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.