Medical Policy: 04.01.06
Original Effective Date: April 1999
Reviewed: June 2018
Revised: June 2018
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This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Fetal ultrasound is a test performed during pregnancy, either to assess the gestational age or to evaluate fetal size, position, heartbeat, congenital malformations, suspected multiple fetuses or placental abnormalities. Two dimensional ultrasound is most commonly used. Three dimensional (3-D) and four dimensional (4-D) ultrasound create computer generated images viewed on video monitor that provide more detail and can produce more life-like images of the fetus. Five dimensional (5-D) ultrasound has been proposed as a means to automate the process of navigating the data obtained in a 3-D ultrasound to reduce dependency on ultrasound operator skill and experience and to increase reproducibility. This policy addresses the use of 3-D, 4-D, and 5-D fetal ultrasound in maternity care.
Although 3-D fetal ultrasound can produce more “realistic” and recognizable images than conventional 2-D ultrasound, the clinical significance of this remains unclear. The perceived superiority of 3-D ultrasound for a number of fetal abnormalities has not been established, and 2-D imaging remains the principal diagnostic modality.
Three dimensional (3-D) or volume ultrasonography acquires a volume (rather than a slice) of ultrasonographic data allowing one to see width, height and depth of images which is then stored. The stored data can be reformatted and analyzed in numerous ways. For example, surface rendering involves projecting the surface of a structure onto the screen, which allows curved structures, such as the fetal face, to be viewed in a single image that appears photographic in nature.
Suggested advantages of 3-D ultrasound compared to 2-D ultrasound in obstetrics include the following:
Limitations of 3-D ultrasound of the fetus are as follows:
Four dimensional (4-D) ultrasonography refers to real-time visualization of 3-D images. The time vector (the fourth dimension) makes it possible to perceive a rapid update of the successive individual images displayed on the monitor at very short intervals which creates the impression of real-time. Fetal movements can be seen, providing a "live action" view. 4-D ultrasonography is also known as dynamic 3-D sonography.
Five dimensional (5-D) ultrasonography builds upon 3-D sonography, automating the process of acquiring diagnostic images based upon volume data through the use of a software package. The ultrasound system WS80A (Samsung Medison Co, Ltd, Seoul, Korea) includes several software packages focusing on specific areas including fetal brain and heart structure, nuchal translucency and fetal biometry.
The 5-D technology includes the following:
5-D technology in fetal assessment in clinical practice:
Although three dimensional (3-D), four dimensional (4-D) and five dimensional (5-D) ultrasound may provide improved imaging for certain areas of the fetal anatomy and abnormalities, it has not been demonstrated in clinical studies to alter management over standard two-dimensional (2-D) ultrasounds such that clinical outcomes are improved. Additional studies are needed to support this technology as a replacement for standard 2-D ultrasound. The evidence is insufficient to determine the effects of this technology on net health outcomes.
2009 ACOG guideline on Ultrasonography in Pregnancy including the following: The technical advantages of three-dimensional ultrasonography include its ability to acquire and manipulate an infinite number of planes and to display ultrasound planes traditionally inaccessible by 2-dimensional ultrasonography. Despite these technical advantages, proof of a clinical advantage of three-dimensional ultrasonography in prenatal diagnosis in general is still lacking. Potential areas of promise include fetal facial anomalies, neural tube defects, and skeletal malformations where three-dimensional ultrasonography may be helpful in diagnosis as an adjunct to, but not a replacement for, two-dimensional ultrasonography. Until clinical evidence shows a clear advantage to conventional two-dimensional ultrasonography, three-dimensional ultrasonography is not considered a required modality at this time.
2012 ACOG reaffirmed their committee opinion regarding “Non-Medical use of Obstetric Ultrasonography”: ACOG has endorsed the following statement from the American Institute of Ultrasound in Medicine (AIUM) discouraging the use of obstetric ultrasonography for non-medical purposes (e.g., solely to create keepsake photographs or videos):
The AIUM advocates the responsible use of diagnostic ultrasound. The AIUM strongly discourages the non-medical use of ultrasound for psychosocial or entertainment purposes. The use of either two dimensional (2-D) or three dimensional (3-D) ultrasound to only view the fetus, obtain a picture of the fetus or determine the fetal gender without a medical indication is inappropriate and contrary to responsible medical practice. Although there are no confirmed biological effects on patients caused by exposures from present diagnostic ultrasound instruments, the possibility exists that such biological effects may be identified in the future. Thus ultrasound should be used in a prudent manner to provide medical benefit to the patient.
In summary, although 3-D and 4-D ultrasound may provide improved imaging for certain areas of fetal anatomy and abnormalities, it has not been demonstrated in clinical studies to result in improved health outcomes when compared to conventional 2-D ultrasound amaging.
In 2016, the American Academy of Obstetricians and Gynecologists (ACOG), issued practice bulletin No. 175 ultrasound in pregnancy, which states the following regarding three-dimensional ultrasonography: “Three-dimensional ultrasonography represents an advance in imaging technology. With three-dimensional ultrasonography, the volume of a target anatomic region can be calculated. The defined volume then can be displayed in three orthogonal two-dimensional planes representing the sagittal, transverse, and coronal planes of a reference two-dimensional image within the volume. The volume also can be displayed in its rendered format, which depicts the topographic anatomy of the volume. The technical advantages of three-dimensional ultrasonography include its ability to acquire and manipulate a large number of planes and to display ultrasound planes traditionally inaccessible by two-dimensional ultrasonography. Despite these technical advantages, proof of a clinical advantage of three-dimensional ultrasonography in prenatal diagnosis in general still is lacking. Potential areas of promise include fetal facial anomalies, neural tube defects, fetal tumors, and skeletal malformations for which three-dimensional ultrasonography may be helpful in diagnosis as an adjunct to but not a replacement for two-dimensional ultrasonography.”
In 2013, ACR-ACOG-AIUM-SRU issued a practice parameter for the performance of obstetrical ultrasound, this guideline does not mention or indicate the use of 3D or 4D ultrasound.
Equipment specifications: These studies should be conducted with real-time scanners, using a transabdominal and/or transvaginal approach. A transducer of appropriate frequency should be used. Real time sonography is necessary to confirm the presence of fetal life through observation of cardiac activity and active movement.
First Trimester Ultrasound Examination: A standard obstetrical sonogram in the first trimester includes evaluation of the presence, size, location, and number of gestational sac(s). The gestational sac is examined for the presence of the yolk sac and embryo/fetus. When and embryo/fetus is detected, it should be measured and cardiac activity recorded by 2D video clip or M-Mode. Use of spectral Doppler is discouraged. The uterus, cervix, adnexa and cul de sac region should be examined.
Standard Second or Third Trimester Examination: A standard obstetrical sonogram in the second or third trimester includes an evaluation of fetal presentation, amniotic fluid volume, cardiac activity, placental position, fetal biometry, and fetal number, plus an anatomic survey. The maternal cervix and adnexa should be examined as clinically appropriate when technically feasible.
Limited Examination: A limited examination is performed when a specific question requires investigation. For example, in most routine nonemergency cases a limited examination could be performed to confirm fetal heart activity in a bleeding patient, or to verify a fetal presentation in laboring patient. In most cases limited sonographic examination are appropriate only when a prior complete examination is on record.
Specialized Examination: A detailed anatomic examination is performed when an anomaly is suspected on the basis of history, biochemical abnormalities, or the results of either the limited or standard scan. Other specialized examinations might include fetal doppler ultrasound, biophysical profile, fetal echocardiogram, or additional biometric measurements.
2012 The Institute for Clinical Systems Improvement (ICSI) Health Care Guideline for Routine Prenatal Care, states three dimensional (3-D) and four dimensional (4-D) ultrasound is considered investigational and is not routinely recommended at this time.
The FDA considers such use of ultrasounds for keepsake video purposes to be an unauthorized use of a medical device and these vendors have largely been eliminated as a result of enforcement efforts. However, some clinicians continue to market them as a way to enhance prenatal bonding despite a lack of clinical evidence to support this claim.
Not applicable
The use of three dimensional (3-D), four dimensional (4-D), or five dimensional (5-D) fetal ultrasounds in maternity care is considered investigational for all indications.
Although three dimensional (3-D), four dimensional (4-D) and five dimensional (5-D) ultrasound may provide improved imaging for certain areas of the fetal anatomy and abnormalities, it has not been demonstrated in clinical studies to alter management over standard two-dimensional (2-D) ultrasounds such that clinical outcomes are improved. Additional studies are needed to support this technology as a replacement for standard 2-D ultrasound. The evidence is insufficient to determine the effects of this technology on net health outcomes.
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