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临床试验/NCT01762826
NCT01762826Unknown不适用

Adverse Obstetric Outcomes in Gestational Diabetes Mellitus and Inositol Stereoisomears

G. d'Annunzio University0 个研究点目标入组 120 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
主要终点
OGTT result

研究概览

简要总结

Comparison of different inositol stereoisomears in preventing adverse obstetric outcomes in non-obese pregnant women at high risk for gestational diabetes mellitus.

详细描述

The investigators compared outcomes from metabolic and obstetric point of view in GDM pregnant non-obese patient with different stereoisomears of inositol supply. Dietary control and placebo or inositol steroisomears were administered starting at the enrolling time (first fasting oral glucose above 92 mg%; usually before 20 weeks gestations') till the delivery and/or pregnancy end/termination. Oral glucose tolerance test results at 24-28 weeks' gestation was evaluated (as glucose values and oGTT screening). Fetal growth, delivery data, obstetric outcomes and necessity of insulin therapy were taken into account.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnancy below 20 weeks gestation BMI below 30 Fasting glucose between 92 and 126 mg% Singleton pregnancy Naturally conceived

排除标准

  • obese patient Fasti g glucose above 126 or below 92

结局指标

主要结局

OGTT result

时间窗: 24-28 weeks' gestation

OGTT is the mainstay of obstetric outcomes in GDM

次要结局

  • Fetal measurements at third trimester(28 weeks)
  • Adverse obstetric outcome(from first elevated oral fasting glucose (above 92 mg%) till the end/termination of pregnancy (latter 42 weeks gestation))
  • Delivery data(25-42 weeks gestations')

研究者

发起方
G. d'Annunzio University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Claudio Celentano

MD

G. d'Annunzio University

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