Primary outcome
The primary outcome was compliance with the protocol, i.e. the use of
the appropriate color code for the indication of cesarean section and
compliance with the decision-delivery interval imposed by the protocol.
Four situations were identified in the event of non-compliance with the
protocol:
- Color code used did not correspond to that proposed
by the protocol for a given indication.
- Decision-delivery interval greater than that indicated in the
protocol.
- Simultaneous presence of the two situations mentioned above
(total non-compliance with protocol)
- No mention of a color code or time of decision in the medical
file, whether computerized or paper (”missing data” group).
Based on these five situations, we categorized patients into five
categories to make it easier to read the results:
- Category 1: Full compliance with protocol
- Category 2: Decision-delivery interval greater than that
indicated by the protocol
- Category 3: The color code used did not match that provided
by the protocol
- Category 4: Non-compliance with the protocol in both cases
(inappropriate color code and decision-delivery interval greater than
the maximum time imposed by the protocol)
- Category 5: Missing data (decision time and/or color code not
mentioned in medical record)