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).