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.

Objective:
Evaluate through a cluster randomised trial if implementation of the APT-sepsis programme reduces infection related maternal mortality and severe morbidity, evaluate implementation of the programme, and determine cost effectiveness.

Study Design:
Multi-country, parallel cluster randomised trial with baseline phase

Project duration:
42 months

Research location:
Malawi and Uganda

Population:
Clusters will be health care facilities managing > 1,500 births per year, offering comprehensive emergency obstetric care.
The primary outcome will be collected from all women who are admitted whilst pregnant or within 42 days of delivery.

Intervention:
APT-Sepsis is a complex intervention, developed to target care providers behaviours to improve adherence to best practice in 1) hand hygiene, 2) prevention and management of maternal infections 3) maternal sepsis management, including the FAST-M maternal sepsis bundle. It includes a carefully optimised set of implementation co-interventions to promote behaviour change.

Control:
Passive guidelines dissemination

Randomisation:
30 of the 60 health facilities will be randomly allocated to the intervention; minimisation for facility size, country and primary outcome baseline rate

Primary outcome:
The primary outcome is maternal infection related mortality and severe morbidity. This is a composite of infection related maternal mortality, infection related maternal near-miss or severe infection related morbidity (adapted CDC definition of deep surgical site infection or body cavity infection).

Implementation evaluation:
Mixed-methods evaluation will be undertaken to provide detailed understanding of the process of implementation, facilitate interpretation of trial outcomes and enable development of a longer-term implementation strategy.

Health economic evaluation:
Evaluate the cost effectiveness of the APT-sepsis intervention, from a provider perspective

Sample size:
172,500 births

Mothers with sepsis: This research seeks to reduce death and severe morbidity due to sepsis that occurs during and after pregnancy, in low income countries, in particular Malawi and Uganda. We will seek to do this by introducing the APT-Sepsis programme. Women who are admitted to 30 health facilities in Malawi and Uganda, will directly benefit from the APT-sepsis programme. Which we anticipate will improve adherence to best practice in these facilities with improved hand hygiene, infection prevention and management, and sepsis detection and management, including the use of the FAST-M maternal sepsis bundle.
We will setup support groups for survivors of sepsis in Malawi and Uganda. These forums will provide women with support from a health-care professional and their peers. Members of these groups will also be given the opportunity to work with the study team to highlight this issue in their communities.

The wider public in Malawi and Uganda: The wider public will be actively engaged to participate in the study through patient and public involvement steering groups in each country. These groups will be asked to provide insights into the study processes to ensure that they are optimal for the setting. We will also have lay membership on the key trial steering committee. We will use social media and traditional media to also communicate about the issue of maternal infections and sepsis with the public.

The health care providers and health care systems: We hope that the engagement of health care facilities with this study will give providers additional training and understanding of how to better manage maternal sepsis. We anticipate that these benefits will last beyond the life of the trial itself.

Capacity building for researchers: We are working with the WHO HRP Alliance for Capacity Strengthening to provide opportunities for junior researchers from Malawi and Uganda to use this study as a platform to enhance their research skills and knowledge.

Policy change: To maximise the benefit from this research it is important that the findings inform policy, and can therefore impact on practice globally. We are working closely with the WHO who have a vital role in determining health care policy worldwide. We will also ensure that we collaborate with the ministries of health in Malawi and Uganda to inform them of the research findings and implications for care and other key international stakeholders such as the Global Sepsis Alliance, International Federation of Gynaecology and Obstetrics (FIGO), International Confederation of Midwives (ICM) and national professional organisations.