Active prevention and treatment of maternal sepsis in health care facilities in Malawi and Uganda
| ISRCTN | ISRCTN42347014 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42347014 |
| Secondary identifying numbers | UoL001663 |
- Submission date
- 19/08/2022
- Registration date
- 10/10/2022
- Last edited
- 09/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Every 4 minutes, a mother dies from a sepsis-related cause somewhere in the world, with the greatest burden borne by women in Low-Middle Income Countries (LMICs). The Active Prevention and Treatment of Maternal Sepsis (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. APT-Sepsis involves 60 hospital facilities (30 in Malawi and 30 in Uganda). Each facility will be a cluster from which baseline (starting) data will be collected before the start of the APT-sepsis intervention. Then 30 clusters (15 in each country) will be randomised for the APT-sepsis intervention, the remaining sites will continue with their usual practices. The study will evaluate if running the APT-sepsis programme is effective at reducing infection-related maternal death and disease burden. Process evaluation will also be conducted to understand how the programme works in practice and its cost-effectiveness.
Who can participate?
Health care facilities offering maternity care will be included as a cluster following completion of a successful feasibility report requiring the minimum prerequisites of a minimum of 1500 births per year and they provide comprehensive emergency obstetric care. Staff who are invited to complete the interviews and surveys will be healthcare workers who are responsible for the care of pregnant or postnatal women and who are willing to participate.
What does the study involve?
Clusters will be randomised to the study intervention or the control group. The intervention is a training programme that brings together evidence-based practice for the prevention of maternal sepsis. The study will evaluate the effectiveness of the intervention by measuring the incidents of severe infection, maternal deaths and near misses before and after randomisation. The study will also evaluate the staff experience, measuring their acceptability and compliance with the intervention through interviews, surveys and observations. Sites in the control group will also be evaluated to see if their practice changes. Following the completion of the project, all participating sites will be offered the opportunity to receive the training.
What are the possible benefits and risks of participating?
In this study, the Clusters (hospital facilities) are the participants. Providing the APT-Sepsis programme training to staff will improve their knowledge and understanding of the prevention, identification and treatment of maternal sepsis and consequently reduce cases of maternal sepsis in their cluster. These are evidence-based practices (treatments which have been previously researched) to reduce maternal sepsis, therefore the risks are low.
Where is the study run from?
Liverpool Clinical Trials Centre, the University of Liverpool (United Kingdom)
When is the study starting and how long is it expected to run for?
February 2021 to October 2025
Who is funding the study?
This project is supported by the Joint Global Health Scheme (United Kingdom)
Who is the main contact?
Sonia Whyte (United Kingdom)
apt-sepsis@liverpool.ac.uk
Contact information
Public
Liverpool Clinical Trials Centre
University of Liverpool
Liverpool
L69 3BX
United Kingdom
 ORCID ID |
0000-0003-0878-4244 |
|---|---|
| Phone | +44 (0)151 795 8751 |
| apt-sepsis@liverpool.ac.uk |
Principal Investigator
Malawi-Liverpool-Wellcome Trust research institute
Queen Elizabeth Central Hospital
College of Medicine
P.O. Box 30096
Chichiri, Blantyre
3
Malawi
| ORCID ID |
0000-0002-7878-2327 |
|---|---|
| Phone | +265 (0)1812423 |
| david.lissauer@liverpool.ac.uk |
Study information
| Study design | Cluster-randomized hybrid-implementation effectiveness study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The Active Prevention and Treatment of Maternal Sepsis: A cluster randomised, hybrid implementation effectiveness trial, to improve prevention and management of maternal sepsis in health care facilities in Malawi and Uganda |
| Study acronym | APT-Sepsis |
| Study hypothesis | To examine the implementation of the APT-Sepsis programme and understand if it is effective at reducing infection related maternal mortality and severe morbidity in resource limited settings. |
| Ethics approval(s) | 1. Approved 13/07/2022, College of Medicine Research and Ethics Malawi (Private Bag 360,, Chichiri Blantyre 3 , 3, Malawi; 265 187 4377 ; mandal@medcol.mw), ref: 3635 2. Approved 24/02/2023, Uganda National Council for Science and Technology (Plot 6, PO Box 6884, Kampala, x, Uganda; 256 414 707700; info@uncst.go.ug), ref: HS2613ES 3. Approved 07/09/2022, University of Liverpool, Central University Research Ethics Committee D (University of Liverpool, Liverpool, L69 7ZX , United Kingdom; 0151; ethics@liv.ac.uk), ref: 11309 4. Approved 08/12/2022, Infectious Diseases Institute Research Ethics Committee (IDI-REC office, Mulago, 12345, Uganda; +256 39 319 3144; rec@idi.co.ug), ref: IDIREC REF 022/2022 5. Approved 26/01/2023, WHO/HQ/FWC/RHR (20, Avenue Appia, Geneva, CH-1211, Switzerland; 41 22 791 4171; reproductivehealth@who.int), ref: A66039 |
| Condition | Maternal Sepsis |
| Intervention | The APT-Sepsis intervention brings together evidence-based practice to address maternal sepsis prevention and treatment via an integrated programme with three interventional domains and an implementation strategy. 1.The first interventional domain is ‘hand hygiene’, ensuring compliance with the WHO 5 movements of hand hygiene. 2. The second interventional domain is infection prevention and management and ensures adoption of evidence-based practices for infection prevention in maternity, including appropriate antibiotic prophylaxis for high-risk women and improved surgical practices. 3. The third interventional domain is better sepsis management and consists of ensuring consistent measurement of patient vital signs and when there is suspected sepsis the triggering of the FAST-M maternal sepsis bundle. This bundle includes Fluids, Antibiotics, Source control, Transfer and Monitoring. |
| Intervention type | Behavioural |
| Primary outcome measure | Composite outcome of infection-related maternal mortality, infection-related maternal near-miss and severe infection-related morbidity (deep surgical site infection or body cavity infection) measured by the collection of daily observations from routine health facility records from all women who are admitted to the healthcare facility, during pregnancy or within 42 days of delivery with a severe infection from the baseline phase to the end of cluster participation |
| Secondary outcome measures | 1. Effectiveness of the APT-Sepsis programme to reduce the secondary clinical outcomes of stillbirth, early neonatal death (infection-related and total), maternal mortality (any cause), and a maternal near miss (any cause) measured using daily observations of the routine health facility records from the baseline phase to the end of cluster participation 2. Differential or subgroup effects of the APT-Sepsis programme defined by country, facility size, and high versus low performing facilities at the end of the study 3. Fidelity, sustainability, acceptability and context of the APT-sepsis programme in Malawi and Uganda, to facilitate interpretation of trial outcomes and development of a longer-term implementation strategy, measured using observations, interviews, and surveys conducted from randomisation to the end of cluster participation 4. Health economic analysis to determine if the APT-Sepsis programme was cost effective measured using data collected during the study, and will be based on the principal outcome of the trial and be reported in terms of disaggregated costs and consequences and cost per major outcome averted where the major outcome is defined as maternal infection-related mortality and severe morbidity. |
| Overall study start date | 01/02/2021 |
| Overall study end date | 31/10/2025 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Clusters: 60 (Minimum 172,500 women) Facility Staff: Interviews 60 |
| Participant inclusion criteria | Cluster: Health care facilities offering maternity care, will be included as a cluster following the completion of a successful feasibility report requiring the minimum prerequisites of: 1. A minimum of 1500 births per year 2. Providers of comprehensive emergency obstetric care (e.g., able to perform caesarean sections and blood transfusions) 3. Completed the site readiness assessment process Research participant: Healthcare workers and managers responsible for the care of women during or after pregnancy in the study facility |
| Participant exclusion criteria | Cluster exclusion criteria: Facilities not willing to participate in the study Research participant exclusion criteria: Healthcare workers not willing to consent to participation |
| Recruitment start date | 13/11/2022 |
| Recruitment end date | 30/04/2025 |
Locations
Countries of recruitment
- Malawi
- Uganda
Study participating centres
Balaka
302100
Malawi
Chikwawa
315100
Malawi
Chiradzulu
306100
Malawi
Dedza
209100
Malawi
Mzimba
104104
Malawi
Phalombe
307100
Malawi
Karonga
102100
Malawi
Kasungu
201300
Malawi
Liwonde
303100
Malawi
Thyolo
310111
Malawi
Mangochi
301400
Malawi
Mchinji
205100
Malawi
Mangochi
301109
Malawi
Dedza
209104
Malawi
Mulanje
308100
Malawi
Mulanje
308104
Malawi
Mwanza
314100
Malawi
Mzimba
104100
Malawi
Nkhatabay
106100
Malawi
Lilongwe
206111
Malawi
Nkhotakota
202100
Malawi
Nsanje
316100
Malawi
Ntcheu
210100
Malawi
Ntchisi
203100
Malawi
Rumphi
103100
Malawi
Salima
208100
Malawi
Namitete Lilongwe
206115
Malawi
Chilema
304102
Malawi
Thyolo
310100
Malawi
Arua
-
Uganda
Koboko
-
Uganda
Adjumani
-
Uganda
Nebbi
-
Uganda
Arua City
-
Uganda
Moyo
-
Uganda
Mukono
-
Uganda
Lugazi
-
Uganda
Jinja
-
Uganda
Bugiri
-
Uganda
Kamuli
-
Uganda
Iganga
-
Uganda
Mbale
-
Uganda
Luwero
-
Uganda
Nakaseke
-
Uganda
Kiboga
-
Uganda
Masindi
-
Uganda
Kigumba
-
Uganda
Lira
-
Uganda
Soroti
-
Uganda
Gulu
-
Uganda
Fortportal
-
Uganda
Kyejonjo
-
Uganda
Mubende
-
Uganda
Kyotera
-
Uganda
Mpigi
-
Uganda
Tororo
-
Uganda
Pallisa
-
Uganda
Kumi
-
Uganda
Katawi
-
Uganda
Phalombe
307100
Malawi
Sponsor information
University/education
Clinical Directorate
4th Floor Thompson Yates Building
Faculty of Health and Life Sciences
University of Liverpool
Liverpool
L69 3GB
England
United Kingdom
| Phone | +44 (0) 7717 863747, +44 (0)151 794 2000 |
|---|---|
| sponsor@liverpool.ac.uk | |
| Website | https://www.liv.ac.uk/ |
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- UKRI
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results from different participating sites will be analysed together and published as soon as possible, always maintaining participant confidentiality. Individual clinicians must undertake not to submit any part of their individual data for publication without the prior consent of the Study Trial Management Group (TMG). We expect that at least the primary publication, implementation evaluation and health economic evaluation will be attributed to the “APT-Sepsis Collaborative Group”. The TMG will advise on the basis of the writing committee, authorship details and the nature of publications. The Uniform Requirements for Manuscripts Submitted to Biomedical Journals (http://www.icmje.org/) will be respected. The study registration number allocated will be attached to any publications resulting and members of the TOC will be acknowledged. Any publications arising from this research will be reviewed internally by the TMG and peer reviewed by journals prior to publication. Following the primary publications each participating site will be encouraged to conduct appropriate further analyses on their country data. The TMG should be informed of any planned additional analysis and publications that result. The APT-Sepsis collaborative group as well as the funder must be appropriately acknowledged. Study specific documents will be developed to ensure equitable and transparent plans for additional analysis that ensure inclusion of interested parties from the study team, with a special focus on leadership by junior researchers or PhD students supported through this study. The PPI steering groups in each country will provide advice not only on trial design and materials but also, on how best to engage the public and on our messaging. In both countries we will establishing peer support groups for women who have survived maternal sepsis. These will be facilitated by an experienced midwife and not only provide support for these women but also enable the trial team to maintain engagement with users at the sites and receive feedback on any concerns or issues. We have previously found Facebook to be an effective platform for engagement across the public and care providers in these settings and will again promote social media use to create a community who will act as advocates around maternal sepsis and an audience for the study findings. We will give the sepsis survivors engaged through our PPI programme the opportunity to participate in sharing their sepsis. story in a video format, which with their explicit consent, will form part of a social media campaign to highlight the impact of maternal sepsis on mothers and their families |
| IPD sharing plan | At the end of the trial, after the primary results have been published, the anonymised individual participant data (IPD) and associated documentation (e.g., protocol, statistical analysis plan, annotated blank CRF) will be prepared to be shared with external researchers. All requests for access to the IPD will be reviewed by an internal committee at the CTU and discussed with the Chief Investigator in accordance with the CTU policy on data sharing. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | Malawi version 6.0 |
07/11/2024 | 09/04/2025 | No | No |
| Protocol file | Uganda version 3.0 |
07/11/2024 | 09/04/2025 | No | No |
Additional files
Editorial Notes
09/04/2025: Protocols uploaded.
10/02/2025: The following changes were made to the trial record:
1. The ethics approval was added.
2. The overall end date was changed from 31/07/2024 to 31/10/2025.
3. The recruitment end date was changed from 31/07/2024 to 30/04/2025.
4. The study participating centres Lisungwi Community Hospital, Mlambe Mission hospital, Pirimiti Mission Hospital, Midigo HC4, River Oli HC4 were removed and Phalombe district hospital was added.
04/09/2023: The study participating centres were updated to remove Kisenyi HC4, Kawala HC4, Kasangati HC4, Wakiso HC4, Ndejje HC4, Namayumba HC4, and add Kalisizo General Hospital, Gombe General Hospital, Tororo General Hospital, Pallisa General Hospital, Atutur General Hospital, Katakwi General Hospital.
23/01/2023: Kyejonjo General Hospital and Mubende RRH were added to the trial participating centres.
24/11/2022: Arua RRH, Koboko Hospital, Adjumani Hospital, Nebbi Hospital, Midigo HC4, Yumbe HC4, River Oli HC4, Moyo Hospital, Kisenyi HC4, Kawala HC4, Kasangati HC4, Wakiso HC4, Ndejje HC4, Namayumba HC4, Mukono General Hospital, Kawolo Hospital, Jinja RRH, Bugiri Hospital, Kamuli Hospital, Iganga Hospital, Mbale RRH, Luwero Hospital, Nakaseke Hospital, Kiboga Hospital, Masindi Hospital, Kiryandogo Hospital, Lira RRH, Soroti RRH, Gulu RRH, and Fortportal RRH were added to the trial participating centres.
14/11/2022: The recruitment start date was changed from 07/11/2022 to 13/11/2022.
06/09/2022: Trial's existence confirmed by the College of Medicine Research and Ethics Committee (COMREC) at the University of Malawi.
