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

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 Overview

• Status: Unknown
• Conditions: Severe Preeclampsia; Mild Pre-eclampsia

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 6400
    • Recruiting
    • Zekai Tahir Burak Maternity Teaching Hospital
    • Contact: ayse kirbas, md; Phone Number: +90 0 533 646 92 13; Email: ayseozdemirkirbas@hotmail.com
    • Contact: sibel ozler, md
    • Sub-Investigator: sibel ozler
  • Ankara, Turkey
    • Recruiting
    • Zekai Tahir Burak Education and Research Hospital
    • Contact: ayse kirbas, md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

pregnant women with preeclampsia

Description

Inclusion Criteria:

Clinical diagnosis of preeclampsia (diagnosed per ACOG criteria)

Exclusion Criteria:

known chronic disease multipl pregnancies

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
increased levels of heavy metals in preeclamptic women	mercury, cadmium and lead levels in maternal blood and hair	6 months

Collaborators and Investigators

• Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: July 5, 2013
• First Submitted That Met QC Criteria: July 20, 2013
• First Posted (Estimate): July 24, 2013

Study Record Updates

• Last Update Posted (Estimate): August 6, 2013
• Last Update Submitted That Met QC Criteria: August 4, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: pregnancy; lead; preeclampsia; mercury; cadmium
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: zekai tahir burak heavy metal