İs There a Relationship Between Severity of Preeclampsia and Maternal Heavy Metal Levels?

Severe Preeclampsia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01906567
• Other study ID #: zekai tahir burak heavy metal
• 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

• Mild Pre-eclampsia
• Pre-Eclampsia
• Severe Preeclampsia

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

External Links

•   Environmental lead level and pregnancy-induced hypertension.
•   Maternal Blood Lead Levels and the Risk of Pregnancy-Induced Hypertension: The EDEN Cohort Study