Tranexamic Acid to improve Quality of Life and hAemoglobin levels in Bangladeshi Adolescent girls (TAQLABA)

TAQLABA is a randomised controlled trial to build evidence for oral tranexamic acid (TXA) to treat heavy menstrual bleeding in Bangladeshi adolescent girls, in order to improve wellbeing and reduce anaemia. Heavy menstrual bleeding (HMB) - excessive menstrual blood loss that interferes with a woman's quality of life - can promote iron deficiency and iron deficiency anaemia due to blood losses, and by definition, implies significant impairment of health-related quality of life and functioning (e.g. missed days of school). Anaemia (low haemoglobin levels) affects >500 million women (30%) globally, and the prevalence is not decreasing despite being prioritised in international guidelines and targets. Adolescence is a time of substantial physical, emotional and cognitive growth. However, adolescents remain overlooked in global nutrition policies. The impact of menstruation on quality of life is highest in adolescents. Our preliminary studies indicate that 14% of Bangladeshi adolescent girls report HMB. Previous studies indicate that 41% of Bangladeshi adolescents miss school during their period, usually due to embarrassment and the volume of blood loss. Crucially, adolescence is a time of peak anaemia risk in girls. Oral tranexamic acid (TXA) is a cheap, well-tolerated medication that reduces bleeding; it is the most effective non-contraceptive medical therapy for HMB. In adolescents in low-income settings, TXA offers an opportunity to reduce menstrual blood loss, improve haemoglobin, and improve quality of life and social functioning. However, critical knowledge gaps preclude this approach; e.g. there are no RCTs evaluating TXA in adolescents, no trials in low-income countries, and minimal data evaluating effects on anaemia or quality of life. To address these gaps and facilitate policy, we propose TAQLABA - Tranexamic Acid to increase Quality of Life and hAemoglobin levels in Bangladeshi Adolescent girls - a double-blind, placebo controlled, individually randomised controlled trial. TAQLABA will provide evidence for use of TXA to treat HMB (selected via a simple screening tool) in Bangladeshi adolescent girls. The primary aim of TAQLABA is to demonstrate that oral TXA is superior to placebo in improving haemoglobin concentration or menstrual-related quality of life at the end of the study period in Bangladeshi adolescent girls with self-reported HMB in the community and school- setting. The need and design of TAQLABA were influenced by extensive consultation and feasibility studies with local adolescent girls and stakeholder consultations with local community, health and education leaders. We surveyed 3475 Bangladeshi adolescents to define the scope of the problem, assess their willingness to participate in a trial, and define the key outcomes of value to consumers. We interviewed local educators and health care providers, and met with key officials from multiple government departments. In addition, we have discussed the proposal with relevant departments of the World Health Organization (WHO). All have endorsed the concept. The trial will run in our established sites in rural Bangladesh, and be supported by health economic, policy and implementation science analyses to support translation of the study results to practice.