Maternal Cesarian Section Infection (MACSI) in Sierra Leone

Doctors with Africa - CUAMM

Status: Unknown

Conditions: Cesarean Section Complications; Infection; Site Infection; Maternal Death

Treatments: Other: Observational

Study type: Observational

Funder types: Other

Identifiers

NCT03929991

1902

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 2 patient groups

Case

Description:

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.

Treatment:

Other: Observational

Control

Description:

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

Treatment:

Other: Observational