Maternal Cesarian Section Infection (MACSI) in Sierra Leone

Study Overview
=================
Brief Summary
-----------------
Up to 1 in 5 women in Africa who deliver their baby by cesarean section get a wound infection. Surgical site infections (SSIs) are largely preventable, but they represent a considerable burden for health-care systems, particularly in low-income and middle-income countries. The prevention of these infections is complex and requires the integration of a range of preventive measures before, during, and after surgery. The aim of the proposed project is to determine the risk factors of Surgical Site Infection post-Cesarean Section in women admitted to Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra Leone. Secondary aims are to determine the incidence of SSI and the predictors of a negative outcome in women with post-CS SSI.

Detailed Description
-----------------
Rationale: More than 1 in 10 people who have surgery in low and middle-income countries (LMICs) get surgical site infection. People's risk of SSI in LMICs is 3 to 5 times higher than in high-income countries. Up to 1 in 5 women in Africa who deliver their baby by cesarean section get a wound infection. Surgical site infections (SSIs) are largely preventable, but they represent a considerable burden for health-care systems, particularly in low-income and middle-income countries. The prevention of these infections is complex and requires the integration of a range of preventive measures before, during, and after surgery. Objective: The aim of the proposed project is to determine the risk factors of Surgical Site Infection post-Cesarean Section in women admitted to Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra Leone. Secondary aims are to determine the incidence of SSI and the predictors of a negative outcome in women with post-CS SSI. Study design: This is a prospective case-control (1:3 ratio) study. Study population and Methods: All women admitted or already hospitalized with suspected or confirmed infection after C/S will be screened for inclusion in the study as a case. Case confirmation will be clinically established by an infectious disease expert. For each case, 3 patients undergoing the C/S on the same day and admitted to the same ward but not presenting SSI, will be selected as controls. Sample size: No formal sample size calculation is performed. Main study parameters/primary endpoints: SSI post C/S will be classified as: Superficial incisional surgical site infection, Deep incisional surgical site infection; Organ/space surgical site infection Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Because all proceedings in the method of this study are based on common clinical practice, there are no serious adverse events (SAEs) expected.

Official Title
-----------------
Maternal Cesarian Section Infection (MACSI) in Sierra Leone: an Observational Study

Conditions
-----------------
Infection, Cesarean Section Complications, Site Infection, Maternal Death

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pregnant women undergoing a C/S in on the hospitals during the study period will be eligible to participate in this study. Exclusion Criteria: The following conditions will not be considered as outcome, unless they present with systemic repercussion due to infection. For example: Vaginosis, candidiasis Lower tract urinary infection Fungal infections of the skin (athlete's foot, jockitch, ringworm, and yeast infections) Otitis Pharyngitis Herpes simplex, Herpes Zoster (Shingles) Uncomplicated chronic infection Sexually transmitted infections (Gonorrhoea, Syphilis, Trichomonas, Chlamydia, Hepatitis, HIV) Tuberculosis Bacterial colonization (presence of microorganisms without clinical signs/symptoms) Known vaginal, urethral and/or rectal GBS colonization Asymptomatic bacteriuria Known oropharyngeal colonization Non-infectious hypothermia/hyperthermia (e.g. related to epidural, thyroid storm, prostaglandin administration) during hospital stay
Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br>All women admitted or already hospitalized with suspected or confirmed infection after C/S will be screened for inclusion in the study as a case. Case confirmation will be clinically established by an infectious disease expert.SSI post C/S will be classified as: Superficial incisional surgical site infection, Deep incisional surgical site infection, Organ/space surgical site infection. | Other: Observational<br>* To record social and clinical characteristics<br>|
| Control<br>For each case, 3 patients undergoing the C/S on the same day and admitted to the same ward but not presenting Surgical Site Infection | Other: Observational<br>* To record social and clinical characteristics<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence | To determine the incidence of SSI after CS at PCMH during the study period | From hospital admission to hospital discharge, an overage of 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Main Features | To describe the main features of SSI after CS in women admitted at PCMH | From hospital admission to hospital discharge, an overage of 1 month | 
| Prevalence of Negative Outcome | To assess predictor of negative outcomes of SSI after CS | From hospital admission to hospital discharge, an overage of 1 month | 
| Screening of Risk factors | To determine the risk factors of Surgical Site Infection post Cesarean Section | From hospital admission to hospital discharge, an overage of 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Site infection, Sierra Leone, Africa, Cesarean Infection, Maternal Mortality