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 |