APT-Sepsis study

The Active Prevention and Treatment of Maternal Sepsis (APT-Sepsis) study

The Active Prevention and Treatment of Maternal Sepsis (APT-Sepsis) is a carefully developed complex programme designed specifically to be used in countries and facilities where there are limited resources available. It aims to change healthcare workers’ behaviours to ensure mothers get the best care possible to better prevent and manage infections. The APT-Sepsis intervention brings together evidence-based practice to address these issues via an integrated program with 3 interventional domains and an implementation strategy. The first interventional domain is ‘hand hygiene’, ensuring compliance with the WHO 5 moments of hand hygiene. The second interventional domain is infection prevention and management which ensures the adoption of evidence-based practices for infection prevention in maternity, including appropriate antibiotic prophylaxis for high-risk women and improved surgical practices, the third intervention is the identification and treatment of sepsis.

We will evaluate if implementation of the APT- Sepsis programme is effective at reducing infection related maternal mortality and severe morbidity. We will also conduct a rigorous process evaluation to understand the implementation of the programme and will determine its cost effectiveness. This will be done to understand the implementation of APT-Sepsis and develop a longer-term implementation strategy. The study will be conducted for a period of 26 months, split into baseline, transition and intervention.

This is a cluster randomised study consisting of 60 hospitals in Malawi (n=30) and Uganda (n=30). Each hospital is a cluster from whom baseline data will be collected prior to the implementation of APT-Sepsis. Then 15 clusters in each country will be randomised for the APT- Sepsis intervention, the remaining sites will continue with their usual practices. In Malawi the clusters are secondary level care hospitals which includes public district hospitals, and rural hospitals in the districts of Karonga, Rumphi. Nkhata Bay, Mzimba, Kasungu, Nkhotakota, Salima, Ntchisi, Lilongwe, Mchinji, Dedza, Ntcheu, Balaka, Neno, Mwanza, Machinga, Mangochi, Zomba, Blantyre, Chiradzulu, Phalombe, Mulanje, Thyolo, Chikwawa and Nsanje. This covers 90% of the districts in Malawi.

Staff from the sites will benefit from increased training and knowledge in the prevention identification and treatment of APT-Sepsis. The patients they care for will be beneficiaries of this knowledge and it is our hope this will lead to improvements in the reduction of maternal mortality. The ministry of health in Malawi is part of the team implementing this study through the Reproductive health and quality management directorate.

The study team.

Principal investigator: Associate prof Luis Gadama

Trial Coordinator: Regina Makuluni

Site leads: Mirriam Kanyemba, James Kasenda, Tionge Mkandawire, Chimwemwe Kachiwaya, and Adrian Malunga

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