Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-01-03 @ 11:50 PM
Study NCT ID:
NCT02270593
Status:
UNKNOWN
Last Update Posted:
2014-10-21
First Post:
2014-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of Placenta Previa Totalis (Accreta, Increta, Percreta).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010923', 'term': 'Placenta Previa'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010922', 'term': 'Placenta Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'serum and fetal membranes (placenta) and maternal myometrial sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-10-16', 'studyFirstSubmitDate': '2014-08-22', 'studyFirstSubmitQcDate': '2014-10-16', 'lastUpdatePostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of maternal serum in patients with the diagnosis of Placenta Previa (Accreta, increta, percreta)', 'timeFrame': 'Up to 6 months'}], 'secondaryOutcomes': [{'measure': 'ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of myometrial samples in patients with the diagnosis of Placenta Previa (Accreta, increta, percreta)', 'timeFrame': 'Up to 6 months'}, {'measure': 'ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of Fetal Membranes in patients with the diagnosis of Placenta Previa (Accreta, increta, percreta)', 'timeFrame': 'Up to 6 months'}, {'measure': 'placenta previa totalis in the development, progression and in exacerbating; ADAMTS and proteoglycans, to determine the relationship of changes in expression.', 'timeFrame': 'Up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Placenta Previa']}, 'descriptionModule': {'briefSummary': 'Placenta previa totalis (accreta, increta, percreta); ADAMTS and proteoglycans and the oxidant / antioxidant enzyme levels.', 'detailedDescription': 'Placenta previa totalis (accreta, increta, percreta) of pregnant women in the maternal serum, fetal membranes (placenta) and hysterectomy of women with myometrial strips measured the ADAMTS and proteoglycans expression levels, and the oxidant / antioxidant enzyme levels.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'tertiary health institutions', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women diagnosed with placenta previa by obstetric ultrasound and doppler\n\nExclusion Criteria:\n\n* Pregnant women with comorbid diseases other than previa totalis .'}, 'identificationModule': {'nctId': 'NCT02270593', 'briefTitle': 'ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of Placenta Previa Totalis (Accreta, Increta, Percreta).', 'organization': {'class': 'OTHER', 'fullName': "Zekai Tahir Burak Women's Health Research and Education Hospital"}, 'officialTitle': 'ADAMTS, Proteoglycan and Oxidant / Antioxidant Enzyme Levels of Placenta Previa Totalis(Accreta, Increta, Percreta)', 'orgStudyIdInfo': {'id': 'prospective study-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Placenta previa', 'description': 'first; maternal serum, fetal membranes (placenta) and maternal myometrial samples will be investigated for ADAMTS, Proteoglycans and oxidative/antioxidative enzyme status levels in patients with placental invasion anomalies Placenta Previa totalis by ELISA, western blot, immunohystochemistry and PCR (polymerase chain reaction).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'SİBEL ÖZLER, MD', 'role': 'CONTACT', 'phone': '0(312)30650000'}, {'name': 'AHMET NURİ DANIŞMAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'ALİ TURHAN ÇAĞLAR, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'SİBEL ÖZLER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Zekai Tahir Burak Women's Health Education and Research Hospital", 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'sibel özler, md', 'role': 'CONTACT', 'email': 'sibelozler@gmail.com', 'phone': '05457970257'}], 'overallOfficials': [{'name': 'ahmet nuri danısman, md', 'role': 'STUDY_DIRECTOR', 'affiliation': "zekai tahir burak women's health education and research hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Zekai Tahir Burak Women's Health Research and Education Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ADAMTS, Proteoglycan and Oxidant / Antioxidant Enzyme Levels of Placenta Previa Totalis(Accreta, Increta, Percreta)', 'investigatorFullName': 'sibel özler', 'investigatorAffiliation': "Zekai Tahir Burak Women's Health Research and Education Hospital"}}}}