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临床试验/NCT02643199
NCT02643199已完成不适用

Automated Fetal Heart Echocardiography by Five-Dimensional Ultrasound in the Third Trimester of Pregnancy

Ain Shams University0 个研究点目标入组 90 人开始时间: 2015年12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
90
主要终点
Number of Satisfactory Fetal Echocardiography Views by Two-Dimensional Ultrasound

研究概览

简要总结

The aim of the study to evaluate Five-Dimensional Ultrasound in automated assessment of the fetal heart from 20-36 weeks of gestation.

详细描述

This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.

90 pregnant women will be recruited from the Fetal Care Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.

All cases will be subjected to:

  1. Full history taking including patient's age, parity, last menstrual period, estimated gestational age by dates, past history of medical disorders, clinical examinations (General and abdominal).
  2. Two-Dimensional Ultrasound and Five-Dimensional Ultrasound will be done for all cases for assessment of fetal Heart.
  • 90 consecutive patients will undergo 2D fetal echocardiography by one observer
  • Then they will undergo blindly Five-Dimensional fetal echocardiography by another observer
  • The data collected will be compared to evaluate the accuracy of Five-Dimensional US in fetal heart assessment.

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
18 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton pregnancy.
  • Gestational age at 34-36 weeks as determined be date and last menstrual period.
  • Normal Amniotic Fluid Index.

排除标准

  • Multiple pregnancies.
  • Oligohydramnios or Polyhydramnios (AFI > 95th percentile or < 5th percentile).
  • Obese patient, BMI > 30
  • Intrauterine growth restriction.
  • Fetal spine between the 11- and 1- O'clock positions due to possibility of shadowing from ribs or spine

结局指标

主要结局

Number of Satisfactory Fetal Echocardiography Views by Two-Dimensional Ultrasound

时间窗: 20 - 36 weeks of gestation

Fetal Echocardiography by Two-Dimensional Ultrasound measurement was done to examine fetal heart in both sagittal Views and transverse views: 1. Four chamber view 2. Five chamber view 3. Left outflow tract 4. Right outflow tract 5. 3 vessels and Trachea View 6. Abdomen/Stomach 7. Ductal arch 8. aortic arch 9. Bicaval view then we count howmuch views of nine views were satisfactory

次要结局

  • Number of Satisfactory Fetal Echocardiography Views by Five-Dimensional Ultrasound(20 - 36 weeks of gestation)

研究者

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

Rehab Mohamed Abdelrahman

Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University

Ain Shams University

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