Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-29 @ 2:43 AM
Study NCT ID:
NCT04274803
Status:
WITHDRAWN
Last Update Posted:
2021-06-14
First Post:
2020-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C545823', 'term': 'soybean oil, phospholipid emulsion'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no patient enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-09', 'studyFirstSubmitDate': '2020-02-15', 'studyFirstSubmitQcDate': '2020-02-15', 'lastUpdatePostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fetal loss', 'timeFrame': 'within 9 months', 'description': 'Fetal demise'}, {'measure': 'Premature delivery', 'timeFrame': 'Before 37 weeks', 'description': 'occurrence of preterm labour before 37 weeks'}, {'measure': 'Preeclampsia', 'timeFrame': '> 20 weeks', 'description': 'Hypertesion, proteiuria and or edema'}, {'measure': 'fetal growth restriction', 'timeFrame': 'within 9 months', 'description': 'Fetal poderal index less than normal'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Antiphospholipid Syndrome in Pregnancy']}, 'descriptionModule': {'briefSummary': 'This study will address the value of adding intralipid infusion in reducing pregnancy complications related to antiphospholipid syndrome', 'detailedDescription': 'This study will be conducted in the Department of Obstetrics and Gynecology, Tanta University on patients attending the antenatal care clinic and also on patients attending the researchers private clinics for antenatal care. The number of patients enrolled in the study will be 105 patients after application of inclusion and exclusion criteria.\n\nAll women wil be thoroughly informed about the study aims and through discussion about the procedure, associated benefits and risks and will sign a written consent.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women at booking date who were already diagnosed to have antiphospholipid syndrome (APS) .\n\nExclusion Criteria:\n\n* Patients with gestational age ≥ 9 weeks\n* patients with diagnosed other auto-immune disorder\n* patients with chronic hypertension, diabetes mellitus, thyroid disorders,\n* patient with renal diseases\n* patients who requested to withdraw from the study at any point .'}, 'identificationModule': {'nctId': 'NCT04274803', 'briefTitle': 'Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?', 'orgStudyIdInfo': {'id': 'INTRALIPID-APS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intralipid group', 'description': 'the patients will receive the conventional basic treatment of APS (Dual low dose aspirin (LDA) (Ezacard 75mg) once daily and Low molecular weight heparin (LMWH) (clexane 4000 IU) injection once daily. In addition intralipid 20% (Frezenius, Clayton, NC, USA) in a dose of 4 ml diluted in 250 ml 0.9% regular saline to be infused IV and to be repeated every 2 weeks all over the pregnancy.', 'interventionNames': ['Drug: Intralipid, 20% Intravenous Emulsion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care group', 'description': 'the patients will receive the conventional basic treatment of APS (Dual low dose aspirin (LDA) (Ezacard 75mg) once daily and Low molecular weight heparin (LMWH) (clexane 4000 IU) injection once daily.', 'interventionNames': ['Drug: Conventional therapy of antiphospholipis syndrome']}], 'interventions': [{'name': 'Intralipid, 20% Intravenous Emulsion', 'type': 'DRUG', 'description': 'intralipid 20% (Frezenius, Clayton, NC, USA) in a dose of 4 ml diluted in 250 ml 0.9% regular saline to be infused IV and to be repeated every 2 weeks all over the pregnancy.', 'armGroupLabels': ['Intralipid group']}, {'name': 'Conventional therapy of antiphospholipis syndrome', 'type': 'DRUG', 'description': 'the conventional basic treatment of APS (Dual low dose aspirin (LDA) (Ezacard 75mg) once daily and Low molecular weight heparin (LMWH) (clexane 4000 IU) injection once daily.', 'armGroupLabels': ['Standard care group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3111', 'city': 'Tanta', 'country': 'Egypt', 'facility': 'Adel Elgergawy', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '9 months', 'ipdSharing': 'YES', 'description': 'when approved by ethical committee'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Ayman S Dawood, MD', 'investigatorAffiliation': 'Tanta University'}}}}