Tranexamic Acid 500 MG
DrugTablets
NCT Number: NCT06519422
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)
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Phase 3
World-wide, half a billion women of reproductive age are anaemic. Anaemia has major health consequences for pregnant women and their babies. Anaemia increases the risk of ante-partum haemorrhage, prematurity, stillbirth, neonatal death, post-partum haemorrhage and maternal death. Early intervention to reduce the risk of anaemia before pregnancy offers the potential to reduce adverse maternal and birth outcomes and improve well-being across the reproductive life course.
Unfortunately, global efforts to reduce anaemia prevalence by 2025 are far off track. Anaemia worsens bleeding through multiple biological mechanisms. Anaemia increases blood flow from bleeding vessels due to reduced blood viscosity and anaemic blood clots are more susceptible to fibrinolysis. Although iron and multivitamin replacement is the mainstay of anaemia treatment, iron stores in young women depend more on menstrual iron loss than on dietary intake. Because anaemia worsens bleeding, women with anaemia have heavier menstrual periods than if they were not anaemic. For this reason, offering iron replacement without reducing menstrual iron loss may be inefficient.
The antifibrinolytic tranexamic acid (TXA) reduces menstrual bleeding by preventing blood clot breakdown. The investigators propose that giving TXA with iron and vitamin replacement will be more effective in treating anaemia than iron and vitamin replacement alone.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(Individuals with known thalassaemia are eligible to participate and take the trial treatment but will not receive standard of care iron supplementation. They will continue to receive their standard care.)
Exclusion criteria
Tablets
Matched placebo tablets (inactive ingredients only, including microcrystalline cellulose, magnesium stearate BP and lactose)
Time frame: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.
The proportion of participants with anaemia, defined as Haemoglobin (Hb) < 120 g/L (measured on venous blood)
Time frame: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.
Hb measured on venous blood
Time frame: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.
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
Time frame: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.
Serum ferritin (from venous blood sample) and CRP-adjusted ferritin (see below, under C-reactive protein)
Time frame: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.
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)
Time frame: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.
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
Time frame: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.
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)
Time frame: During 3 menstrual periods (on average about 3 months, but no longer than 6 months from baseline)
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
Time frame: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.
Participant's subjective assessment of change in menstrual bleeding from baseline, e.g. expressed on a Likert scale ('greatly improved' to 'much worse')
Time frame: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.
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.)
Time frame: During 3 menstrual periods (on average about 3 months, but no longer than 6 months from baseline)
'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")
Contact information is provided by the study sponsor or research team.
Dr Sima Berendes
CONTACT
Professor Ian Roberts
CONTACT
London School of Hygiene and Tropical Medicine
Other
The Effects of Tranexamic Acid on Anaemia, Menstrual Health and the Wellbeing of Women: an International Randomised, Placebo-controlled Trial Among Menstruating Women With Anaemia
Acronym: WOMAN-3
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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