Methods
Forty births were assisted with the Odon Device at North Bristol NHS Trust, UK between October 2018 and January 2019. A case was defined as the single use of the Odon Device and could contain data from one or more of the following: formal observation of the Odon assisted birth, or an interview with obstetricians, midwives or women involved in an Odon assisted birth. Written consent was provided by all participants. Full methods of the ASSIST Study have been published.
Case study methodology enabled the exploration and determination of factors that improve optimal device use through bridging multiple factors relating to the device – technique, design and parameters for use (Figure 2).