Maternal Cesarian Section Infection (MACSI) in Sierra Leone: an Observational Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Incidence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All pregnant women undergoing a C/S in on the hospitals during the study period will be eligible to participate in this study.
排除标准
- •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)
- •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
结局指标
主要结局
Incidence
时间窗: 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
次要结局
- 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)