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临床试验/NCT05469256
NCT05469256已完成不适用

Group B Streptococcus Colonization in Mother-newborn Dyads and Association With Serotype-specific Capsular Antibodies in Karachi, Pakistan.

Aga Khan University1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2019年4月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
600
试验地点
1
主要终点
Prevalence of GBS colonization in pregnant women

研究概览

简要总结

Group B Streptococcus (GBS) of which there are 10 serotypes of varying invasive potential is a major cause of invasive bacterial disease in neonates and young infants. Approximately two-thirds of invasive GBS disease occurs during the first three days of life of which 75%-90% occur within 24 hours of birth in the absence of clinical interventions such as intrapartum antibiotic prophylaxis (IAP). Invasive GBS disease during the first week (Early onset disease, EOD) of life results from vertical acquisition of GBS in utero by the foetus or during labour from recto-vaginally colonized women. The incidence of EOD in full-term new-borns has declined by approximately 90% in countries where there is routine screening of pregnant women for GBS recto-vaginal colonization at 35-37 weeks of gestational age and where IAP is provided 4 hours prior to delivery to colonized women. The strategy for routine screening for GBS colonization coupled with IAP, however, is not logistically feasible in most resource-constrained countries including Pakistan and has also been shown to be not cost-effective including in some high-income countries. The current CDC recommendation for the isolation of GBS from vaginal and rectal or recto-vaginal swabs is by initial growth in a selective broth medium with antibiotics, followed by subculture on blood agar or selective media.

This study aims to address the knowledge gaps to better inform the epidemiology of GBS in a low income setting and address some of the critical limitations of current data from low-middle income countries. Women who had normal vaginal delivery at term (>37 weeks of gestation age) will be enrolled in this study. Recto-vaginal swabs from the mothers will be collected for GBS.

All samples will be collected by trained midwives/physician before delivery. All newborns born to these mothers will be followed at 28th day after birth to assess their health status with emphasis on possible invasive disease episodes.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
13 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women age 13-49 years age.
  • Pregnant women ≥37 weeks' gestation.
  • Delivering by normal vaginal delivery.
  • Are able to provide informed consent.

排除标准

  • Unwilling to consent to be on the study
  • Women who had taken any antibiotic treatment in previous two weeks 3 .Women who have blood transfusion in 30 days before delivery.

结局指标

主要结局

Prevalence of GBS colonization in pregnant women

时间窗: 6-8 months

i) Define the prevalence of GBS colonization in pregnant women at term-delivery and vertical acquisition thereof by the new-born in low income settlements in Karachi, Pakistan.

次要结局

未报告次要终点

研究者

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

Dr Fyezah Jehan

Assistant Professor

Aga Khan University

研究点 (1)

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