An International Collaboration to Implement and Evaluate at Scale the Active Prevention and Treatment of Maternal Sepsis (APT-Sepsis Programme)

MATERNAL SEPSIS - AN URGENT RESEARCH NEED "Maternal sepsis" is a life threatening condition caused by infection during or after pregnancy. It occurs if the body's response to a developing infection causes damage to its own organs. Maternal sepsis contributes to half of all maternal deaths. Internationally, organisations such as the World Health Organisation and United Nations are committed to reducing the numbers of women who die due to pregnancy and childbirth. Tackling maternal sepsis is an important part of this effort. However, there has been inadequate international focus on this issue, and there is an urgent need to identify effective ways to combat this problem. A POTENTIAL SOLUTION "The Active Prevention and Treatment of Maternal Sepsis" or APT-sepsis is a carefully developed programme designed specifically to be used in countries and facilities where there are limited resources available. It aims to change health care workers behaviours to ensure mothers get the best care possible to better prevent and manage infections. In particular the programme will improve care by ensuring that health care workers: 1) always wash their hands to prevent the transmission of infections, 2) prevent infections by following all the World Health Organisation guidelines on infection prevention during pregnancy and birth 3) carry out regular vital sign monitoring and act rapidly to ensure women with suspected sepsis are given all the correct initial treatments using a specially developed maternal sepsis treatment "bundle". This programme is based on an understanding that changing behaviours of health care workers required a carefully planned approach. Our approach helps provide the information, motivation and tools needed. This includes training delivered at the site, paper based checklists and reminders, a network of site champions who can help encourage change and provide ongoing feedback and coaching, involvement of the site management, re-organising sharing of tasks between staff and helping motivate sites and individuals. WORK PREPARING FOR THE TRIAL We have been working over several years with the World Health Organisation and healthcare workers in low resource countries to develop ATP-sepsis. We have tested all parts of the programme in multiple hospitals and shown that it improves the quality of care given to women, and that it is acceptable and that change in practice can be maintained. However, to show that it improves the most important outcomes such as women dying or having very severe infections needs a large trial involving many centres and women and this is what we now plan to do. THE APT-SEPSIS TRIAL To carefully answer the question if the APT-sepsis programme reduces mothers dying or having the most severe infections will involve a clinical trial. This will be done in Malawi and Uganda. We will work across 30 hospitals in each country. After a period where the outcomes will be carefully measured across all facilities, half of the hospitals will then test the APT-sepsis intervention and half will continue their usual practices. Which hospitals will use APT-sepsis will be decided by chance, but making sure that there is a balance in the facilities between both groups. For the next 20 months we will then compare the outcomes in those hospitals taking part in APT-sepsis and those where usual practice is occurring. We will also look in detail at the way the programme is being carried out. This aspect will involve measuring what is happening at the facilities and also detailed interviews to understand the opinions of staff. This research will tell us if the APT-sepsis programme can reduce bad outcomes and stop deaths from maternal sepsis in low resource settings. It will also help us understand how APT-sepsis is used in the study sites so that we can plan further implementation if it is shown to be useful. We also will discover if the APT-sepsis programme is cost effective.