İs There a Relationship Between Severity of Preeclampsia and Maternal Heavy Metal Levels?
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|ClinicalTrials.gov Identifier: NCT01906567|
Recruitment Status : Unknown
Verified July 2013 by Ayse Kirbas, Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was: Recruiting
First Posted : July 24, 2013
Last Update Posted : August 6, 2013
|Condition or disease|
|Mild Pre-eclampsia Severe Preeclampsia|
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.
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||90 participants|
|Observational Model:||Ecologic or Community|
|Target Follow-Up Duration:||6 Months|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||December 2013|
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
• Oligohydramnios, decreased fetal growth, or placental abruption
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.
Healthy Pregnant Women
healthy pregnant women at term who not developed any complication of pregnancy
- increased levels of heavy metals in preeclamptic women [ Time Frame: 6 months ]mercury, cadmium and lead levels in maternal blood and hair
Biospecimen Retention: None Retained
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01906567
|Contact: ayse kirbas||+90 0533 646 firstname.lastname@example.org|
|Contact: sibel ozler||+ 90 545 233 email@example.com|
|Zekai Tahir Burak Maternity Teaching Hospital||Recruiting|
|Ankara, Turkey, 6400|
|Contact: ayse kirbas, md +90 0 533 646 92 13 firstname.lastname@example.org|
|Contact: sibel ozler, md|
|Principal Investigator: ayse kirbas, md|
|Sub-Investigator: sibel ozler|
|Zekai Tahir Burak Education and Research Hospital||Recruiting|
|Contact: ayse kirbas, md|
|Principal Investigator: ayse kirbas, md|
|Principal Investigator:||ayse kirbas, md||Zekai Tahir Burak Women's Health Research and Education Hospital|