PP Sepsis Study

Supplement to Aetiology of Neonatal Infection in South Asia: Development of a community-based presumptive clinical diagnosis algorithm and treatment regimen for maternal puerperal sepsis.

Objective: To adapt the accepted clinical criteria for diagnosing suspected postpartum infection into a tool that can be used by Community Health Workers (CHWs) with limited training in a community setting to identify suspected PP sepsis.

Summary of study design elements:

Study Objective

Methods

Procedures

Measurement of Outcomes

1. Validate a CHW tool to identify women with PP sepsis, used during home visits in the first 60 days postpartum

Compare CHW use of tool against repeat assessment of study physician as gold standard

-  Train CHWs and study physicians

-  Add maternal assessment using tool into existing ANISA home visit schedule

-  Manage suspected PP sepsis cases via referral to study hospitals, or home care for those that refuse referral

-  Revisit a sample of women for second assessment by study physician

Sensitivity, specificity, Kappa

2. Identify aetiology and antibiotic resistance of organisms responsible for PP sepsis

Perform aerobic and anaerobic culture and real-time PCR of specimens;  test antibiotic susceptibility of significant isolates 

-  Collect specimens from women identified by the tool with suspected PP sepsis

-  At study hospitals (blood, urine, endometrial) for successful referrals

-  At home (urine) for refusals

Aetiology-specific incidence, antibiotic resistance patterns

3. Measure incidence and correlation of risk factors for PP sepsis

Access existing variables from ANISA profiles of women and collect supplemental information related to pregnancy history and labor and delivery characteristics

-  Add additional questions on pregnancy history during first prenatal home visit

-  Add additional questions on labor and delivery characteristics during first postpartum home visit

Risk factor incidence, multivariate analysis of risk factors on PP sepsis (odds ratio, etc.)

 

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