Phase I Trial: Safety and Feasibility Study of the Odon Device for Assisted Vaginal Delivery
The objective of the study is to evaluate the safety and feasibility of the Odon device, a low cost, easy to use technological innovation, in assisting vaginal delivery in singleton term pregnancies during the second stage of labor. Interim evaluation of the device for safety and feasibility showed no major severe adverse events among women or infants enrolled in the study. The experience suggests that the device is easy to use and allows successful expulsion of the baby. The Odon device could play a major role in improving intrapartum obstetric care in the most vulnerable populations with the least access to well-trained specialists, extraction procedures or timely caesarean section.