[Focus on the Odon Device™: Technical improvements, mechanical principles and progress of the clinical research program]

Abstract

The Odon Device™ has been described in the literature since 2013 and the World Health Organization supports its development through the Human Reproduction Program. This innovative device could be easier to use than usual instruments and could be an alternative to caesarean section during the second stage of labor, especially in countries where access to obstetric care is limited. The aim of the Odon Device™ is to position an air cuff over the fetal head, past its widest point (around the level of the fetal mouth anteriorly and the nape of the fetal neck posteriorly). Three mechanical principles favor the progression of the fetal head with the Odon Device™: partial propulsion, limited flexion and traction. Preliminary clinical studies on animals and simulators are reassuring and show that an appropriate use is no more at risk than the vaccum or forceps. A phase 1 study was conducted in Argentina and South Africa between 2011 and 2017. The reported failure rate was 29%, of which 77% was secondary to a mechanical failure of one of the components of the device. Improvements concerning the applicator, the handles and the inflatable air cuff have been made to the device. Phase II of the clinical research program began in 2018 and includes two studies in two different centers: The ASSIST Study in Bristol, England, and The BESANCON ASSIST Study, Besançon, France.

Keywords: Accouchement instrumental; Assisted delivery; Innovation; Mecanique obstétricale; Obstetrical mecanics; Recherche; Research.