Maternal Cesarian Section Infection (MACSI) in Sierra Leone

Infection Clinical Trial

— MACSI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03929991
• Other study ID #: 1902
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: April 2019
• Source: Doctors with Africa - CUAMM
• Contact: Francesco Di Gennaro, MD
• Phone: 3924804707
• Email: cicciodigennaro[@]yahoo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 1, 2020
• Est. primary completion date: October 1, 2019
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Communicable Diseases
• Infection
• Maternal Death
• Site Infection

Intervention

Other:
• Observational
To record social and clinical characteristics

Locations

Country	Name	City	State
Sierra Leone	Princess Christian Maternity Hospital	Freetown

Sponsors (3)

Lead Sponsor	Collaborator
Doctors with Africa - CUAMM	University of Bari, University of Palermo

Country where clinical trial is conducted

Sierra Leone, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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