Analysis of Maternal Plasma/Urine/Hair Magnesium and Vanadium Levels in Preeclampsia (PrE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- magnesium and vanadium levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •preeclampsia
- •healthy pregnancy
- •healthy women
排除标准
- •pregnant women with any systemic condition (such as chronic hypertension, renal disease and diabetes mellitus)
- •using any kind of medication/supplement intake throughout pregnancy (such as heparin)
- •history of medication for PE treatment at the time of first admission
- •patients who had fetal congenital abnormalities or genetic syndromes
- •multiple-gestation pregnancies
- •pregnancies resulting from in vitro fertilization
- •intrauterine fetal death
- •having a family history of preeclampsia
- •Women who have menstrual irregularity
- •Women who have dyed their hair in the last 9 months
- •Gestational diabetes mellitus
- •Women receiving vanadium and/or magnesium treatment
结局指标
主要结局
magnesium and vanadium levels
时间窗: 10 day
The primary outcome in these analyses will be magnesium and vanadium levels in LOPE group and control groups.
次要结局
- magnesium and vanadium levels in severy LOPE group(1 day)
研究者
Ali Ovayolu
Principal Investigator
Cengiz Gokcek Women's and Children's Hospital