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NCT Number: NCT07419568

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

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.

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Key information

Conditions

Tuberculosis (TB) Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Latent Infection Latent Tuberculosis Maternal Health Mycobacterium Infections Pregnancy Tuberculosis Tuberculosis Diagnosis Tuberculosis Infection, Latent

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Projecto Saude de Bandim

Bissau, Guinea-Bissau

Location contact

Anita Magdalena Zalisz

CONTACT

[email protected]

957007723 ext. +245

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced protocol

Diagnostic Test

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.

Primary outcomes

  1. Number of active TB cases

    Time frame: From enrolment to 6 months postpartum

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

Secondary outcomes

  1. TBI prevalence

    Time frame: At enrolment

    Number of pregnant women with confirmed TBI

  2. Progression from TBI to active TB disease

    Time frame: From enrolment to 6 months postpartum

    Number of women which develop active TB disease during pregnancy or postpartum period

Study contacts

Contact information is provided by the study sponsor or research team.

Anita Magdalena Zalisz, MSc

CONTACT

[email protected]

957007723 ext. +245

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Bandim Health Project

Registry information

Official study title

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

Acronym: TIPP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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