Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT03657433
Status:
COMPLETED
Last Update Posted:
2022-09-07
First Post:
2018-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-03-13', 'mcpReleaseN': 6, 'releaseDate': '2023-02-14'}], 'estimatedResultsFirstSubmitDate': '2023-02-14'}}, 'interventionBrowseModule': {'meshes': [{'id': 'C020748', 'term': 'ferrous sulfate'}, {'id': 'D052203', 'term': 'Ferrosoferric Oxide'}], 'ancestors': [{'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005296', 'term': 'Ferrous Compounds'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-05', 'studyFirstSubmitDate': '2018-08-30', 'studyFirstSubmitQcDate': '2018-08-30', 'lastUpdatePostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in hemoglobin', 'timeFrame': '1 day - 22 weeks', 'description': 'We will assess the increase in maternal hemoglobin during the study timeframe'}], 'secondaryOutcomes': [{'measure': 'Change in other laboratory values', 'timeFrame': '1 day - 22 weeks', 'description': 'Including hematocrit, serum iron, transferrin saturation, ferritin'}, {'measure': 'Blood loss at delivery', 'timeFrame': '1 day - 22 weeks', 'description': 'Estimated or quantified blood loss at delivery'}, {'measure': 'Hemoglobin change after delivery', 'timeFrame': '1 day - 22 weeks', 'description': 'Measured change in hemoglobin after delivery'}, {'measure': 'Blood transfusion', 'timeFrame': '1 day - 22 weeks', 'description': 'Whether the mother requires a blood transfusion'}, {'measure': 'Iron infusion', 'timeFrame': '1 day - 22 weeks', 'description': 'Whether the mother requires additional iron infusions'}, {'measure': 'Concentration of substances in cord blood (iron studies)', 'timeFrame': '1 day - 22 weeks', 'description': 'Cord blood indices for iron, transferrin saturation and ferritin'}, {'measure': 'Preterm delivery', 'timeFrame': '1 day - 22 weeks', 'description': 'Whether the delivery occurs at less than 37 weeks of gestation'}, {'measure': 'Indication for delivery', 'timeFrame': '1 day - 22 weeks', 'description': 'Indication for delivery if not spontaneous'}, {'measure': 'Birth weight', 'timeFrame': '1 day - 22 weeks', 'description': 'Neonatal weight immediately after delivery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iron Deficiency Anemia of Pregnancy']}, 'referencesModule': {'references': [{'pmid': '37348817', 'type': 'DERIVED', 'citation': 'Awomolo AM, McWhirter A, Sadler LC, Coppola LM, Hill MG. Neonatal outcomes from a randomized controlled trial of maternal treatment of iron deficiency anemia with intravenous ferumoxytol vs oral ferrous sulfate. Am J Obstet Gynecol MFM. 2023 Sep;5(9):101063. doi: 10.1016/j.ajogmf.2023.101063. Epub 2023 Jun 20.'}, {'pmid': '37348816', 'type': 'DERIVED', 'citation': 'Awomolo AM, McWhirter A, Sadler LC, Coppola LM, Hill MG. Intravenous infusions of ferumoxytol compared to oral ferrous sulfate for the treatment of anemia in pregnancy: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Sep;5(9):101064. doi: 10.1016/j.ajogmf.2023.101064. Epub 2023 Jun 20.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial includes pregnant women with anemia. They are randomized to IV iron infusions or to oral iron supplementation. Pregnancy outcomes are assessed.', 'detailedDescription': 'This is a randomized controlled trial aimed at assessing whether IV Iron administration (Ferumoxytol x 2 infusions) is superior to oral ferrous sulfate for the treatment of iron-deficiency anemia in pregnancy.\n\n140 patients will be randomized in a 1:1 ratio. Patients in the IV Iron group will receive two infusions of Ferumoxytol, one week apart. Patients in the oral Ferrous Sulfate group will receive medication to take at home during their pregnancy.\n\nPatients will have iron studies performed at study entry, and again at presentation for delivery. Cord blood will also be sampled for iron studies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Maternal age \\>/= 18\n* Singleton gestation\n* \\>/=20 weeks gestation, \\<37 weeks gestation\n* Hemoglobin \\<11g/dL and/or hematocrit \\<33%\n* Able to read/speak English or Spanish\n\nExclusion Criteria:\n\n* Maternal age \\<18\n* Multiple gestation\n* \\<20 weeks gestation, \\</= 37 weeks gestation\n* Hemoglobin \\>/=11g/dL and/or hematocrit \\>/=33%\n* Unable to read or speak English or Spanish\n* Incarcerated patients'}, 'identificationModule': {'nctId': 'NCT03657433', 'briefTitle': 'Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1807765944'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ferumoxyltol', 'description': 'Patients will receive two infusions of Ferumoxyltol, 510mg, intravenously, one week apart.\n\nIron studies will be completed at study inclusion and again at presentation for delivery. Cord blood will also be assessed for iron studies.', 'interventionNames': ['Drug: Ferumoxytol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ferrous Sulfate', 'description': 'Patients will be provided with oral ferrous sulphate, 325mg, to take 2x daily at home.\n\nIron studies will be completed at study inclusion and again at presentation for delivery. Cord blood will also be assessed for iron studies.', 'interventionNames': ['Dietary Supplement: Ferrous sulfate 325mg']}], 'interventions': [{'name': 'Ferrous sulfate 325mg', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral tablets supplied for home use', 'armGroupLabels': ['Ferrous Sulfate']}, {'name': 'Ferumoxytol', 'type': 'DRUG', 'description': 'Ferumoxytol will be administered in two infusions, one week apart', 'armGroupLabels': ['Ferumoxyltol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'collaborators': [{'name': 'AMAG Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Meghan Hill', 'investigatorAffiliation': 'University of Arizona'}}}}