[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474807":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":45,"responsibleParty":148,"collaborators":151,"id":165,"slug":166,"hasResults":167,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":167,"sex":173,"minAge":174,"maxAge":175,"enrollmentInfo":176,"targetDuration":43,"studyType":179,"phases":180,"briefSummary":182,"conditions":183,"keywords":43,"overallStatus":48,"whyStopped":43,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},{"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",[46,63,76,89,102,115,128,135],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"University of Alabama Medical Center","RECRUITING","Birmingham","Alabama","35401","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-86.80249,33.52066,{"lat":58,"lon":57},[61],{"name":62,"role":41,"phone":43,"phoneExt":43,"email":43},"Carolyn Webster, MD",{"facility":64,"status":48,"city":65,"state":66,"zip":67,"country":52,"countryCode":53,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"GNP Research at Heme-on-Call","Miami","Florida","33143",{"type":55,"coordinates":69},[70,71],-80.19366,25.77427,{"lat":71,"lon":70},[74],{"name":75,"role":41,"phone":43,"phoneExt":43,"email":43},"Steven Fein, MD",{"facility":77,"status":48,"city":78,"state":79,"zip":80,"country":52,"countryCode":53,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Michigan University Medical Center","Ann Arbor","Michigan","48109",{"type":55,"coordinates":82},[83,84],-83.74088,42.27756,{"lat":84,"lon":83},[87],{"name":88,"role":41,"phone":43,"phoneExt":43,"email":43},"Molly Stout, MD, MSCI",{"facility":90,"status":48,"city":91,"state":92,"zip":93,"country":52,"countryCode":53,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Washington University Medical Center","St Louis","Missouri","65105",{"type":55,"coordinates":95},[96,97],-90.19789,38.62727,{"lat":97,"lon":96},[100],{"name":101,"role":41,"phone":43,"phoneExt":43,"email":43},"Ebony Carter, MD, MPH",{"facility":103,"status":48,"city":104,"state":105,"zip":106,"country":52,"countryCode":53,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Oregon Health and Sciences Uiversity Medical Center","Portland","Oregon","97239",{"type":55,"coordinates":108},[109,110],-122.67621,45.52345,{"lat":110,"lon":109},[113],{"name":114,"role":41,"phone":43,"phoneExt":43,"email":43},"Ashley Benson, MD",{"facility":116,"status":48,"city":117,"state":118,"zip":119,"country":52,"countryCode":53,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Hasbro Children's Hospital","Providence","Rhode Island","02905",{"type":55,"coordinates":121},[122,123],-71.41283,41.82399,{"lat":123,"lon":122},[126],{"name":127,"role":41,"phone":43,"phoneExt":43,"email":43},"Viren D'sa, MD",{"facility":129,"status":48,"city":117,"state":118,"zip":119,"country":52,"countryCode":53,"cosmosGeoPoint":130,"geoPoint":132,"contacts":133},"Women & Infants Hospital of Rhode Island",{"type":55,"coordinates":131},[122,123],{"lat":123,"lon":122},[134],{"name":36,"role":41,"phone":43,"phoneExt":43,"email":43},{"facility":136,"status":48,"city":137,"state":138,"zip":139,"country":52,"countryCode":53,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"University of Utah Hospital","Salt Lake City","Utah","84132",{"type":55,"coordinates":141},[142,143],-111.89105,40.76078,{"lat":143,"lon":142},[146],{"name":147,"role":41,"phone":43,"phoneExt":43,"email":43},"Ann Bruno, MD",{"type":37,"investigatorFullName":149,"investigatorTitle":150,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Methodius Tuuli","Professor and Chair of Obstetrics and Gynecology",[152,153,155,157,159,161,163],{"name":116,"class":6},{"name":154,"class":6},"University of Michigan",{"name":156,"class":6},"Washington University School of Medicine",{"name":158,"class":6},"University of Utah",{"name":160,"class":6},"University of Alabama at Birmingham",{"name":162,"class":6},"Oregon Health and Science University",{"name":64,"class":164},"UNKNOWN","100474807","phase-3-intravenous-versus-oral-iron-for-treating-iron-deficiency-anemia-in-pregnancy-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":177,"type":178},300,"ESTIMATED","INTERVENTIONAL",[181],"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.",[184,185],"Iron Deficiency Anemia","Pregnancy","2025-06-05",{"date":188,"type":189},"2025-06-10","ACTUAL",{"date":191,"type":189},"2023-01-17",{"date":193,"type":178},"2027-03-31",{"name":5,"class":6},8]