Screening for TB in Pregnancy A Supplement to: The Effect of Tuberculosis and Its Treatment on HIV-Infected Pregnant Women and Their Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Proportion of women diagnosed with TB
研究概览
简要总结
Pregnant women who develop active Tuberculosis (TB) are at increased risk of poor maternal and infant outcomes. Our data from South Africa show that up to 3% of HIV-infected pregnant women have active TB , many with advanced disease, contributing to the 40% of maternal mortality associated with TB or HIV in South Africa . Screening for TB in pregnant women in this setting is therefore essential to reduce maternal mortality. Symptom-directed screening for TB has been recommended by the World Health Organization and by the South African National Department of Health; however, no implementation framework is in place to operationalize the guidelines. Symptom-based testing is an efficient process that limits use of diagnostic tests, but may miss many cases. In Soweto, we found that 0.7% (700/100,000) of HIV-infected women had active TB when a symptom-based strategy was employed once, but in Klerksdorp we found that 3.3% (3,300/100,000) had active TB when universal testing, regardless of symptoms, was performed; most TB cases were newly diagnosed among women who reported no symptoms .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HIV seropositive by two rapid tests, or documented history of a positive Enzyme Immunoassay EIAs, or HIV RNA >1000 copies/mL
- •Pregnancy confirmed by urine pregnancy test or clinical exam
- •Estimated gestational age of 13 weeks or older
- •Age 18 years or greater
- •Willing to provide verbal consent
排除标准
- •Currently diagnosed with TB
- •Completed TB treatment within the last 6 months
- •Inability to communicate in one of the study languages.
- •Lack of comprehension of the study based on inability to meet basic understanding questions during the screening process.
研究组 & 干预措施
Universal screening
All HIV + pregnant women will be asked to give a sputum sample for TB prior to TB symptom screen
干预措施: Sputum sample (Other)
Symptom- directed screening
Only symptomatic HIV+ pregnant women will be asked to give a sputum sample for TB
干预措施: Sputum sample (Other)
结局指标
主要结局
Proportion of women diagnosed with TB
时间窗: One year
1. Proportion of women who are diagnosed with TB in each arm
次要结局
未报告次要终点
