Randomisation Process V6.0 17/01/17

How to randomise women In order to randomise a woman the clinician must have firstly obtained informed consent (see previous slides) Randomisation must only be performed AFTER the instrumental delivery, as the woman is not eligible until this time V6.0 17/01/17

Confirmation of eligibility Prior to randomisation you must complete Form 1 – Confirmation of Eligibility This is to ensure that the woman is fully eligible to participate. Once this has been completed and eligibility confirmed the woman can be randomised to the trial V6.0 17/01/17

Randomisation and Intervention Form 2: Randomisation and Intervention should then be completed as instructed on the form Women are randomised by selecting the next sequentially numbered pack from the ANODE drug dispensing box Please follow strict clinical guidelines surrounding drug preparation, administration and accountability within your unit V6.0 17/01/17

Randomisation and Intervention Remove the tear-off label showing the Study/Pack Number from the Intervention Pack and apply it to the space indicated in table A1 Form 2 Record the date and time the pack was taken V6.0 17/01/17

IMP Accountability Log Please ensure that you complete the IMP Accountability Log when removing the intervention packs from the ANODE Drug dispensing box – leaving the Log with the Drug box Complete a line for each pack removed V6.0 17/01/17