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临床试验/NCT03159234
NCT03159234已完成不适用

Evaluation of New Methods for Prediction of Fetal Lung Maturity in Diabetic Mothers

Assiut University2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2016年4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
54
试验地点
2
主要终点
APGAR score

研究概览

简要总结

Diabetes is the most common medical complication of pregnancy in the united states four to five percent of pregnancies are complicated by diabetes.

Pregestational diabetes (diabetes diagnosed before pregnancy, type 1 or type 2 diabetes mellitus) comprises approximately 13 percent of all diabetes in pregnancy, while gestational diabetes ( diabetes with onset or first recognition in pregnancy) comprises the remaining 87 percent . The prevalence of pregestational diabetes has been increasing due to the increasing prevalence of type 2 diabetes in women of reproductive age . The mainstay of the medical management of pregestational diabetes involves frequent monitoring of blood glucose levels with adjustment of diet and insulin therapy to achieve normoglycemia. Normoglycemia is important because maintenance of maternal blood glucose concentration at or near normoglycemic levels decreases the likelihood of adverse pregnancy outcomes, such as miscarriage , congenital anomalies , macrosomia and fetal death.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All pregnant diabetic women
  • 37 weeks gestational age .

排除标准

  • Women before 37 and after 39 weeks gestational age
  • Pregnancies with known fetal anomalies that may potentially affect the lung maturity .
  • Multiple pregnancies.
  • Women received steroids for lung maturation after ultrasound image acquisition and before delivery .
  • Women with premature rupture of membranes (prom)
  • Pregnancies complicated by medical disorders other than diabetes mellitus .
  • Failure to obtain an informed consent .

结局指标

主要结局

APGAR score

时间窗: 5 minutes

次要结局

未报告次要终点

研究者

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

Mohammed Khairy Ali

Lecturer of obstetrics and gynecology

Assiut University

研究点 (2)

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