跳至主要内容
临床试验/NCT03583216
NCT03583216已完成不适用

Comparison of Factor XII Levels in Gestational Diabetic and Healthy Pregnancies

Acibadem University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年7月20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
60
试验地点
1
主要终点
Factor XII level

研究概览

简要总结

To compare Factor XII levels in gestational diabetic and healthy pregnancies.

详细描述

Thirty singleton term pregnant women with a diagnosis of Type I, Type II or gestational diabetes and thirty singleton uncomplicated term healthy pregnant women will be included in our study. Our study will be performed at Istanbul Acibadem Maslak Hospital, Turkey. Blood will be drawn from each patient when they are hospitalized and before they deliver either vaginally or by cesarean section. Blood will be drawn into two citrate tubes, each will contain 4 ml blood. Blood will be transferred to the lab immediately and will be centrifuged. The supernatant will be stored at -80°C. When the anticipated number of samples are completed Factor XII levels will be calculated in each sample.

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Term pregnancy
  • Pregnant patients with a diagnosis of Type I diabetes
  • Pregnant patients with a diagnosis of Type II diabetes
  • Pregnant patients with a diagnosis of Gestational diabetes
  • Non-diabetic pregnancies
  • Uncomplicated pregnancies

排除标准

  • Preterm pregnancy
  • Postterm pregnancy
  • Pregnant patients with a diagnosis of systemic diseases other than diabetes
  • Complicated pregnancies

结局指标

主要结局

Factor XII level

时间窗: Blood will be drawn when the patient is hospitalized before they deliver.

The primary outcome is to evaluate Factor XII level in diabetic pregnancies. If the investigators can prove that Factor XII, which has a mitogenic activity and can increase the risk for thrombosis, increases more in diabetic pregnancies in the future usage of Factor inhibitors may reduce macrosomia, thrombosis and the complications due to these conditions in diabetic pregnancies

次要结局

  • Macrosmia(Blood will be drawn when the patient is hospitalized before they deliver.)

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra Ozbasli

Ass. Prof.

Acibadem University

研究点 (1)

Loading locations...

相似试验