Clinical trial NCT03929991: Maternal Cesarian Section Infection (MACSI) in Sierra Leone
Official title: Maternal Cesarian Section Infection (MACSI) in Sierra Leone: an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection
Cesarean Section Complications
Site Infection
Maternal Death
Keywords: Site infection
Sierra Leone
Africa
Cesarean Infection
Maternal Mortality
Lead sponsor: Doctors with Africa - CUAMM
Sponsor class: OTHER
Collaborators: name: University of Bari
name: University of Palermo
First posted: 2019-04-29
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women undergoing a C/S in an urban tertiary referral maternity hospital PCMH, Freetown (population served: 1'500'000; n. of total deliveries in 2017: 6'861; number of C/S in 2017: 2'028 ).

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.

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

Primary outcomes:
measure: Incidence
timeFrame: From hospital admission to hospital discharge, an overage of 1 month
Secondary outcomes:
measure: Prevalence of Main Features
timeFrame: From hospital admission to hospital discharge, an overage of 1 month
measure: Prevalence of Negative Outcome
timeFrame: From hospital admission to hospital discharge, an overage of 1 month
measure: Screening of Risk factors
timeFrame: From hospital admission to hospital discharge, an overage of 1 month
Other outcomes:
Locations:
city: Freetown
country: Sierra Leone
facility: Princess Christian Maternity Hospital
Study officials:
affiliation: Department of operational research Doctors with Africa CUAMM Padova, Italy
name: Giovanni Putoto, PhD
role: PRINCIPAL_INVESTIGATOR
References: