Early recognition and management of maternal sepsis in Pakistan
| ISRCTN | ISRCTN17105658 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17105658 |
| Secondary identifying numbers | 2.5 07/08/2019 |
- Submission date
- 27/10/2021
- Registration date
- 04/11/2021
- Last edited
- 31/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Maternal sepsis is a severe bacterial infection (usually of the womb) that can occur in pregnant women or in the days following childbirth. The World Health Organization estimates suggests that globally, maternal sepsis accounts for about one-tenth of the maternal deaths around the time of childbirth and is the third most common cause of maternal death. Whilst the maternal death rate related to sepsis has decreased considerably in high-income countries accounting for 2.1% of the total maternal deaths, the numbers are still high in the lower-income countries accounting for up to 15.1% of maternal deaths annually. However, more recent WHO estimates that were focused specifically on understanding better the contribution of maternal infection to adverse outcomes suggested that up to half of all maternal deaths were actually infection-related.
The FAST-M intervention was implemented in districts of Malawi to evaluate the feasibility of early identification and management of maternal sepsis and demonstrated significant improvements in maternal sepsis care in Malawi. The components included 1) the Maternal Early Obstetric Warning System (MEOWS) chart and FAST-M decision tool, 2) the FAST-M treatment bundle and 3) the FAST-M implementation programme which consisted of the following: training programme, sepsis champions, task shifting, performance dashboards and data feedback to promote systems-level change. Therefore, this study aims to determine whether it is feasible to introduce a complex intervention (including a bundled approach) for maternal sepsis care in Pakistan.
Who can participate?
Women who are pregnant or within 6 weeks of miscarriage, termination of pregnancy or delivery, and are receiving inpatient healthcare
What does the study involve?
After a period of 2 months when standard care is assessed in all the three obstetrics and gynecology units of the study site, the intervention will be introduced for up to 4 months. All units will receive 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?
Individual components of this care bundle have been shown to improve quality of care. However, 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 will be provided during the training programme. When fluid resuscitating patients with suspected maternal sepsis, the decision regarding the rate of fluid administration will be made by the responsible clinician based on clinical examination findings and ongoing monitoring. 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 study site.
Where is the study run from?
The study will be conducted at Liaquat University of Medical Health Sciences (LUMHS), which is a public sector tertiary hospital located in the Hyderabad district of Pakistan. LUMHS has three Obstetrics and Gynecology units where the study will be carried out.
When is the study starting and how long is it expected to run for?
February 2019 to February 2022
Who is funding the study?
1. University of Birmingham (UK)
2. University of Liverpool (UK)
3. National Institute for Health Research (UK)
4. Bill and Melinda Gates Foundation (USA)
Who is the main contact?
1. Dr Sheikh Irfan Ahmed (public), sheikh.irfan@aku.edu
2. Prof David Lissauer (scientific), David.Lissauer@liverpool.ac.uk
Contact information
Public
Aga Khan University Hospital, Karachi
Stadium Road, PO Box 3500
Karachi
74800
Pakistan
 ORCID ID |
0000-0002-8391-8559 |
|---|---|
| Phone | +92 (0)21 1234 4644 |
| sheikh.irfan@aku.edu |
Scientific
Global Maternal and Fetal Health at the University of Liverpool
Liverpool
L69 3BX
United Kingdom
| ORCID ID |
0000-0002-7878-2327 |
|---|---|
| Phone | +265 (0)992892149 |
| David.Lissauer@liverpool.ac.uk |
Public
Aga Khan University Hospital, Karachi
Stadium Road, PO Box 3500
Karachi
74800
Pakistan
| Phone | +92 (0)21 1234 4641 |
|---|---|
| lumaan.sheikh@aku.edu |
Public
Liaquat University of Medical and Health Sciences
Hyderabad
74000
Pakistan
| Phone | +92 (0)22 9213322 |
|---|---|
| raheel.sikandar@lumhs.edu.pk |
Study information
| Study design | Mixed method study with a before and after design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Evaluation of the FAST-M maternal sepsis bundle in Pakistan: a feasibility study |
| Study acronym | FAST-M (PK) |
| Study objectives | Introducing the FAST-M intervention into the healthcare system of Pakistan is feasible. |
| Ethics approval(s) | Approved 26/12/2019, Aga Khan University Ethical Review Committee (Stadium Road, PO Box 3500, Karachi 74800, Pakistan; +92 (0)21 3493 0051 Ext: 4988/2445; erc.pakistan@aku.edu), ref: 2019-2061-7102 |
| Health condition(s) or problem(s) studied | Maternal sepsis |
| Intervention | The study will be conducted in two phases. In the first phase (qualitative) the researchers will adapt the FAST-M bundle care tools for the local context. In the second phase, they will evaluate the feasibility of the FAST-M 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 in all obstetrics and gynecology (OBGYN) units at the study site, the intervention phase will commence in all OBGYN units and will run for up to 4 months (or until saturation - whichever takes place first). All units will get all three components of the intervention for the same duration of time each. |
| Intervention type | Behavioural |
| Primary outcome measure | Collected using CRFs every 2 weeks throughout the intervention phase: 1. The proportion of patients admitted with features of sepsis who received appropriate monitoring (full set of vital sign measurements on admission recorded on MEOWS chart) 2. The proportion of women with suspected maternal sepsis received antibiotics within 1 hour (if required) 3. The proportion of women with suspected maternal sepsis receiving the FAST-M treatment bundle (including each bundle component) within 1 hour of identification of sepsis 4. One focus group will be conducted before the initiation of the study to adapt the tools and identify implementation approaches 5. A second focus group will be conducted at the end of the study as a summative evaluation of the study to identify perceptions about the success of implementation |
| Secondary outcome measures | Collected using CRFs every 2 weeks throughout the intervention phase: 1. The proportion of women with suspected maternal sepsis referred to clinical decision-maker on the basis of abnormal vital signs records 2. The proportion of women with suspected maternal sepsis receiving a clinical review by a senior clinical decision-maker following their diagnosis |
| Overall study start date | 04/02/2019 |
| Completion date | 28/02/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | 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. However, assuming baseline compliance is less than 10% grounded on observations from FAST-M study in Malawi, to detect an increase in compliance to 20%, with an alpha of 0.05, the study will require the observation of 199 participants in each phase to achieve a power of 80%. |
| Total final enrolment | 400 |
| Key inclusion criteria | 1. Women who are pregnant or within 6 weeks of miscarriage, termination of pregnancy or delivery 2. Receiving inpatient health care |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 20/10/2020 |
| Date of final enrolment | 31/12/2021 |
Locations
Countries of recruitment
- Pakistan
Study participating centre
74000
Pakistan
Sponsor information
University/education
Jamshoro
Hyderabad
74000
Pakistan
| Phone | +92 (0)22 9213322 |
|---|---|
| aliwaryah@lumhs.edu.pk | |
| Website | http://www.lumhs.edu.pk/home/ |
"ROR" |
https://ror.org/015jxh185 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Government organisation / Universities (academic only)
- Alternative name(s)
- The University of Liverpool, 利物浦大学, Universidad de Liverpool, UoL
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Bill & Melinda Gates Foundation, Gates Foundation, BMGF, B&MGF, GF
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. Results will be disseminated to all collaborators through quarterly interim reports and meetings with the University of Birmingham team 2. The study team plans the dissemination of results not only to the academic community but internationally through the WHO, FIGO and other non-governmental organizations (NGOs) 3. Planned publication in a high impact peer-reviewed journal around 1 year after the overall trial date end date |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 01/11/2021 | No | No | ||
| Interim results article | Results of qualitative exploratory study | 09/09/2022 | 24/01/2023 | Yes | No |
| Results article | 30/07/2023 | 31/07/2023 | Yes | No |
Additional files
Editorial Notes
31/07/2023: Publication reference added.
24/01/2023: Publication reference added.
05/01/2023: The intention to publish date was changed from 31/01/2023 to 31/03/2023.
13/01/2022: The overall trial end date was changed from 31/01/2022 to 28/02/2022. Total final enrolment added.
01/11/2021: Trial's existence confirmed by the National Bioethics Committee (NBC) Pakistan and Liaquat University of Medical and Health Sciences (LUMHS).
