跳至主要内容
临床试验/NCT02520973
NCT02520973已完成不适用

Screening for TB in Pregnancy A Supplement to: The Effect of Tuberculosis and Its Treatment on HIV-Infected Pregnant Women and Their Infants

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2015年5月最近更新:
适应症
干预措施

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

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

Experimental

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

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验