Device application with a contraction
The original IFU stated that the Odon Device should be applied between contractions, as is standard practice with other devices for AVB (forceps and ventouse). It became apparent during the first two attempted AVBs that this disimpacted the fetal head out of the pelvis and operators were unable to correctly place the device:
D1: ‘Again, I had to use significant pressure to try and get the device over the fetal head. And loads of liquor came down during the application suggesting that there was some degree of disimpaction.’
By the third attempted birth, operators had adapted their technique to include fundal pressure to aid application, which resulted in successful device application and the first successful AVB. The use of fundal pressure, although successful, was not well tolerated by women without a regional anaesthetic:
M3: ‘Significant fundal pressure that was used at the time…she was uncomfortable…maybe that will be something up for review.’
Following feedback from qualitative findings, the application technique was adapted again during the eighth birth. This was the first time the Odon Device was applied during a contraction without the use of fundal pressure, resulting in a successful application and birth:
D2: ‘I haven’t used fundal pressure since delivery number two or three for me, but what has been very successful is putting it on during a contraction. I think.’