Maternal Cesarian Section Infection (MACSI) in Sierra Leone

NCT03929991 | Unknown DMC

• 1 other identifier: 1902
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection; Cesarean Section Complications; Site Infection; Maternal Death

Keywords

Site infection; Sierra Leone; Africa; Cesarean Infection; Maternal Mortality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Prevalence of Main Features

  From hospital admission to hospital discharge, an overage of 1 month

• Prevalence of Negative Outcome

  From hospital admission to hospital discharge, an overage of 1 month

• Screening of Risk factors

  From hospital admission to hospital discharge, an overage of 1 month

Study Arms (2)

Case

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

Control

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

Interventions

Observational OTHER

To record social and clinical characteristics

Case; Control

Eligibility Criteria

• Gender Eligibility Details: All women admitted to Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra Leone.
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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 ).

You may qualify if:

• All pregnant women undergoing a C/S in on the hospitals during the study period will be eligible to participate in this study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Doctors with Africa - CUAMM: lead
• University of Bari: collaborator
• University of Palermo: collaborator

Study Sites (1)

Princess Christian Maternity Hospital

Freetown, Sierra Leone

RECRUITING

MeSH Terms

Conditions

Infections; Maternal Death

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Giovanni Putoto, PhD

  Department of operational research Doctors with Africa CUAMM Padova, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Di Gennaro, MD

CONTACT

3924804707; cicciodigennaro@yahoo.it

Giovanni Putoto, PhD

CONTACT

3475791347; g.putoto@cuamm.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 29, 2019
• Study Start: May 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: May 1, 2020
• Last Updated: April 30, 2019

Record last verified: 2019-04

Locations

SI (1)