For the first time since it left the garage of its inventor, the Argentine mechanic Jorge Odon, the OdonAssist™ device has been used in the delivery room by healthcare personnel and not only by specialist doctors. This took place in Wolisso, Ethiopia, at St. Luke Hospital, where midwives and surgical technicians personally assisted women during childbirth.
“The success of these eight deliveries shows that we are on the right track,” says Michele Orsi, gynecologist at the Policlinico of Milan and project lead with CUAMM. “Thanks to its ease of use, low associated risks, effectiveness, and high acceptability, the device has the potential to be truly revolutionary in expanding access to operative delivery in fragile settings.”
This first result highlights the potential of OdonAssist™, a tool that is as simple as it is effective and innovative. Thanks to this “inflatable sleeve,” the risks associated with operative vaginal delivery—necessary in cases of prolonged labor or fetal distress and traditionally performed using instruments such as forceps and vacuum extractors—are minimized.
“The tools available so far are instruments that require greater training and familiarity in their use,” says Michele Orsi, “and if they are not used correctly, they can cause complications that are difficult to manage in the absence of specialists and adequate equipment.”
Limited staff, often not highly specialized, and lack of equipment are common conditions in healthcare facilities across sub-Saharan Africa, where specialist doctors are scarce. The need, therefore, is to minimize risks and ensure safe childbirth. Safety, effectiveness, and acceptability are precisely what make OdonAssist™ a promising tool. For these reasons, in the pilot study in Wolisso, delivery-room healthcare staff were directly involved alongside the gynecologist. Assessing acceptability among both healthcare workers and women in labor in this context will be a key parameter in understanding the future prospects of this innovation.
The women who gave birth thanks to OdonAssist™, assisted by staff at St. Luke’s Hospital, met specific inclusion and exclusion criteria of the feasibility study launched early this year at the hospital thanks to an initiative funded by FID and implemented by CUAMM in collaboration with the University of Besançon and St. Luke’s Hospital in Wolisso. This study made Ethiopia the first low-resource country on the African continent to be involved in this type of research and today makes it the first and only country in which healthcare personnel have used OdonAssist™ operationally in a delivery room.
THE DEVICE
OdonAssist™ is safe and designed to be affordable. The device—born from the innovative intuition of Argentine mechanic Jorge Odon—is an inflatable tool intended for assisted vaginal delivery and is produced by Maternal and Newborn Health Innovation, a company registered as a Public Benefit Corporation. Compared to other instruments currently in use, OdonAssist™ is designed to be safer, easier to use, and more acceptable to both women and healthcare providers. It consists of a thin polyethylene sleeve and a retractable plastic introducer, at the end of which is a small cup that rests on the fetal head. Once positioned around the fetal head, the operator inflates a small air chamber at the end of the sleeve, ensuring a secure yet gentle grip around the baby’s head and facilitating traction through the birth canal. Thanks to this innovative design, the device combines three key mechanical principles that support the progression of the fetal head: propulsion, flexion, and traction. OdonAssist™ therefore presents itself as a potential alternative to forceps and vacuum extractors, helping to avoid cesarean section during the second stage of labor, when the mother is actively pushing.
