NCT04387565

Brief Summary

Introduction: Vanadium important pollutants produced from anthropogenic activities, has been suggested to be embryotoxic and fetotoxic in a lot of studies. Magnesium sulfate therapy is used very common to prevent seizures in women with preeclampsia. However, the causes of preeclampsia are little known and heavy metals merit further investigation. The investigators will be tested whether late - onset preeclampsia (LOPE) was associated with exposure to these metals. Methods: This study was designed to determine maternal plasma/urine/hair magnesium and vanadium concentrations in women with LOPE (n=70) compared to those of normotensive pregnant women (n=70) and to those of normotensive-healthy non-pregnant women (n=70). These metals concentrations will be measured using inductively coupled plasma-mass spectrometry were compared.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

1.3 years

First QC Date

May 10, 2020

Last Update Submit

August 26, 2024

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

  • magnesium and vanadium levels

    The primary outcome in these analyses will be magnesium and vanadium levels in LOPE group and control groups.

    10 day

Secondary Outcomes (1)

  • magnesium and vanadium levels in severy LOPE group

    1 day

Other Outcomes (1)

  • magnesium and vanadium levels in SGA group

    1 day

Study Arms (3)

Preeclampsia

The diagnosis of LOPE, as will be defined by the Committee on Terminology of the American College of Obstetricians and Gynecologists (ACOG), will be established based on the presence of proteinuria and a blood pressure level of ≥140/90 mmHg that occurs after 34 weeks of gestation in a previously normotensive woman. The diastolic and/or systolic blood pressure ≥ 160/110 mm Hg, it will be accepted as mild; and in case these values exceeded this level, it will be accepted as severe.

Other: magnesium and vanadium measurements and compare

control pregnant group

These participants with normal healthy pregnancies at the third trimester (before birth)

Other: magnesium and vanadium measurements and compare

control non-pregnant group

A volunteer group of healthy women who visited the gynaecology clinic for routine examinations and women who were admitted for pre-pregnancy tests were invited randomly to this research as a control group.

Other: magnesium and vanadium measurements and compare

Interventions

magnesium and vanadium measurements and compareOTHER

Magnesium and vanadium will be measured using inductively coupled plasma-mass spectrometry (Thermo Scientific ICAPQc, USA).

Preeclampsiacontrol non-pregnant groupcontrol pregnant group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The investigators consecutively will be recruited 70 late-onset preeclampsia patients as a study group, 70 participants with normal pregnancies as control pregnant group and 70 participants with healthy volunteer women as control non-pregnant group.

You may qualify if:

  • preeclampsia
  • healthy pregnancy
  • healthy women

You may not qualify if:

  • pregnant women with any systemic condition (such as chronic hypertension, renal disease and diabetes mellitus)
  • 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 a family history of preeclampsia
  • Women who have menstrual irregularity
  • Women who have dyed their hair in the last 9 months
  • Gestational diabetes mellitus
  • Women receiving vanadium and/or magnesium treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cengiz Gokcek Women's and Child's hospital

Gaziantep, 27010, Turkey (Türkiye)

Location

Related Publications (6)

  • 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: 31743503RESULT

  • Scibior A. Vanadium (V) and magnesium (Mg) - In vivo interactions: A review. Chem Biol Interact. 2016 Oct 25;258:214-33. doi: 10.1016/j.cbi.2016.09.007. Epub 2016 Sep 13.

    PMID: 27620816RESULT

  • Elongi Moyene JP, Scheers H, Tandu-Umba B, Haufroid V, Buassa-Bu-Tsumbu B, Verdonck F, Spitz B, Nemery B. Preeclampsia and toxic metals: a case-control study in Kinshasa, DR Congo. Environ Health. 2016 Apr 5;15:48. doi: 10.1186/s12940-016-0132-1.

    PMID: 27044488RESULT

  • Euser AG, Cipolla MJ. Magnesium sulfate for the treatment of eclampsia: a brief review. Stroke. 2009 Apr;40(4):1169-75. doi: 10.1161/STROKEAHA.108.527788. Epub 2009 Feb 10.

    PMID: 19211496RESULT

  • Jiang M, Li Y, Zhang B, Zhou A, Zheng T, Qian Z, Du X, Zhou Y, Pan X, Hu J, Wu C, Peng Y, Liu W, Zhang C, Xia W, Xu S. A nested case-control study of prenatal vanadium exposure and low birthweight. Hum Reprod. 2016 Sep;31(9):2135-41. doi: 10.1093/humrep/dew176. Epub 2016 Jul 4.

    PMID: 27381766RESULT

  • Ovayolu A, Turksoy VA, Turan AI, Dogan I, Bostancieri N. Does magnesium, one of the treatments for preeclampsia, interact with vanadium? Naunyn Schmiedebergs Arch Pharmacol. 2025 Sep 29. doi: 10.1007/s00210-025-04609-7. Online ahead of print.

    PMID: 41020941DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma, urine, and hair

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • Ali Ovayolu, MD

    Cengiz Gökçek Kadın Doğum Ve Çocuk Hastalıkları Hastanesi

    PRINCIPAL INVESTIGATOR

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

May 10, 2020

First Posted

May 14, 2020

Study Start

June 1, 2020

Primary Completion

September 30, 2021

Study Completion

November 30, 2021

Last Updated

August 28, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)