Vanadium in Late-onset Preeclampsia

NCT04200222 | Completed

• 1 other identifier: CengizGWCH1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (1)

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

  1 day

Other Outcomes (1)

• Tertiary outcome was to compare the cadmium, lead and vanadium levels in SGA group and non-SGA group.

  1 day

Study Arms (2)

Preeclampsia

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. The study population consisted of 50 late-onset preeclampsia patients as study group and 50 patients with normal pregnancies as control group.

Diagnostic Test: cadmium, lead and vanadium measurements and compare

Control

Pregnant 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.

Diagnostic Test: cadmium, lead and vanadium measurements and compare

Interventions

cadmium, lead and vanadium measurements and compare DIAGNOSTIC_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.

Control; Preeclampsia

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Preeclampsia, is a pregnancy complication characterized by high blood pressure and signs of damage to another organ system, most often the liver and kidneys. Preeclampsia usually begins after 20 weeks of pregnancy in women whose blood pressure had been normal. Late-onset preeclampsia is usually defined as preeclampsia that develops after 34 weeks of gestation.
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• preeclampsia
• healthy pregnancy

You may not qualify if:

• 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
• multiple-gestation pregnancies
• pregnancies resulting from in vitro fertilization
• intrauterine fetal death
• having family history of preeclampsia

Sponsors & Collaborators

• Cengiz Gokcek Women's and Children's Hospital: lead

Study Sites (1)

Cengiz Gokcek Women's and Child's hospital

Gaziantep, 27010, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 25371519 BACKGROUND

• 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.

  PMID: 29651732 BACKGROUND

• 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.

  PMID: 27511439 BACKGROUND

• 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.

  PMID: 31743503 BACKGROUND

• 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.

  PMID: 28938191 RESULT

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 16, 2019
• Study Start: March 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: August 30, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Locations

TU (1)