Table 1.

Primary outcome for the ASSIST II Study

Criteria	Source	Collected by
The birth of the baby is expedited with the Odon Device	AVB pro forma Medical notes	Research team member including device operator
There are no serious maternal adverse events related to the use of the device during birth	AVB pro forma Medical notes	Research team member including device operator
There are no serious neonatal adverse events related to the use of the device during birth	AVB pro forma Medical notes	Research team member including device operator