[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482482":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":37,"centralContacts":42,"locations":51,"responsibleParty":66,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":46,"enrollmentInfo":81,"targetDuration":46,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":54,"whyStopped":46,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"London School of Hygiene and Tropical Medicine","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Intramuscular TXA","EXPERIMENTAL","1g TXA as 2 x 5 ml IM injections (100mg\u002Fml) and slow IV injection of placebo (1 x 10 ml of 0.9% sodium chloride)",[13,14],"Drug: Tranexamic acid","Other: Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"Intravenous TXA","ACTIVE_COMPARATOR","1g TXA by slow IV injection and 2 x 5 ml IM injections of placebo",[13,14],{"label":21,"type":22,"description":23,"interventionNames":24},"Placebo","PLACEBO_COMPARATOR","Placebo by 1 x slow 10ml IV injection and 2 x 5 ml IM injections",[14],[26,33],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Tranexamic acid","Ampoules and packaging for all arms will be identical in appearance.",[9,16],[32],"Cyklokapron",{"type":6,"name":21,"description":29,"armGroupLabels":34,"otherNames":35},[9,16,21],[36],"(Sodium Chloride 0.9%)",[38],{"name":39,"affiliation":40,"role":41},"Amy Brenner","London School oh Hygiene and Tropical Medicine","STUDY_DIRECTOR",[43,48],{"name":39,"role":44,"phone":45,"phoneExt":46,"email":47},"CONTACT","+44 (0)20 7958 8283",null,"imwoman@lshtm.ac.uk",{"name":49,"role":44,"phone":50,"phoneExt":46,"email":46},"Ian Roberts","+44 (0)20 7958 8128",[52],{"facility":53,"status":54,"city":55,"state":46,"zip":46,"country":56,"countryCode":46,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Mbeya Regional Referral Hospital","RECRUITING","Mbeya","Tanzania",{"type":58,"coordinates":59},"Point",[60,61],33.45,-8.9,{"lat":61,"lon":60},[64],{"name":65,"role":44,"phone":46,"phoneExt":46,"email":46},"Soter Vitalis, MD",{"type":67,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR",[69],{"name":70,"class":6},"UNITAID","100482482","phase-3-tranexamic-acid-to-prevent-heavy-bleeding-after-childbirth-in-women-at-higher-risk-100482482",false,"NCT05562609","Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women At Higher Risk","Tranexamic Acid by the Intramuscular or Intravenous Route for the Prevention of Postpartum Haemorrhage in Women At Increased Risk: a Randomised, Double-blind, Placebo-controlled Trial","I'M-WOMAN","Inclusion Criteria:\n\n* Women aged 18 years or older who are admitted to hospital to give birth vaginally or by caesarean section, who have one or more known risk factors for PPH\n\nExclusion Criteria:\n\n* Women who have a clear indication or contraindication for TXA","FEMALE","18 Years",{"count":82,"type":83},30000,"ESTIMATED","INTERVENTIONAL",[86],"PHASE3","Heavy bleeding after childbirth, known as a postpartum haemorrhage (PPH), causes about 70,000 maternal deaths every year. Tranexamic acid (TXA) is a lifesaving treatment for women with PPH. The I'M WOMAN trial is a research study to see whether giving TXA just before childbirth will stop women developing PPH. The trial will assess the effects of intramuscular (IM) and intravenous (IV) tranexamic acid on PPH, side effects and other important maternal health outcomes.",[89],"Postpartum Hemorrhage",[91,92,93,94,95,96],"tranexamic acid","postpartum haemorrhage","bleeding","pregnancy","antifibrinolytic","intramuscular","2025-03-07",{"date":99,"type":100},"2025-03-11","ACTUAL",{"date":102,"type":100},"2024-04-22",{"date":104,"type":83},"2025-09",{"name":5,"class":6},1]