Azin V

Study Outcomes

Outcome 1: Clinical Outcome

Primary Clinical Outcome:

The primary clinical outcome is the incidence of maternal sepsis within six weeks (42 days) post-delivery.

Secondary Clinical Outcomes:

  1. Incidence of culture confirmed maternal sepsis within 6 weeks of birth, defined as a positive blood culture in the presence of suspected maternal sepsis.
  2. Number of new prescriptions of antibiotics for a specific maternal infection after randomisation for any reason (including bacterial vaginosis, chorioamnionitis, endometritis, abdominal or pelvic abscess, mastitis or breast abscess, pneumonia, or pyelonephritis or acute cystitis – as in table 2).
  3. Number of new prescriptions of antibiotics (use of subsequent maternal antibiotic therapy after randomisation to 6 weeks for any reason).
  4. Incidence of neonatal sepsis within 28 days of birth, defined as proven or possible serious bacterial infection (PSBI) or pneumonia, or meningitis. PSBI will be determined using WHO criteria of severe chest in-drawing, fever, hypothermia, no movement at all or movement only on stimulation, feeding poorly or not feeding at all and/or convulsions.  Clinical and laboratory signs of infection will also be considered for diagnosis. Other neonatal infections (e.g. eye infection, skin infection, omphalitis, urinary tract infection, respiratory rate ≥60 breaths/minute).
  5. Incidence of stillbirth.
  6. Incidence of neonatal death, defined as death within 28 days of birth.
  7. Duration of initial hospital stay for neonate, defined as time of delivery until time of hospital discharge.
  8. Duration of hospital stay for mother, defined as time from azithromycin administration until discharge (in hours).
  9. Incidence of maternal readmission, or admission to a special care unit for any other condition within 6 weeks of delivery.
  10. Incidence of neonatal readmission, or admission to a special care unit for any other condition within 28 days of birth.
  11. Incidence of adverse drug events (fainting or dizziness, nausea, vomiting, diarrhoea, and dyspepsia) and other reported side effects.
  12. Incidence of secondary post-partum haemorrhage, defined as excessive bleeding requiring intervention from 24hrs after delivery till 6-week post-partum.

Outcome 2: Cost-Effectiveness Outcomes

Healthcare Costs: direct medical costs associated with administering azithromycin, including medication costs, healthcare personnel time, and any additional resources required. Cost elements for both groups will be comparatively assessed at an individual participant level, using a decision tree. Comparative analyses of direct medical costs of the intervention and usual routine care including the costs for administration of full course of treatment with both products (medicines, consumables, and supplies) will be included. Analysis of all cost borne by participants from potential adverse events and any loss of productivity losses while incapacitated by these adverse events will be conducted for the study population (all enrolled women).

Incremental Cost-Effectiveness Ratio (ICER): additional cost per unit of health gain with azithromycin compared to the usual care for individual participants as a component of the sepsis prevention protocol in healthcare facilities.

Outcome 3: Implementation Outcomes

Fidelity, Adoption, Reach, Feasibility, Acceptability, and Sustainability

Our Methodology