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PreeclampsiaVanadium PENCT04200222

Vanadium in Late-onset Preeclampsia

An observational study of Preeclampsia, run by Cengiz Gokcek Women's and Children's Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Introduction: Cadmium, lead and vanadium important pollutants produced from anthropogenic activities, has been suggested to be embryotoxic and fetotoxic in a lot of studies. However, the causes of preeclampsia are little known and heavy metals merit further investigation. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Preeclampsia
What is being tested?
cadmium, lead and vanadium measurements and compare
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2018to 30 Aug 2019
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 40 years
  • Women only
  • Adult

Study population: The investigators consecutively recruited 50 subjects with preeclampsia, and 50 healthy pregnancies selected for the control group.

Who may be able to join

  • preeclampsia
  • healthy pregnancy

Who cannot join

  • pregnant women with any systemic condition (such as chronic hypertension, renal disease and )
  • using any kind of medication/supplement intake throughout pregnancy (such as heparin)
  • history of medication for PE treatment at the time of first admission
  • smoking
  • drug user
  • patients who had fetal congenital abnormalities or genetic syndromes
Show all 10Show fewer
  • multiple-gestation pregnancies
  • pregnancies resulting from in vitro fertilization
  • intrauterine fetal death
  • having family history of preeclampsia

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Cengiz Gokcek Women's and Child's hospital

    Gaziantep, 27010

Other trials in Turkey (Türkiye)

About this study

Official title: Analyses of Maternal Plasma Cadmium, Lead and Vanadium Levels in the Diagnosis and Severity of Late-onset Preeclampsia; A Prospective and Comparative Study From Turkey

Introduction: Cadmium, lead and vanadium important pollutants produced from anthropogenic activities, has been suggested to be embryotoxic and fetotoxic in a lot of studies. However, the causes of preeclampsia are little known and heavy metals merit further investigation. We tested whether late-onset preeclampsia (L-PrE) was associated with exposure to these metals.

Methods: This study was designed to determine maternal plasma cadmium, lead and vanadium concentrations in women with L-PrE (n=46) compared to those of normotensive women (n=46). These three heavy metals concentrations measured using inductively coupled plasma-mass spectrometry were compared.

Read the detailed description

This observational case-control study was conducted at the Department of Obstetrics and Gynecology, Cengiz Gokcek Public Hospital, Gaziantep, Turkey, between March 2018 and June 2019. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (reference no: 2019/36). The study strictly adhered to the principles of the Declaration of Helsinki. All subjects included in the study gave oral and written informed consent. Ninety-two women were enrolled in the study in two groups.

Data collection and Study intervention:

The diagnosis of L-PrE, as defined by the Committee on Terminology of the American College of Obstetricians and Gynecologists (ACOG), is established based on the presence of proteinuria (urinary excretion of protein ≥300 mg in a 24-h urine specimen, or proteinüria ≥1+ in dipstick) and a blood pressure level of ≥90/140 mmHg (two blood pressure measurements 6 h apart) that occurs after 34 weeks of gestation in a previously normotensive woman. The diastolic and/or systolic blood pressure <110/160 mm Hg, it was accepted as mild; and in case these values exceeded this level, it was accepted as severe. Every women in the study population underwent obstetric ultrasound examination and fetal-maternal assesment was carried out by one of the authors. The obstetric anamnesis were obtained from all subjects. The dempograhic data like age, gravidity, parity, body mass index (BMI) and gestational age were recorded. The gestational age was determined by calculation from the last menstrual period and supported by the ultrasonography measurements at first trimester of gestation. Maternal venous plasma samples were taken for measurement of cadmium, lead and vanadium levels after the diagnosis of L-PrE in outpatient clinic. These samples quickly centrifuged at 1,500 g for 10 min, plasma samples were seperated and stored at -80 C until the day of measurement. All patients with L-PrE were also hospitalized and their pregnancies were terminated. The samples of the control groups were obtained during the routine obstetrical care examination in the third trimester of pregnancy. Then, these pregnant women were followed-up until the delivery. Both groups were compared in terms of maternal age, BMI, week of gestation, gravida, parity, live born, systolic/diastolic blood pressure, total protein in spot urine sample, hemoglobin, hematocrit, platelet count, white blood cell count, urea, uric acid, albümin, blood urea nitrogen, creatinine, liver function tests (AST, ALT), lactic acid dehydrogenase, cadmium, lead and vanadium concentrions and infant weight at delivery. Small for gestational age (SGA) neonate was defined as birth weight <10th percentile for gestational age with Turkey's national nomogram as the reference for fetal growth. The samples were transferred within boxes in ice molds to Yozgat Bozok University Science and Technology Application and Research Center (Occupational and Environmental Toxicology Laboratory) for measuring heavy metal and trace element levels. The frequency of seafood consumption was divided into four categories: 2-3 per week, 1-2 per week, 1-2 per month, and rare. Smoking was classified into 3 groups (none, formerly smoker, and active smoking). Passive smoking was also categorized into 2 groups (no and yes). The education levels was classified into 4 groups (illiterate, primary education, high school, and university). The residences of women was classified as rural and urban. Furthermore, the residences of women have divided either living near a busy street (around 100 metres) or not.Small for gestational age (SGA) neonate was defined as birth weight <10th percentile for gestational age with Turkey's national nomogram as the reference for fetal growth.

The method developed by Aliyev et al. was used for preparing the samples for analysis One milliliter of plasma samples was placed into high-temperature-resistant Teflon tubes in a microwave oven, and 5 mL Suprapur® (Merck, Darmstadt, Germany) nitric acid (HNO3) and 5 mL ultra-pure water was added. All plasma samples were digested using a microwave digestion system (Start D; Milestone, MD, USA). After digestion, each sample was made to a total volume of 20 mL with 9 mL ultra-pure water in a 50 mL polypropylene tube. Nitric acid (Suprapur®, 65%) was used for digestion of samples and standard reference material. Ultra-pure water (Direct-Q®; Millipore, Darmstadt, Germany) was used for dilution of the standard (multi-element standard Chem-Lab, Zedelgem, Belgium) and sample preparations.

The three metals (cadmium, lead and vanadium) were measured using inductively coupled plasma-mass spectrometry (Thermo Scientific ICAPQc, USA). The operating parameters were set as follows: radiofrequency power 1550 W, nebulizer gas 0.96 L/min, plasma gas 0.88 L/min, nebulizer pressure 3.01 bar, dwell time 0.01 milliseconds, and spray chamber temperature 3.7°C. The sampler probe was washed between injections by rinsing with ultrapure water for 30 s, followed by washing with 2% HNO3 for 45 s, and finally rinsing with ultrapure water for 45 s. After the washing steps, the instrument automatically ran the next sample. An 11-point calibration curve (0.5-500 µg/L) was used to measure the level of each element. The r2 values of the calibration curves of all metals were calculated, and the minimum value was 0.9994. To ensure the accuracy of the results, each measurement of the samples and standards was repeated three times. The results of these measurements showed that the relative standard deviation (RSD) did not exceed 5%. Certified Reference Material (CRM-Seronorm™ Trace Elements Whole Blood L-2, Sero AS, Billingstad, Norway) was used for the validation method. To check the stability and sensitivity of the instrument, a mixture of internal standards (Hf) was used, and the mean and RSD values of metals were also calculated. The variations of each measurement of the quality controls was <15%. The relative percentage differences in replicate analyses were <5% in the samples and standards.

Conditions
Preeclampsia
Being tested
cadmium, lead and vanadium measurements and compare
Medical subject headings
Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cadmium, lead and vanadium measurements and compareDiagnostic test

    The method developed by Aliyev et al. was used for preparing the samples for analysis (1).

    The three metals (cadmium, lead and vanadium) were measured using inductively coupled plasma-mass spectrometry (Thermo Scientific ICAPQc, USA).

    1. Ovayolu A, Ovayolu G, Karaman E, Yuce T, Ozek MA, Turksoy VA. Amniotic fluid levels of selected trace elements and heavy metals in pregnancies complicated with neural tube defects. Congenit Anom (Kyoto). 2019:10.1111/cga.12363.
Study groups in NCT04200222
Study groupRoleWhat they receive
PreeclampsiaThe diagnosis of L-PrE, as defined by the Committee on Terminology of the American College of Obstetricians and Gynecologists (ACOG), is established based on the presence of proteinuria (urinary excretion of protein ≥300 mg in a 24-h urine specimen, or proteinüria ≥1+ in dipstick) and a blood pressure level of ≥90/140 mmHg (two blood pressure measurements 6 h apart) that occurs after 34 weeks of gestation in a previously normotensive woman. The diastolic and/or systolic blood pressure <110/160 mm Hg, it was accepted as mild; and in case these values exceeded this level, it was accepted as severe. The study population consisted of 50 late-onset preeclampsia patients as study group and 50 patients with normal pregnancies as control group.
Receives: Diagnostic Test: cadmium, lead and vanadium measurements and compare
ControlPregnant women with uncomplicated pregnancies were randomly selected to serve as controls. Healthy subjects who had a normal pregnancy and outcomes without any fetal-neonatal complications were accepted into the control group.
Receives: Diagnostic Test: cadmium, lead and vanadium measurements and compare

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary outcome in these analyses was to compare cadmium, lead and vanadium levels in L-PrE group and control group.

    The primary outcome in these analyses was to compare cadmium, lead and vanadium levels in L-PrE group and control group.

    Measured: 3 months

Secondary outcomes (1)
  1. The secondary outcome was to compare the cadmium, lead and vanadium levels in mild L-PrE group and severity L-PrE group.

    The secondary outcome was to compare the cadmium, lead and vanadium levels in mild L-PrE group and severity L-PrE group.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2019
  2. Study start1 Mar 2018
  3. Primary completion30 Jun 2019
  4. Study completion30 Aug 2019

Resources

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
Case-control
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04200222
Sponsor's protocol ID
CengizGWCH1
Acronym
Vanadium PE
Status last verified
Dec 2019
First submitted
12 Dec 2019
Last updated
17 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Gruzewska K, Michno A, Pawelczyk T, Bielarczyk H. Essentiality and toxicity of vanadium supplements in health and pathology. J Physiol Pharmacol. 2014 Oct;65(5):603-11.

    PubMed 25371519
  • Wang F, Fan F, Wang L, Ye W, Zhang Q, Xie S. Maternal Cadmium Levels During Pregnancy and the Relationship with Preeclampsia and Fetal Biometric Parameters. Biol Trace Elem Res. 2018 Dec;186(2):322-329. doi: 10.1007/s12011-018-1312-3. Epub 2018 Apr 12.

    PubMed 29651732
  • Zhang Q, Huang Y, Zhang K, Huang Y, Yan Y, Wang F, Wu J, Wang X, Xu Z, Chen Y, Cheng X, Li Y, Jiao J, Ye D. Cadmium-induced immune abnormality is a key pathogenic event in human and rat models of preeclampsia. Environ Pollut. 2016 Nov;218:770-782. doi: 10.1016/j.envpol.2016.07.073. Epub 2016 Aug 7.

    PubMed 27511439
  • Ovayolu A, Ovayolu G, Karaman E, Yuce T, Ozek MA, Turksoy VA. Amniotic fluid levels of selected trace elements and heavy metals in pregnancies complicated with neural tube defects. Congenit Anom (Kyoto). 2020 Sep;60(5):136-141. doi: 10.1111/cga.12363. Epub 2019 Nov 27.

    PubMed 31743503
  • Poropat AE, Laidlaw MAS, Lanphear B, Ball A, Mielke HW. Blood lead and preeclampsia: A meta-analysis and review of implications. Environ Res. 2018 Jan;160:12-19. doi: 10.1016/j.envres.2017.09.014. Epub 2017 Sep 21.

    PubMed 28938191

Questions about this trial

What is this clinical trial studying?

An observational study of Preeclampsia, run by Cengiz Gokcek Women's and Children's Hospital at 1 site 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 2 inclusion and 10 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: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome in these analyses was to compare cadmium, lead and vanadium levels in L-PrE group and control group. (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04200222, which also lists 5 linked publications.

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 17 Dec 2019.

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Vanadium in Late-onset Preeclampsia (NCT04200222) | AzTrials