Tranexamic Acid for Anaemia Trial

Proportion of participants with hemoglobin (Hb) <120 g/L, measured via venous blood samples at baseline and at the end of the intervention period.

Hb measured on venous blood at baseline and end of treatment/ early withdrawal

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

Serum ferritin (from venous blood sample) and CRP-adjusted ferritin (see below, under C-reactive protein) measured at baseline and end of the intervention period; we will report change in iron status from baseline

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); we will report change in iron status from baseline

Note: CRP-adjusted ferritin (see below);

Measured to adjust ferritin values. 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

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)

Self-reported number of menstrual products used

Participant's subjective assessment of intensity and impact of menstrual bleeding, using visual analogue scales (HMB-VAS), assessed at baseline and final visit

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.)

Evaluated longitudinally via participant daily diary logs to assess changes in bleeding length across treatment cycles.

Measured on a standard 0 to 10 numerical rating scale inside the participant diary, where 0 represents no pain and 10 represents the worst imaginable period pain.

Analysed via laboratory venous blood collection to document efficacy on maternal anemia resolution.

Evaluated via venous blood sample to track maternal iron storage status. Ferritin values will be adjusted against C-reactive protein levels within the final Statistical Analysis Plan (SAP) to prevent acute inflammation from masking underlying iron depletion.

Monitored via a standard automated digital sphygmomanometer during in-person clinical visits.

Pulse rates monitored on-site alongside vital sign collections.

Evaluation of the cost-effectiveness of the trial interventions based on health-related unit costs calculated at the time of the analysis and clinical health outcomes (proportion of participants with anaemia resolved).

Administered at the final clinical follow-up visit using a structured questionnaire question. Evaluation parameters rely on an explicit 5-point Likert scale layout: 1 = Very satisfied, 2 = Satisfied, 3 = Neutral, 4 = Dissatisfied, and 5 = Very dissatisfied. Lower numerical values signify superior levels of overall participant intervention satisfaction.

Routine surveillance of systemic toxicities and safety outcomes detailed in the protocol, tracking the proportions of participants who develop nausea, vomiting, diarrhea, seizures, or thromboembolic events.

Measured quantitatively by counting remaining study tablets within returned treatment bottles at in-person follow-up contacts.