Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-01-07 @ 2:01 PM
Study NCT ID:
NCT05462704
Status:
RECRUITING
Last Update Posted:
2025-06-10
First Post:
2022-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
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': 'C000718030', 'term': 'ferric derisomaltose'}, {'id': 'C020748', 'term': 'ferrous sulfate'}, {'id': 'D007505', 'term': 'Iron-Dextran Complex'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003911', 'term': 'Dextrans'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will receive matching ferrous sulfate or placebo formulate to appear and taste similar. They will also each receive an infusion of 1000mg ferric derisomaltose in 250ml of normal saline or 250ml of normal saline only, camouflaged in an opaque intravenous bag and tubing covers.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2022-05-15', 'studyFirstSubmitQcDate': '2022-07-14', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of maternal anemia (hgb<11mg/dL) at delivery', 'timeFrame': 'Within 24 hours of admission to inpatient obstetrics unit for delivery of infant', 'description': 'Hemoglobin \\<11mg/dL on admission to inpatient obstetrics unit for labor and delivery'}], 'secondaryOutcomes': [{'measure': 'Concentration of maternal hemoglobin at delivery', 'timeFrame': 'Within 24 hours of admission to inpatient obstetrics unit for delivery of infant', 'description': 'Hemoglobin on admission to inpatient obstetrics unit for labor and delivery'}, {'measure': 'Rate of maternal blood transfusion at delivery', 'timeFrame': 'Delivery to 7 days postpartum', 'description': 'Maternal blood transfusion from delivery to 7 days postpartum'}, {'measure': 'Concentration of maternal ferritin at delivery', 'timeFrame': 'Within 24 hours of admission to inpatient obstetrics unit for delivery of infant', 'description': 'Maternal ferritin on admission to inpatient obstetrics unit for labor and delivery'}, {'measure': 'Concentration of maternal hemoglobin postpartum day 1', 'timeFrame': 'On day after participant delivered her infant; postpartum day 1', 'description': 'Maternal hemoglobin on postpartum day 1'}, {'measure': 'Rate of cesarean delivery', 'timeFrame': 'Once at infant delivery', 'description': 'Cesarean delivery for any indication in patients without prior cesarean deliveries'}, {'measure': 'Rate of severe infusion adverse events', 'timeFrame': '2 days after intravenous iron or placebo infusion', 'description': 'Safety and tolerability'}, {'measure': 'Rate of mild medication adverse events', 'timeFrame': '4 weeks after initiation of oral iron or placebo', 'description': 'Safety and tolerability'}, {'measure': 'Edinburgh Perinatal Depression Scale score', 'timeFrame': 'At randomization (baseline) and at 4-6 weeks postpartum', 'description': 'Edinburgh Perinatal Depression Scale score. Minimum score 0, maximum score 30, higher scores indicate worse depressive symptoms.'}, {'measure': 'Maternal EuroQol Group Quality-of-Life Questionnaire score', 'timeFrame': 'At 6 weeks postpartum by phone or in person', 'description': 'Maternal EuroQol Group Quality-of-Life Questionnaire (EQ-5D-5L). Minimum score 11111 (full health), maximum score 55555 (worst health), higher scores indicate worse quality of life.'}, {'measure': 'Rate of Maternal infection', 'timeFrame': 'From initiation of treatment until 6 weeks postpartum', 'description': 'Any infection diagnosed from initiation of treatment until 6 weeks postpartum'}, {'measure': 'Rate of Composite Maternal Complications', 'timeFrame': 'At 6 weeks postpartum', 'description': 'Maternal mortality or any one of several maternal morbidities'}, {'measure': 'Gestational age at delivery', 'timeFrame': 'At delivery', 'description': 'Gestational age at delivery'}, {'measure': 'Rate of preterm birth at less then 37 weeks', 'timeFrame': 'At delivery', 'description': 'Preterm birth; gestational age at delivery at less than 37 weeks (spontaneous or indicated)'}, {'measure': 'Rate of Neonatal Intensive Care Unit Admission', 'timeFrame': 'At birth through through 30 days from birth', 'description': 'Admission to the neonatal intensive care unit for any indication'}, {'measure': 'Neonatal birth weight', 'timeFrame': 'At birth', 'description': 'Infant birth weight'}, {'measure': 'Concentration of umbilical artery pH', 'timeFrame': 'At birth', 'description': 'Concentration of umbilical artery pH from umbilical cord gases from infant umbilical cord segment at birth'}, {'measure': 'Concentration of umbilical artery bicarbonate', 'timeFrame': 'At birth', 'description': 'Concentration of umbilical artery bicarbonate from umbilical cord gases from infant umbilical cord segment at birth'}, {'measure': 'Concentration of umbilical artery base excess', 'timeFrame': 'At birth', 'description': 'Concentration of base excess from umbilical cord gases from infant umbilical cord segment at birth'}, {'measure': 'Concentration of umbilical artery lactate', 'timeFrame': 'At birth', 'description': 'Concentration of umbilical artery lactate from umbilical cord gases from infant umbilical cord segment at birth'}, {'measure': 'Concentration of neonatal hemoglobin', 'timeFrame': 'At birth', 'description': 'Concentration of neonatal hemoglobin from umbilical cord blood at birth or first neonatal complete blood count'}, {'measure': 'Concentration of neonatal ferritin', 'timeFrame': 'At birth', 'description': 'Concentration of neonatal ferritin from umbilical cord blood at birth or first neonatal blood draw'}, {'measure': 'Neonatal Apgar scores', 'timeFrame': 'At 1 minute and 5 minutes of life', 'description': 'Apgar scores at 1 and 5 minutes of life. Minimum score 0, maximum score 10, higher scores indicate better well being.'}, {'measure': 'Rate of composite neonatal complication', 'timeFrame': 'Through 30 days from birth', 'description': 'Neonatal mortality or any one of several neonatal morbidities'}, {'measure': 'Concentration of child brain myelin', 'timeFrame': 'At an average of 6 months and 36 months', 'description': 'Concentration of infant brain myelin from magnetic resonance imaging'}, {'measure': 'Child Mullen Scale of Early Learning Score', 'timeFrame': 'At an average of 6 months and 36 months', 'description': 'Mullen Scale of Early Learning Score as percentile. Minimum score 1, maximum score 99, higher scores indicate better neurodevelopment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iron Deficiency Anemia', 'Pregnancy']}, 'descriptionModule': {'briefSummary': '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\\<11 g/dL and ferritin\\<30 ng/mL) 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.', 'detailedDescription': 'Iron-deficiency anemia (IDA) is a common, undertreated problem in pregnancy. According to data from the U.S. National Health and Nutrition Examination Survey (NHANES), 25% of pregnant women in the U.S. have iron deficiency, with rates of 7%, 24%, and 39% in the first, second, and third trimesters, respectively. The prevalence of IDA is estimated at 16.2% overall and up to 30% at delivery. Iron deficiency is associated with significant adverse maternal and fetal outcomes including blood transfusion, cesarean delivery, depression, preterm birth, and low birth weight. Moreover, iron-deficient mothers are at risk of delivering iron-deficient neonates who, despite iron repletion, remain at risk for delayed growth and development. While treatment with iron supplementation is recommended during pregnancy, questions remain about the optimal route of delivery. Oral iron therapy, the current standard, is often suboptimal: up to 70% of patients experience significant gastrointestinal side effects (nausea, constipation, diarrhea, indigestion, and metallic taste) that prevent adherence to treatment, resulting in persistent anemia. Intravenous (IV) iron is an attractive alternative because it mitigates the adherence and absorption challenges of oral iron. However, IV iron costs more, and there are historical concerns about adverse reactions.\n\nThe American College of Obstetricians and Gynecologists (ACOG) recommends oral iron for the treatment of IDA in pregnancy, with IV iron reserved for the restricted group of patients. Our preliminary data show that this approach leads to 30% of patients with persistent IDA at delivery and an associated 3 to 6-fold increased risk of peripartum blood transfusion. ACOG\'s preferential recommendation of oral iron is based on paucity of data on the benefits and safety of IV iron, compared with oral iron, in pregnancy. Our published systematic review and meta-analysis showed that IV iron is associated with greater increase in maternal hemoglobin (Hb), but most of the primary trials were conducted in developing countries, included small sample sizes (50 - 252), and did not assess meaningful maternal and neonatal outcomes. The current Cochrane review noted that despite the high incidence and disease burden associated with IDA in pregnancy, there is paucity of quality trials assessing clinical maternal and neonatal effects of iron administration in women with anemia. The authors called for "large, good quality trials assessing clinical outcomes." The only large randomized trial of IV versus oral iron, conducted in India, showed no difference in a maternal composite outcome, but it is limited by use of iron sucrose which required five infusions, resulting in a wide range of iron doses (200 - 1600 mg). In addition, the primary composite outcome included some components not directly related to anemia. In contrast, our pilot trial of a single infusion of 1000 mg of IV low molecular weight iron dextran in pregnant women in the U.S. with moderate-to-severe IDA significantly reduced the rate of maternal anemia at delivery and showed promise for improving maternal morbidity by reducing rates of blood transfusion.\n\nThis is the first definitive 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\\<11 g/dL and ferritin\\<30 ng/mL) 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. A multidisciplinary team of investigators in the U.S., will pursue the following specific aims:\n\nPrimary Aim: Evaluate the effectiveness and safety of IV iron, compared with oral iron, in reducing the rate of anemia at delivery in pregnant women with IDA.\n\nSecondary Aim 1: Estimate the cost-effectiveness of IV iron , compared with oral iron, in pregnant women with IDA as measured by incremental cost per Quality Adjusted Life-year (QALY).\n\nSecondary Aim 2: Assess the effect of IV iron, compared with oral iron, on offspring brain myelin content and neurodevelopment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Patients must be pregnant in order to participate', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women between the ages of 18-45\n* Singleton gestation\n* Iron-deficiency anemia (serum ferritin \\<30ng/mL and Hb\\<11 g/dL)\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'}, 'identificationModule': {'nctId': 'NCT05462704', 'acronym': 'IVIDA2', 'briefTitle': 'Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Women and Infants Hospital of Rhode Island'}, 'officialTitle': 'Double-blind Placebo-controlled Multicenter Randomized Trial of Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy', 'orgStudyIdInfo': {'id': 'Pro00060930'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV Iron', 'description': '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.', 'interventionNames': ['Drug: Ferric derisomaltose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Iron', 'description': '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.', 'interventionNames': ['Drug: Ferrous sulfate']}], 'interventions': [{'name': 'Ferric derisomaltose', 'type': 'DRUG', 'otherNames': ['Monoferric'], 'description': '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.', 'armGroupLabels': ['IV Iron']}, {'name': 'Ferrous sulfate', 'type': 'DRUG', 'otherNames': ['Ferosul'], 'description': '325mg ferrous sulfate tablets (65 mg of elemental iron), 1 to 3 orally per day.', 'armGroupLabels': ['Oral Iron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35401', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carolyn Webster, MD', 'role': 'CONTACT'}], 'facility': 'University of Alabama Medical Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steven Fein, MD', 'role': 'CONTACT'}], 'facility': 'GNP Research at Heme-on-Call', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Molly Stout, MD, MSCI', 'role': 'CONTACT'}], 'facility': 'Michigan University Medical Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '65105', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ebony Carter, MD, MPH', 'role': 'CONTACT'}], 'facility': 'Washington University Medical Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley Benson, MD', 'role': 'CONTACT'}], 'facility': 'Oregon Health and Sciences Uiversity Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': "Viren D'sa, MD", 'role': 'CONTACT'}], 'facility': "Hasbro Children's Hospital", 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Methodius Tuuli, MD, MPH, MBA', 'role': 'CONTACT'}], 'facility': 'Women & Infants Hospital of Rhode Island', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ann Bruno, MD', 'role': 'CONTACT'}], 'facility': 'University of Utah Hospital', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Crystal Ware, BSN, CCRP', 'role': 'CONTACT', 'email': 'cware@wihri.org', 'phone': '401-274-1122'}], 'overallOfficials': [{'name': 'Methodius Tuuli, MD, MPH, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Women and Infants Hospital of Rhode Island'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '5 years after completion of study', 'ipdSharing': 'YES', 'description': 'Data will be collected from human subjects and will be shared according to NIH guidelines. The investigators are committed to the sharing of final data, being mindful that the rights and privacy of people who participate in research must be protected at all times. The investigators will make a complete study dataset available for sharing. The investigators will have a description of study dataset, including code books, meta-data related to the dataset, and documented programming code used for creating the final study population, for creating variables, and for conducting all outcomes analyses. The investigators will remain HIPAA compliant, and therefore any datasets resulting from participants will be free of any identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of individual subjects.', 'accessCriteria': 'The investigators will make the data and associated documentation available to users under a data-sharing agreement that provides for commitment to: a) using the data only for research purposes and not to identify any individual participant; b) securing the data using appropriate computer technology; and c) destroying or returning the data after analyses are completed. Timelines for distribution of data will vary depending on any required restrictions as mentioned above. Data may be distributed by a number of electronic methods, including web-based databases, datasets, and spreadsheets, or via electronic media such as compact discs.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Women and Infants Hospital of Rhode Island', 'class': 'OTHER'}, 'collaborators': [{'name': "Hasbro Children's Hospital", 'class': 'OTHER'}, {'name': 'University of Michigan', 'class': 'OTHER'}, {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, {'name': 'University of Utah', 'class': 'OTHER'}, {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, {'name': 'GNP Research at Heme-on-Call', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chair of Obstetrics and Gynecology', 'investigatorFullName': 'Methodius Tuuli', 'investigatorAffiliation': 'Women and Infants Hospital of Rhode Island'}}}}