跳至主要内容
临床试验/NCT02675595
NCT02675595Unknown不适用

Prospective Evaluation of Fetal Intelligent Navigation Echocardiography (FINE)(5D) Versus Conventional 2D Echocardiography in Comprehensive Fetal Cardiac Imaging in the Second Trimester of Pregnancy

Ain Shams University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Obtaining standard 9 views of fetal echocardiography by 5D as well as 2D

研究概览

简要总结

Hypothesis:

In Women in the second trimester of pregnancy 5D offers an alternative method for fetal Echocardiography compared to conventional 2D scanning

Question:

Does 5D software technology is as efficient as 2D scanning in fetal echocardiography of second trimesteric fetuses?

Aim:

This study aims at assessing the accuracy of performance of the 5D as a new scanning technology in fetal Echocardiography compared to the conventional use of 2D scanning.

详细描述

Congenital malformations account for more than 20% of all infant deaths(CDC,2014), and congenital heart defects are the most common types of birth defects.

The prenatal diagnosis of major congenital heart defects remains a challenge. Publications by Acherman et al (Acherman RJ .et al) and Sklansky et al (Sklansky MS.et al)have found that approximately 35% of cardiac anomalies are detected prenatally, a frequency that is not substantially different from that documented by Wigton et al in 1993 (Wigton TR, et al) Advances in prenatal ultrasonography have improved prenatal care in recent decades and increased the detection of a large number of congenital malformations. The prenatal detection rate of congenital heart disease (CHD), however, has not shown the same increase as the detection of malformations in other fetal systems (DeVore GR, et al). CHDs are the most commonly overlooked lesions in prenatal screening programs(Garne E et al, Tegnander E et al). This causes concern as CHD represents the most common congenital malformation and is the leading cause of infant mortality in the first year of postnatal life(Garne E). It has been estimated that the prevalence of CHD is 4-8 per 1000 neonates(Hoffman JI et al).

Early detection and accurate prenatal diagnosis of CHD reduces neonatal morbidity and mortality rates by allowing provision of adequate prenatal and postnatal care(Randall P et al, Goncalves LF et al). Before viability is reached, parents can be counseled on the diagnosis, severity and prognosis. Furthermore, it provides parents with the opportunityto make informed decisions on the further course of pregnancy. The four-chamber view has become the standard approach in screening for CHD. Identification of the right and left outflow tracts markedly improves the detection rate of CHD(DeVore GR et al, Stumpflen I et al).

Prenatal detection of these anomalies has proved challenging. In a British study from 1999, Bull(AIUM 2013) reported on 4799 pregnancies affected by major congenital heart defects and found that the antenatal detection rate was only 24%. Lower detection rates were noted in centers that only assessed the 4-chamber view. Correspondingly, in an attempt to improve the antenatal detection rates of congenital heart defects, the American Institute of Ultrasound in Medicine, American College of Obstetricians and Gynecologists, and International Society of Ultrasound in Obstetrics and Gynecology all have recommended that an attempt should be made to image the ventricular outflow tracts during the fetal anatomic survey.( Carvalho JS et al. , Bull C., AIUM 2003)

However, imaging of these outflow tracts can be challenging, and it is not clear that they can be typically obtained in generalized non-tertiary care settings. A 2007 study from the United States, which included 77,000 births, found that only 36% of major congenital heart defects were detected antenatally. It is not clear from the study whether outflow views were routinely obtained at all of the laboratories involved, but the study suggests that better detection rates could be achieved if outflow views were more routinely imaged.( Bull C. )

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

性别
Female
接受健康志愿者

入选标准

  • Living fetus.
  • Singleton
  • No gross fetal structural malformation
  • No maternal Medical Disorders
  • G.A : in between 20-26 wks.
  • Verbal consent informing the aim and process of this study

排除标准

  • the fetal spine between the 9- and 3-o'clock positions
  • Missed Abortion.
  • women with body mass index (BMI) ≥30 kg/m2
  • GA : before 20 wk.
  • presence of polyhydramnios or oligohydramnios (amniotic fluid index >95th percentile or < 5th percentile)
  • Detectable or suspected fetal cardiac anomaly
  • Fetal congenital malformation

结局指标

主要结局

Obtaining standard 9 views of fetal echocardiography by 5D as well as 2D

时间窗: 2 years

All 80 fetuses will undergo 2D and 5D detailed fetal echocardiography to obtain the standard nine cardiac views according to standards set by AIUM (American Institute of Ultrasound in Medicine) and both modalities will be compared by their ability to obtain the nine standard cardiac views.

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

Omneya Nagy ELmakhzangy

Specialist

Ain Shams University

研究点 (1)

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