Feasibility and safety of a new device (Odon device) for assisted vaginal deliveries

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Intrapartum complications are responsible for approximately half of all maternal deaths and two million stillbirth and neonatal deaths per year. Prolonged second stage of labor is associated with potentially fatal maternal complications and is a major cause of stillbirth and newborn morbidity and mortality. Currently, the three main options for managing prolonged second stage of labor are cesarean section, forceps and vacuum extractor. All three clinical practices require relatively expensive equipment, highly trained staff that are often not available in low resource settings and, even if available, their use is associated with increased maternal and perinatal complications. The specific aim of the proposed study is to test the safety and feasibility of a new device (Odon Device) to deliver the fetus during prolonged second stage of labor. The Odon device is a low cost, easy to use technological innovation to facilitate operative vaginal delivery and designed to minimize trauma to the mother and baby. This device may be potentially safer and easier to apply than forceps/vacuum extractor for assisted deliveries, and a safe alternative to some caesarean sections. If proven safe and effective, the Odon Device will be the first innovation in operative vaginal delivery since the independent development of forceps and the vacuum extractor centuries ago. The Odon device could play a major role in improving intrapartum obstetric care in low resource settings by making possible effective management of intrapartum complications in facilities lacking surgical capacity and/or personnel adequately trained in the use of forceps and the vacuum extractor.