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

NCT01906567 | Unknown

• 1 other identifier: zekai tahir burak heavy metal
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Mild Pre-eclampsia; Severe Preeclampsia

Keywords

cadmium; lead; mercury; preeclampsia; pregnancy

Outcome Measures

Primary Outcomes (1)

• increased levels of heavy metals in preeclamptic women

  mercury, cadmium and lead levels in maternal blood and hair

  6 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women with preeclampsia

You may qualify if:

• Clinical diagnosis of preeclampsia (diagnosed per ACOG criteria)

You may not qualify if:

• known chronic disease multipl pregnancies

Sponsors & Collaborators

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

Study Sites (2)

Zekai Tahir Burak Maternity Teaching Hospital

Ankara, Ankara, 6400, Turkey (Türkiye)

RECRUITING

Zekai Tahir Burak Education and Research Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Related Links

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

Biospecimen

Retention: NONE RETAINED

maternal whole blood maternal hair umbilical whole blood

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• ayse kirbas, md

  Zekai Tahir Burak Women's Health Research and Education Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ayse kirbas

CONTACT

+90 0533 646 9213; ayseozdemirkirbas@hotmail.com

sibel ozler

CONTACT

+ 90 545 233 1363; dr_sibelozler@hotmail.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ayse Kirbas, MD

Study Record Dates

• First Submitted: July 5, 2013
• First Posted: July 24, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 6, 2013

Record last verified: 2013-07

Locations

TU (2)