Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:32 AM
Study NCT ID:
NCT07419568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Burden of Tuberculosis Among Pregnant and Postpartum Women in Guinea-Bissau
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D055985', 'term': 'Latent Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000085343', 'term': 'Latent Infection'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2026-02-14', 'size': 569563, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-02-14T11:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Designed as stepped-wedge cluster randomised trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 720}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-14', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-14', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of active TB cases', 'timeFrame': 'From enrolment to 6 months postpartum', 'description': 'Number of number of bacteriologically or radiologically confirmed active TB cases comparing baseline and intervention (enhanced protocol)'}], 'secondaryOutcomes': [{'measure': 'TBI prevalence', 'timeFrame': 'At enrolment', 'description': 'Number of pregnant women with confirmed TBI'}, {'measure': 'Progression from TBI to active TB disease', 'timeFrame': 'From enrolment to 6 months postpartum', 'description': 'Number of women which develop active TB disease during pregnancy or postpartum period'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tuberculosis (TB)', 'Tuberculosis Infection, Latent', 'Pregnancy', 'Tuberculosis Diagnosis', 'Maternal Health']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women ≥ 15 years of age\n* Residing in the study\n* Attending ANC consultations at health centre in Bandim, Belem or Cuntum\n* Must provide informed consent\n\nExclusion Criteria:\n\n* Pregnant women ≤ 15 years of age\n* Inability to provide informed consent\n* Residing outside of the study area\n* Receives TB treatment at the time of, or a year prior to, enrolment'}, 'identificationModule': {'nctId': 'NCT07419568', 'acronym': 'TIPP', 'briefTitle': 'Burden of Tuberculosis Among Pregnant and Postpartum Women in Guinea-Bissau', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Assessing the Burden of Tuberculosis Among Pregnant and Postpartum Women: Implications for Integrating Tuberculosis Screening Into Routine Antenatal Care in Guinea-Bissau', 'orgStudyIdInfo': {'id': '044/CNES/INASA/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Baseline', 'description': 'At enrolment and during subsequent ANC visits, midwives at the participating health centres will perform a systematic, symptom-based evaluation, inquiring about the presence of multiple TB-related symptoms, as delineated by the Bandim TBscore II. Notably, in this phase of the study, the outcome of the Bandim TBscore II will not serve as basis for diagnostic decision-making. Throughout the baseline phase, midwives will exercise clinical discretion, adhering to national guidelines and established routine practices, to determine whether referral for TB diagnostic testing is warranted. The only TB diagnostics available and used in standard ANC routine is sputum GeneXpert. In line with national guidelines and practices, all pregnant women undergo HIV testing at their first ANC visit.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention (Enhanced protocol)', 'description': '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.', 'interventionNames': ['Diagnostic Test: Enhanced protocol']}], 'interventions': [{'name': 'Enhanced protocol', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Intervention (Enhanced protocol)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bissau', 'country': 'Guinea-Bissau', 'contacts': [{'name': 'Anita Magdalena Zalisz', 'role': 'CONTACT', 'email': 'anita.magdalena.zalisz@clin.au.dk', 'phone': '957007723', 'phoneExt': '+245'}], 'facility': 'Projecto Saude de Bandim', 'geoPoint': {'lat': 11.86357, 'lon': -15.59767}}], 'centralContacts': [{'name': 'Anita Magdalena Zalisz, MSc', 'role': 'CONTACT', 'email': 'anita.magdalena.zalisz@clin.au.dk', 'phone': '957007723', 'phoneExt': '+245'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bandim Health Project', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Frauke Rudolf', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}