The odon device for assisted vaginal birth - update from the besancon assist study

Introduction: The Odon DeviceTM is an innovative investigational device for assisted vaginal birth (AVB) and has not yet been granted regulatory approval for sale in any country. The device consists of an applicator, sleeve and cuff. The device is designed for use by different level of trained health care providers. Efficacy studies are presently in progress in two centers: The ASSIST II Study, Bristol, England, and The BESANCON ASSIST Study, Besançon, France. Methods: The “Besançon ASSIST study” will recruit 104 women to receive the Odon Device when an assisted vaginal birth is required. Births are conducted by obstetricians who have received training in the use of the device. Data collected at recruitment includes: birth characteristics, safety, acceptability, patient-reported and operator-reported outcomes. Follow-up is on day 1, 7, 28 and 90 postnatally. Results: In Besançon, 1,597 eligible women consented to participate between December 2019 and March 2021. An Odon device was used for 98 eligible cases and was successful in 86 (88%).There have been no reports of any serious maternal or neonatal adverse events related to the use of the device during birth or serious adverse device effects for either trial thus far. Conclusions: This rate of success is highly encouraging and comparable to currently available devices.The Odon Device appears to easy to use, and results to date suggest it is safe, effective and acceptable to women. A randomised controlled trial is required to compare the Odon Device with currently available alternatives.