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ClinicalIndex Comparison Record
N/ACompleted· 2,120 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT03305991
NCT03305991N/ACompleted

The Role of Maternal TB Infection for Adverse Pregnancy and Infant Health Outcomes in Ethiopia - a Long-term Prospective Cohort Study

Lund University·observational·Posted Oct 10, 2017·Updated Mar 13, 2024

In Brief

An observational study for Tuberculosis and Pregnancy Complications. Completed, enrolled 2,120 participants across 3 sites.

Detailed Summary

Women living in low-income countries are at elevated risk of death in connection to pregnancy, as well as infants born to women in such settings. It is probable that several factors are involved, such as poverty, lack of education and access to healthcare. Infectious diseases constitute important threats to maternal health in resource-limited settings. Tuberculosis (TB) is reported to be the third leading cause of maternal death globally. Furthermore, TB can be transmitted from mother to child during pregnancy, with high risk of severe consequences for the infant. Despite these data, neither the role of TB in relation to co-existing risk factors for adverse pregnancy outcomes, nor the mechanisms involved, are well understood. It is likely that TB interacts with other characteristics, in particular socio-economic condition and HIV infection, which could obscure associations between TB and pregnancy outcomes. For this reason, it is critical to design studies so that the independent role of TB can be deduced. This project aims to investigate how TB infection in women affects the risk of adverse pregnancy outcomes in relation to co-existing factors, and how exposure to TB infection may impact growth and development of infants born to women with TB. In addition, mechanisms in which TB and the immune system during pregnancy will be explored. The project is conducted at public health facilities in Ethiopia, where 2 000 women have been recruited during antenatal care. These women will be followed until 5 years after delivery, along with their offspring born during the study period. Detailed data is collected at inclusion and at study visits during follow-up, with submission of samples for TB testing and immunological analyses. Better knowledge on the characteristics of TB infection in association with pregnancy, and how TB affects maternal and child health, can be used to construct new guidelines for management of TB in women of fertile age. This may contribute to reductions in adverse pregnancy outcomes, including maternal and infant deaths.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesEthiopia
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 10, 2017
Enrollment StartDec 1, 2015
Primary CompletionMar 12, 2024
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 8.7 years ago