Maternal sepsis Pregnancy and Childbirth
Conditions
Interventions
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
Sponsors
University of Birmingham
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Malawi
Contacts
Public ContactJames Cheshire
Outcome results
None listed