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Table 1 Primary outcome

From: The ASSIST Study - The BD Odon Device for assisted vaginal birth: a safety and feasibility study

Criterion

Source

Collected by

The birth of the baby is expedited with the BD 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

There are no serious adverse device effects

AVB pro-forma medical notes

Research team member including device operator

The woman’s perception of her birth is rated above a score of 6

Case report form

Research team member

The practitioner reported outcome is above 12.

Case report form

Device operator

  1. AVB assisted vaginal birth