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临床试验/NCT02139254
NCT02139254已完成不适用

First Trimester Glycosylated Haemoglobin Und Plasma Glucose in Women at High Risk for Gestational Diabetes

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2013年8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
1,800
试验地点
1
主要终点
Number of women with gestational diabetes

研究概览

简要总结

Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance with onset or first recognition during pregnancy. If insulin resistance and hyperglycemia are recognized before pregnancy, the term pregestational diabetes (PGD) is used. In the last years, much has been invested to uniformly define worldwide the diagnostic criteria and the management of gestational diabetes. A general screening in a low risk population should be implemented into routine prenatal care. Similarly, pregnant women at high risk for metabolic disorders should be screened in the early pregnancy.

The aim of the following study ist to investigate the role of first trimester glycosylated haemoglobin (HbA1c) of pregnant women with risk factors in developing gestational diabetes mellitus (GDM).

详细描述

Background

Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance with onset or first recognition during pregnancy. If insulin resistance and hyperglycemia are recognized before pregnancy, the term pregestational diabetes (PGD) is used. In the last years, much has been invested to uniformly define worldwide the diagnostic criteria and the management of gestational diabetes. Recently, the American Diabetes Association stated that a general screening in a low risk population should be implemented into routine prenatal care. However, there are still controversies on which diagnostic criteria to use. Similarly, screening of pregnant women at high risk for PGD is also a matter of debate. This is an important issue as the prevalence of this group is increasing worldwide. Of interest, the ADA as well as the international expert committee on diabetes published a consensus statement in which the use of HbA1c was supported for the diagnosis of diabetes rather than the measurement of fasting or post-prandial plasma glucose in a non-pregnant population. A value of ≥6.5% (≥48mmol/mol) was proposed as criterion for diagnosis. There is no doubt that the measurement of glycosylated haemoglobin may be of value in particular preconceptional in diabetes type 1. Difference exist in using HbA1c during pregnancy. At the pregnant state, the different red cell turnover and other physiologic changes in pregnancy may interfere with HbA1c. Indeed, mean HBA1c levels in healthy pregnant women are lower than in the non-pregnant women. Moreover, O'Connor et al. showed that first and second trimester HbA1c values are significantly different to a non-pregnant population, whereas no difference was found comparing HbA1c values from the third trimester. Therefore, it has been suggested, that only blood glucose criteria should be used to diagnose or exclude PGD in particular during the first trimester as the data on HBA1c in the first trimester is limited .

Objective

To observe the values of HbA1c obtained from pregnant women in the early pregnancy, the difference between those who develop GDM and those who do not and the comparison of first trimester HBA1c, Plasma Glucose and angiogenesis factors.

Methods

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnancy
  • 8-13 weeks of gestation
  • Written informed consent
  • Exclusion Criteria
  • Pregestational diabetes

排除标准

  • 未提供

结局指标

主要结局

Number of women with gestational diabetes

时间窗: Week 28 of pregnancy

次要结局

  • Delivery Mode(At delivery, expected to be on average after 40 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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