Introduction
Each year approximately 82,000 women in the UK have an assisted vaginal
birth (AVB). In recent years, despite the known advantages of AVB, there
has been a rate reduction with a corresponding increase in Caesarean
births in the second stage of labour. Despite AVB being an important
skill in modern obstetric practice, there have been no new methods for
AVB introduced since the 1950s.
Current devices for AVB require a high level of training and skill (with
expertise required to define the fetal position) and can be associated
with significant maternal and neonatal morbidity if used incorrectly. An
innovative device that is easier to use and potentially safer, could
contribute to increasing women’s access AVB, which in turn would help to
reduce the number and associated morbidity of emergency Caesarean
sections performed in the second stage. An ideal new device would have a
(i) lower rate of maternal complications, (ii) lower rate of neonatal
complications, (iii) lower failure rate and (iv) be acceptable to women,
obstetricians, midwives and neonatologists.
The Odon Device (Figure 1) is a Class I sterile device. Medical devices
are developed to be clinically effective, with safety and performance
crucial in ensuring their intended action is achieved without fault.
Devices are developed with accompanying Instructions For Use (IFU),
which detail the technique and specified parameters for use.
The Odon Device has undergone rigorous pre-clinical, simulation, human
factors and Phase 1 first-in human investigation which demonstrated that
it appeared to be safe. However, the device had not yet been used in the
intended population: women who require an AVB for a clinical indication.
Before the device can be introduced into widespread practice the
efficacy, expected indications for device use, technique for device use
and design of the device need to be examined in the clinical setting.
This study applied qualitative case study methodology to examine in
detail how the Odon Device (version 4.1) is used for AVB, and how this
use varies with different contextual factors with the aim of (i)
establishing the optimal device design, (ii) describing the ‘usual’
steps for use and (iii) setting clinical parameters for device use. This
qualitative research was embedded in the ASSIST Study – a feasibility
study of the Odon Device.