Burden of Tuberculosis Among Pregnant and Postpartum Women in Guinea-Bissau
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enhanced protocol.
- Who it may be relevant to
- Registry conditions: Tuberculosis (TB), Tuberculosis Infection, Latent, Pregnancy, Tuberculosis Diagnosis. Basic parameters: from 15 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Guinea-Bissau
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessing the Burden of Tuberculosis Among Pregnant and Postpartum Women: Implications for Integrating Tuberculosis Screening Into Routine Antenatal Care in Guinea-Bissau
Overview
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.
Interventions
- Diagnostic test Enhanced protocol
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
Primary outcome measures
- Number of active TB cases [Time frame: From enrolment to 6 months postpartum]
Secondary outcome measures (2)
- TBI prevalence [Time frame: At enrolment]
- Progression from TBI to active TB disease [Time frame: From enrolment to 6 months postpartum]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Guinea-Bissau · 1 center
- Projecto Saude de Bandim — Bissau
Identifiers
NCT: NCT07419568 · 044/CNES/INASA/2025