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临床试验/NCT02586922
NCT02586922已完成不适用

Fetal Lung Volume and Pulmonary Artery Resistance Index Measurement in Term Diabetic Pregnancy and Their Correlation With Neonatal Outcome: a Pilot Study

Ain Shams University0 个研究点目标入组 70 人开始时间: 2015年11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
70
主要终点
neonatal respiratory distress

研究概览

简要总结

The aim of this study is to determine cut-off values for fetal lung volume by VOCAL and pulmonary artery resistance index by pulsed Doppler in fetuses of diabetic mothers, and correlate the results with postnatal respiratory distress of the term neonates.

详细描述

Research question:

Can the assessment of fetal lung volume by Virtual Organ Computed-aided Analysis (VOCAL) and pulmonary artery resistance index by pulsed Doppler predict neonatal respiratory distress syndrome in term fetuses of diabetic mothers?

Research hypothesis:

The assessment of fetal lung volume by VOCAL and pulmonary artery resistance index by pulsed Doppler can predict neonatal respiratory distress syndrome in term fetuses of diabetic mothers.

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

入选标准

  • Diabetic pregnant women 38 weeks gestation admitted for elective termination due to various obstetric indications

排除标准

  • Pregnancy complicated by medical disorders other than Diabetes Mellitus (hypertension, pre-eclampsia, cardiac disorders, thyroid disorders, anemia with pregnancy...etc).
  • Autoimmune disorders.
  • Congenital fetal anomalies.
  • Macrosomia and intrauterine growth restriction (IUGR).
  • Intrauterine fetal death (IUFD).
  • Amniotic fluid index <5cm or >20cm.
  • Patients taking steroids within one week of measurement of lung volume.

结局指标

主要结局

neonatal respiratory distress

时间窗: immediately after delivery

Occurrence of neonatal respiratory distress immediately after delivery utilizing APGAR score at birth in numbers

次要结局

  • • Neonatal mortality rate(One week after delivery)

研究者

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

dr mohamed laban

Professor Mohamed Laban

Ain Shams University

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