Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-22 @ 3:16 AM
Study NCT ID:
NCT01906567
Status:
UNKNOWN
Last Update Posted:
2013-08-06
First Post:
2013-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
İs There a Relationship Between Severity of Preeclampsia and Maternal Heavy Metal Levels?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'maternal whole blood maternal hair umbilical whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-08-04', 'studyFirstSubmitDate': '2013-07-05', 'studyFirstSubmitQcDate': '2013-07-20', 'lastUpdatePostDateStruct': {'date': '2013-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'increased levels of heavy metals in preeclamptic women', 'timeFrame': '6 months', 'description': 'mercury, cadmium and lead levels in maternal blood and hair'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cadmium', 'lead', 'mercury', 'preeclampsia', 'pregnancy'], 'conditions': ['Mild Pre-eclampsia', 'Severe Preeclampsia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2790505/', 'label': 'Maternal Blood Lead Levels and the Risk of Pregnancy-Induced Hypertension: The EDEN Cohort Study'}, {'url': 'http://ncbi.nlm.nih.gov/', 'label': 'Environmental lead level and pregnancy-induced hypertension.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study, to investigate whether severity of preeclampsia is associated with altered levels of heavy metals (Cd, Hg, arsenic and Pb) in maternal blood, fetal blood, and maternal hair.', 'detailedDescription': 'The unfavorable effects of heavy metals on human health is well known. The main threats to human health from heavy metals are associated with exposure to lead, cadmium, mercury and arsenic. They may be toxic at the levels previously thought to have no adverse effect on human.In utero environmental exposures can have long term consequences to health and development.İn spite of what is known about the neurotoxicity from exposure to heavy metals, the health effects from co-exposure to these chemicals and the biologically effective doses are not known exactly.\n\nPreeclampsia is associated with increased maternal and infant mortality and morbidity. The exact etiology is not clear. Several evidences indicate that various environmental factors and elements may play a role in pre-eclampsia.\n\nsignificant increase in Pb, cadmium (Cd), copper (Cu) and magnesium (Mg) and decrease in zinc (Zn) in amniotic fluid are associated with preeclampsia. Pb as this metal has well known adverse effects on renal system and blood pressures Effects of Pb on reproductive system have been studied intensively, e.g. other pregnancy outcome and pregnancy hypertension.\n\nHowever, the relationship between the severity of pre-eclampsia and heavy metal levels have not been investigated.\n\nThe purpose of this study, to investigate whether severity of preeclampsia is associated with altered levels of heavy metals (Cd, Hg, arsenic and Pb) in maternal blood, fetal blood, and maternal hair.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women with preeclampsia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of preeclampsia (diagnosed per ACOG criteria)\n\nExclusion Criteria:\n\nknown chronic disease multipl pregnancies'}, 'identificationModule': {'nctId': 'NCT01906567', 'briefTitle': 'İs There a Relationship Between Severity of Preeclampsia and Maternal Heavy Metal Levels?', 'organization': {'class': 'OTHER', 'fullName': "Zekai Tahir Burak Women's Health Research and Education Hospital"}, 'orgStudyIdInfo': {'id': 'zekai tahir burak heavy metal'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'severe preeclamptic women', 'description': 'Severe preeclampsia is defined as the presence of 1 of the following symptoms or signs in the presence of preeclampsia:\n\n• SBP of 160 mm Hg or higher or DBP of 110 mm Hg or higher on 2 occasions at least 6 hours apart\n\n• Proteinuria of more than 5 g in a 24-hour collection or more than 3+ on 2 random urine samples collected at least 4 hours apart\n\n• Pulmonary edema or cyanosis\n\n• Oliguria (\\< 400 mL in 24 h)\n\n• Persistent headaches\n\n• Epigastric pain and/or impaired liver function\n\n• Thrombocytopenia\n\n• Oligohydramnios, decreased fetal growth, or placental abruption'}, {'label': 'mild preeclamptic women', 'description': 'Mild preeclampsia is defined as the presence of hypertension (BP ≥140/90 mm Hg) on 2 occasions, at least 6 hours apart, but without evidence of end-organ damage in the patient.'}, {'label': 'Healthy Pregnant Women', 'description': 'healthy pregnant women at term who not developed any complication of pregnancy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6400', 'city': 'Ankara', 'state': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'ayse kirbas, md', 'role': 'CONTACT', 'email': 'ayseozdemirkirbas@hotmail.com', 'phone': '+90 0 533 646 92 13'}, {'name': 'sibel ozler, md', 'role': 'CONTACT'}, {'name': 'ayse kirbas, md', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'sibel ozler', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Zekai Tahir Burak Maternity Teaching Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'ayse kirbas, md', 'role': 'CONTACT'}, {'name': 'ayse kirbas, md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zekai Tahir Burak Education and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'ayse kirbas', 'role': 'CONTACT', 'email': 'ayseozdemirkirbas@hotmail.com', 'phone': '+90 0533 646 9213'}, {'name': 'sibel ozler', 'role': 'CONTACT', 'email': 'dr_sibelozler@hotmail.com', 'phone': '+ 90 545 233 1363'}], 'overallOfficials': [{'name': 'ayse kirbas, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Zekai Tahir Burak Women's Health Research and Education Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Zekai Tahir Burak Women's Health Research and Education Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ayse Kirbas, MD', 'investigatorFullName': 'Ayse Kirbas', 'investigatorAffiliation': "Zekai Tahir Burak Women's Health Research and Education Hospital"}}}}