Tranexamic Acid for Anaemia Trial (WOMAN-3)

London School of Hygiene and Tropical Medicine

Status and phase: Enrolling; Phase 3

Conditions: Anaemia

Treatments: Drug: Placebo; Drug: Tranexamic Acid 500 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06519422

PACTR (Registry Identifier)

WOMAN-3

ISRCTN (Registry Identifier)

Details and patient eligibility

About

Anaemia is when the body does not have enough healthy red blood cells to carry oxygen. It is common in women because they lose blood every month during their periods. Anaemia can womwn make feel tired, weak, dizzy and out of breath. It can also make it harder to study, work or look after their family. If woman become pregnant with anaemia, it can cause problems for both mother and baby, such as early birth or heavy bleeding when giving birth. 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. 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)

Full description

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.

The global target, set in 2000, to halve the prevalence of anaemia in women of reproductive age by 2025 was not met. 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.

Enrollment: 4,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4,000 participants in 2 patient groups, including a placebo group

Tranexamic acid (TXA)

Experimental group

Description:

Tranexamic acid (TXA) 2 x 500 mg oral tablets, taken three times daily from the first to the last day of the menstrual period (maximum 5 days), for six consecutive menstrual cycles (up to a maximum of 9 months). Participants also receive standard of care oral iron and folic acid supplementation for three months from randomisation.

Treatment:

Drug: Tranexamic Acid 500 MG

Placebo

Placebo Comparator group

Description:

Matching placebo 2 x 500 mg oral tablets, taken three times daily from the first to the last day of the menstrual period (maximum 5 days), for six consecutive menstrual cycles (up to a maximum of 9 months). Participants also receive standard of care oral iron and folic acid supplementation for three months from randomisation.

Treatment:

Drug: Placebo