Magnesium and Vanadium Levels in Preeclampsia

Completed

• Conditions: Preeclampsia
• Interventions: Other: magnesium and vanadium measurements and compare

• Registration Number: NCT04387565
• Lead Sponsor: Cengiz Gokcek Women's and Children's Hospital

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-05-10
• Study First Submitted QC: 2020-05-10
• Study First Posted: 2020-05-14
• Study Start: 2020-06-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-11-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

Inclusion Criteria

• preeclampsia
• healthy pregnancy
• healthy women

Exclusion Criteria

1. pregnant women with any systemic condition (such as chronic hypertension, renal disease and diabetes mellitus)
2. using any kind of medication/supplement intake throughout pregnancy (such as heparin)
3. history of medication for PE treatment at the time of first admission
4. smoking
5. drug user
6. patients who had fetal congenital abnormalities or genetic syndromes
7. multiple-gestation pregnancies
8. pregnancies resulting from in vitro fertilization
9. intrauterine fetal death
10. having a family history of preeclampsia
11. Women who have menstrual irregularity
12. Women who have dyed their hair in the last 9 months
13. Gestational diabetes mellitus
14. Women receiving vanadium and/or magnesium treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control non-pregnant group	magnesium and vanadium measurements and compare	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.
Preeclampsia	magnesium and vanadium measurements and compare	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.
control pregnant group	magnesium and vanadium measurements and compare	These participants with normal healthy pregnancies at the third trimester (before birth)

Primary Outcome Measures

Name	Time	Method
magnesium and vanadium levels	10 day	The primary outcome in these analyses will be magnesium and vanadium levels in LOPE group and control groups.

Secondary Outcome Measures

Name	Time	Method
magnesium and vanadium levels in severy LOPE group	1 day	The secondary outcome will be compare the magnesium and vanadium levels in mild LOPE group and severy LOPE group.

Trial Locations

Locations (1)

Cengiz Gokcek Women's and Child's hospital; 🇹🇷 Gaziantep, Turkey