Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519422
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Tranexamic Acid for Anaemia Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WOMAN-3
Brief Summary:
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
Detailed 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None