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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15+
SponsorAarhus University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Enhanced protocol

Treatment groups

720 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Aarhus University Hospital

Lead sponsor

Bandim Health Project

Collaborator