Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT06061393
Status:
UNKNOWN
Last Update Posted:
2023-10-06
First Post:
2023-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer 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': 'D000077605', 'term': 'Ferric Oxide, Saccharated'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'C522335', 'term': 'ferric carboxymaltose'}], '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'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2023-09-24', 'studyFirstSubmitQcDate': '2023-09-24', 'lastUpdatePostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ratio of women with Hb level >11 at delivery', 'timeFrame': 'at delivery', 'description': 'Hb level'}, {'measure': 'postpartum Hb level', 'timeFrame': 'during 48 hours after delivery', 'description': 'gr/dl'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anemia, Iron Deficiency', 'Pregnancy Anemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare maternal outcomes such as increased hemoglobin need for blood transfusion and hemoglobin level before and post partum in women with hemoglobin \\<9 gr/dl , treated with venofer and women treated with ferinject.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\npregnancy\\>24 weeks of gestation anemia with Hb\\<8 anemia with Hb\\<9 if symptomatic anemia of previous postpartum hemorrhage\n\nExclusion Criteria:\n\n* Allergy to one of the study's drugs\n* IV iron treatment in the last month\n* chronic anemia- thalassemia, renal failure Twins pregnancy\n* non iron deficiency anemia"}, 'identificationModule': {'nctId': 'NCT06061393', 'briefTitle': 'Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Western Galilee Hospital-Nahariya'}, 'officialTitle': 'Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia (Hb<9)', 'orgStudyIdInfo': {'id': '0120-23-NHR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'venofer', 'description': 'Women with iron def. anemia aith hemoglobin level \\<9 gr/dl who will be traeted with venofer', 'interventionNames': ['Drug: Venofer 200 MG Per 10 ML Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ferinject', 'description': 'Women with iron def. anemia aith hemoglobin level \\<9 gr/dl who will be traeted with ferinject', 'interventionNames': ['Drug: Ferinject']}], 'interventions': [{'name': 'Venofer 200 MG Per 10 ML Injection', 'type': 'DRUG', 'description': 'treat anemia with venofer up to 5 doses', 'armGroupLabels': ['venofer']}, {'name': 'Ferinject', 'type': 'DRUG', 'description': 'ferinject 500 mg, once a week for 2 weeks', 'armGroupLabels': ['Ferinject']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'maya Wolf, MD', 'role': 'CONTACT', 'email': 'mayaw@gmc.gov.il', 'phone': '972507887800'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Galilee Hospital-Nahariya', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator.', 'investigatorFullName': 'Dr. Maya Wolf', 'investigatorAffiliation': 'Western Galilee Hospital-Nahariya'}}}}