İs There a Relationship Between Severity of Preeclampsia and Maternal Heavy Metal Levels?
Recruitment status was: Recruiting
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Ecologic or Community
Time Perspective: Prospective
|Target Follow-Up Duration:||6 Months|
- increased levels of heavy metals in preeclamptic women [ Time Frame: 6 months ] [ Designated as safety issue: No ]mercury, cadmium and lead levels in maternal blood and hair
Biospecimen Retention: None Retained
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01906567
|Zekai Tahir Burak Maternity Teaching Hospital|
|Ankara, Turkey, 6400|
|Zekai Tahir Burak Education and Research Hospital|
|Principal Investigator:||ayse kirbas, md||Zekai Tahir Burak Women's Health Research and Education Hospital|