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临床试验/NCT07419568
NCT07419568尚未招募不适用

Assessing the Burden of Tuberculosis Among Pregnant and Postpartum Women: Implications for Integrating Tuberculosis Screening Into Routine Antenatal Care in Guinea-Bissau

Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
720
试验地点
1
主要终点
Number of active TB cases

研究概览

简要总结

This study aims to address critical diagnostic and data gaps in tuberculosis (TB) care among pregnant and postpartum women in Guinea-Bissau, a high-burden, resource-limited setting. Recognising that current TB screening during antenatal care (ANC) relies largely on unstructured symptom questions, the study will integrate more systematic and innovative approaches into routine maternal health services.

The project will implement the Bandim TBscore II as a structured triage tool to classify symptom severity and guide referrals. To strengthen diagnostic capacity, two novel tools will be evaluated: stool-based GeneXpert testing (a method recommended in children and explored here as a feasible alternative for pregnant women) and artificial intelligence-powered chest X-ray interpretation software designed to enhance TB detection where radiological expertise is lacking.

The study will also generate comprehensive, population-based data on TB and TB infection (TBI) among pregnant, postpartum women and women of reproductive age in Guinea-Bissau. The results are intended to inform health policy, both locally and in high-income countries, by providing evidence to improve TB screening protocols and care for this vulnerable group. Ultimately, the study seeks to develop scalable strategies that can be replicated across low- and middle-income countries to advance maternal and child health and support global TB eradication efforts.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women ≥ 15 years of age
  • Residing in the study
  • Attending ANC consultations at health centre in Bandim, Belem or Cuntum
  • Must provide informed consent

排除标准

  • Pregnant women ≤ 15 years of age
  • Inability to provide informed consent
  • Residing outside of the study area
  • Receives TB treatment at the time of, or a year prior to, enrolment

研究组 & 干预措施

Baseline

No Intervention

At enrolment and during subsequent ANC visits, midwives at the participating health centres will perform a systematic, symptom-based evaluation, inquiring about the presence of multiple TB-related symptoms, as delineated by the Bandim TBscore II. Notably, in this phase of the study, the outcome of the Bandim TBscore II will not serve as basis for diagnostic decision-making. Throughout the baseline phase, midwives will exercise clinical discretion, adhering to national guidelines and established routine practices, to determine whether referral for TB diagnostic testing is warranted. The only TB diagnostics available and used in standard ANC routine is sputum GeneXpert. In line with national guidelines and practices, all pregnant women undergo HIV testing at their first ANC visit.

Intervention (Enhanced protocol)

Active Comparator

In the intervention, and inclusion and subsequent ANC visits, pregnant women will be interviewed by midwives regarding TB exposure and previous TB, and systematically screened with the Bandim TBscore II, which categorises patients based on the severity of their symptoms. Women exhibiting moderate symptoms (TBscoreII=2-3) suggestive of TB will be referred for GeneXpert testing sputum and/or faecal samples, while individuals with more severe symptoms (TBscoreII=4-8) will additionally receive chest radiography, which will be analysed with AI software. Due to high co-infection rates, all HIV-positive women, regardless of their Bandim TBscore II, will be tested with both GeneXpert and chest radiography. Women with positive GeneXpert results will be referred for treatment, while women with chest radiography will attend a consultation with a TB specialist. Participants will be reassessed for TB symptoms at each subsequent ANC visit and at 6 months postpartum.

干预措施: Enhanced protocol (Diagnostic Test)

结局指标

主要结局

Number of active TB cases

时间窗: From enrolment to 6 months postpartum

Number of number of bacteriologically or radiologically confirmed active TB cases comparing baseline and intervention (enhanced protocol)

次要结局

  • TBI prevalence(At enrolment)
  • Progression from TBI to active TB disease(From enrolment to 6 months postpartum)

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Frauke Rudolf

MD, PhD

Aarhus University Hospital

研究点 (1)

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