Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-29 @ 3:16 AM
Study NCT ID:
NCT04523233
Status:
UNKNOWN
Last Update Posted:
2021-08-31
First Post:
2020-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metals/Vitamins Levels in NTD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009436', 'term': 'Neural Tube Defects'}], 'ancestors': [{'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000649', 'term': 'Amniocentesis'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019152', 'term': 'Paracentesis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D011296', 'term': 'Prenatal Diagnosis'}, {'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-15', 'size': 291187, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-08-19T11:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2020-08-19', 'studyFirstSubmitQcDate': '2020-08-20', 'lastUpdatePostDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'elements/vitamins concentrations in both group', 'timeFrame': '1 week', 'description': 'The primary outcome in these analyses will compare folic acid, zinc (Zn), molybdenum (Mo), vanadium (V), strontium (Sr), aluminum (Al), tin (Sn), antimony (Sb), mercury (Hg), calcium (Ca), iron ( Fe), magnesium (Mg), phosphorus (P), barium (B) and selenium (Se) concentrations in NTD group and control group.'}], 'secondaryOutcomes': [{'measure': 'compore in NTDs group', 'timeFrame': '1 week', 'description': 'The secondary outcome in these analyses will compare the elements and vitamins concentrations in the spinal NTD group and the cranial NTD group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neural Tube Defects']}, 'referencesModule': {'references': [{'pmid': '31743503', 'type': 'RESULT', 'citation': 'Ovayolu A, Ovayolu G, Karaman E, Yuce T, Ozek MA, Turksoy VA. Amniotic fluid levels of selected trace elements and heavy metals in pregnancies complicated with neural tube defects. Congenit Anom (Kyoto). 2020 Sep;60(5):136-141. doi: 10.1111/cga.12363. Epub 2019 Nov 27.'}, {'pmid': '25375307', 'type': 'RESULT', 'citation': 'Wilson RD; SOGC GENETICS COMMITTEE; SPECIAL CONTRIBUTOR. RETIRED: Prenatal screening, diagnosis, and pregnancy management of fetal neural tube defects. J Obstet Gynaecol Can. 2014 Oct;36(10):927-939. doi: 10.1016/S1701-2163(15)30444-8.'}, {'pmid': '27918138', 'type': 'RESULT', 'citation': 'Yan L, Wang B, Li Z, Liu Y, Huo W, Wang J, Li Z, Ren A. Association of essential trace metals in maternal hair with the risk of neural tube defects in offspring. Birth Defects Res. 2017 Feb 15;109(3):234-243. doi: 10.1002/bdra.23594.'}, {'pmid': '28196803', 'type': 'RESULT', 'citation': 'Nikolopoulou E, Galea GL, Rolo A, Greene ND, Copp AJ. Neural tube closure: cellular, molecular and biomechanical mechanisms. Development. 2017 Feb 15;144(4):552-566. doi: 10.1242/dev.145904.'}]}, 'descriptionModule': {'briefSummary': 'Introduction: Heavy metals important pollutants produced from anthropogenic activities, has been suggested to be embryotoxic and fetotoxic in a lot of studies. The aims of this study were to determine the levels of trace elements and heavy metals, namely folic acid, zinc (Zn), molybdenum (Mo), vanadium (V), strontium (Sr), aluminium (Al), tin (Sn), antimony (Sb), mercury (Hg), calcium (Ca), iron ( Fe), magnesium (Mg), phosphorus (P), barium (B) and selenium (Se), in the amniotic fluid of pregnant women, and to investigate their relationship with neural tube defects (NTDs).\n\nMethods: The study will be included 70 pregnant women whose fetuses were complicated with NTDs (study group) and 70 pregnant women with unaffected healthy fetuses (control group). The samples levels of elements and vitamins will be measured using inductively coupled plasma-mass spectrometry and will be compared between the two groups.', 'detailedDescription': "Detailed Description:\n\nThis observational case-control study will be conducted at the Department of Obstetrics and Gynecology, Cengiz Gokcek Public Hospital, Gaziantep, Turkey, between August 2020 and March 2021. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (reference no: 2020/167). The study strictly will be adhered to the principles of the Declaration of Helsinki. All women will be provided written informed consent before the acquisition of all samples. The study will be included 140 pregnant women who underwent amniocentesis at the investigator's perinatology department.\n\nThe study group will be included 70 pregnant women whose fetuses were found to have congenital NTDs (eg, anencephaly, spina bifida, acrania, and encephalocele) on detailed ultrasonographic examinations between 16 and 37 weeks of pregnancy. The control group included pregnant women with healthy fetuses (n = 70), who were matched for gestational weeks and maternal age and underwent amniocentesis because of age-related risk or increased risk in the triple test. Then, this study will be determined maternal plasma/urine/hair, and amniotic fluid folic acid, zinc (Zn), molybdenum (Mo), vanadium (V), strontium (Sr), aluminium (Al), tin (Sn), antimony (Sb), mercury (Hg), calcium (Ca), iron ( Fe), magnesium (Mg), phosphorus (P), barium (B) and selenium (Se) concentrations in women with NTD compared to those of volunteer healthy pregnant women."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study group included 70 pregnant women with congenital NTDs (e.g. anencephaly, spina bifida, acrania, NTDs, and encephalocele) with a normal karyotype, which were detected in detailed ultrasonographic examinations, and 70 healthy pregnancies will be selected for the control group.', 'genderDescription': 'pregnancy', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women complicated with Neural tube defects\n* Healthy pregnancy\n* Singleton pregnancy\n\nExclusion Criteria:\n\n1. pregnant women with any systemic condition (such as chronic hypertension, renal disease and )\n2. women who have dyed their hair in the last 5 months\n3. history of using any medication\n4. presence of gestational hypertension or gestational diabetes\n5. drug user\n6. patients who had other fetal congenital abnormalities or genetic syndromes\n7. multiple-gestation pregnancies\n8. intrauterine fetal death\n9. oligohydramnios'}, 'identificationModule': {'nctId': 'NCT04523233', 'acronym': 'NTD&HMs', 'briefTitle': 'Metals/Vitamins Levels in NTD', 'organization': {'class': 'OTHER', 'fullName': "Cengiz Gokcek Women's and Children's Hospital"}, 'officialTitle': 'Maternal Plasma/Urine/Hair/Amniotic Fluid Levels of Selected Trace Elements and Heavy Metals in Pregnancies Complicated With Neural Tube Defects', 'orgStudyIdInfo': {'id': 'CengizGWCH8'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neural tube defects (NTDs)', 'description': 'NTDs are a group of birth defects in which an opening in the spine or cranium remains from early in human development. Neural tube defects may be diagnosed during the ultrasound scan that is carried out around week 12 of the pregnancy or, more likely, during the anomaly scan that is carried out at around weeks 19 to 20.', 'interventionNames': ['Diagnostic Test: Amniocentesis']}, {'label': 'Control group', 'description': 'The control group will be included pregnant women with healthy fetuses (n = 70), who were matched for gestational weeks and maternal age and underwent amniocentesis because of age-related risk or increased risk in the triple test.', 'interventionNames': ['Diagnostic Test: Amniocentesis']}], 'interventions': [{'name': 'Amniocentesis', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['elements/vitamins concentrations measurements'], 'description': 'Amniocentesis is a procedure in which amniotic fluid is removed from the uterus for testing or treatment.', 'armGroupLabels': ['Control group', 'Neural tube defects (NTDs)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27010', 'city': 'Gaziantep', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ali Ovayolu, MD', 'role': 'CONTACT', 'email': 'drovayolu@yahoo.com', 'phone': '00905326404060'}], 'facility': "Cengiz Gokcek Women's and Child's hospital", 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Cengiz Gokcek Women's and Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'The Scientific Research Project Fund of Yozgat Bozok University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ali Ovayolu', 'investigatorAffiliation': "Cengiz Gokcek Women's and Children's Hospital"}}}}