[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474807":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":45,"responsibleParty":147,"collaborators":150,"id":164,"slug":43,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":165,"sex":171,"minAge":172,"maxAge":173,"enrollmentInfo":174,"targetDuration":43,"studyType":177,"phases":178,"briefSummary":180,"conditions":181,"keywords":43,"overallStatus":48,"whyStopped":43,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},{"fullName":5,"class":6},"Women and Infants Hospital of Rhode Island","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IV Iron","EXPERIMENTAL","Participants assigned to the IV iron group will receive a single IV infusion of 1000 mg ferric derisomaltose (Monoferric, Pharmacosmos Therapeutics Inc., Morristown, NJ) in 250 mL given over 20 minutes and daily placebo tablets until delivery.",[13],"Drug: Ferric derisomaltose",{"label":15,"type":16,"description":17,"interventionNames":18},"Oral Iron","ACTIVE_COMPARATOR","Participants assigned to the oral iron group will receive a single 250 mL IV normal saline infusion given over 20 minutes and 325mg tablets of ferrous sulfate (65 mg of elemental iron) to be taken until delivery.",[19],"Drug: Ferrous sulfate",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ferric derisomaltose","Participants assigned to the IV iron group will receive a single IV infusion of 1000 mg ferric derisomaltose (Monoferric, Pharmacosmos Therapeutics Inc., Morristown, NJ) in 250 mL given over 20 minutes.",[9],[27],"Monoferric",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Ferrous sulfate","325mg ferrous sulfate tablets (65 mg of elemental iron), 1 to 3 orally per day.",[15],[33],"Ferosul",[35],{"name":36,"affiliation":5,"role":37},"Methodius Tuuli, MD, MPH, MBA","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Crystal Ware, BSN, CCRP","CONTACT","401-274-1122",null,"cware@wihri.org",[46,62,75,88,101,114,127,134],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University of Alabama Medical Center","RECRUITING","Birmingham","Alabama","35401","United States",{"type":54,"coordinates":55},"Point",[56,57],-86.80249,33.52066,{"lat":57,"lon":56},[60],{"name":61,"role":41,"phone":43,"phoneExt":43,"email":43},"Carolyn Webster, MD",{"facility":63,"status":48,"city":64,"state":65,"zip":66,"country":52,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"GNP Research at Heme-on-Call","Miami","Florida","33143",{"type":54,"coordinates":68},[69,70],-80.19366,25.77427,{"lat":70,"lon":69},[73],{"name":74,"role":41,"phone":43,"phoneExt":43,"email":43},"Steven Fein, MD",{"facility":76,"status":48,"city":77,"state":78,"zip":79,"country":52,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Michigan University Medical Center","Ann Arbor","Michigan","48109",{"type":54,"coordinates":81},[82,83],-83.74088,42.27756,{"lat":83,"lon":82},[86],{"name":87,"role":41,"phone":43,"phoneExt":43,"email":43},"Molly Stout, MD, MSCI",{"facility":89,"status":48,"city":90,"state":91,"zip":92,"country":52,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Washington University Medical Center","St Louis","Missouri","65105",{"type":54,"coordinates":94},[95,96],-90.19789,38.62727,{"lat":96,"lon":95},[99],{"name":100,"role":41,"phone":43,"phoneExt":43,"email":43},"Ebony Carter, MD, MPH",{"facility":102,"status":48,"city":103,"state":104,"zip":105,"country":52,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Oregon Health and Sciences Uiversity Medical Center","Portland","Oregon","97239",{"type":54,"coordinates":107},[108,109],-122.67621,45.52345,{"lat":109,"lon":108},[112],{"name":113,"role":41,"phone":43,"phoneExt":43,"email":43},"Ashley Benson, MD",{"facility":115,"status":48,"city":116,"state":117,"zip":118,"country":52,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Hasbro Children's Hospital","Providence","Rhode Island","02905",{"type":54,"coordinates":120},[121,122],-71.41283,41.82399,{"lat":122,"lon":121},[125],{"name":126,"role":41,"phone":43,"phoneExt":43,"email":43},"Viren D'sa, MD",{"facility":128,"status":48,"city":116,"state":117,"zip":118,"country":52,"cosmosGeoPoint":129,"geoPoint":131,"contacts":132},"Women & Infants Hospital of Rhode Island",{"type":54,"coordinates":130},[121,122],{"lat":122,"lon":121},[133],{"name":36,"role":41,"phone":43,"phoneExt":43,"email":43},{"facility":135,"status":48,"city":136,"state":137,"zip":138,"country":52,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"University of Utah Hospital","Salt Lake City","Utah","84132",{"type":54,"coordinates":140},[141,142],-111.89105,40.76078,{"lat":142,"lon":141},[145],{"name":146,"role":41,"phone":43,"phoneExt":43,"email":43},"Ann Bruno, MD",{"type":37,"investigatorFullName":148,"investigatorTitle":149,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Methodius Tuuli","Professor and Chair of Obstetrics and Gynecology",[151,152,154,156,158,160,162],{"name":115,"class":6},{"name":153,"class":6},"University of Michigan",{"name":155,"class":6},"Washington University School of Medicine",{"name":157,"class":6},"University of Utah",{"name":159,"class":6},"University of Alabama at Birmingham",{"name":161,"class":6},"Oregon Health and Science University",{"name":63,"class":163},"UNKNOWN","100474807",false,"NCT05462704","Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy","Double-blind Placebo-controlled Multicenter Randomized Trial of Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy","IVIDA2","Inclusion Criteria:\n\n* Pregnant women between the ages of 18-45\n* Singleton gestation\n* Iron-deficiency anemia (serum ferritin \\\u003C30ng\u002FmL and Hb\\\u003C11 g\u002FdL)\n* At 13-30 weeks gestation\n* Plan to deliver at participating hospital\n\nExclusion Criteria:\n\n* Non-iron-deficiency anemia e.g thalassemia, sickle cell disease, B12 or folate deficiency, hypersplenism.\n* Malabsorptive syndrome, inflammatory bowel disease, gastric bypass, or sensitivity to oral or IV iron\n* Multiple gestation\n* Inability or unwillingness to provide informed consent\n* Inability to communicate with members of the study team, despite the presence of an interpreter\n* Planned delivery at a non-study affiliated hospital","FEMALE","18 Years","45 Years",{"count":175,"type":176},300,"ESTIMATED","INTERVENTIONAL",[179],"PHASE3","Double blind, placebo controlled, multicenter randomized trial in pregnant women in the U.S. (N=300) to test the central hypothesis that IV iron in pregnant women with IDA (Hb\\\u003C11 g\u002FdL and ferritin\\\u003C30 ng\u002FmL) at 13 - 30 weeks will be effective, safe and cost-effective in reducing severe maternal morbidity-as measured by maternal anemia at delivery-and will also improve offspring neurodevelopment.",[182,183],"Iron Deficiency Anemia","Pregnancy","2025-06-05",{"date":186,"type":187},"2025-06-10","ACTUAL",{"date":189,"type":187},"2023-01-17",{"date":191,"type":176},"2027-03-31",{"name":5,"class":6},8]