1. Prescribing, preparation and administration of the IMP including maintaining blinding
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2. Prescribing the ANODE IMP
Once it has been confirmed that a woman meets the eligibility criteria, verbal or written informed consent has been obtained, and the woman has been randomised, the ANODE trial intervention can be prescribed (this should only be prescribed by a clinician with a minimum of GCP Lite training included in ANODE training presentation ‘A’ and who has been signed off on the delegation log by the PI)
Co-amoxiclav or placebo is an Investigational Medicinal Product (IMP) and should be prescribed electronically or on the woman’s drug chart, to be given in a single intravenous dose
Where the prescription is to be written by hand the wording ‘ANODE IMP Study number XXXXX single dose, IV’ should be included. The Study number of the allocated pack is an essential component of the prescription
Complete the ‘Name of person prescribing section’ on Section B Form 2: Randomisation and Trial Intervention Form
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3. Preparation of the intervention
Please note: The active drug and the placebo are not matched; neither is the method of preparation. It will be impossible to distinguish which packs contain the placebo and which contain co-amoxiclav – but the person opening a pack and preparing or checking the intervention will not be blinded to allocation.
Therefore, the following people should not open a pack, prepare or check the intervention and should remain blinded to the woman’s allocation:
The Local Research Midwives involved in collecting outcome data for the woman
Any member of the clinical team who may be involved in her ongoing clinical care, to ensure her future clinical treatment is not influenced by knowledge of intervention allocation
The woman receiving the intervention should remain blinded to intervention allocation
To maintain the integrity of the trial the intervention allocation should NOT be disclosed to anyone.
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4. Staff checking the intervention
All staff responsible for checking the ANODE IMP should read the laminated ‘Information sheet for all staff checking the ANODE IMP’ stored with the ANODE dispensing box.
They should then sign Form 2: Randomisation and Trial Intervention to confirm they have read and understood that they must NOT:
Disclose the intervention allocation to anyone.
Be involved in the ongoing clinical care of the woman receiving the IMP today or during any subsequent shifts.
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5. Trial intervention Active Intervention Pack Contents
Placebo Intervention Pack Contents
Vial containing 1000 mg amoxicillin/200 mg clavulanic acid
1 x 20 ml vial sterile water for injection
Needle for drawing up liquid
50 ml Amber syringe
1 x 20 ml vial of normal saline 0.9%
Empty vial (for blinding purposes – to be discarded)
Needle for drawing up liquid
50 ml Amber syringe

6. Preparation and administration of the intervention
PLEASE ENSURE THAT INTERVENTION PREPARATION IS CARRIED OUT OUTSIDE OF THE DELIVERY ROOM TO MAINTAIN BLINDING OF THE ALLOCATION
The active intervention should be prepared and administered as per your trust clinical guidelines for the preparation and administration of Co-amoxiclav powder for solution for injection or infusion (1000mg amoxicillin/200mg clavulanic acid)
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7. Preparation and administration of the intervention
PLEASE ENSURE THAT INTERVENTION PREPARATION IS CARRIED OUT OUTSIDE OF THE ROOM OF DELIVERY TO MAINTAIN BLINDING OF THE ALLOCATION
The placebo intervention does not require reconstitution and should be drawn up in to the provided syringe
Administration of the placebo should mirror the administration of the co-amoxiclav to maintain blinding
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8. Preparation and administration of the intervention
Record if the preparation of the pack was successfully or unsuccessful in Table A1.
If there is a problem with the pack taken or a mistake is made during preparation, take the next sequentially numbered pack from the ANODE Dispensing Box
Include the Study/Pack Numbers from ALL of the packs taken in table A1 on Form 2: Randomisation and Trial Intervention. All packs MUST be accounted for
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9. Preparation and administration of the intervention
Only ONE pack should be administered to a woman.
The number on the pack taken and successfully prepared for a woman to be administered will be her Study Number
It is very important to clearly mark the pack which was successfully prepared in Table A1
This Study Number should be written on all data collection forms and the woman’s Consent Form
All empty vials should be disposed of in a sharps bin to maintain blinding
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10. Timing of administration
The intervention should be administered as soon as possible following delivery
This should be within 1-2 hours of delivery
The latest that the intervention should be administered is within 6 hours, after which time you should consult the ANODE team for advice
An intervention pack should not be opened to be prepared until it is due to be administered as co-amoxiclav should be administered within 20 minutes of reconstitution
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11. Trial Intervention
For the intervention pack taken and successfully prepared for a woman to be administered complete Section B on Form 2: Randomisation and Trial Intervention
The following people should sign and date where indicated:
1. The person prescribing the intervention
2. The person preparing the intervention (and checking the drug if applicable)
3. The person administering the intervention
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