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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| control pregnant group | These participants with normal healthy pregnancies at the third trimester (before birth) |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnesium and vanadium measurements and compare | Other | Magnesium and vanadium will be measured using inductively coupled plasma-mass spectrometry (Thermo Scientific ICAPQc, USA). |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Pregnancy
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.
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| Name | Affiliation | Role |
|---|---|---|
| Ali Ovayolu, MD | Cengiz Gökçek Kadın Doğum Ve Çocuk Hastalıkları Hastanesi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cengiz Gokcek Women's and Child's hospital | Gaziantep | 27010 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31743503 | Result | 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. | |
| 27620816 | Result | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2020 | May 10, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008274 | Magnesium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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plasma, urine, and hair
| 27044488 | Result | 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. |
| 19211496 | Result | 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. |
| 27381766 | Result | 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. |
| 41020941 | Derived | Ovayolu A, Turksoy VA, Turan AI, Dogan I, Bostancieri N. Does magnesium, one of the treatments for preeclampsia, interact with vanadium? Naunyn Schmiedebergs Arch Pharmacol. 2026 Feb;399(3):3447-3459. doi: 10.1007/s00210-025-04609-7. Epub 2025 Sep 29. |
| D008670 |
| Metals |