Magnesium and Vanadium Levels in Preeclampsia (V-Mg&PrE)

Cengiz Gokcek Women's and Children's Hospital

Status: Completed

Conditions: Preeclampsia

Treatments: Other: magnesium and vanadium measurements and compare

Study type: Observational

Funder types: Other

Identifiers

NCT04387565

CengizGWCH7

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

210 participants in 3 patient groups

Preeclampsia

Description:

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.

Treatment:

Other: magnesium and vanadium measurements and compare

control pregnant group

Description:

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

Treatment:

Other: magnesium and vanadium measurements and compare

control non-pregnant group

Description:

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.

Treatment:

Other: magnesium and vanadium measurements and compare