Data collection
Observation of Odon assisted births were undertaken by the lead qualitative researcher and Odon operator through participant observation. All observations including contextual factors and communication were prospectively recorded on a bespoke observation schedule. Detailed analysis of the operative steps performed by the obstetrician during AVBs were recorded enabling a stepwise account of the ‘usual steps’ to be generated and compared against the IFU. Changes or adaptations to the technique were disseminated to all operators by the lead researcher and through the training programme.
All women who had the birth of their baby formally observed were invited to participate in an interview at day one postnatal. The operator and midwives present during an Odon assisted birth were invited to take part in an interview conducted within five days of the birth.
Data regarding whether the Odon Device had been successful or unsuccessful was taken from the case report forms.