Evaluation of the FAST-M maternal sepsis bundle

Plain English summary of protocol

Background and study aims
Maternal sepsis is a life-threatening condition caused by infection during or after pregnancy or childbirth. It is the third most common direct cause of maternal death worldwide and in Malawi post-partum sepsis accounts for 9.9% of all maternal deaths. In Malawi, a report has highlighted a lack of prompt recognition and inadequate management of maternal sepsis. It concluded that the use of early warning scores and a structured approach to patient monitoring, alongside an educational programme to improve the recognition and management of maternal sepsis, would likely improve sepsis care. In high-income settings there is evidence that this approach can improve patient outcomes, but none of these interventions are specific to mothers or designed to be feasible in resource-poor settings. The development of a maternal sepsis bundle has been identified as an international priority action for the next 5 years. This study aims to find out whether the introduction of a complex intervention for maternal sepsis is feasible and improves sepsis care in resource-poor settings.

Who can participate?
Women who are pregnant or within 6 weeks of miscarriage, termination of pregnancy or delivery, and are receiving either inpatient or outpatient healthcare

What does the study involve?
After a period of 2 months when standard care is assessed across all 15 study sites, the intervention is introduced at all 15 study sites and runs for up to 10 months. All sites receive all three components of the intervention for the same duration of time each. The components include: a modified early warning score and a decision tool to enable recognition of maternal sepsis; a treatment bundle for those with suspected maternal sepsis; and a teaching programme and implementation strategy to educate healthcare practitioners on how to use the early warning scores, decision tool and treatment bundle to manage maternal sepsis.

What are the possible benefits and risks of participating?
All patients receive a maternal sepsis care bundle. Individual components of this care bundle have been shown to improve quality of care. Although rare, there is the possibility that a patient with a previously unknown penicillin allergy receives a penicillin-based antibiotic. If patient develops an anaphylactic reaction they will be treated appropriately. Clinicians are educated on the signs and symptoms of potential anaphylactic reactions during the site training. It is hoped that this study will improve antibiotic use with more appropriate and targeted prescribing, but the researchers will carefully look for and report any evidence of unnecessary or increased antibiotic prescribing. Fluid resuscitation (replacing lost bodily fluid) if not managed appropriately can cause volume overload and subsequent pulmonary oedema (fluid accumulation in the lungs). This is a particular concern in patients with pre-eclampsia (high blood pressure). Clear teaching and guidance regarding fluid resuscitation is provided during the training programme. When fluid resuscitating patients with suspected maternal sepsis, the decision regarding the rate of fluid administration is made by the responsible clinician based on clinical examination findings and ongoing monitoring. There is a possibility that the patient may further deteriorate whilst being transported to high level care, for instance from a health centre to district hospital setting or district hospital to central hospital setting. The decision to transfer a patient to higher level care is made by the clinician responsible for the patient’s care after weighing up the risks and benefits. Training and guidance regarding these considerations and localised policies is determined as part of the intervention. The researchers actively monitor to ensure patient transport for maternal sepsis care does not adversely affect the ability of any centres to transport any other patients, or adversely affect receiving institutions. Any changes in practice to improve sepsis care could inadvertently adversely affect other aspects of care, or skew resource allocation. The study has been designed and resourced with the aim of preventing any such effects, but the researchers will actively monitor for any such adverse impacts on other aspects of care within the participating centres.

Where is the study run from?
1. Dowa District Hospital (Malawi)
2. Kabudula Community Hospital (Malawi)
3. Mitundu Community Hospital (Malawi)
4. Msakambewa Health Centre (Malawi)
5. Mwangala Health Centre (Malawi)
6. Chankhungu Health Centre (Malawi)
7. Mponela Rural Hospital (Malawi)
8. Ukwe Health Centre (Malawi)
9. Malembo Health Centre (Malawi)
10. Nsaru Health Centre (Malawi)
11. Khongoni Health Centre (Malawi)
12. Dickson Health Centre (Malawi)
13. Katchale Health Centre (Malawi)
14. Chadza Health Centre (Malawi)
15. Chiwoza Health Centre (Malawi)

When is the study starting and how long is it expected to run for?
August 2016 to June 2019

Who is funding the study?
1. University of Birmingham (UK)
2. MSD for Mothers
3. Ammalife

Who is the main contact?
1. Dr James Cheshire (public)
2. Dr David Lissauer (scientific)

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• Malawi

Study participating centres

Results and Publications

Study outputs

Additional files

ISRCTN87339737_BasicResults_04Oct2020.pdf

Uploaded 07/10/2020

Editorial Notes

07/10/2020: The following changes have been made:
1. The basic results summary has been uploaded.
2. The intention to publish date has been changed from 05/06/2020 to 01/01/2021.
20/08/2020: Internal review.