Haematological Disorders Fertility-female
Conditions
Interventions
Tranexamic acid
Placebo
Sponsors
London School of Hygiene and Tropical Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Adult women aged 18 years and older. Currently menstruating, with menstrual periods occurring at least every 38 days and lasting =2 days. Anaemia at screening, defined as hemoglobin (Hb) <120 g/L by point-of care finger prick test. Willing and able to provide informed consent. Able to attend in-person follow-up visits during the trial period. Individuals with known thalassaemia and sickle cell disease are eligible to participate and take the trial treatment but will not be given standard of care iron supplementation unless it is prescribed by their own treating clinician. They will continue to receive their usual standard care.
Exclusion criteria
Exclusion criteria: Planning to get pregnant during the trial period Already taking TXA Known to have possible contraindications to TXA treatment (including allergy to TXA or its excipients, renal impairment, active thromboembolic disease, history of venous or arterial thrombosis, history of convulsion)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with hemoglobin (Hb) <120 g/L, measured via venous blood samples at baseline and at the end of the intervention period.;Participant Feedback - Collection of open feedback on trial experiences | — |
Secondary
| Measure | Time frame |
|---|---|
| Haemoglobin (Hb) concentration - measured on venous blood at baseline and end of treatment/ early withdrawal;Severity of anaemia - Mild Anaemia (Hb=110-119 g/L); Moderate Anaemia (Hb=80-109 g/L); Severe Anaemia (Hb 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.);Menstrual Cycle Characteristics - Assessment of cycle frequency, duration, regularity, flow volume, and period pain severity.;Haemoglobin, Serum Ferritin, and Vital Signs - Blood pressure, heart rate, and Hb via HemoCue® at each in-person follow-up visit; serum ferritin and Hb via venous sample at final visit.;Cost-Effectiveness Analysis - Evaluation of cost-effectiveness of trial interventions as detailed in the Statistical Analysis Plan (SAP).;Participant Satisfaction - Assessment of participant satisfaction with trial treatment at the final visit.;Treatment Side Effects and Adherence - Collection of data on side effects of trial treatment and assessment of adherence as outlined in the protocol. | — |
Countries
Nigeria, Pakistan, United Republic of Tanzania
Contacts
Public ContactHaleema;Folasade Adenike Shakur Still;Bello
Professor Global Health Clinical Trials Emeritus ;Professor of Obstetrics and Gynaecology
Outcome results
None listed