NCT03305991

Tuberculosis Infection in Women of Reproductive Age and Their Infants

Completed Last updated 13 March 2024

What this trial tests

trial in Tuberculosis in 2,120 participants. Completed in 12 March 2024.

Timeline

1 December 2015

Primary endpoint
12 March 2024

12 March 2024

Quick facts

Lead sponsor	Lund University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2,120
Start date	1 December 2015
Primary completion	12 March 2024
Estimated completion	12 March 2024
Sites	3 locations across Ethiopia

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →
• Pregnancy Complications — all drugs for Pregnancy Complications →

Sponsor

Lund University

Who can join

Eligibility, female only, with Tuberculosis or Pregnancy Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Indoor Air Pollution Exposure of Women in Adama, Ethiopia, and Assessment of Disease Burden Attributable to Risk Factor.
   Balidemaj F, Isaxon C, Abera A, Malmqvist E. · · 2021 · cited 19× · PMID 34574780 · DOI 10.3390/ijerph18189859
2. Tuberculosis Infection in Women of Reproductive Age: A Cross-sectional Study at Antenatal Care Clinics in an Ethiopian City.
   Walles J, Tesfaye F, Jansson M, Balcha TT, et al · · 2021 · cited 18× · PMID 32412638 · DOI 10.1093/cid/ciaa561
3. Dynamics of Mycobacterium tuberculosis-Specific and Nonspecific Immune Responses in Women with Tuberculosis Infection during Pregnancy.
   Tesfaye F, Sturegård E, Walles J, Bekele B, et al · · 2022 · cited 7× · PMID 35969076 · DOI 10.1128/spectrum.01178-22
4. Tuberculosis infection and stillbirth in Ethiopia-A prospective cohort study.
   Walles J, Otero LG, Tesfaye F, Abera A, et al · · 2022 · cited 5× · PMID 35404930 · DOI 10.1371/journal.pone.0261972