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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Preeclampsia
• Intervention / Treatment: Other: magnesium and vanadium measurements and compare

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 Type: Observational
• Enrollment (Anticipated): 210

Contacts and Locations

• Study Contact: Name: Ali Ovayolu; Phone Number: 05326404060; Email: drovayolu@yahoo.com

Study Locations

• Turkey
  • Gaziantep, Turkey, 27010
    • Recruiting
    • Cengiz Gokcek Women's and Child's hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Magnesium and vanadium will be measured using inductively coupled plasma-mass spectrometry (Thermo Scientific ICAPQc, USA).
control pregnant group; These participants with normal healthy pregnancies at the third trimester (before birth)	Other: magnesium and vanadium measurements and compare; Magnesium and vanadium will be measured using inductively coupled plasma-mass spectrometry (Thermo Scientific ICAPQc, USA).
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; Magnesium and vanadium will be measured using inductively coupled plasma-mass spectrometry (Thermo Scientific ICAPQc, USA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
magnesium and vanadium levels in severy LOPE group	The secondary outcome will be compare the magnesium and vanadium levels in mild LOPE group and severy LOPE group.	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
magnesium and vanadium levels in SGA group	Tertiary outcome will be compared the magnesium and vanadium levels in SGA group and non-SGA group.	1 day

Collaborators and Investigators

• Sponsor: Cengiz Gokcek Women's and Children's Hospital
• Investigators: Principal Investigator: Ali Ovayolu, MD, Cengiz Gökçek Kadın Doğum Ve Çocuk Hastalıkları Hastanesi

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ANTICIPATED): September 30, 2021
• Study Completion (ANTICIPATED): November 30, 2021

Study Registration Dates

• First Submitted: May 10, 2020
• First Submitted That Met QC Criteria: May 10, 2020
• First Posted (ACTUAL): May 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Physiological Effects of Drugs; Trace Elements; Micronutrients; Vanadium
• Other Study ID Numbers: CengizGWCH7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No