Information Pathway and Eligibility Criteria

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Presentation transcript:

Information Pathway and Eligibility Criteria

Information pathway We anticipate that all woman when they are admitted to hospital in labour will already be aware of the trial The ANODE Antenatal Information Sheet should be given to women antenatally and when entering delivery suite in labour Areas to introduce this Antenatal Information Sheet include, anomaly scan clinics, antenatal classes, GTT clinics and during induction of Labour Display the Antenatal Poster within these areas V6.0 17/01/17

Information pathway In addition to the ANODE Antenatal Information Sheet there are two versions of the ANODE Participant Information Leaflet These leaflets should not be given to women until an Instrumental Delivery is confirmed Leaflet A should be given to women who have no time constraint and are considered able to give written consent. Leaflet B should be given to women who have given verbal consent and have received the trial intervention prior to obtaining written consent V6.0 17/01/17

Who can take part? Inclusion Criteria Women aged 16 years or above, willing and able to give informed consent Women who have had an operative vaginal delivery at 36+0 weeks or greater gestation V6.0 17/01/17

Who can take part? Exclusion Criteria Women may not enter the trial if ANY of the following apply: Clinical indication for ongoing antibiotic administration post-delivery e.g. due to confirmed antenatal infection or 3rd of 4th degree tears Note that receiving antenatal antibiotics e.g. for maternal Group B Streptococcal carriage or prolonged rupture of membranes, is not a reason for exclusion if there is no indication for ongoing antibiotic prescription post-delivery. Known allergy to penicillin or to any of the components of co-amoxiclav, as documented in hospital notes   History of anaphylaxis (a severe hypersensitivity reaction) to another B-lactam agent (e.g. cephalosporin, carbapenem or monobactam), as documented in hospital notes   V6.0 17/01/17

Intervention arm/Control arm Women will be randomised to either the active intervention arm or the placebo control arm of the trial via the taking of a sequentially numbered indistinguishable sealed box Those in the active intervention arm will receive a single dose of intravenous co-amoxiclav (1000 mg amoxicillin/200 mg clavulanic acid) Those in the placebo control arm will receive a single dose of intravenous normal saline (0.9% normal saline) V6.0 17/01/17