1. Randomisation Process
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2. 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
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3. 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
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4. 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
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5. 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
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6. 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
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