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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01906567
Other study ID # zekai tahir burak heavy metal
Secondary ID
Status Recruiting
Phase N/A
First received July 5, 2013
Last updated August 4, 2013
Start date July 2013
Est. completion date December 2013

Study information

Verified date July 2013
Source Zekai Tahir Burak Women's Health Research and Education Hospital
Contact ayse kirbas
Phone +90 0533 646 9213
Email ayseozdemirkirbas@hotmail.com
Is FDA regulated No
Health authority Republic of Turkey : Ministry of HealthRepublic of Turkey : Public health institute
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date December 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 39 Years
Eligibility Inclusion Criteria:

Clinical diagnosis of preeclampsia (diagnosed per ACOG criteria)

Exclusion Criteria:

known chronic disease multipl pregnancies

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Zekai Tahir Burak Education and Research Hospital Ankara
Turkey Zekai Tahir Burak Maternity Teaching Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary increased levels of heavy metals in preeclamptic women mercury, cadmium and lead levels in maternal blood and hair 6 months No
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