Sleeve alterations
One operator noted that the sleeve seal lines tore during traction, with
this happening on several occasions:
D4: ‘The deliveries have been fine, but the sleeve is not
sturdy….That it might actually rip it open, which has happened
with me a few times.’
During device inspection, it was noted that all devices had small tears
(<2cm) in the seal lines of the sleeve, and one had a
significant tear (>7cm). There was no evidence any of these
tears had had any negative effect on the function of the Odon Device.
Tearing was thought to have occurred when operators opened the sleeve
handles before and between tractions to physically look at the station
of the vertex. In contrast to standard device use for AVB, there was
little proprioceptive feedback to ascertain the station of the baby, so
visual inspection was useful:
O5: ‘…I got the impression that the operator was unsure as
to whether the head had descended so opened the handles to look inside
the sleeve. Could see the baby had descended nicely.’
It was recommended that the opening between the two handles was made
wider to enable operators to view the progression of the baby’s head
more easily (Figure S1).