Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT04278651
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2020-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Antenatal Support for Iron Deficiency Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052203', 'term': 'Ferrosoferric Oxide'}, {'id': 'C020748', 'term': 'ferrous sulfate'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2020-02-04', 'studyFirstSubmitQcDate': '2020-02-18', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hemoglobin', 'timeFrame': '90 days', 'description': 'Change in hemoglboin at day 90 following treatment initiation'}], 'secondaryOutcomes': [{'measure': 'Anemia resolution', 'timeFrame': '90 days', 'description': 'Percent of participants in each group with Hb\\>=11.0 at day 90'}, {'measure': 'Anemia at Delivery', 'timeFrame': '9 months', 'description': 'Percent of participants in each group with Hb\\>=11.0 at delivery'}, {'measure': 'Need for additional therapy', 'timeFrame': '9 months', 'description': 'Percent of participants in each group requiring additional therapy for iron deficiency anemia after 28 weeks'}, {'measure': 'Quality of life scale', 'timeFrame': '30, 60, 90 days', 'description': 'Linear Analogue Scale Assessment'}, {'measure': 'Adherence', 'timeFrame': '90 days', 'description': 'adherence to assigned group. Measured by what % of IV infusions completed of the two required in IV iron group, and for oral iron group, what %pills taken/prescribed based on pill counts'}, {'measure': 'Need for post partum transfusion', 'timeFrame': '9 months', 'description': 'Incidence of transfusion after delivery/post partum'}, {'measure': 'Neonatal outcomes: cord blood iron indices', 'timeFrame': '9 months', 'description': 'Hb, ferritin, total iron saturation'}, {'measure': 'Neonatal outcomes: birth weight', 'timeFrame': '9 months', 'description': 'birth weight (grams)'}, {'measure': 'Neonatal outcomes gestational age of delivery (weeks)', 'timeFrame': '9 months', 'description': 'gestational age of delivery (weeks)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Related', 'Anemia, Iron Deficiency', 'Anemia of Pregnancy']}, 'descriptionModule': {'briefSummary': 'This is a randomized, controlled multi-site trial of iron therapy in pregnancy. The purpose of this research is to see if second trimester initiation of intravenous (IV) iron therapy is better than oral iron therapy for treatment of anemia in pregnancy by improving blood count, quality of life and reducing side effects.', 'detailedDescription': 'Pregnant singletons diagnosed with iron deficiency anemia will be enrolled between 14-24 weeks and will be randomized 1:1 to either a course of ferumoxytol (510mg x 2 doses 3-8 days apart) or oral iron (325mg) twice daily.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton gestation\n* Gestational age \\<24 weeks\n* Baseline Hb ≥9.0 and \\<11.0 with evidence of iron deficiency anemia\n\nIron deficiency anemia diagnosed (at any point in patient history) by:\n\n* Hb\\<11.0\n* Ferritin\\<30 and/or total iron saturation \\<20\n\nExclusion Criteria:\n\n* Sickle cell Disease (NOT sickle cell trait)\n* Evidence of acute anemia requiring transfusion or IV iron therapy\n* Major congenital or chromosomal anomaly\n* Previous use of IV iron in this pregnancy\n* Severe cardiac, renal, or liver disease\n* Autoimmune disease (ie Systemic Lupus Erythematosus (SLE)\n* Allergy or contraindication to either study drug\n* History of medication allergy, reaction to IV infusion, or reaction to Feraheme or other IV iron products'}, 'identificationModule': {'nctId': 'NCT04278651', 'acronym': 'EASI-A', 'briefTitle': 'Early Antenatal Support for Iron Deficiency Anemia', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Early Antenatal Support for Iron Deficiency Anemia: A Randomized Controlled Trial of Early Initiation of Intravenous Versus Oral Iron Therapy for Treatment of Iron Deficiency Anemia in Pregnancy', 'orgStudyIdInfo': {'id': '19G.929'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Iron', 'description': '325mg oral iron (ferrous sulfate) twice daily', 'interventionNames': ['Drug: Ferrous Sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'Intravenous Iron', 'description': '510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose.', 'interventionNames': ['Drug: Ferumoxytol']}], 'interventions': [{'name': 'Ferumoxytol', 'type': 'DRUG', 'description': '510mg infusion x 2 doses 3-8 days apart', 'armGroupLabels': ['Intravenous Iron']}, {'name': 'Ferrous Sulfate', 'type': 'DRUG', 'description': '325mg oral twice daily', 'armGroupLabels': ['Oral Iron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rupsa C Boelig, MD', 'role': 'CONTACT', 'email': 'rupsa.boelig@jefferson.edu'}], 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Rupsa C Boelig, MD', 'role': 'CONTACT', 'email': 'rupsa.boelig@jefferson.edu', 'phone': '215-955-9196'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '1 year after publication of study results', 'ipdSharing': 'YES', 'description': 'After completion of planned primary and secondary analysis, IPD data may be available on request with completion of appropriate data sharing agreements', 'accessCriteria': 'After completion of planned primary and secondary analysis, IPD data may be available on request with completion of appropriate data sharing agreements'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Auerbach Hematology and Oncology', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}