Do the expected complications of postpartum bleeding need to be reported as adverse events?
Adverse events to be reported will be limited to those NOT already listed as primary or secondary outcomes, yet, which might reasonably occur as a consequence of the trial drug. Events that are part of the natural history of the primary event of PPH or expected complications of PPH should not be reported as adverse events. For example, low blood pressure and tachycardia are expected consequences of PPH and would not need to be reported.
