Mild Pre-eclampsiaNCT01906567
İs There a Relationship Between Severity of Preeclampsia and Maternal Heavy Metal Levels?
An observational study of Mild Pre-eclampsia and Severe Preeclampsia, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mild Pre-eclampsia, Severe Preeclampsia
- How many people
- 90 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Jul 2013to Dec 2013
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant women with preeclampsia
Who may be able to join
- Clinical diagnosis of preeclampsia (diagnosed per ACOG criteria)
Who cannot join
- known chronic disease multipl pregnancies
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, Ankara, 6400
ayse kirbas, md, +90 0 533 646 92 13, ayseozdemirkirbas@hotmail.com
sibel ozler, md
- Recruiting
Zekai Tahir Burak Education and Research Hospital
Ankara
ayse kirbas, md
ayse kirbas, md
About this study
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.
Read the 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.
- Conditions
- Mild Pre-eclampsia, Severe Preeclampsia
- Keywords
- cadmium, lead, mercury, preeclampsia, pregnancy
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
increased levels of heavy metals in preeclamptic women
mercury, cadmium and lead levels in maternal blood and hair
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Pre-eclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Kirbas, Zekai Tahir Burak Women's Health Research and Education Hospital
- Investigators
- ayse kirbas, md, Principal investigator, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906567
- Sponsor's protocol ID
- zekai tahir burak heavy metal
- Status last verified
- Jul 2013
- First submitted
- 5 Jul 2013
- Last updated
- 6 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- İs There a Relationship Between Severity of Preeclampsia and Maternal Heavy Metal Levels?
- ClinicalTrials.gov ID
- NCT01906567
- Acronym / sponsor ID
- zekai tahir burak heavy metal
- Conditions
- Mild Pre-eclampsia, Severe Preeclampsia
- Keywords
- cadmium, lead, mercury, preeclampsia, pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women with preeclampsia
Key inclusion criteria (1 listed)
- Clinical diagnosis of preeclampsia (diagnosed per ACOG criteria)
Key exclusion criteria (1 listed)
- known chronic disease multipl pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
increased levels of heavy metals in preeclamptic women
Time frame: 6 months
mercury, cadmium and lead levels in maternal blood and hair
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2013.
- Maternal Blood Lead Levels and the Risk of Pregnancy-Induced Hypertension: The EDEN Cohort StudyLink provided by the sponsor.
- Environmental lead level and pregnancy-induced hypertension.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ayse kirbas, md principal investigator
Zekai Tahir Burak Women's Health Research and Education Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Pre-eclampsia and Severe Preeclampsia, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ayse kirbas (+90 0533 646 9213, ayseozdemirkirbas@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increased levels of heavy metals in preeclamptic women (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2013; AzTrials last refreshed its copy on 7 Nov 2026.