Contact details and IMP description
- What are the contact details for the Trial Co-ordinator?
- Shan Gray, ANODE Trial Coordinator
National Perinatal Epidemiology Unit, Old Road Campus, Headington, Oxford, OX3 7LF
Tel: 01865 289 750 – Fax: 01865 289 740 – Email: firstname.lastname@example.org
- Where is the IMP manufactured?
- Guy's and St.Thomas' NHS Foundation Trust
Pharmacy Manufacturing Unit
13th Floor Tower Wing
Great Maze Pond
Tel: 0207 188 7188 ex 51674 Emal: email@example.com
- What are the dimensions/description of the ANODE dispensing boxes?
- Each dispensing pack measures 21cm x 24.5 cm x 10.5 cm (insert photo) and contains five boxes of IMP. Each box of IMP (insert photo) contains either:-
The active drug - A vial containing 1000mg amoxicillin/200mg clavulanic acid, 1 x 20ml vial sterile water for injection, needle for drawing up liquid, 50 ml amber syringe or
The placebo – 1 x 20ml vial of normal saline 0.9%, empty vial for blinding purposes, needle for drawing up liquid, 50 ml amber syringe
Each pack contains a randomly allocated trial number in the form of a sticker on the back of the pack.
Do not open the top lid of the box and please dispose of all packaging following dispensing of the IMP to maintain blinding.
- How much stock will pharmacy and labour ward be expected to hold?
- We would normally supply up to 12 dispensing boxes to your pharmacy (60 doses in total) – two of these dispensing boxes should be held on labour ward or in theatre.
- Is it necessary for the IMP to be temperature monitored when it is on labour ward/theatre?
- It is not a requirement of the ANODE trial that the IMP be temperature monitored when on labour ward or in theatres but some Trusts specify that all IMPs be temperature monitored – please check with your Trust.
- Why are women who receive intrapartum antibiotics still eligible for ANODE?
- Antibiotics given in labour (particularly for GBS prophylaxis) have a different spectrum of activity i.e. don’t kill the bugs which are the main cause of infection following instrumental delivery. Co-amoxiclav has a wider spectrum and would therefore act differently to prevent infection.
- Why was co-amoxiclav chosen for the trial over other antibiotics?
- Co-amoxiclav is the antibiotic with the best spectrum of coverage to prevent infection with the widest range of organisms which might infect the perineum/genital tract after forceps/ventouse delivery, bearing in mind that unlike general surgical wounds, it is impossible to cover with a dressing and always contaminated because of its anatomical position.
- One of our sites queried whether women participating in ANODE would be at an increased risk of developing C.difficile?
- Women undergoing Caesarean Section all get antibiotic prophylaxis, usually with cefuroxime which is a higher risk antibiotic than the co-amoxiclav that we are using. Moreover most of these women will be fit and well and young, and therefore at low risk of C.difficile. A review in BJOG of the risks of antibiotic prophylaxis in CS concluded that there was little risk associated with antibiotic prophylaxis.
- If a woman receives IV Benzylpenicillin for group B strep, is there a time period after she has the last dose in labour before administration of the IMP?
- Co-amoxiclav should be administered as soon as it is indicated in this situation. Benzylpenicillin is a very narrow spectrum antibiotic that will not provide adequate prophylaxis. Therefore any delay in administering co-amoxiclav here will potentially disadvantage the participant. If she has normal renal function there should be no problem with administering a single dose of co-amoxiclav on top of even the high dose penicillin used as intrapartum prophylaxis.
- On the Entry Form Question 6 – ‘Did this woman receive antibiotics in the 7 days prior to delivery? Does this include intrapartum antibiotics for GBS or PROM?
- If a woman has a pyrexia not associated with any infection or suspected infection, does this preclude them from taking part in the study?
- No, as long as they haven’t been judged to have a need for ongoing antibiotics.
- Question 5 on section C of the entry form which asks ‘did the membranes rupture prior to delivery?’ Does this mean prior to labour rather than prior to delivery? Do you still want us to answer yes if they ruptured in labour but say only 6 hours prior to actual delivery?
- This should be clicked ‘yes’ to any membrane rupture before delivery (NOT just before labour). Once yes is clicked, the box for duration of membrane rupture should open up.
- If a woman is enrolled in the HOLDS trial is she still eligible for ANODE?
- If a woman is enrolled in the PITCHES trial is she still eligible for ANODE?
- If a woman is enrolled in the GOT- IT trial is she still eligible for ANODE?
- No – their sponsor doesn’t permit co-enrolment with other trials for insurance reasons.