vizcaino, Francisco M.
Von Petery, Felicitas
Marroquin, Victoria
Cafferata, María Luisa
Mazzoni, Agustina
Vannevel, Valerie
Pattinson, Robert C.
Gülmezoglu, A. Metin
Althabe, Fernando
Bonet, Mercedes
author_role author
author2 Krupitzki, Hugo Bernardo
Merialdi, Mario
Betrán, Ana Pilar
Requejo, Jennifer
Nguyen, My Huong
Vayena, Effy
Fiorillo, Angel Eduardo
Gadow, Enrique Curt
Vizcaino, Francisco M.
Von Petery, Felicitas
Marroquin, Victoria
Cafferata, María Luisa
Mazzoni, Agustina
Vannevel, Valerie
Pattinson, Robert C.
Gülmezoglu, A. Metin
Althabe, Fernando
Bonet, Mercedes
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv INSTRUMENTAL VAGINAL DELIVERY
ODON DEVICE
SECOND STAGE OF LABOUR
topic INSTRUMENTAL VAGINAL DELIVERY
ODON DEVICE
SECOND STAGE OF LABOUR
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.2
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv 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.
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
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
Fil: Merialdi, Mario. Organización Mundial de la Salud; Suiza
Fil: Betrán, Ana Pilar. Organización Mundial de la Salud; Suiza
Fil: Requejo, Jennifer. Organización Mundial de la Salud; Suiza
Fil: Nguyen, My Huong. Organización Mundial de la Salud; Suiza
Fil: Vayena, Effy. ETH Zurich; Suiza
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
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
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
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
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
Fil: Cafferata, María Luisa. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Vannevel, Valerie. University of Pretoria; Sudáfrica
Fil: Pattinson, Robert C.. University of Pretoria; Sudáfrica
Fil: Gülmezoglu, A. Metin. Organización Mundial de la Salud; Suiza
Fil: Althabe, Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Bonet, Mercedes. Organización Mundial de la Salud; Suiza
description 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.
publishDate 2018
dc.date.none.fl_str_mv 2018-03
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/11336/96228
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
1742-4755
CONICET Digital
CONICET
url http://hdl.handle.net/11336/96228
identifier_str_mv 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
1742-4755
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
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info:eu-repo/semantics/altIdentifier/url/https://reproductive-health-journal.biomedcentral.com/articles/10.1186/s12978-018-0485-8
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
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application/pdf
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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
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
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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