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Table 1 Primary outcome for the ASSIST II Study

From: The Odon Device™ for assisted vaginal birth: a feasibility study to investigate safety and efficacy—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