Status:
COMPLETED
Dried Blood Spot Test to Assess TB in Pregnancy
Lead Sponsor:
Institut Pasteur de Madagascar
Collaborating Sponsors:
National Tuberculosis Program, Madagascar
Analakely Hospital University Care and Public Health, Madagascar
Conditions:
Tuberculosis
Eligibility:
FEMALE
15+ years
Brief Summary
Despite being a key contributor to maternal mortality in high-burden regions, TB in pregnancy is a hugely neglected area of global public health. During pregnancy, the symptoms of TB are often overloo...
Detailed Description
With this Grand Challenges Canada Transition to scale DROP-TB program, the Institut Pasteur de Madagascar will: 1. Conduct a validation trial of the DROP-TB screening program in rural Madagascar, enr...
Eligibility Criteria
Inclusion
- Group cases:
- pregnant women aged over 15 adressed to TB diagnostic and treatment centers for a bacteriological diagnosis of pulmonary TB
- Or with one or more symptoms of presumptive TB: cough, fatigue, weight loss, fever, chills, night sweats, shortness of breath, loss of appetite
- agreed to participate in the study with full knowledge of the facts and signed an informed consent
- Group control:
- pregnant women over 15 years referred to a prenatal health center,
- without known or clinically observed pathology associated with pregnancy
- agreed to participate in the study with full knowledge of the facts and signed an informed consent
Exclusion
- Group cases :
- Patients undergoing TB treatment for more than 2 weeks
- Treatments with immunosuppressive drugs (≥ 14 consecutive days);
- Progressive disease which does not allow venous blood sampling and venous capillary sampling;
- All other clinical manifestations deemed incompatible for the study
- Group Control :
- No clinical signs of TB, no history of previous TB
- No other known or clinically observed pathologies
Key Trial Info
Start Date :
October 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
1424 Patients enrolled
Trial Details
Trial ID
NCT04871230
Start Date
October 27 2021
End Date
September 30 2022
Last Update
September 28 2023
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
CHRR Ambositra, CDT Ivato
Ambositra, Amoron'i Mania Region, Madagascar
2
CSBII Ivato, AMIT Behoririka, OSTIE Behoririka, CSB II Tanjombato, CSB II Analamahitsy
Antananarivo, Analamanga Region, Madagascar, 101
3
CSB II Isotry Central, Dispensaire SALFA 67 ha, Centre Hospitalier d'Ambohidroa
Antananarivo, Analamanga Region, Madagascar
4
CSBII Ambohimanarina, CSB II Anosipatrana, CSB II Ambohipo, CHRD Itaosy
Antananarivo, Analamanga Region, Madagascar