ANODE Trial Overview V6.0 17/01/17.

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Presentation transcript:

ANODE Trial Overview V6.0 17/01/17

Background Sepsis is now the most important cause of direct maternal death in the UK (Lewis, Cantwell et al. 2011) In addition to every maternal death, an estimated 50 women suffer severe sepsis (requiring level 2 or 3 critical care) but survive NICE Guidance recommends the use of prophylactic antibiotics at all caesarean deliveries (based on substantial RCT evidence of effectiveness) V6.0 17/01/17

Background Studies conducted in both the UK and the US have documented an additional risk associated with operative vaginal delivery, particularly in relation to Group A Streptococcal infection but there is currently insufficient evidence to support prophylactic antibiotic use for OVDs A Cochrane Review updated in 2012 recommends that further robust evidence is needed (Liabsuetrakul, Choobun et. al. 2004) v.6.0 17/01/17

Facts and figures Approximately 13% of women in the UK undergo an Operative Vaginal Delivery (OVD) (forceps or ventouse) - an estimated 104,000 women annually (Health and Social Care Information Centre 2012) A conservative estimate of maternal infection following OVD is 4% (Liabsuetrakul, Choobun et al. 2004) This equates to an estimated 4,160 women potentially having an infection following OVD Of these women around 200 will be diagnosed with severe sepsis (Acosta, Bhatta Charya et.al. 2012) and up to four may die V6.0 17/01/17

What is the ANODE trial? ANODE is a randomised controlled trial of prophylactic ANtibiotics to investigate the prevention of infection following Operative vaginal DElivery Multicentre randomised, blinded, placebo-controlled trial Aiming to recruit 3,424 women over 30 hospital sites in the UK The main aim will be to test the effectiveness of a single intravenous dose of co-amoxiclav against a placebo in reducing the incidence of infection following OVD There will be a follow-up period of six weeks V6.0 17/01/17

Who is running the Trial? The National Perinatal Epidemiology Unit at the University of Oxford (NPEU) ANODE is funded by the National Institute for Health Research HTA Programme (project number 13/96/07) V6.0 17/01/17

Trial Objectives The Primary Objectives of the trial are to compare the incidence of confirmed or suspected maternal infection in the first six weeks after OVD amongst women who have been randomised to receive prophylactic antibiotic versus placebo The Secondary Objectives are to investigate the effect of the intervention on various other short-term maternal outcomes, including severe sepsis, perineal wound infection/pain, hospital admission and maternal general health V6.0 17/01/17