[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556002":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":57,"studyPopulation":45,"armGroups":58,"interventions":71,"overallOfficials":81,"centralContacts":86,"locations":45,"responsibleParty":94,"collaborators":96,"id":100,"slug":45,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":45,"enrollmentInfo":109,"targetDuration":45,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":124,"whyStopped":45,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":45},{"fullName":5,"class":6},"London School of Hygiene and Tropical Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"Anaemia","The proportion of participants with anaemia, defined as Haemoglobin (Hb) \\\u003C 120 g\u002FL (measured on venous blood)","After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.",[14,17,20,23,26,29,32,36,39,42],{"measure":15,"description":16,"timeFrame":12},"Haemoglobin (Hb) concentration","Hb measured on venous blood",{"measure":18,"description":19,"timeFrame":12},"Severity of anaemia","Mild Anaemia (Hb=110-119 g\u002FL); Moderate Anaemia (Hb=80-109 g\u002FL); Severe Anaemia (Hb \\\u003C 80 g\u002FL); Hb measured on venous blood",{"measure":21,"description":22,"timeFrame":12},"Ferritin","Serum ferritin (from venous blood sample) and CRP-adjusted ferritin (see below, under C-reactive protein)",{"measure":24,"description":25,"timeFrame":12},"Iron deficiency","Iron deficiency defined as ferritin \\\u003C15 ug\u002FL (WHO definition) and defined as ferritin \\\u003C30 ug\u002FL, (new clinical consensus); Serum ferritin from venous blood sample; CRP-adjusted ferritin (see below, under C-reactive protein)\n\nNote: CRP-adjusted ferritin (see below)",{"measure":27,"description":28,"timeFrame":12},"C-reactive protein (CRP)","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",{"measure":30,"description":31,"timeFrame":12},"Iron-deficiency anaemia","The proportion of participants with iron-deficiency anaemia, defined as presence of both anaemia (Hb\\\u003C120 g\u002FL) plus iron deficiency (ferritin \\\u003C15 ug\u002FL AND\u002FOR \\\u003C30 ug\u002FL), measured as detailed above (using CRP-adjusted ferritin levels, as explained above)",{"measure":33,"description":34,"timeFrame":35},"Menstrual blood loss","Blood loss assessed semi-quantitatively by pictorial blood assessment chart (PBAC), adapted from Higham et al (1990), DOI: 10.1111\u002Fj.1471-0528.1990.tb16249.x","During 3 menstrual periods (on average about 3 months, but no longer than 6 months from baseline)",{"measure":37,"description":38,"timeFrame":12},"Perceived change in menstrual blood loss","Participant's subjective assessment of change in menstrual bleeding from baseline, e.g. expressed on a Likert scale ('greatly improved' to 'much worse')",{"measure":40,"description":41,"timeFrame":12},"Degree of effect of menstrual bleeding on health-related Quality of Life","SAMANTA scale (ref: Calaf, 2020, DOI: 10.1089\u002Fjwh.2018.7446 and Sinharoy 2023, DOI: 10.1016\u002FS2214-109X(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.)",{"measure":43,"description":44,"timeFrame":35},"Flooding","'Flooding' experienced during menstrual period (provisionally defined by Cooper 2013, DOI: 10.1111\u002F1471-0528.17473, as \"sudden overwhelming blood loss that exceeds the saturation of the menstrual products being used\")",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":45,"primaryPurpose":49,"observationalModel":45,"timePerspective":45,"maskingInfo":50},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":51,"maskingDescription":45,"whoMasked":52},"QUADRUPLE",[53,54,55,56],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","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.\n\nUnfortunately, 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.\n\nThe 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.",[59,65],{"label":60,"type":61,"description":62,"interventionNames":63},"Tranexamic acid (TXA)","EXPERIMENTAL","Tranexamic acid 1 gram (2x 500 mg) orally taken three times a day from the first to the last day of the menstrual period for up to 5 days, for 3 successive periods.",[64],"Drug: Tranexamic Acid 500 MG",{"label":66,"type":67,"description":68,"interventionNames":69},"Placebo","PLACEBO_COMPARATOR","Matched placebo tablets taken three times a day from the first to the last day of the menstrual period for up to 5 days, for 3 successive periods.",[70],"Other: Matched placebo",[72,77],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":45},"DRUG","Tranexamic Acid 500 MG","Tablets",[60],{"type":6,"name":78,"description":79,"armGroupLabels":80,"otherNames":45},"Matched placebo","Matched placebo tablets (inactive ingredients only, including microcrystalline cellulose, magnesium stearate BP and lactose)",[66],[82],{"name":83,"affiliation":84,"role":85},"Dr Sima Berendes","London School of Hygiene and Tropical Medicine (Clinical Trials Unit)","STUDY_DIRECTOR",[87,91],{"name":83,"role":88,"phone":89,"phoneExt":45,"email":90},"CONTACT","+44 (0)20 7958 8161","woman3@lshtm.ac.uk",{"name":92,"role":88,"phone":93,"phoneExt":45,"email":45},"Professor Ian Roberts","+44 (0)20 7958 8128",{"type":95,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[97],{"name":98,"class":99},"The Jon Moulton Charity Trust","UNKNOWN","100556002",false,"NCT06519422","Tranexamic Acid for Anaemia Trial","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","WOMAN-3","Inclusion Criteria:\n\n* Adult women (aged 18 years and older)\n* Having menstrual periods every 21 to 38 days that last 2 to 9 days\n* Having anaemia (Hb \\\u003C 120 g\u002FL) according to point-of-care finger prick screening test\n* Willing to provide informed consent and able to attend study visits during the trial period\n\n(Individuals with known thalassaemia are eligible to participate and take the trial treatment but will not receive standard of care iron supplementation. They will continue to receive their standard care.)\n\nExclusion Criteria:\n\n* Planning to get pregnant during trial period\n* Already taking TXA\n* Known to have 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.)","FEMALE","18 Years",{"count":110,"type":111},4000,"ESTIMATED","INTERVENTIONAL",[114],"PHASE3","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)",[117],"Anemia",[119,120,10,121,122,123],"Tranexamic acid","Antifibrinolytic","Menstrual health","Menstruation","Bleeding","NOT_YET_RECRUITING","2024-07-19",{"date":127,"type":128},"2024-07-25","ACTUAL",{"date":130,"type":111},"2025-09",{"date":132,"type":111},"2028-09",{"name":5,"class":6}]