Phase I trial: Safety and feasibility study of the Odon device for assisted vaginal delivery

Organization Location: 
Geneva, Switzerland

Currently, the three options for managing prolonged second stage of labour are forceps, vacuum extractor or caesarean section. All these interventions require relatively expensive equipment (e.g. operative theatre for caesarean section, maintenance of vacuum extractor) and highly trained health professionals. In addition, all these options are associated with increased risk of maternal and perinatal complications. The objective of the study is to evaluate the safety and feasibility of the Odon device, a 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.

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