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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