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

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ClinicalTrials.gov Identifier: NCT03929991
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborators:
University of Bari
University of Palermo
Information provided by (Responsible Party):
Doctors with Africa - CUAMM

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.


Condition or disease Intervention/treatment
Infection Cesarean Section Complications Site Infection Maternal Death Other: Observational

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.


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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Maternal Cesarian Section Infection (MACSI) in Sierra Leone: an Observational Study
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All women admitted to Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra Leone.
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 ).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929991


Contacts
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Contact: Francesco Di Gennaro, MD 3924804707 cicciodigennaro@yahoo.it
Contact: Giovanni Putoto, PhD 3475791347 g.putoto@cuamm.org

Locations
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Sierra Leone
Princess Christian Maternity Hospital Recruiting
Freetown, Sierra Leone
Contact: Francesco Di Gennaro    3924804707    cicciodigennaro@yahoo.it   
Sponsors and Collaborators
Doctors with Africa - CUAMM
University of Bari
University of Palermo
Investigators
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Principal Investigator: Giovanni Putoto, PhD Department of operational research Doctors with Africa CUAMM Padova, Italy

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Responsible Party: Doctors with Africa - CUAMM
ClinicalTrials.gov Identifier: NCT03929991     History of Changes
Other Study ID Numbers: 1902
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Doctors with Africa - CUAMM:
Site infection
Sierra Leone
Africa
Cesarean Infection
Maternal Mortality

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Maternal Death
Pregnancy Complications
Parental Death
Death
Pathologic Processes