Maternal sepsis Pregnancy and Childbirth Maternal sepsis
Conditions
Interventions
There is a baseline phase of 3 weeks, where the current standard of care will be assessed in maternity settings at the 3 study sites. Following this, a training programme and study tools will be deliv
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient: 1. All women who are pregnant or within 6 weeks of miscarriage, termination of pregnancy or delivery 2. Receiving either inpatient or outpatient health care. Healthcare worker: All healthcare workers who work in obstetric, gynaecology or outpatient departments in the 3 included sites, or healthcare workers who attended the intervention training programme
Exclusion criteria
Exclusion criteria: N/A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fidelity, assessed by: 1. Percentage adherence to WHO hand hygiene guidance. Data will be collected using specifically designed case report forms (CRFs) based on the observation form developed by the WHO. Hand hygiene audits will be performed weekly throughout the baseline and intervention phase. 2. Appropriate adherence to WHO recommendations for antibiotic prophylaxis and infection prevention practices in Caesarean section, measured by continuous notes review throughout the study period. Recommended practice taken from the 'WHO recommendations for prevention and treatment of maternal peripartum infections'. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Dose: The number of training and facilitation meetings required, measured continually throughout the intervention phase. The number of training sessions delivered will be counted, along with the number of feedback meetings delivered at each site during the training programme and intervention phase. The length of these sessions will also be recorded. This will be assessed using study records, and qualitative interviews with key stakeholders in the study who delivered the training and meetings. 2. Adaptions: Suggestions and alterations to protocol and interventions throughout the study and at individual sites, recorded continually throughout the study. This will be assessed using site study files and qualitative interviews. When changes have been made to the protocol and interventions, this will be recorded in the study site file. Qualitative interviews with keys stakeholders in the study will investigate any adaptions that were required during the study. 3. Acceptability: The facilitators and barriers to adopting the hand hygiene practices and the recommendations for infection prevention. Data will be collected using semi-structured interviews and focus group discussions. This data will be measured at 2 months and 4 months in the intervention phase. 4. Adoption: How well each healthcare facility adopts the intended practices, assessed using the following, with a mixed methods analysis to perform an overall assessment: 4.1. Hand hygiene audits, conducted continuously throughout the study 4.2. Case report form (CRF) data collection, conducted continuously throughout the study 4.3. Semi-structured interviews, at 2 and 4 months in the intervention phase 4.4. Focus group discussions, at 4 months in the intervention phase 4.5. Hand hygiene infrastruture maintenance, assessed using CRF data collection (4.2) at the baseline and after 2 weeks and 2 and 4 months in the intervention phase, along with semi-structured interviews (4.3) and focus group discussions (4.4) 5. Appro | — |
Countries
Malawi, United Kingdom
Contacts
Public ContactCatherine Dunlop
Outcome results
None listed