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临床试验/NCT03927014
NCT03927014已完成不适用

Serum Thiol/Disulphide Homeostasis Level and Its Correlation With the Severity of Preeclampsia

Cengiz Gokcek Women's and Children's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Thiol/ disulfide hemostasis

研究概览

简要总结

Objective: To evaluate serum evaluate thiol/ disulfide levels in preeclampsia and address its relationship with its severity.

Methods: This prospective study will include 50 pregnancies complicated with preeclampsia and 50 healthy pregnancies. The blood for analysis will obtain at the admission and serum thiol/ disulfide levels will measure using commercially available reagent kits. The continuous values were evaluated using Student's t-test, and categorical values were evaluated using the Chi-square test. P values < .05 were accepted as significant.

详细描述

This is an observational prospective cohort study will conduct at Obstetrics and Gynecology Department of Cengiz Gokcek Obstetrics and Children's Hospital between April and October 2019. One hundred women will enrol in the study in two groups. We will consecutively recruit 50 pregnancies complicated with preeclampsia, and 50 healthy pregnancies will select for the control group. All patients will give their oral and written informed consent before their inclusion in the study. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (Reference number: 2019/147). The study strictly will adhere to the principles of the Declaration of Helsinki.

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

入选标准

  • preeclampsia
  • healthy pregnancy

排除标准

  • pregnant women with any systemic condition (such as chronic hypertension, diabetes mellitus, thyroid diseases, liver and kidney diseases)
  • women with a history of drug use throughout pregnancy
  • history of medication for PE treatment at the time of first admission
  • patients who had fetal congenital abnormalities or genetic syndromes
  • multiple gestation
  • active labor

结局指标

主要结局

Thiol/ disulfide hemostasis

时间窗: 1 day

The primary endpoint in this analysis is to evaluate thiol/disulfide levels in preeclampsia and address its relationship with its severity.

次要结局

未报告次要终点

研究者

发起方
Cengiz Gokcek Women's and Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Ovayolu

Principal Investigator

Cengiz Gokcek Women's and Children's Hospital

研究点 (1)

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