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

• 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
• Año de publicación: 2013
• Idioma: inglés
• Tipo de recurso: artículo
• Materia: Assisted vaginal delivery; Obstructed labour; Intrapartum complications; Odón device; Maternal mortality; Maternal morbidity; Fetal mortality
• Institución: Consejo Nacional de Investigaciones Científicas y Técnicas

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).
Fil: Schvartzman, Javier A.. Centro de Educaciones Médicas e Investigación Clínica "Norberto Quirno"; Argentina
Fil: Krupitzki, Hugo Bernardo. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina
Fil: Betran, Ana Pilar. Department of Reproductive Health and Research. Ginebra; Suiza
Fil: Requejo, Jennifer. Department of Reproductive Health and Research. Ginebra; Suiza
Fil: Bergel, Eduardo. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Fiorillo, Angel Eduardo. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina
Fil: Gadow, Enrique Curt. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina
Fil: Vizcaino, Francisco M.. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina
Fil: Von Petery, Felicitas. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina
Fil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Belizan, Jose. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Borruto, Franco. Centre Hospitalier Princesse Grace; Mónaco
Fil: Boulvain, Michel. Hopitaux Universitaires de Ginebra. Ginebra; Suiza
Fil: Di Renzo, Gian Carlo. Santa Maria Della Misericordia University Hospital; Italia
Fil: Gülmezoglu , Metin. World Health Organization. Ginebra; Suiza
Fil: Hofmeyr, Justus. University of the Witwatersrand; Sudáfrica
Fil: Judge, Kevin. Becton Dr. Franklin Lakes. New York; Estados Unidos
Fil: Leung, Tak Yeung. The Chinese University of Hong Kong; Hong Kong
Fil: Nguyen, My Huong. Department of Reproductive Health and Research. Ginebra; Suiza
Fil: Saugstad, Ola Didrik. University of Oslo; Noruega
Fil: Temmerman, Marleen. Department of Reproductive Health and Research. Ginebra; Suiza
Fil: Treisser, Alain. Centre Hospitalier Princesse Grace; Mónaco
Fil: Vayena, Effy. Universitat Zurich; Suiza
Fil: Merialdi, Mario. Department of Reproductive Health and Research. Ginebra; Suiza