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临床试验/NCT04227730
NCT04227730撤回不适用

Maternal And Neonatal Screening For Group B Streptococci in Fayoum Governrate: A Follow Up Study

Fayoum University Hospital1 个研究点 分布在 1 个国家开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
prevalence of GBS in Fayoum

研究概览

简要总结

Group B Streptococcus (GBS), is a facultative gram positive diplococcus originally known for causing bovine mastitis and was not demonstrated to be a human pathogen until 1938. In the 1970s, GBS emerged as the leading cause of neonatal morbidity and mortality, with a frequency of 2-3 cases per 1,000 live births and case-fatality ratios as high as 50%

详细描述

Group B Streptococcus (GBS), is a facultative gram positive diplococcus originally known for causing bovine mastitis and was not demonstrated to be a human pathogen until 1938 (1). In the 1970s, GBS emerged as the leading cause of neonatal morbidity and mortality, with a frequency of 2-3 cases per 1,000 live births and case-fatality ratios as high as 50% (2). It causes severe invasive infection in newborns 80% of which occur within the first week of life (early-onset neonatal sepsis) that results from ascending spread of GBS into the amniotic fluid through both ruptured and intact membranes (3,4). Infants who have such infections may require prolonged hospitalization, and those who survive may have mental retardation or visual loss (5).

Transmission from mother to child has been reported to be 29 times higher in GBS-colonized mothers than in noncolonized mothers. The prevalence of GBS colonization in the vagina and/or rectum among pregnant women can vary among ethnic groups and geographical locations, ranging from approximately 10% to 40% (6). Although GBS colonization is not associated with disease in healthy women, colonization in pregnant women may be associated with urinary tract infection, bacteremia, amnionitis, endometritis, postpartum wound infections, and rarely, meningitis (7).

A number of obstetric factors have been associated with an increased likelihood of early-onset GBS disease in the newborn. These include maternal colonization of the vagina and rectum with GBS, preterm birth, prolonged rupture of membranes, intrapartum fever, women younger than 20 years (8), women with prior GBS-infected infant, women with heavy colonization- GBS bacteriuria equal to or greater than 104 colony forming units or low levels of anti-GBS capsular antibody(9,10).

Intrapartum antibiotic prophylaxis (IAP) has been shown not only to interrupt the transmission of GBS from mother to infant but also to reduce the incidence of early-onset GBS disease (11). Guidelines from the Federal Centers for Disease Control and Prevention (CDC) (12), the American College of Obstetricians and Gynecologists (ACOG) (6) and the American Academy of Pediatrics (AAP) issued in 1996 and 2002(13, 14) recommended two different strategies for the selection of candidates for IAP: either screening for GBS vaginorectal carriers or identification of maternal clinical risk factors for early-onset neonatal GBS disease. They recommended obtaining rectovaginal cultures at 35-37 weeks of gestation with the culture-based approach (12).

The value and practicality of both strategies has been debated in the literature. At issue is potential overtreatment (in the case of the culture strategy) and under treatment (in the case of the risk-factor strategy) of patients, as well as the associated cost. For example, the standard screening test, a rectovaginal culture taken at 35 to 37 weeks, has been controversial because it may not accurately predict genital tract colonization at time of labor (with an estimated sensitivity of 87%-91% and specificity of 89%-96%). The risk-factor method, on the other hand, would target treatment toward the mothers believed to be at greatest risk but would miss many colonized mothers and at-risk infants (15, 16). Despite their limitations, both approaches are effective in reducing early-onset group B streptococcal infection rate in infants, although more widespread implementation of the guidelines is needed (11, 17).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 46 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant females 35-37 weeks of gestational age Patients who were followed till delivery without prolonged rupture of membrane

排除标准

  • patients lost follow up and or had prolonged rupture of membrane>12 hours

结局指标

主要结局

prevalence of GBS in Fayoum

时间窗: one year

Percentage of maternal GBS infection and its reflection on neonatal infection

次要结局

  • improve and simplify the diagnosis of GBS(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sahar MY Elbaradie

associate Professor

Fayoum University Hospital

研究点 (1)

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