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临床试验/NCT03007186
NCT03007186已完成不适用

Glucose Monitoring During Threatening Preterm Birth With Particular Focus on Insulin Sensitivity and Glucose Tolerance in Patients With and Without Gestational Diabetes Mellitus

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Blood glucose measurements

研究概览

简要总结

This study aims to show whether the hyperglycaemic phases following a treatment with glucocorticoids, as well as blood measurements correlated to high blood glucose levels and insulin resistance, vary significantly between patients with and without gestational diabetes mellitus.

详细描述

BACKGROUND:

The therapy with glucocorticoids for fetal lung maturation in the case of threatening preterm birth is an long existing part of the obstetric routine procedures. Under this therapy it should not be forgotten, that glucocorticoids can lead to a decrease of the maternal insulin sensitivity as well as they can cause an impaired maternal glucose tolerance.

Therefore a threatening preterm birth as well as the including medical therapy do challenge the glucose metabolism of mother and child.

Gestational diabetes mellitus (GDM) is one of the most common complications during pregnancy, and the numbers are on the rise. GDM is characterized through an insulin resistance during the pregnancy.

High blood glucose level during pregnancy or labour can cause complications like a fetal hypoglycaemia right after birth.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • gestational age between 23+0 and 34+6
  • an oral glucose tolerance test was made and attests a healthy glucose tolerance (control group) a gestational diabetes mellitus (case group)
  • threatening preterm birth

排除标准

  • missing consent to participate
  • age under 18 years
  • age over 50 years
  • preexistent diabetes (type 1 or 2)
  • apparent disease of the thyroid gland
  • infectious diseases as HIV or Hepatitis C
  • insulin dependent gestational diabetes mellitus

结局指标

主要结局

Blood glucose measurements

时间窗: Seven days after betamethasone medication.

The patient measures their blood glucose level six times a day for seven days. The times of the measurements are before and one hour after every meal.

次要结局

  • Blood Glucose Level(One week after the medication with Betamethasone for lung maturation.)
  • HbA1C(One week after the medication with Betamethasone for lung maturation.)
  • Insulin level(One week after the medication with Betamethasone for lung maturation.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lara Linsenmeier

Principal Investigator

Medical University of Vienna

研究点 (1)

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