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临床试验/NCT02494440
NCT02494440已完成不适用

Automated Fetal Femur Length Measurement by Five-Dimensional Ultrasound

Ain Shams University0 个研究点目标入组 90 人开始时间: 2015年5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
Gestational Age Calculated by Accurate Dates of the Last Menstrual Period

研究概览

简要总结

The purpose of the study to evaluate Five-Dimensional Ultrasound in automated measurement of the fetal femur length at third trimester of pregnancy.

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.

Ninety pregnant women will be recruited from the 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 femur length .

The FL at Two-Dimensional Ultrasound (Gold standard) will be made from the center of the 'U' shape at each end of the bone.

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 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton pregnancy.
  • At third trimester of pregnancy.
  • The patient must be sure of her last normal menstrual period, last three regular cycles and no hormonal contraception before pregnancy.

排除标准

  • Multiple pregnancies.
  • Fetal anomalies.
  • Amniotic fluid index < 5 cm.
  • Medical disorder as diabetes mellitus, hypertension.
  • Obese patients. BMI > 30
  • Intrauterine growth retardation.
  • Post term pregnancy > 41 weeks.

结局指标

主要结局

Gestational Age Calculated by Accurate Dates of the Last Menstrual Period

时间窗: 26 - 40 weeks of gestation

The patient must be sure of her last normal menstrual period, last three regular cycles and no hormonal contraception before pregnancy. Gestational age calculated by the last menstrual period

次要结局

  • Gestational Age Calculated by Femur Length Measurement by Two-Dimensional Ultrasound(26 - 40 weeks of gestation)
  • Gestational Age Calculated by Femur Length Measurement by Five-Dimensional Ultrasound(26 - 40 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

Rehab Mohamed Abdelrahman

Ain Shams University

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