Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 11:44 AM
Study NCT ID:
NCT06911034
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2025-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ferric Carboxymaltose Versus Iron Sucrose for Treating Anemia in Pregnant Women
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': 'C522335', 'term': 'ferric carboxymaltose'}, {'id': 'D000077605', 'term': 'Ferric Oxide, Saccharated'}, {'id': 'C000599459', 'term': 'sucroferric oxyhydroxide'}], 'ancestors': [{'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005937', 'term': 'Glucaric Acid'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2025-03-28', 'studyFirstSubmitQcDate': '2025-03-28', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in hemoglobin', 'timeFrame': 'After three weeks of completing parenteral iron therapy', 'description': 'Rise in hemoglobin (g/dl) will be calculated by subtracting post treatment hemoglobin from pre-treatment hemoglobin'}], 'secondaryOutcomes': [{'measure': 'Ferritin levels', 'timeFrame': 'Three weeks after completion of parenteral iron therapy', 'description': 'Post treatment ferritin levels will be done'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Iron deficiency anemia', 'Pregnancy', 'Ferric carboxymaltose', 'Iron sucrose'], 'conditions': ['Iron Deficiency Anemia (IDA)', 'Pregnancy']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Bharadwaj MK, Patrikar S, Singh Y. Comparative analysis of injection ferric carboxymaltose vs iron sucrose for treatment of iron-deficiency anemia in pregnancy: systematic review and meta-analysis. J South Asian Fed Obstet Gynaecol. 2023;15(5):629-36.'}, {'type': 'BACKGROUND', 'citation': 'Comparison of ferric carboxymaltose and iron sucrose for treatment of iron deficiency anemia in pregnancy at tertiary care centre, Western India. Int J Reprod Contracept Obstet Gynecol. 2023;12(6):1844-8.'}, {'pmid': '30717690', 'type': 'BACKGROUND', 'citation': 'Jose A, Mahey R, Sharma JB, Bhatla N, Saxena R, Kalaivani M, Kriplani A. Comparison of ferric Carboxymaltose and iron sucrose complex for treatment of iron deficiency anemia in pregnancy- randomised controlled trial. BMC Pregnancy Childbirth. 2019 Feb 4;19(1):54. doi: 10.1186/s12884-019-2200-3.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial aimed to determine whether intravenous ferric carboxymaltose is more useful than iron sucrose for treating anemia in pregnant women.\n\nThe main question it aimed to answer was:\n\nIs intravenous ferric carboxymaltose is more useful than iron sucrose for treating iron deficiency anemia in pregnant women.\n\nSixty pregnant women with iron deficiency anemia were enrolled to one of two intravenous treatments.\n\n* Participants in ferrous carboxymaltose group received a maximum dose of 1000 mg per sitting diluted in 200 ml 0.9% normal saline and administered as an IV infusion over 30 min.\n* Participants in iron sucrose group were administered an infusion of 300 mg in 200 ml NS over 15-20 min twice weekly till dosage was completed, not exceeding 600 mg per week.', 'detailedDescription': "The study was conducted after the ethics review committee approval. A total of 60 pregnant women presenting to the department of Obstetrics and Gynecology and fulfilling the eligibility criteria were enrolled in the study after informed consent. Patient's characteristics including age, parity, area of residence, educational status, socioeconomic status and baseline Hb were recorded. All women were administered anthelminthic therapy with tablet mebendazole 100 mg twice daily for three days and given 5 mg Folic acid once daily. Patients were be randomly assigned to group A \\& B.\n\nPatients in group A were treated with intravenous ferrous carboxymaltose and group B were given intravenous iron sucrose complex. Parenteral iron therapy was administered under doctor's supervision. The women were then followed up after 3 weeks of completion of therapy. On follow up, hemoglobin and serum ferritin were measured again."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 28-34 weeks of gestation\n* Iron deficiency anemia (IDA): IDA will be labelled if Hemoglobin is \\<10 gm% and serum Ferritin \\< 30 ng/ml.\n\nExclusion Criteria:\n\n* Hepatitis (serum transaminases more than 1.5 times the upper limit of normal) and HIV infection\n* serum creatinine level of more than 2.0 mg/dL\n* history of allergic reaction to intravenous iron infusion'}, 'identificationModule': {'nctId': 'NCT06911034', 'briefTitle': 'Ferric Carboxymaltose Versus Iron Sucrose for Treating Anemia in Pregnant Women', 'organization': {'class': 'OTHER_GOV', 'fullName': 'CMH Multan Institute of Medical Sciences'}, 'officialTitle': 'Comparison of Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anemia in Pregnant Women', 'orgStudyIdInfo': {'id': 'U1111-1319-2291'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carboxymaltose', 'description': 'Intravenous infusion', 'interventionNames': ['Drug: Iron Carboxymaltose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sucrose', 'description': 'Intravenous infusion', 'interventionNames': ['Drug: Iron Sucrose Injection']}], 'interventions': [{'name': 'Iron Carboxymaltose', 'type': 'DRUG', 'otherNames': ['Ferrous Carboxymaltose'], 'description': "In ferrous carboxymaltose treatment maximum dose per sitting was 1000 mg, diluted in 200 ml 0.9% normal saline and administered as an IV infusion over 30 min. Parenteral iron therapy was administered under doctor's supervision. The women were then followed up after 3 weeks of completion of therapy. On follow up, hemoglobin and serum ferritin were measured again.", 'armGroupLabels': ['Carboxymaltose']}, {'name': 'Iron Sucrose Injection', 'type': 'DRUG', 'otherNames': ['sucroferric oxyhydroxide', 'Iron saccharate'], 'description': "Iron sucrose infusion was administered as 300 mg in 200 ml NS over 15-20 min twice weekly till dosage was completed, not exceeding 600 mg per week. Parenteral iron therapy was administered under doctor's supervision. The women were then followed up after 3 weeks of completion of therapy. On follow up, hemoglobin and serum ferritin were measured again.", 'armGroupLabels': ['Sucrose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60000', 'city': 'Multan', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Cmh Multan Institute of Medical Sciences', 'geoPoint': {'lat': 30.19679, 'lon': 71.47824}}], 'overallOfficials': [{'name': 'Nidda Ya Consultant, FCPS', 'role': 'STUDY_CHAIR', 'affiliation': 'CMH Multan Institute of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sharing IPD can compromise patient privacy, even if identifying details are removed. Sensitive medical information could potentially be re-identified, violating ethical guidelines.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CMH Multan Institute of Medical Sciences', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kiran Saleem', 'investigatorAffiliation': 'CMH Multan Institute of Medical Sciences'}}}}