Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-01-05 @ 5:23 PM
Study NCT ID:
NCT03836703
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2019-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Doubling the Iron Dose to Prevent IDA in Twin Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011250', 'term': 'Pregnancy Complications, Hematologic'}, {'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-16', 'studyFirstSubmitDate': '2019-02-08', 'studyFirstSubmitQcDate': '2019-02-08', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin level below 11 g/dl', 'timeFrame': '32 weeks gestation', 'description': 'Iron deficiency anemia'}, {'measure': 'Hemoglobin level below 11 g/dl', 'timeFrame': '24 hours before delivery', 'description': 'incidence of Iron deficiency anemia'}], 'secondaryOutcomes': [{'measure': 'blood product administration', 'timeFrame': '24 hours after delivery', 'description': 'Number of times of need for blood transfusion at delivery time'}, {'measure': 'GIT side effects', 'timeFrame': 'all over the pregnancy time 14 weeks gestation to delivery', 'description': 'Incidence of Complications of iron supplementation mostly are GIT related'}, {'measure': 'Preterm Birth', 'timeFrame': 'delivery before 37 weeks gestation', 'description': 'number of preterm birth'}, {'measure': 'neonatal Birth weidht', 'timeFrame': '5 min. after delivery', 'description': 'birth weight in Kg'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy, Twins , Iron Deficiency Anaemia'], 'conditions': ['Hematologic Pregnancy Complications']}, 'referencesModule': {'references': [{'pmid': '28829001', 'type': 'BACKGROUND', 'citation': 'Shinar S, Skornick-Rapaport A, Maslovitz S. Iron Supplementation in Twin Pregnancy - The Benefit of Doubling the Iron Dose in Iron Deficient Pregnant Women: A Randomized Controlled Trial. Twin Res Hum Genet. 2017 Oct;20(5):419-424. doi: 10.1017/thg.2017.43. Epub 2017 Aug 22.'}, {'pmid': '25700159', 'type': 'BACKGROUND', 'citation': 'Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015 Feb 20;10(2):e0117383. doi: 10.1371/journal.pone.0117383. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'In twin pregnancies, the maternal iron demands are magnified, estimated at 1.8 times more than in singleton pregnancies due to greater maternal red blood cell mass and plasma volume expansion as well as increased fetal and placental requirements.\n\nWith a lack of randomized controlled trials assessing the adequacy of iron supplements on twin pregnancy, various recommendations are based on level 3 clinical expert opinions at most.', 'detailedDescription': 'Iron deficiency anemia (IDA) is a very prevalent condition in pregnancy, affecting nearly 18% of all pregnant women during all three trimesters, with as many as 29%of women affected during the third trimester.\n\nIn twin pregnancies, the maternal iron demands are magnified, estimated at 1.8 times more than in singleton pregnancies due to greater maternal red blood cell mass and plasma volume expansion as well as increased fetal and placental requirements. Thus, maternal hemoglobin (Hgb) in multiple pregnancies is lower in all trimesters compared with singleton gestations, with a rate of IDA estimated to be 2.4 to even 4 times higher.\n\nExpert opinion relying on the increased risk for micronutrient deficiency in twin pregnancies recommends supplementation of iron beyond that contained in a typical prenatal vitamin. Moreover, some experts support doubling the dose of multivitamins containing 30 mg of elemental iron during the second and third trimesters of a twin pregnancy, regardless of maternal Hgb and ferritin concentrations.\n\nWith a lack of randomized controlled trials assessing the adequacy of iron supplements on twin pregnancy, various recommendations are based on level 3 clinical expert opinions at most. The purpose of our study was to assess the efficacy of a single versus a double daily iron supplement dose in iron deficient women with twin pregnancies. Determining the effect of this intervention on maternal iron stores and immediate neonatal outcome measures will assist in defining evidence based recommendations for prenatal care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Twin pregnancy.\n* Hemoglobin ≥ 10.5 gm/d l. at booking visit\n\nExclusion Criteria:\n\n* Continuous hyper-emesis gravid arum lasting beyond 20 weeks of gestation\n* Thalassemia minor (alpha or beta).\n* Mal-absorption disorders (such as inflammatory bowel diseases, Crohn's disease, ulcerative colitis, previous bowel resection).\n* Anemia from chronic illness.\n* Any use of multi-vitamin supplements containing iron.\n* Any chronic blood loss. e.g: hemorrhoids.\n* Autoimmune disorders."}, 'identificationModule': {'nctId': 'NCT03836703', 'acronym': 'IDA', 'briefTitle': 'Doubling the Iron Dose to Prevent IDA in Twin Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Doubling the Iron Dose VS Single Dose Iron Supplementation to Prevent Iron Deficiency Anemia (IDA) in Twin Pregnant Women: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '3201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Single Dose Daily Iron', 'description': "single dose daily Iron'IRON FUM\\&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE supplementation From 14 weeks gestation to prevent iron deficiency anemia", 'interventionNames': ['Drug: Feroglobin single daily use']}, {'type': 'EXPERIMENTAL', 'label': 'Double dose Daily iron', 'description': "Double dose daily Iron'IRON FUM\\&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE supplementation From 14 weeks gestation to prevent iron deficiency anemia", 'interventionNames': ['Drug: Feroglobin twice daily dose']}], 'interventions': [{'name': 'Feroglobin single daily use', 'type': 'DRUG', 'otherNames': ['IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE'], 'description': 'Feroglobin single daily use ( IRON FUM\\&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE ) to prevent iron deficiency anemia during pregnancy from 14 weeks gestation going on.', 'armGroupLabels': ['Single Dose Daily Iron']}, {'name': 'Feroglobin twice daily dose', 'type': 'DRUG', 'otherNames': ["'IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE"], 'description': 'Feroglobin twice daily dose ( IRON FUM\\&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE ) to prevent iron deficiency anemia during pregnancy from 14 weeks gestation going on.', 'armGroupLabels': ['Double dose Daily iron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11311', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ahmed Abass', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Khaled Ibrahem, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'AinShams U'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Ahmed Abass', 'investigatorAffiliation': 'Ain Shams University'}}}}