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Taqlaba

Tranexamic Acid to increase Quality of Life and hAemoglobin levels in Bangladeshi Adolescent girls

The problem

Heavy menstrual bleeding (HMB) is defined as excessive menstrual blood loss that interferes with woman’s quality of life. Due to excessive blood loss, HMB can promote iron deficiency and iron deficiency anaemia, which is associated with increased risk to mother and baby in future pregnancy. Almost half of Bangladeshi adolescents are anaemic. Given that adolescent pregnancy remains common in Bangladesh, preventing iron deficiency is crucial for optimizing the health of young mothers and their children.

Several small, short-term randomized controlled trials (RCTs) in high-income countries have demonstrated the efficacy of tranexamic acid (TXA) in reducing menstrual blood loss. Oral TXA could be a cost-effective solution for adolescents in low- and middle-income countries (LMICs), including Bangladesh. Unfortunately, there are significant gaps in evidence for TXA for HMB. For example, they measured blood loss rather than clinically relevant self-reported HMB for inclusion, excluded adolescents, and did not focus on LMICs. Crucially, trials were brief (3 cycles), required invasive screening, and rarely assessed anaemia/iron status or quality of life. This evidence lacks generalizability for young women in resource-limited settings.

The trial

TAQLABA is a phase-3, double-blind, placebo-controlled, two-arm parallel-group, individually randomized controlled trial of oral TXA to treat self-reported HMB in unmarried school-attending Bangladeshi adolescent girls. The primary objective 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 12-month study period.

This trial will be conducted in established sites in rural Bangladesh and supported by health economic and implementation science analyses to facilitate the translation of study results into practice. TAQLABA addresses several critical evidence gaps, including the lack of RCTs evaluating TXA for HMB in adolescents, the absence of trials in LMICs, and limited data on the impacts of HMB treatment on anaemia, iron status, quality of life, and functional health outcomes.

The team

More information

Global maternal and child health trials in Africa and Asia
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