NCT07419568

Burden of Tuberculosis Among Pregnant and Postpartum Women in Guinea-Bissau

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: Female
• Age: 15 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Tuberculosis (TB)
• Tuberculosis Infection, Latent
• Pregnancy
• Tuberculosis Diagnosis
• Maternal Health

Interventions

Type	Name	Description
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 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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: Guinea-Bissau