Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:46 AM
Study NCT ID:
NCT07340450
Status:
COMPLETED
Last Update Posted:
2026-01-14
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Oral vs Intravenous Iron Therapy for the Treatment of Postpartum Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'C020748', 'term': 'ferrous sulfate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-05', 'studyFirstSubmitDate': '2026-01-05', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in hemoglobin level', 'timeFrame': 'Baseline to 6 weeks postpartum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postpartum Anaemia']}, 'descriptionModule': {'briefSummary': 'Postpartum anemia is a common condition associated with adverse maternal outcomes. This study aimed to compare the effectiveness of oral iron therapy versus intravenous iron therapy in women with postpartum anemia.', 'detailedDescription': 'This randomized, open-label, parallel-group study was conducted at Shahida Islam Medical College and Hospital, Lodhran, Pakistan. Women diagnosed with postpartum anemia who fulfilled the eligibility criteria were randomly allocated using a lottery method to receive either intravenous iron (ferric carboxymaltose) or oral iron therapy (ferrous sulfate). The primary outcome was the change in hemoglobin level from baseline to 6 weeks of follow-up.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All women with postpartum anaemia as per operational definition i.e Haemoglobin \\<11 g/dl at 24 hours after delivery (either caesarean or SVD).\n2. Age 20-40 years.\n3. BMI 19-25.\n4. Pre-operative haemoglobin \\>10 g/dl.\n5. Both primiparous and multiparous.\n6. Both primigravida and multigravida.\n\n \\-\n\nExclusion Criteria:\n\n1. Iron Intolerance or previous history of allergy to iron\n2. Parenteral Iron hypersensitivity\n3. Patients with thalassemia\n4. Indication of blood transfusion\n5. Patients with bleeding/ clotting disorders\n6. Patients with postpartum haemorrhage\n7. Patients with chronic diseases.'}, 'identificationModule': {'nctId': 'NCT07340450', 'briefTitle': 'Comparison of Oral vs Intravenous Iron Therapy for the Treatment of Postpartum Anemia', 'organization': {'class': 'OTHER', 'fullName': 'Shahida Islam Medical Complex'}, 'officialTitle': 'Comparison of Oral vs Intravenous Iron Therapy for the Treatment of Postpartum Anemia', 'orgStudyIdInfo': {'id': 'SIMC-postpartumanemia-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: Intravenous Iron Therapy', 'description': 'Participants received intravenous iron therapy for the treatment of postpartum anemia', 'interventionNames': ['Drug: Ferric Carboxy Maltose']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: Oral Iron Therapy', 'description': 'Participants received oral iron therapy for the treatment of postpartum anemia.', 'interventionNames': ['Drug: Ferrous Sulfate']}], 'interventions': [{'name': 'Ferric Carboxy Maltose', 'type': 'DRUG', 'description': 'Participants received Intravenous iron i.e ferric carboxymaltose (≤1,000 mg) were given to patients in Group "A" either as a single dose or as two doses spaced three days apart in 100 milliliters of 0.9% normal saline during a half-hour period.', 'armGroupLabels': ['Group A: Intravenous Iron Therapy']}, {'name': 'Ferrous Sulfate', 'type': 'DRUG', 'description': 'Participants given tablet Ferrous sulfate, 325 mg orally three times a day.', 'armGroupLabels': ['Group B: Oral Iron Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lodhrān', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Shahida Islam Medical College and Hospital, Lodhran', 'geoPoint': {'lat': 29.307, 'lon': 71.22358}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahida Islam Medical Complex', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PGR obstetrics and Gynaecology', 'investigatorFullName': 'Sidra Jalil Khan', 'investigatorAffiliation': 'Shahida Islam Medical Complex'}}}}