Tranexamic Acid for Anaemia Trial
NCT Number: NCT06519422
Acronym: WOMAN-3
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Anemia
Interventions: DRUG: Tranexamic Acid 500 MG|OTHER: Matched placebo
Sponsor: London School of Hygiene and Tropical Medicine
Collaborators: The Jon Moulton Charity Trust
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 4000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-09
Completion Date: 2028-09

Summary:
Anaemia is a common health problem in women. It is often due to iron deficiency. Anaemia is a particular problem during pregnancy and is bad for the mother and baby. It is best to treat anaemia in young women well before they get pregnant. Doctors treat anaemia with iron and vitamins. But some people get side effects when taking iron tablets and so they stop taking them. Heavy menstrual periods are a common cause of iron deficiency and even if women do take iron, because they lose so much iron in their periods, they still become iron deficient. Tranexamic acid (TXA) is a medicine used to treat heavy periods. The investigators of this study would like to find out if taking TXA with the usual iron and vitamin supplements is better at treating anaemia than taking iron and vitamin supplements alone. (Lay Summary)

Primary Outcome Measures: Anaemia, The proportion of participants with anaemia, defined as Haemoglobin (Hb) \< 120 g/L (measured on venous blood), After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.
Secondary Outcome Measures: Haemoglobin (Hb) concentration, Hb measured on venous blood, After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.|Severity of anaemia, Mild Anaemia (Hb=110-119 g/L); Moderate Anaemia (Hb=80-109 g/L); Severe Anaemia (Hb \< 80 g/L); Hb measured on venous blood, After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.|Ferritin, Serum ferritin (from venous blood sample) and CRP-adjusted ferritin (see below, under C-reactive protein), After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.|Iron deficiency, Iron deficiency defined as ferritin \<15 ug/L (WHO definition) and defined as ferritin \<30 ug/L, (new clinical consensus); Serum ferritin from venous blood sample; CRP-adjusted ferritin (see below, under C-reactive protein)

Note: CRP-adjusted ferritin (see below), After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.|C-reactive protein (CRP), The Statistical Analysis Plan (SAP) will include details on how ferritin values will be corrected by taking into account CRP levels (inflammation marker), because normal ferritin concentrations may mask an iron deficient state if inflammation is present, After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.|Iron-deficiency anaemia, The proportion of participants with iron-deficiency anaemia, defined as presence of both anaemia (Hb\<120 g/L) plus iron deficiency (ferritin \<15 ug/L AND/OR \<30 ug/L), measured as detailed above (using CRP-adjusted ferritin levels, as explained above), After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.|Menstrual blood loss, Blood loss assessed semi-quantitatively by pictorial blood assessment chart (PBAC), adapted from Higham et al (1990), DOI: 10.1111/j.1471-0528.1990.tb16249.x, During 3 menstrual periods (on average about 3 months, but no longer than 6 months from baseline)|Perceived change in menstrual blood loss, Participant's subjective assessment of change in menstrual bleeding from baseline, e.g. expressed on a Likert scale ('greatly improved' to 'much worse'), After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.|Degree of effect of menstrual bleeding on health-related Quality of Life, SAMANTA scale (ref: Calaf, 2020, DOI: 10.1089/jwh.2018.7446 and Sinharoy 2023, DOI: 10.1016/S2214-109X(23)00416-3; Affirmative answers to two questions ('experiencing menstrual bleeding for \>7 days per month' and 'being bothered by menstruation due to its Abundance') each receive 3 points, while affirmative answers to all other questions each receive 1 point ('≥3 days of heavier bleeding', 'blood spotting on clothes at night', 'worried about staining furniture', 'avoid some activities because of the need to change menstrual materials'). These values are summed, resulting in a potential range of values for the heavy menstrual bleeding score from 0 to 10.), After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.|Flooding, 'Flooding' experienced during menstrual period (provisionally defined by Cooper 2013, DOI: 10.1111/1471-0528.17473, as "sudden overwhelming blood loss that exceeds the saturation of the menstrual products being used"), During 3 menstrual periods (on average about 3 months, but no longer than 6 months from baseline)