Magnesium and Vanadium Levels in Preeclampsia

Preeclampsia Clinical Trial

— V-Mg&PrE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04387565
• Other study ID #: CengizGWCH7
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: August 2021
• Source: Cengiz Gokcek Women's and Children's Hospital
• Contact: Ali Ovayolu
• Phone: 05326404060
• Email: drovayolu[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: November 30, 2021
• Est. primary completion date: September 30, 2021
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Other:
• magnesium and vanadium measurements and compare
Magnesium and vanadium will be measured using inductively coupled plasma-mass spectrometry (Thermo Scientific ICAPQc, USA).

Locations

Country	Name	City	State
Turkey	Cengiz Gokcek Women's and Child's hospital	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Cengiz Gokcek Women's and Children's Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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. Review. — View Citation

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/d — View Citation

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. Epu — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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