Condition category
Pregnancy and Childbirth
Date applied
28/11/2017
Date assigned
13/12/2017
Last edited
12/12/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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)

Trial website

https://www.birmingham.ac.uk/research/activity/fast-m/index.aspx

Contact information

Type

Public

Primary contact

Dr James Cheshire

ORCID ID

Contact details

3rd Floor Academic Department
Birmingham Women's Hospital
Mindelsohn Way
Edgbaston
Birmingham
B15 2TG
United Kingdom

Type

Scientific

Additional contact

Dr David Lissauer

ORCID ID

Contact details

3rd Floor Academic Department
Birmingham Women's Hospital
Mindelsohn Way
Edgbaston
Birmingham
B15 2TG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RG_16-150

Study information

Scientific title

Evaluation of the FAST-M maternal sepsis bundle: a feasibility study

Acronym

Study hypothesis

Introducing the FAST-M intervention into the Malawian healthcare system is feasible.

Ethics approval

College of Medicine Research and Ethics Committee (COMREC), University of Malawi, 16/05/2017, ref: P.02/17/2112

Study design

Interventional multi-centered controlled study with a before and after design

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Maternal sepsis

Intervention

Component 1: introduction of a modified early obstetric warning score to enable the observation of patients to be recorded and also the FAST-M decision tool to enable recognition of maternal sepsis
Component 2: introduction of the FAST-M treatment bundle for those with suspected maternal sepsis
Component 3: introduction of a teaching programme and implementation strategy educating healthcare practitioners on how to use the early warning scores, decision tool and treatment bundle to manage maternal sepsis
Control: standard care

After a baseline phase of 2 months during which standard care will be assessed across all 15 study sites, the intervention phase will commence at all 15 study sites and will run for up to 10 months (or until saturation - whichever takes place first). All sites will get all 3 components of the intervention for the same duration of time each. The maintenance phase will be up to a year.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Fidelity: Time to bundle completion after recognition of sepsis. Data will be collected using specifically designed case report forms (CRFs). Data will be measured continually throughout baseline and intervention phase.
2. Number of training refresher courses: How often healthcare practitioners require training refresher sessions. Data will be measured continually throughout intervention phase.
3. Acceptability: Barriers to healthcare workers using the FAST-M toolkit. Data will be collected using a mix of semi-structured interviews and focus groups. This data will be measured at 1 month, 5 month and 6 months of intervention study.
4. Adoption: How well each healthcare facility adopts the intended practice. Data will be collected using a mix of semi-structured interviews, focus groups, CRF data collection and spot audits. Mixed method analysis using qualitative and quantitative assessment will be used to derive an overall assessment of the level of adoption. Quantitative data (spot audits and CRF data collection) will be measured continually throughout the intervention phase. Qualitative data (semi-structured interviews and focus groups) will be conducted at 1, 5 and 6 months of intervention study
5. Appropriateness: Is the intervention required at the study site and is it clinically relevant? Data will be collected using a mix of semi-structured interviews and focus groups. This data will be measured at 1, 5 and 6 months of intervention study.
6. Feasibility: Ability to achieve each element of the treatment bundle within the specified time limit. Data will be collected using a mix of semi-structured interviews, focus groups, CRF data collection and spot audits. Mixed method analysis using qualitative and quantitative assessment will be used to derive an overall assessment of the level of feasibility. Quantitative data (spot audits and CRF data collection) will be measured continually throughout the intervention phase. Qualitative data (semi-structured interviews and focus groups) will be conducted at 1, 5 and 6 months of intervention study
7. Sustainability: Ability to incorporate intervention into evidence based practice at local level. Adoption into regular practice will be assessed using CRFs and spot audits continually during intervention phase and by spot audits 4 monthly during maintenance phase.
8. Penetration: Number of healthcare workers aware of the FAST-M intervention. Data will be collected using a mix of semi-structured interviews, focus groups conducted at 1, 5 and 6 months of intervention study
9. Resource availability: Resource availability during the study period of antibiotics, intravenous fluids, blood pressure machines, thermometers, fetoscopes, ambulances. Data will be collected using a mix of semi-structured interviews, focus groups, CRF data collection. Mixed method analysis using qualitative and quantitative assessment will be used to derive an overall assessment of the level of resource availability. Quantitative data (CRF data collection) will be measured every two weeks throughout the baseline and intervention phase. Qualitative data (semi-structured interviews and focus groups) will be conducted at 1, 5 and 6 months of intervention study
10. Costs: Total costs of delivering FAST-M intervention over the study period. Will be determined at end of intervention phase.
11. Unintended consequences: Any negative unintended consequences that occurred as a direct consequence of the FAST-M intervention. Data will be collected using a mix of semi-structured interviews, focus groups, CRF data collection. Mixed method analysis using qualitative and quantitative assessment will be used to derive an overall assessment of the unintended consequences. Quantitative data (CRF data collection) will be measured every two weeks throughout the intervention phase. Qualitative data (semi-structured interviews and focus groups) will be conducted at 1, 5 and 6 months of intervention study.

Secondary outcome measures

1. Pregnancy outcome: Live birth, still birth, miscarriage, induced abortion, ectopic. Data collected continually throughout study
2. Maternal morbidity: Maternal in-hospital morbidity. Data collected continually throughout study
3. Maternal mortality: Maternal in-hospital mortality. Data collected continually throughout study
4. Maternal length of stay in days. Data collected continually throughout study
5. Maternal near miss events: As defined by the WHO near miss events. Data collected continually throughout study
6. Neonatal APGAR scores at 5 minutes. Data collected continually throughout study
7. Neonatal length of stay in days. Data collected continually throughout study
8. Neonatal need for antibiotics: Whether the neonate received antibiotics. Data collected continually throughout study
9. Admission to neonatal unit: Whether the neonate was admitted to a neonatal unit. Data collected continually throughout study

Other pre-specified outcome measures:
10. Theory of Change model: To prepare the FAST-M intervention for a large scale trial. Data collected continually throughout study

Overall trial start date

01/08/2016

Overall trial end date

05/06/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women who are pregnant or within 6 weeks of miscarriage, termination of pregnancy or delivery
2. Receiving either inpatient or outpatient health care

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

As this is a feasibility trial there is no target number of participants required for the study as this study is looking at whether introducing an intervention in this setting is possible. The trialists have decided that 15 sites (11 health centers, 1 rural hospital, 2 community hospitals and 1 district hospitals). However, to ensure they are 90% powered to detect an improvement in sepsis care (delivery of bundle components within 1 hour), they have estimated they will need to recruit 240 patients with maternal infections.

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

05/06/2017

Recruitment end date

05/06/2018

Locations

Countries of recruitment

Malawi

Trial participating centre

Dowa District Hospital
PO Box 25
Malawi

Trial participating centre

Kabudula Community Hospital
PO Box 25
Malawi

Trial participating centre

Mitundu Community Hospital
PO Box 25
Malawi

Trial participating centre

Msakambewa Health Centre
PO Box 25
Malawi

Trial participating centre

Mwangala Health Centre
PO Box 25
Malawi

Trial participating centre

Chankhungu Health Centre
PO Box 25
Malawi

Trial participating centre

Mponela Rural Hospital
PO Box 25
Malawi

Trial participating centre

Ukwe Health Centre
PO Box 25
Malawi

Trial participating centre

Malembo Health Centre
PO Box 25
Malawi

Trial participating centre

Nsaru Health Centre
PO Box 25
Malawi

Trial participating centre

Khongoni Health Centre
PO Box 25
Malawi

Trial participating centre

Dickson Health Centre
PO Box 25
Malawi

Trial participating centre

Katchale Health Centre
PO Box 25
Malawi

Trial participating centre

Chadza Health Centre
PO Box 25
Malawi

Trial participating centre

Chiwoza Health Centre
PO Box 25
Malawi

Sponsor information

Organisation

University of Birmingham

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Birmingham

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Funder name

MSD for Mothers

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ammalife

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Results will be disseminated to all collaborators through quarterly interim reports and meetings with the University of Birmingham team, at in-country meetings at the individual study sites, through peer reviewed scientific journals and at national and international conferences including the College of Medicine’s Annual Research Conference
2. The study team plans the dissemination of results not only to the academic community but internationally through the WHO, FIGO and other NGOs
3. Planned publication in a high impact peer reviewed journal around one year after the overall trial date end date
4. Additional documents will not be available. Protocol is not yet published

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available.

Intention to publish date

05/06/2020

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes