The Principal Investigator reports that the Preclinical Phase of their trial was performed in a Simulation Center in Des Moines, USA, under the supervision of the WHO. Phase I (Feto-maternal feasibility and security) was launched at the Saavedra branch of CEMIC (Center for Medical Education and Clinical Research “Norberto Quirno”), Buenos Aires, Argentina; with WHO’s support and under their constant supervision.
The "Odón Device," which is a plastic bag that fits over the baby’s head, may offer an alternative for assisting with fetus extraction in cases of prolonged labor, especially where birth attendants may not have the requisite skills for forceps or vacuum delivery. Jorge Ernesto Odón invented the device. It is fitted on the top of the baby’s head while in the birth canal and creates an air clamp around the fetal head, allowing a birth attendant to aid delivery timed with the mother’s contractions. This “Odón Method” is low-tech, low-cost, disposable, and doesn’t require medical expertise as the lack of rigid instruments reduces the risk of injury to both mother and child. The method was tested successfully in 2008 at Des Moines University and holds potential for addressing prolonged labor without advanced medical technology or expertise. Watch the youtube video of testing at Des Moines here.
