The Role of Maternal TB Infection for Adverse Pregnancy and Infant Health Outcomes in Ethiopia - a Long-term Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,120
- 试验地点
- 3
- 主要终点
- Incidence of adverse pregnancy outcomes
研究概览
简要总结
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.
详细描述
Objective The overall objective of this project is to investigate longitudinal patterns and consequences of tuberculosis (TB) infection in a prospective cohort of women recruited during pregnancy. The relation between maternal TB infection and pregnancy outcomes, as well as infant health and development, will be evaluated over time.
Specific aims
- To determine whether maternal TB infection is associated with adverse pregnancy outcomes
- To determine the excess risk of incident active TB during pregnancy and post-partum, with regard to the prevalence of latent TB infection at registration in antenatal care
- To investigate long-term health and survival in infants in relation to maternal TB and adverse pregnancy outcomes
Methods Study setting and participants This project is conducted in public health facilities in the city of Adama, Central Ethiopia. Participants are recruited and followed at antenatal care (ANC) clinics until delivery. After delivery their children are followed at clinics for extended program for immunization (EPI); continued follow-up of the mothers after the first post-natal visit also takes place in these clinics.
All study procedures, including interviews, physical examination, and collection of informed consent, are performed by health facility staff (nurses and midwives) in the respective clinics. Biological samples including blood and sputum are collected at the respective health facility laboratory. Study samples are transported to the Adama Regional Laboratory. At this laboratory, additional analyses and storage of plasma will be done.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women attending antenatal care at any of the study facilities
- •First antenatal care visit for current pregnancy
- •Written informed consent
- •Accepts HIV testing
- •Residence in uptake area during pregnancy period
排除标准
- 未提供
结局指标
主要结局
Incidence of adverse pregnancy outcomes
时间窗: 2015-2023
Reports of pregnancy outcomes of participating women, collected and assessed during study follow-up and categorized with regard to normal or adverse pregnancy outcomes
次要结局
- Incidence of active tuberculosis in participants during pregnancy, post-partum period and periods outside pregnancy, respectively(2015-2023)
- Pattern of child growth with regard to maternal tuberculosis infection status during pregnancy(2016-2023)
- Incidence of tuberculosis infection in Ethiopian infants during the first four years of life(2021-2023)