İs There a Relationship Between Severity of Preeclampsia and Maternal Heavy Metal Levels?
NCT ID: NCT01906567
Last Updated: 2013-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
90 participants
OBSERVATIONAL
2013-07-31
2013-12-31
Brief Summary
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Detailed Description
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Preeclampsia 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.
significant 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.
However, the relationship between the severity of pre-eclampsia and heavy metal levels have not been investigated.
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.
Conditions
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Keywords
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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severe preeclamptic women
Severe preeclampsia is defined as the presence of 1 of the following symptoms or signs in the presence of preeclampsia:
• SBP of 160 mm Hg or higher or DBP of 110 mm Hg or higher on 2 occasions at least 6 hours apart
• 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
• Pulmonary edema or cyanosis
• Oliguria (\< 400 mL in 24 h)
• Persistent headaches
• Epigastric pain and/or impaired liver function
• Thrombocytopenia
• Oligohydramnios, decreased fetal growth, or placental abruption
No interventions assigned to this group
mild preeclamptic women
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.
No interventions assigned to this group
Healthy Pregnant Women
healthy pregnant women at term who not developed any complication of pregnancy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
39 Years
FEMALE
Yes
Sponsors
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Zekai Tahir Burak Women's Health Research and Education Hospital
OTHER
Responsible Party
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Ayse Kirbas
Ayse Kirbas, MD
Principal Investigators
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ayse kirbas, md
Role: PRINCIPAL_INVESTIGATOR
Zekai Tahir Burak Women's Health Research and Education Hospital
Locations
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Zekai Tahir Burak Maternity Teaching Hospital
Ankara, Ankara, Turkey (Türkiye)
Zekai Tahir Burak Education and Research Hospital
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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ayse kirbas, md
Role: primary
sibel ozler, md
Role: backup
ayse kirbas, md
Role: primary
Related Links
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Maternal Blood Lead Levels and the Risk of Pregnancy-Induced Hypertension: The EDEN Cohort Study
Environmental lead level and pregnancy-induced hypertension.
Other Identifiers
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zekai tahir burak heavy metal
Identifier Type: -
Identifier Source: org_study_id