Maternal Cesarian Section Infection (MACSI) in Sierra Leone

Last updated: April 29, 2019
Sponsor: Doctors with Africa - CUAMM
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03929991
1902
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria: The following conditions will not be considered as outcome, unless they present withsystemic repercussion due to infection. For example:

  • Vaginosis, candidiasis

  • Lower tract urinary infection

  • Fungal infections of the skin (athlete's foot, jockitch, ringworm, and yeastinfections)

  • 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 Design

Total Participants: 1000
Study Start date:
May 01, 2018
Estimated Completion Date:
May 01, 2020

Study 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.

Connect with a study center

  • Princess Christian Maternity Hospital

    Freetown,
    Sierra Leone

    Active - Recruiting

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