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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 4,000
- 试验地点
- 3
- 主要终点
- Anaemia
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.)
研究组 & 干预措施
Tranexamic acid (TXA)
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.
干预措施: Tranexamic Acid 500 MG (Drug)
Placebo
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Anaemia
时间窗: 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)
Proportion of Participants with Anaemia
时间窗: From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.
Proportion of participants with hemoglobin (Hb) \<120 g/L, measured via venous blood samples at baseline and at the end of the intervention period.
次要结局
- C-reactive protein (CRP)(After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.)
- Menstrual blood loss(During 3 menstrual periods (on average about 3 months, but no longer than 6 months from baseline))
- Ferritin(After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.)
- Iron-deficiency anaemia(After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.)
- Flooding(During 3 menstrual periods (on average about 3 months, but no longer than 6 months from baseline))
- Severity of anaemia(After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.)
- Haemoglobin (Hb) concentration(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(After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.)
- Iron deficiency(After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.)
- Perceived change in menstrual blood loss(After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.)
- Haemoglobin (Hb) concentration(From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.)
- Severity of anaemia(From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.)
- Ferritin(From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.)
- Iron deficiency(From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.)
- C-reactive protein (CRP)(From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.)
- Iron-deficiency anaemia(From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.)
- Menstrual blood loss(Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).)
- Perceived change in menstrual blood loss(Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).)
- Degree of effect of menstrual bleeding on health-related Quality of Life(Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).)
- Mean Menstrual Period Duration(Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).)
- Change From Baseline in Menstrual Pain Severity Score(Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).)
- Mean Hemoglobin (Hb) Concentration at Final Visit(Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).)
- Mean Serum Ferritin Concentration at Final Visit(Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomisation).)
- Mean Systolic and Diastolic Blood Pressure at Study Completion(Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).)
- Mean Heart Rate at Study Completion(Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomisation))