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NCT Number: NCT04387565

Magnesium and Vanadium Levels in Preeclampsia

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.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Cengiz Gokcek Women's and Child's hospital

Gaziantep, 27010, Turkey (Türkiye)

About this study

This observational case-control study will be conducted at the Department of Obstetrics and Gynecology, Cengiz Gokcek Public Hospital, Gaziantep, Turkey, between May 2020 and February 2021. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (reference no: 2020/130). The study strictly will be adhered to the principles of the Declaration of Helsinki. All participants will be included in the study gave oral and written informed consent. Two-hundred ten women will be enrolled in the study in three groups.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • preeclampsia
  • healthy pregnancy
  • healthy women

Exclusion criteria

  • 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

Treatment and study plan

magnesium and vanadium measurements and compare

Other

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

Primary outcomes

  1. magnesium and vanadium levels

    Time frame: 10 day

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

Secondary outcomes

  1. magnesium and vanadium levels in severy LOPE group

    Time frame: 1 day

    The secondary outcome will be compare the magnesium and vanadium levels in mild LOPE group and severy LOPE group.

Other outcomes

  1. magnesium and vanadium levels in SGA group

    Time frame: 1 day

    Tertiary outcome will be compared the magnesium and vanadium levels in SGA group and non-SGA group.

Sponsors and collaborators

Lead sponsor

Cengiz Gokcek Women's and Children's Hospital

Other

Registry information

Official study title

Analysis of Maternal Plasma/Urine/Hair Magnesium and Vanadium Levels in Preeclampsia (PrE)

Acronym: V-Mg&PrE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 14, 2020
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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