Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 4:04 AM
Study NCT ID:
NCT01538134
Status:
UNKNOWN
Last Update Posted:
2015-01-05
First Post:
2012-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antiphospholipid Antibodies and Fetal Growth Restriction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005317', 'term': 'Fetal Growth Retardation'}, {'id': 'D016736', 'term': 'Antiphospholipid Syndrome'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-01', 'studyFirstSubmitDate': '2012-02-19', 'studyFirstSubmitQcDate': '2012-02-22', 'lastUpdatePostDateStruct': {'date': '2015-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lupus anticoagulant', 'timeFrame': '8 months', 'description': 'Number of cases positive for Lupus Anticoagulant.'}, {'measure': 'Anticardiolipin antibodies', 'timeFrame': '10 months', 'description': 'Number of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies.'}, {'measure': 'B2 Glycoprotein I', 'timeFrame': '10 months', 'description': 'Number of cases with levels of B2 Glycoprotein I \\> 99%'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antibodies, anticardiolipin', 'Antibodies, B2 Glycoprotein I', 'Lupus Anticoagulant', 'Fetal Growth Restriction'], 'conditions': ['Fetal Growth Restriction', 'Antiphospholipid Syndrome']}, 'descriptionModule': {'briefSummary': 'The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed against cell membrane phospholipids (antiphospholipid antibodies) can cause an hypercoagulable state that causes thrombosis and obstetric complications (miscarriages, stillbirths). Since 1999 the Sapporo Criteria for Antiphospholipid Syndrome diagnosis includes the development of fetal growth restriction (diagnosed postpartum), but this was done without solid evidence of a relation between the two or using the most common form of fetal growth restriction diagnosis (ultrasound). Our study will try to add information to this particular point.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant patients admitted for fetal growth restriction (cases) and normal patients in labor at term (controls).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age between 24-34 weeks.\n* Ultrasonographic evidence of fetal growth restriction\n\n * Abdominal circumference \\< 3rd percentile.\n * Doppler with increase of placental resistance.\n\nExclusion Criteria:\n\n* Known antiphospholipid syndrome.\n* Known presence of antiphospholipid antibodies.\n* Patients with systemic lupus erythematosus.'}, 'identificationModule': {'nctId': 'NCT01538134', 'briefTitle': 'Antiphospholipid Antibodies and Fetal Growth Restriction', 'organization': {'class': 'OTHER', 'fullName': 'Saint Thomas Hospital, Panama'}, 'officialTitle': 'Antiphospholipid Antibodies and Early Fetal Growth Restriction (<34 Weeks of Gestation). A Case Control Study.', 'orgStudyIdInfo': {'id': 'MHST2012-01B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Patients with ultrasonographic diagnosis of fetal growth restriction.'}, {'label': 'Control', 'description': 'Patients with normal pregnancies at term.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Panama City', 'state': 'Provincia de Panamá', 'country': 'Panama', 'facility': 'Saint Thomas Maternity Hospital', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'overallOfficials': [{'name': 'Osvaldo Reyes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Thomas Hospital, Panama'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Thomas Hospital, Panama', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinator of Research & Development', 'investigatorFullName': 'Osvaldo A. Reyes T.', 'investigatorAffiliation': 'Saint Thomas Hospital, Panama'}}}}