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临床试验/NCT01463722
NCT01463722已完成2 期

Study of Accuracy of Amniotic Fluid Lamellar Body Counting for Evaluating of Fetal Lung Maturity

Isfahan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
128
试验地点
1
主要终点
The statues of respiratory of neonates

研究概览

简要总结

The purpose of this study is to determine the accuracy of Amniotic fluid Lamellar Body Counting for Evaluating of Fetal Lung Maturity.

详细描述

Respiratory distress syndrome (RDS) is one of important cause of mortality in neonates. This study was designed to evaluate the amniotic fluid lamellar body counting for predicting fetal lung maturity.

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
Single (Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women, with 28-37 weeks of gestational age, who had been decided to terminate their pregnancy, were enrolled in the study

排除标准

  • Chorioamnionitis
  • Intra Uterine Fetal Death (IUFD)
  • Blood in amniotic fluid
  • Rupture of placenta and patient dissatisfaction were the exclusion criteria.

结局指标

主要结局

The statues of respiratory of neonates

时间窗: at 2 minutes after delivery

Diagnosing of immaturity is based on the following criteria: 1-Physical examinations such as: nasal flaring, retraction, grunting, and tachypnea. 2-Oxygen needing more than 24 hours with three chest x-ray findings.

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

Hamidreza Shemshaki

Research Assistant

Isfahan University of Medical Sciences

研究点 (1)

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