Trial record 2 of 97 for:    Open Studies | "Pre-Eclampsia"

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

This study is currently recruiting participants.
Verified July 2013 by Zekai Tahir Burak Maternity and Teaching Hospital
Sponsor:
Information provided by (Responsible Party):
Ayse Kirbas, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01906567
First received: July 5, 2013
Last updated: August 4, 2013
Last verified: July 2013
  Purpose

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.


Condition
Mild Pre-eclampsia
Severe Preeclampsia

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months

Resource links provided by NLM:


Further study details as provided by Zekai Tahir Burak Maternity and Teaching Hospital:

Primary Outcome Measures:
  • 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

maternal whole blood maternal hair umbilical whole blood


Estimated Enrollment: 90
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)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

pregnant women with preeclampsia

Criteria

Inclusion Criteria:

Clinical diagnosis of preeclampsia (diagnosed per ACOG criteria)

Exclusion Criteria:

known chronic disease multipl pregnancies

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01906567

Contacts
Contact: ayse kirbas +90 0533 646 9213 ayseozdemirkirbas@hotmail.com
Contact: sibel ozler + 90 545 233 1363 dr_sibelozler@hotmail.com

Locations
Turkey
Zekai Tahir Burak Education and Research Hospital Recruiting
Ankara, Turkey
Contact: ayse kirbas, md         
Principal Investigator: ayse kirbas, md         
Zekai Tahir Burak Maternity Teaching Hospital Recruiting
Ankara, Turkey, 6400
Contact: ayse kirbas, md    +90 0 533 646 92 13    ayseozdemirkirbas@hotmail.com   
Contact: sibel ozler, md         
Principal Investigator: ayse kirbas, md         
Sub-Investigator: sibel ozler         
Sponsors and Collaborators
Zekai Tahir Burak Maternity and Teaching Hospital
Investigators
Principal Investigator: ayse kirbas, md Zekai Tahir Burak Maternity and Teaching Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Ayse Kirbas, Ayse Kirbas, MD, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01906567     History of Changes
Other Study ID Numbers: zekai tahir burak heavy metal
Study First Received: July 5, 2013
Last Updated: August 4, 2013
Health Authority: Republic of Turkey : Ministry of Health
Republic of Turkey : Public health institute

Keywords provided by Zekai Tahir Burak Maternity and Teaching Hospital:
cadmium
lead
mercury
preeclampsia
pregnancy

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on April 15, 2014