Adverse event reporting and harms {22}
death, intracranial and pulmonary haemorrhage, vascular occlusive, seizure, organ dysfunction, pain, dizziness, infection, bruising, nausea,, PPH, adverse skin reaction, sepsis
ADVERSE EVENTS, INFECTION, EVENTS, EVENTS, SEPSIS
Maternal and neonatal events which occur as a consequence of the CS or vaginal birth, events which commonly occur in this population independent of the trial treatment, events which are present before randomisation, and events which are recorded as study outcomes, do not need to be reported as adverse events. Although congenital and genetic abnormalities cannot be attributed to the trial treatment because it is given minutes before birth, we will record these on the outcome form.Events recorded on the outcome form up to discharge, death, or day 42 (whichever is sooner) will be presented to the DMC for regular review, and so will not be reported using the adverse events (AE) reporting procedure. For maternal outcomes, this includes PPH, nausea, vomiting, dizziness, vascular occlusive events, seizure, infection, sepsis, organ dysfunction, and pain or adverse skin reaction at the injection site. For neonatal outcomes, this includes stillbirth/intrapartum death, neonatal death, intracranial and pulmonary haemorrhage, bruising, seizure, and vascular occlusive events.Other medical events that fulfil the AE definition below will be reported up to 42 days after administration of trial treatment. If a woman is discharged before 42 days, outcome events after discharge and up to 42 days that fulfil the AE definition will be reported, including those on the outcome form. At discharge, women will be given an ‘alert card’ identifying them as an I’M WOMAN trial participant and asked to present this card to anyone providing medical care after discharge, up to day 42. The card will have instructions to ensure the AE reporting procedures are followed. A safety reporting overview is provided in Additional file 