Complications due to prolonged second stage of labor include potentially fatal maternal (hemorrhage, infection) and newborn complications (birth asphyxia and trauma).
The Odon device is a new low cost instrument to deliver the fetus when complications occur during the second stage of labor. This device is made of film-like polyethylene material and may be potentially safer and easier to apply than forceps and vacuum extractor (contraindicated in cases of HIV infection) for assisted deliveries, and a safe alternative to some Caesarean sections in settings with limited surgical capacity and human resource constraints.
The Odon device has potential for wide application in resource poor settings even by mid-level providers. If proven safe and effective, the Odon Device will be the first innovation in operative vaginal delivery since the development of forceps centuries ago and vacuum extractor decades ago. By reducing contacts between the baby’s head and the birth channel, the device could prevent infections acquired during delivery.
The Odon Device is being tested in a two-phased study in health care facilities in Argentina and rural South Africa. During phase 1, the device will be tested for safety and feasibility under normal delivery conditions. Testing has already started at a tertiary care center in Argentina in the context of a WHO approved study.