NCT02339077已完成不适用
Group B Streptococcus (GBS) Associated Stillbirths in a High Burden Setting
University of Witwatersrand, South Africa2 个研究点 分布在 1 个国家目标入组 354 人开始时间: 2014年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 354
- 试验地点
- 2
- 主要终点
- Determine the number of stillbirths who have GBS isolated from cord blood, gastric aspirates, placenta and/ or skin swabs
研究概览
简要总结
This is a descriptive study to determine the role of fetal GBS disease as a cause for stillbirths
详细描述
A prospective, descriptive study will be undertaken involving mothers who have a stillbirth at Chris Hani Baragwanath Academic Hospital (CHBAH), a secondary-tertiary care hospital, from 2014 up until 2016.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pregnant women delivering a stillbirth at CHBAH
- •Participants aged ≥18 years
- •Able to understand and comply with planned study procedures
- •Provides written informed consent (either generic ICF or V98_28OBTP)
排除标准
- •Refuses to consent to study participation
结局指标
主要结局
Determine the number of stillbirths who have GBS isolated from cord blood, gastric aspirates, placenta and/ or skin swabs
时间窗: Birth
次要结局
- Number of stillbirths occurring at CHBAH, and identify potential causes of the stillbirths (maternal and obstetric risk factors)(Birth)
- Number of stillbirths related to a probable Infectious cause(Birth)
研究者
Farzanah Laher
Dr
University of Witwatersrand, South Africa
研究点 (2)
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