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NCT07419568Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 19 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
720 (estimated)
First submitted
9 Feb 2026
Start date
Feb 2026
Primary completion date
Nov 2027
Lead sponsor
Aarhus University Hospital
Diseases
Tuberculosis
NCT number
NCT07419568

What you commit to

  • Study type: Interventional
  • Planned participants: 720
  • From Feb 2026 to the primary completion date, Nov 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receives TB treatment at the time of, or a year prior to, enrolment

Age

  • Pregnant women ≤ 15 years of age

Other

  • Inability to provide informed consent
  • Residing outside of the study area

Who the study is looking for

  • 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

Age in the registry: 15 years to - · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Projecto Saude de Bandim
Coordinator of this site? Confirm its status
BissauGuinea-BissauUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.