New Delhi, Aug 22 (UNI) The World Health Organization (WHO) has called upon the international health community to ensure active participation of pregnant women in vital TB research and clinical trials.
Currently, pregnant and lactating women are routinely left out of such studies. However, the WHO noted that more than 200,000 pregnant and postpartum women are globally diagnosed with tuberculosis (TB) each year.
Caused by a bacterium known as Mycobacterium tuberculosis, TB primarily targets the lungs but can also affect other organs like the brain, kidneys, or spine.
TB during pregnancy presents considerably higher risks compared to women of reproductive age who are not pregnant. This heightened susceptibility results in more severe complications, with TB linked to increased maternal illness, including aggravated TB symptoms and pregnancy-related issues such as premature labor and miscarriage.
Moreover, babies born to mothers suffering from TB face greater risks of neonatal infections, low birth weight, and higher rates of infant mortality. Despite these serious concerns, pregnant women have traditionally been excluded from clinical trials, creating significant gaps in scientific knowledge and delaying their access to critical, potentially life-saving treatments and vaccines. The WHO has urged the countries to bring this sector under the research ambit.
“The benefits of TB research must reach all individuals affected by the disease, including pregnant and breastfeeding women. Their inclusion should no longer be an afterthought, but a central part of providing fair and evidence-based carem,” Dr. Tereza Kasaeva, Director of WHO’s Department for HIV, TB, Hepatitis, and STIs said, emphasizing the importance of the move.
The WHO’s latest comprehensive framework supports enhanced surveillance and improved data collection on TB in pregnant and postpartum women as well also recommend prompt initiation of preclinical studies to evaluate the safety and effectiveness of new TB drugs and vaccines in this population, along with their involvement at every stage of TB medication and vaccine trials.
To support these efforts, WHO has highlighted the necessity of overcoming legal, ethical, and regulatory challenges, as well as empowering communities affected by TB to guarantee that research is inclusive, respectful, and responsive.
This consensus statement is the outcome of a global collaboration involving over 80 experts covering areas such as preclinical research, TB therapeutics, vaccine development, maternal TB monitoring, and advocacy. It provides a clear roadmap for drug developers, researchers, regulatory bodies, government agencies, funders, and civil society to take decisive steps toward the inclusion of pregnant and breastfeeding women in TB research.
