Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-03-05 @ 7:52 PM
Study NCT ID:
NCT02694367
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2016-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expression of EPK in Recurrent Miscarriage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000026', 'term': 'Abortion, Habitual'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-26', 'studyFirstSubmitDate': '2016-02-24', 'studyFirstSubmitQcDate': '2016-02-26', 'lastUpdatePostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The levels of ERK and AKT in placenta', 'timeFrame': '48 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['genetic basis'], 'conditions': ['Recurrent Miscarriage']}, 'descriptionModule': {'briefSummary': 'The present study is based on hypotheses that some as yet unknown genetic factors may result in recurrent miscarriage (RM). Consequently, the main aim of this study was to gain new information about the underlying genetic causes of RM in the Egyptian population and to investigate the expression of ERK and p-ERK protein in human placenta and their corresponding tissue, to assess the significance of MAPK signal pathway in progression of recurrent miscarriage and PI3K-Akt Pathway.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women fulfilling the eligibility criteria had been tested and complete history and examination was done', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Gestational age less than 12 weeks.\n2. no uterine abnormalities (examined by ultrasonography or hysterosonogram)\n3. previous history of RM, defined as two or more consecutive miscarriages\n\nExclusion Criteria:\n\n1. Gestational age 12 weeks or more.\n2. Endocrine etiology like (thyroid dysfunction, and uncontrolled diabetes mellitus).\n3. Antiphospholipid syndrome, inherited thrombophilias, alloimmune causes.\n4. Uterine anatomic anomalies'}, 'identificationModule': {'nctId': 'NCT02694367', 'acronym': 'EPK-RM', 'briefTitle': 'Expression of EPK in Recurrent Miscarriage', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'MAP Kinase Signaling Pathways Through ERK and p-ERK Protein in Human Placenta of Women With Recurrent Miscarriage', 'orgStudyIdInfo': {'id': 'ERK'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Recurrent miscarriage group', 'description': 'Women with previous history of RM, defined as two or more consecutive miscarriages', 'interventionNames': ['Other: Investigate the MAP kinase signaling pathways through ERK and p-ERK proteins']}, {'label': 'Control group', 'description': 'Women with no history of RM', 'interventionNames': ['Other: Investigate the MAP kinase signaling pathways through ERK and p-ERK proteins']}], 'interventions': [{'name': 'Investigate the MAP kinase signaling pathways through ERK and p-ERK proteins', 'type': 'OTHER', 'armGroupLabels': ['Control group', 'Recurrent miscarriage group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Assiut', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ahmed Abbas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ahmed Mohamed Abbas', 'investigatorAffiliation': 'Assiut University'}}}}