Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-21 @ 10:21 PM
Study NCT ID:
NCT02326051
Status:
COMPLETED
Last Update Posted:
2017-11-29
First Post:
2014-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Timing of Initiation of LMWH Administration in Pregnant Women With APS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000026', 'term': 'Abortion, Habitual'}, {'id': 'D016736', 'term': 'Antiphospholipid Syndrome'}], 'ancestors': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-27', 'studyFirstSubmitDate': '2014-12-22', 'studyFirstSubmitQcDate': '2014-12-22', 'lastUpdatePostDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hemorrhagic complications', 'timeFrame': 'After 12 weeks gestational age up to birth'}, {'measure': 'Thromboembolic complications', 'timeFrame': 'After 12 weeks gestational age up to birth'}], 'primaryOutcomes': [{'measure': 'Ongoing pregnancy rate', 'timeFrame': 'After 12 weeks gestational age', 'description': 'Number of pregnancies that progressed beyond the critical first trimester (12 weeks gestational age) per number of pregnant women'}], 'secondaryOutcomes': [{'measure': 'Fetal loss', 'timeFrame': 'From 20 weeks to 42 weeks gestational age', 'description': 'Unexplained fetal death of morphologically normal fetus after the first trimester'}, {'measure': 'Preterm delivery', 'timeFrame': 'From 20 weeks to 34 weeks gestational age', 'description': 'Delivery of morphologically normal fetus before 34 weeks of gestation due to severe preeclampsia or placental insufficiency'}, {'measure': 'Intrauterine growth restriction (IUGR)', 'timeFrame': 'At birth', 'description': 'Birth weight less than the 10th percentile for gestational age'}, {'measure': 'Congenital fetal malformations', 'timeFrame': 'At birth'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antiphospholipid syndrome', 'APS', 'LMWH'], 'conditions': ['Recurrent Miscarriage', 'Antiphospholipid Syndrome']}, 'descriptionModule': {'briefSummary': 'Evaluation of the effect of altering the timing of initiation of low molecular weight heparin (LMWH) administration on the pregnancy outcomes in women with antiphospholipid syndrome (APS)', 'detailedDescription': 'Women will be randomly divided into two groups; one will start Enoxaparin therapy once positive pregnancy test is established and the other will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation. In all women, Enoxaparin will be given in a dose of 40 mg/day subcutaneously and the therapy will continue until termination of pregnancy'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women with APS diagnosed according to the revised classification criteria for APS in 2006 in Sydney, Australia\n* Early pregnancy body weight is 50-90 Kg\n\nExclusion Criteria:\n\n* Women with systemic lupus erythematosus (SLE)\n* Women with active thromboembolic disorders\n* Women with history of previous thromboembolic disorders'}, 'identificationModule': {'nctId': 'NCT02326051', 'briefTitle': 'Timing of Initiation of LMWH Administration in Pregnant Women With APS', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Timing of Initiation of Low Molecular Weight Heparin Administration in Pregnant Women With Antiphospholipid Syndrome', 'orgStudyIdInfo': {'id': 'MIE2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Early Enoxaparin initiation', 'description': 'Women will start Enoxaparin therapy once positive pregnancy test is established', 'interventionNames': ['Drug: Enoxaparin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Later Enoxaparin initiation', 'description': 'Women will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation', 'interventionNames': ['Drug: Enoxaparin']}], 'interventions': [{'name': 'Enoxaparin', 'type': 'DRUG', 'otherNames': ['Clexan'], 'description': 'Women will start Enoxaparin therapy in a dose of 40 mg/day subcutaneously once positive pregnancy test is established and the therapy will continue until termination of pregnancy', 'armGroupLabels': ['Early Enoxaparin initiation']}, {'name': 'Enoxaparin', 'type': 'DRUG', 'otherNames': ['Clexan'], 'description': 'Women will start Enoxaparin therapy in a dose of 40 mg/day subcutaneously after sonographic confirmation of fetal cardiac pulsation and the therapy will continue until termination of pregnancy', 'armGroupLabels': ['Later Enoxaparin initiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35111', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Obstetrics and Gynecology Department in Mansoura University Hospital', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}, {'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Private practice settings', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Mohamed I Eid, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}, {'name': 'Mohamed S Abdelhafez, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University'}, {'name': 'Waleed El-refaie, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University'}, {'name': 'Ahmed El-Zayadi, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University'}, {'name': 'Ahmed Badawy, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohamed Sayed Abdelhafez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Mohamed Sayed Abdelhafez', 'investigatorAffiliation': 'Mansoura University'}}}}