What happens if an Adverse Event occurs after discharge?
If a discharged woman is subsequently readmitted to hospital, has any untoward medical event, or is known to have died after she is discharged, this should be reported as an adverse event using the adverse event form, if it occurs within 42 days (6 weeks) of randomisation. An Adverse Event is defined in the Protocol as ‘any untoward medical occurrence’. Please see the Protocol and the Manual of Operating Procedures for further details. All women randomised onto the trial will be given a patient alert card. The woman should be advised that she should; • carry the card with her for at least 6 weeks after her entry to the trial (the date will be written inside the card) • present the card to any healthcare provider she sees • advise her family that she is carrying the card so that in the unlikely event she is seriously ill they can present the card to the healthcare provider on her behalf In addition, to alert all medical staff to the fact that a woman has been randomised to the trial, a
