Maternal Sepsis Infections and Infestations
Conditions
Interventions
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 implementat
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Malawi, Uganda
Contacts
Public ContactSonia Whyte
Outcome results
None listed