Learning from 40 births using the Odon Device for assisted vaginal birth
- using case study methodology to explore optimum use
Abstract
Objective To explore optimum use of the Odon Device by establishing the
optimal device design, describing the ‘usual’ steps for use and setting
clinical parameters for device use. Design Qualitative case study
methodology was embedded in the ASSIST Study – a feasibility study of
the Odon Device. Setting Central Delivery Suite, North Bristol NHS
Trust, UK. Population Women who required a clinically indicated assisted
vaginal birth. Methods Each case was determined by 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, an interview with
obstetricians, midwives or women involved in an Odon assisted birth.
Data collection and analysis ran iteratively and in parallel enabling
rapid dissemination of findings. Main outcome measures Determining the
optimal steps for device use, recommendations for optimal device design
and defining clinical parameters for device use. Results Optimal steps
included applying the device during rather than between contractions,
having a flexible approach to the application angle and deflating the
air cuff sooner than originally proposed. Three design modifications
were proposed. The device can be used under local or regional
anaesthetic and is successful with all vertex presentations. It is not
successful at assisting birth when the vertex is at station spines.
Conclusions Case study methodology facilitated rapid insight into
optimum device design, device use and key clinical parameter for
successful use. This methodology should be considered whenever
innovative devices are introduced to clinical trials and settings.