Maternal Cesarian Section Infection (MACSI) in Sierra Leone (MACSI)

April 29, 2019 updated by: Doctors with Africa - CUAMM

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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 ).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
To record social and clinical characteristics
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
To record social and clinical characteristics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence
Time Frame: From hospital admission to hospital discharge, an overage of 1 month
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
Time Frame: From hospital admission to hospital discharge, an overage of 1 month
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
Time Frame: From hospital admission to hospital discharge, an overage of 1 month
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
Time Frame: From hospital admission to hospital discharge, an overage of 1 month
To determine the risk factors of Surgical Site Infection post Cesarean Section
From hospital admission to hospital discharge, an overage of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Doctors with Africa - CUAMM

Collaborators

University of Palermo
University of Bari

Investigators

  • Principal Investigator: Giovanni Putoto, PhD, Department of operational research Doctors with Africa CUAMM Padova, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

April 24, 2019

First Submitted That Met QC Criteria

April 26, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Actual)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1902

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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