Fleischer’s Sonography in Obstetrics &

Gynecology 8th Edition Arthur C.

Fleischer Et Al.
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This book, previously entitled simply Sonography in
Obstetrics and Gynecology, is now entitled Fleischer’s
Sonography in Obstetrics and Gynecology, in honor of the
lead author, Arthur C. Fleischer, MD, whose brilliance,
intellect, and experience have spanned eight editions.
Arthur C. Fleischer was born in Miami, Florida in
1952. His parents were Lucille and Eugene. Lucille was
a lifelong learner and educator, graduating from Hunter
College in 1942 (when she was 17), obtaining a Master’s
in Education from the University of Miami in 1951, and
graduating first in her class at the University of Miami
School of Law in 1958. Eugene attended the University of
Miami after military service, became a general contractor
in Miami, and was instrumental in starting a new Reform
Jewish congregation, Temple Beth Am in Kendall, Florida.
Art Fleischer’s grandparents were Hungarian immigrants
who came to New York City from Budapest in 1921. As
a child, Art was fortunate to excel at equestrian competi-
tions and was state champion from 11 to 18 years of age. At
Emory University, he completed his thesis on ultrasound
enhancement of treatments and received his BS degree,
magna cum laude, in biology in 1973. He met Lynn in 1974
through the introduction from a mutual medical school
friend, and they were married in 1975.
In 1976, he received the MD degree from the Medical
College of Georgia at Augusta, and in 1980, he complet-
ed the Radiology Residency/Fellowship at Vanderbilt
University Medical Center inNashville, Tennessee.
Dr. Fleischer began his medical career in 1974 as the
Acting Director of Diagnostic Ultrasound at the Medical
College of Georgia. He came to Vanderbilt University School
of Medicine in 1976 and has held the following positions:
Acting Director of Diagnostic Ultrasound; Clinical Fellow in
Ultrasound; Assistant Professor (Radiology and Obstetrics
and Gynecology); and Associate Professor (Radiology and
Obstetrics and Gynecology). Additionally, Dr. Fleischer was
Visiting Professor in Radiology (Diagnostic Ultrasound)
at Thomas Jefferson University Hospital. Presently, he is
Professor of Radiology and Radiological Sciences (1987);
Professor of Obstetrics and Gynecology (Secondary) (1987);
Medical Director of the Sonography Training Program
(1981); and Medical Director of Ultrasound.
Dr. Fleischer has been active in several specialty
societies, including the American Institute of Ultrasound
in Medicine (Board of Governors, Fellow), the American
College of Radiology (Fellow), the Society of Radiologists in
Ultrasound (Fellow), and the Society for the Advancement
of Women’s Imaging (Cofounder and President).
Professor Fleischer has authored more than 200
research papers regarding clinical aspects of diagnostic
ultrasound and 23 textbooks involving the use of diagnostic
sonography in obstetrics/gynecology. He has received numer-
Fleischer_FM_i-xxiv.indd 21
TRIBUTE
ous awards and honors, among them are the Larry Mack
Award for Best Research Paper by the Society of Radiologists
in Ultrasound in 1998, the William Fry Award for Outstanding
Contributions to Ultrasound by the American Institute
of Ultrasound in Medicine in 1999, the Frank H. Boehm
Award for Contribution to Continuing Medical Education
by Vanderbilt University School of Medicine in 2005, and the
Distinguished Alumnus Award from the Medical College of
Georgia in 2007. In 2011, Dr. Fleischer was honored with the
Cornelius Vanderbilt Chair in Radiology.
Art and Lynn have three children, Braden, Jared, and
Amy, and one grandson, Jakob. When asked about her
father, Amy had the following words:
The essence of Dr. Fleischer (our dad, or “Daddio,” as we
know him) is exemplified by an unconditional love of learn­
ing. Whether our family discussions took place at the dinner
table or at his favorite lunch spot (let’s be honest, most of
our chats involved food), he always exuded an enthusiasm
for learning.
In fact, the most valuable gift our dad gave us (besides
life itself!) is his infectious curiosity. His passion for new
technology is not only evidenced by the every-growing stack
of medical and academic publications he has authored
(during his 40-year career) but also by the abundant sea of
gadgets in his office! His thirst for innovative tools and tech­
nology is unquenchable, even when our mom threatens to
purge his “toys” in order to make a path through the house.
In amongst these toys, a plethora of textbooks, articles, pho­
tos, and old x-ray films make our home a monument to his
staggering medical career. To us, such tangible evidence—of
which this book is now a vital part—will always serve to
represent his most deeply held belief in the value of asking
good questions while seeking new understanding about the
world.
Amy Fleischer, MS, OTR/L, on behalf of Art’s
three children
Luis Gonçalves, MD, has the following observations:
There are moments in life when one wonders about how the
Universe conspires to align with perfection those people who
eventually become a permanent part of our path on Earth.
I would like to take this moment to acknowledge the oppor­
tunity of having Arthur Fleischer cross my path 24 years
ago at Vanderbilt University. Art has certainly inspired me
then and will continue to inspire those of us who have been
fortunate enough to have crossed his path and know first-
hand the enormity of the human being who teaches and
leads with a light heart.
08/09/17 5:18 pm
 Tribute xxii

Eugene C. Toy, MD, on behalf of the tens of thousands of knowledge, and so much zeal, and so much compassion
physicians, sonographers, residents and students who have can be in one person!” Dr. Fleischer has been one the cor­
been touched by Dr. Art Fleischer, has these words: nerstones in advancing imaging in women’s health over the
past 40 years, particularly in the areas of gynecologic ultra­
Art Fleischer has been a tremendous inspiration to everyone
sound. Not only has he propelled this embryologic science
around him. He has an amazing sense of humor, a consci­
into a maturing and exciting field in science and informa­
entiousness that goes far beyond the normal “call of duty,”
tion, he has also put his own personal heart and soul into
and a dedication to women’s health through imaging and
gynecologic sonography. I feel so fortunate to be able to call
the prevention and diagnosis of disease. Art is an amazing
Art Fleischer my friend, mentor, and inspiration. For the
educator, and I have sat in his conferences amazed at how
tens of thousands who use imaging to help treat women, and
much he is able to teach—from the anatomical structures,
the millions of women who are dependent on this modal­
to the imaging, to the disease. More than all of this, Art has
ity for their care, we pause a moment to give tribute to a
a tremendous love for people and cares so deeply about all
man who worked tirelessly in his significant contributions
of those who are fortunate enough to cross paths with him.
to the science and art of gynecologic sonography. For this
One physician who was in a medical school radiology rota­
reason, we have entitled this book, Fleischer’s Sonography
tion with Art summed it up: “I don’t know how so much
in Obstetrics and Gynecology.

Fleischer_FM_i-xxiv.indd 22 08/09/17 5:18 pm

 PART 1

GENERAL OBSTETRIC
SONOGRAPHY

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 2 Part 1 GENERAL OBSTETRIC SONOGRAPHY
Chapter 1
ULTRASOUND BIOEFFECTS AND SAFETY:
WHAT THE PRACTITIONER SHOULD KNOW
Jacques S. Abramowicz
Key Terms1
1. Acoustic streaming: movement of tissue or fluid,
resulting from the passage of alternating positive
and negative pressures of the ultrasound wave. Can
also result from movements of bubbles, as a result of
changes in pressure.
2. ALARA principle: stands for As Low As Reasonably
Achievable, a way to obtain the best, clinically rel-
evant image while keeping ultrasound intensity and
exposure as low as possible.
3. Cavitation: bubble activity, secondary to ultrasound
insonation. The positive aspect of the ultrasound
pressure wave causes compression of the bubble
while the negative part, also called rarefactional,
causes production of the bubbles or expansion of
existing ones. Cavitation can be stable or inertial.
• Stable cavitation: bubble activity where bubble
does not collapse (see inertial cavitation) but is
moving back and forth in the tissue or fluid, thus
potentially causing the surrounding medium to
flow (ie, stream, hence the term streaming).
• Inertial (previously known as transient) cavita-
tion: bubbles that are compressed and expanded
but with each compressing (positive) component,
causing the volume to diminish ever more, until
collapse occurs. This collapse can generate tre-
mendously elevated temperature and pressure
for an extremely short time and over an extremely
short space (called an adiabatic reaction). This can
result in production of several more bubbles, local
cell damage, and/or generation of free radicals.
4. Derating: action of multiplying a value measured in
water with standard methods by a correction factor
to account for the attenuation of the ultrasound field
by the tissue traversed by the beam (usually 0.3 dB/
cm/MHz).
5. Dwell time: the time during which the ultrasound
beam impinges on a specific organ, body part, or
entire organism.
6. Mechanical index (MI): expresses the potential for
nonthermal (also known as mechanical) effects in
tissues traversed by the ultrasound wave. Depends
on the pressure and the frequency ( = P/ f ).
Fleischer_CH01_p001-p024.indd 2
● Eyal Sheiner
7. Output Display Standard (ODS): actual name—
Standard for Real-Time Display of Thermal and
Mechanical Acoustic Indices on Diagnostic Ultra-
sound Equipment. Introduced to make end users
aware, in real time, of the potential effects of ultra-
sound in tissues. See also mechanical index and
thermal index.
8. Radiation force: force resulting from absorption of
some of the energy of the acoustic wave by tissue
and transformation into heat.
9. Scanned mode: refers to the ultrasound beam
moving through the field, with energy distributed
over a large volume, such as in B-mode and color-
flow Doppler.
10. Thermal index (TI): expresses the potential for
temperature increase in tissues traversed by the
ultrasound wave. It is given by the ratio of the power
emitted by the transducer to the ultrasonic power
required to raise tissue temperature by 1°C for the
specific exposure conditions. This is a relative indi-
cation and does not necessarily correspond to the
actual temperature increase. One of three thermal
indices is displayed, based on whether soft tissue
(TIS, mostly first and early second trimesters), bone
(TIB, late second and third trimesters), or adult cra-
nium (TIC) is being scanned.
11. Unscanned mode: the ultrasound beam is station-
ary with power concentrated along a single line,
such as in M-mode and spectral Doppler.
INTRODUCTION
“Is this safe for my baby?” Ultrasound practitioners hear
this question almost every day in clinical practice. The
answer generally given is: “Of course. Ultrasound is not
x-rays, it is not invasive; it has been used for close to sixty
years and is perfectly safe.” While this answer may, in fact,
contain some correct facts (ultrasound is not x-rays), the
concept of perfect safety is not scientifically valid, and
furthermore, the level of knowledge regarding poten-
tial effects of ultrasound in tissues is, by and large, very
low among end-users of this technology. Ultrasound in
obstetrics is convenient, painless, and results are available
immediately. The belief exists that is does not pose any risk
08/09/17 10:50 am
 Chapter 1 Ultrasound Bioeffects and Safety: What the Practitioner Should Know
to the pregnant patient or her fetus. Ultrasound, however,
is a form of energy and, as such, has effects in biological
tissues (bioeffects). The physical mechanisms responsible
for these effects are nonthermal (mechanical) or thermal.
The nonthermal mechanisms can further be separated
into acoustic cavitation (inertial and noninertial) and
noncavitational mechanisms, ie, acoustic radiation force
(time-averaged force exerted by the ultrasound beam),
acoustic radiation torque (producing in the insonated tis-
sue a tendency to rotate or spin), and acoustic streaming
(circulatory flow). It is the role of science to show whether
any of these bioeffects may be harmful. The question has
been debated since the introduction of ultrasound in clini-
cal obstetrics, particularly as it relates to the fetal nervous
system2,3 and continues to be discussed currently.4-9(1)
This chapter presents basic notions of acoustics and
physics as they relate to ultrasound, examines some
literature on bioeffects and the safety of ultrasound,
reviews statements of various ultrasound organizations,
and affords a practical approach to limit the potential risks
to the fetus of exposure to diagnostic ultrasound (DUS).
BASIC PHYSICS OF ULTRASOUND
A detailed description of ultrasound physics can be found
in various publications.10-12 However, certain properties of
ultrasound are very important when trying to understand
safety and bioeffects. Equally important are tissue charac-
teristics, such as attenuation coefficient. A basic knowl-
edge of instrument controls (“knobology”) is essential not
only for appropriate clinical usage, but it is imperative to
avoid potential harm.
The Ultrasound Wave
Sound is a mechanical vibratory form of energy. It propa-
gates through a medium by means of the motions of
the particles in the medium, under the influence of the
alternating positive and negative components of the wave.
Megapascal (MPa) is the unit for pressure. Ultrasound
instrumentation can generate peak pressures of 5 MPa
and above. This is in comparison to the atmospheric pres-
sure, which is 0.1 MPa. Several other characteristics define
the ultrasound beam. The ultrasonic wave progresses in
the insonated tissue at a velocity that is related to the
sound characteristics as well as the tissue properties. For
practical purposes, the average speed of sound propaga-
tion in biological tissues is estimated at 1540 ms/sec.
Frequency is the number of cycles per second, measured
in hertz (Hz). The limits of human hearing spans from
approximately 20 to 20,000 Hz. Diagnostic ultrasound is,
generally, 2 to 10 million Hz (megahertz, MHz). Wave-
length is the distance between 2 corresponding points
on a particular wave. It is inversely proportional to the
frequency. Equipment resolution (the shortest distance
between 2 objects or parts of an object to be represented
by 2 separate echoes) depends on the wavelength: axial
resolution ranges between 2 and 4 wavelengths. Hence,
the shorter the wavelength (ie, the higher the frequency),
the better the resolution (the distance between 2 points
is smaller). The trade-off is that the higher the frequency
Fleischer_CH01_p001-p024.indd 3
3
6
Resolution
Penetration
5
4
3
2
1
0
Figure 1-1. Resolution (solid line) and penetration (dotted line) as a
function of increasing frequency, represented by the x-axis. Units on the
y-axis are not actual but representative of increasing values. The green
arrow represents the goal of improving penetration at high frequencies.
(better resolution), the lower the penetration of the beam
through a given tissue (Figure 1-1).
Diagnostic ultrasound is pulsed, ie, pulses of acoustic
energy separated by “silent” gaps. The number of pulses
occurring in 1 second is the pulse repetition frequency
(PRF) and is controlled by the instrument in B-mode. In
Doppler mode, it can be altered by the end user. Another
important parameter is the duty factor: this is the fraction
of time that the pulsed ultrasound is on. With an increase
in PRF, the duty factor increases. The pulse amplitude
reflects pressure and is the maximum variation from the
baseline, expressed in MPa’s. Since the ultrasound wave is
sinusoidal, there are periods of positive and negative pres-
sure. When the ultrasound wave exerts pressure on the
resisting insonated tissue, work is produced. The ability of
the wave to do work is its energy (in joules). The rate at
which the energy is transformed from one form to another
is the power (in watts or milliwatts). Intensity represents
the rate at which energy passes through area unit. Average
intensity of a beam is expressed by the beam power (in
milliwatts, mW), divided by the cross-sectional area of the
beam (in cm2) and is, therefore, expressed in mW/cm2. As
stated earlier, DUS is performed with a pulsed wave. The
intensity is proportional to the square of the instantaneous
ultrasound wave pressure. There are pulses of energy
intermingled with periods where no energy is emitted.
Depending on the time and location of the measurement,
several parameters can be described in relation to time
or space: temporal peak intensity (the greatest intensity),
average intensity over time, ie, including “silent” time
between pulses (temporal-average intensity), maximal
intensity at a particular location (spatial-peak intensity),
as well as average-spatial intensity. By combining time
and space, 6 intensities can be described: spatial average–
temporal average (ISATA), spatial average–pulse average
08/09/17 10:50 am
 4 Part 1 GENERAL OBSTETRIC SONOGRAPHY
 VALUES OF ISPTA BY MODALITY
Table 1-1 AND YEAR OF DEFINITION
Modality/ 1976 1986
Application Values Values
Fetal imaging 46 94
Cardiac 430 430
Peripheral vessel 720 720
Ophthalmic 17 17
Note: All are derated values in mW/cm .
2
Data from Nyborg WL. Biological effects of ultrasound: development of safety
guidelines. Part II: general review. Ultrasound Med Biol. 2001;27:301-333;
Abramowicz JS. Prenatal exposure to ultrasound waves: is there a risk? Ultra-
sound Obstet Gynecol. 2007;29:363-367; Gressens P, Huppi PS. Are prenatal
ultrasounds safe for the developing brain? Pediatr Res. 2007;61:265-266.
(ISAPA), spatial average–temporal peak (ISATP), spatial peak–
temporal average (ISPTA), spatial peak–pulse average (ISPPA),
and spatial peak–temporal peak (ISPTP). The most practical,
and commonly referred to, is the ISPTA.
The maximal permitted value varies by clinical applica-
tion. This had been determined in 1976 by the US Food and
Drug Administration (FDA),13 but was modified in 1986.14
The most recent definition dates from 1992.15 These values
are shown in Table 1-1. One can observe from the table that,
for fetal imaging, the ISPTA has been allowed to increase by a
factor of almost 16-fold from 1976 and almost 8-fold from
1986 to 1992, yet, all epidemiological information available
regarding fetal effects predates 1992. A remarkable fact is
that intensity for ophthalmic examination has not changed
from the original 17 mW/cm2, a value approximately 42.5
times lower than the present allowed value for fetal scanning.
This will be addressed in more detail further in the chapter.
Tissue Characteristics
When the ultrasound wave travels through a medium, its
intensity diminishes with distance.16 In completely homo-
geneous, idealized materials, the signal amplitude would be
reduced only because the wave is spreading. Biologic tissues,
however, are different and induce further weakening by
absorption and scattering (an effect called attenuation) and
by reflection. Many models have been described to help cal-
culate attenuation, particularly in obstetrical scanning,17 but
the most commonly used model uses an average attenuation
of 0.3 dB/cm/MHz.18 It is important to note that the attenu-
ation increases logarithmically with frequency and distance
traveled. Technically, many measurements of acoustic power
are performed in water, which has almost no attenuation.
To apply these calculations to tissues, values are multiplied
by this factor, an action called derating.19 Absorption is the
sound energy being converted to other forms of energy, and
scattering is the sound being reflected in directions other
than its original direction of propagation. Since attenua-
tion is proportional to the square of sound frequency, it
becomes evident why higher frequency transducers have less
penetration (but better resolution; see Figure 1-1). One needs,
therefore, to be closer to the organ of interest, such as through
Fleischer_CH01_p001-p024.indd 4
transesophageal or, in obstetrics and gynecology, transvaginal
scanning. Another possibility is increasing the power of the
instrument, resulting in improved resolution, as depicted by
the green arrow in Figure 1-1. This is seemingly simple, but
1992
instrument outputs are regulated in the United States (see
Values
The Output Display Standard section). Another important
720 parameter is acoustic impedance, which can be described
as the opposition to transmission or progression of the ultra-
720 sound wave. It is proportional to the velocity of sound in the
tissue (estimated at 1540 ms/sec) and to the tissue density.
720
17
Instrument Outputs
Although some publications of various instrument outputs
are available,20-22 these are generally quickly outdated, since
manufacturers introduce new commercial machines to the
market (or modify existing ones) at a rate too fast for imme-
diate objective evaluation. From a clinical standpoint, there is
no easy way to verify the actual output of the instrument in
use. In addition to the variety of instruments, each attached
transducer will generate a specific output, further compli-
cated by the different modes that may be applied.23 When
comparing modes, the ISPTA increases from B-mode (34 mW/
cm2, average) to M-mode to color Doppler to spectral Dop-
pler (1180 mW/cm2). Average values of the temporal aver-
aged intensity are 1 W/cm2 in Doppler mode but can reach 10
W/cm2.23 Therefore, caution should be exercised when apply-
ing Doppler mode, particularly in the first trimester. Color
Doppler, while having higher intensities than B-mode, is still
much lower than spectral Doppler. This is mainly due to the
mode of operation—sequences of pulses, scanned through
the region of interest (ROI or “box”). Most measurements are
obtained from manufacturers’ manuals, having been derived
in laboratory conditions. Real-life conditions may be differ-
ent.24 Furthermore, machine controls can alter the output. If
one keeps in mind that, for instance, the degree of tempera-
ture elevation is proportional to the product of the amplitude
of the sound wave by the pulse length and the PRF, it becomes
immediately evident why any change (augmentation) in these
properties can add to the risk of elevating the temperature, a
potential mechanism for bioeffects (see Thermal Effects). The
3 important parameters under end-user control are the scan-
ning (or operating) mode, including transducer choice; the
system setup and output control; and the dwell time.
1. Scanning mode: as mentioned previously, B-mode
carries the lowest risk, and spectral Doppler carries the
highest (with M-mode and color Doppler in between).
High pulse repetition frequencies are used in pulsed
Doppler techniques, generating greater temporal aver-
age intensities and powers than B- or M-mode, and
hence greater heating potential. An additional risk is
that since, in spectral Doppler, the beam needs to be
held in relatively constant position over the vessel of
interest, there may be a further increase in temporal
average intensity. Naturally, transducer choice is of
great consequence since it will determine frequency,
penetration, resolution, and field of view.
2. System setup: starting or default output power and,
particularly, mode (B-mode, Doppler, etc) control
changes. A subtler element is fine tuning performed
08/09/17 10:50 am
 Chapter 1 Ultrasound Bioeffects and Safety: What the Practitioner Should Know 5

by the examiner to optimize the image and influence

output but with no visible effect (except if one follows
thermal index [TI] and/or mechanical index [MI] dis-
plays). Controls that regularize output include focal
depth (usually with greatest power at deeper focus but
occasionally, on some machines, with highest power
in the near field); increasing frame rate; and limit-
ing the field of view, for instance, by high-resolution
magnification or certain zooms (Figure 1-2).
3. In Doppler mode, changing sample volume and/or
velocity range (all done to optimize received signals)
changes output. Video Clip 1 demonstrates change in
output (as observable by change in TI) when changing
the focal distance. A very important control in every
mode is receiver gain. It often has similar effects to
the above controls on the recorded image but none
on the output of the outgoing beam, and is therefore
completely safe to manipulate (Figure 1-3). In other A
words, the receiver gain should be maximized before
output is increased. In addition, over the years, output
of instruments has increased.22, 25

C
Figure 1-3. A: Image obtained with 100% power (blue arrow). Note
MI = 1.2 and TI + 0.1 (yellow arrow). B: Power has been reduced to 85%
B (blue arrow). Note MI = 0.7 and TI + 0.0 (yellow arrow). This image is less
diagnostic. C: Receiver gain has been increased. Power is unchanged from
Figure 1-2. Acoustic output changes (as reflected by changes in TI).
B (nor are MI and TI) but image is as diagnostic as A.
A: Nonzoomed image. Please note TI = 0.2. B: Zoomed image. Please
note TI = 1.0 (arrow).

Fleischer_CH01_p001-p024.indd 5 08/09/17 10:50 am

 6 Part 1 GENERAL OBSTETRIC SONOGRAPHY
4. Dwell time: is directly under the control of the exam-
iner. Interestingly, dwell time is not taken into account
in the calculation of the safety indices (thermal index,
TI and mechanical index, MI,) nor, in general, until
now, reported in clinical or experimental studies.
However, one needs to remember that it takes only
one pulse to induce cavitation, and about a minute
to raise temperature to its peak. Directly related with
dwell time is examiner experience: knowledge of
anatomy, bioeffects, instrument controls, and scanning
techniques. It can be safely assumed that the more
experienced the examiner, the less scanning time will
be needed to obtain the needed diagnostic images.
A standardized method of providing the end user
a parameter related to acoustic output and expressing
potential for bioeffects is clearly needed; hence, the gener-
ation of the Output Display Standard, based on the 2 most
likely interactions of ultrasound with tissues: thermal
and nonthermal or mechanical.26
THERMAL EFFECTS
Normal core human body temperature is generally accepted
to be 37°C (98.6°F) with a diurnal variation of ±0.5°C to 1.0°C,
although 36.8°C ± 0.4°C (95% confidence interval) may be
closer to the actual mean for large populations.27 During
the entire gestation, temperature of the human embryo/
fetus is higher than maternal core body temperature28 and
gradually rises until the final trimester (near term). The fetal
temperature generally exceeds that of the mother by 0.5°C.29
Thermally induced teratogenesis (production of congenital
malformations in an embryo or fetus) has been demon-
strated in many animal studies, as well as several controlled
human studies.30 While elevated maternal temperature in
early gestation has been associated with an increased inci-
dence of congenital anomalies,31 the majority of these studies
do not involve ultrasound-induced temperature elevation.
Edwards and others have demonstrated that hyperther-
mia is teratogenic for numerous animal species, including
humans,32 and suggested a 1.5°C temperature elevation
above the normal value as a universal threshold.33 Some
scientists believe that there are, indeed, temperature thresh-
olds for hyperthermia-induced birth defects, hence the As
Low As Reasonably Achievable (ALARA) principle. There
is, however, some evidence that any positive tempera-
ture differential for any period of time has some effect. In
other words, that there may be no thermal threshold for
hyperthermia-induced birth defects.34 From careful thermal
dose determinations, derived from published literature in
this area, it may be that hyperthermia-induced birth defects
are produced in accordance with an Arrhenius relation for
chemical rate effects, and thus have no threshold.35 Any tem-
perature increment for any period of time has some effect.
Likewise, the higher the temperature differential or the lon-
ger the temperature increment, the greater the likelihood of
producing an effect. Gestational age is a vital factor: milder
exposure during the preimplantation period can have similar
consequences to more severe exposures during embryonic
and fetal development and can result in prenatal death and
abortion or a wide range of structural and functional defects.
Fleischer_CH01_p001-p024.indd 6
The organ at greatest risk is the central nervous
system (CNS) due to a lack of compensatory growth of
damaged neuroblasts. In experimental animals the most
common defects are of the neural tube, microphthalmia,
cataract, and microencephaly, with associated functional
and behavioral problems.32 Defects of craniofacial develop-
ment including clefts,36 the axial and appendicular skeleton,37
the body wall, teeth, and heart38 are also commonly found.
Hyperthermia in utero (due to maternal influenza) has
been described as a risk factor for congenital anomalies39,40
and subsequent childhood psychological/behavioral distur-
bances41 and, more particularly, schizophrenia.42 Nearly all
these defects have been found in human epidemiological
studies following maternal fever or hyperthermia during
pregnancy. It should be emphasized that these investigations
have not involved ultrasound-induced hyperthermia effects.
Yet, there are data on the effects of hyperthermia and mea-
surements of in vivo temperature induced by pulsed ultra-
sound, but not in human beings.43-46 These data have been
widely reviewed.32,35,47-49 There is, however, a serious lack of
data that examine the effects of ultrasound while rigorously
excluding other confounding factors. Two widely accepted
facts are that ultrasound has the potential to elevate the
temperature of the tissues being scanned,50-53 and elevated
maternal temperature, whether from illness or exposure to
heat, can produce teratologic effects.31,32,35,54-56 The major
question is, therefore, whether DUS can induce a harmful
rise in temperature in the fetus.57-59 Some believe that this
temperature rise is, in fact, a major mechanism for ultrasound
bioeffects.30,35 Temperature elevation in the insonated tissue
can be calculated and estimated fairly accurately if the field is
sufficiently well characterized.60,61 For prolonged exposures,
temperature elevations of up to 5°C have been obtained.57
Temperature change in insonated tissues depends on the
balance between heat production and heat loss. A particular
tissue property that strongly influences the amount of heat
transported is local perfusion, which very clearly diminishes
the risk, if present. Similar experimental conditions caused
a 30% to 40% lower maximal temperature increase in live
versus dead sheep fetuses exposed in the near field,45 while
in guinea pig fetuses exposed at the focus the difference was
approximately 10%.46 These findings were estimated to be
secondary to vascular perfusion in live animals. A significant
cooling effect of vascular perfusion was observed only when
the guinea pig fetuses reached the stage of late gestation near
term, when the cerebral vessels were well developed. In the
midterm, there was no significant difference when guinea
pig fetal brains were exposed, alive (perfused) or postmortem
(nonperfused), in the focal region of the ultrasound beam.46
In early pregnancy, under 6 weeks gestation, there
appears to be minimal maternal-fetal circulation, that is,
minimal fetal perfusion, which may potentially reduce heat
dispersion.62 The lack of perfusion is one reason why the
spatial peak-temporal average intensity (ISPTA) for ophthal-
mic applications has been kept very low, in fact much lower
than peripheral, vascular, cardiovascular, and even obstetric
scanning, despite the general increase in acoustic power
that was allowed after 1992 (see Table 1-1). There are some
similarities in physical characteristics between the early,
first-trimester embryo and the eye. Neither is perfused; they
can be of similar size; and protein is present (in an increasing
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 Chapter 1 Ultrasound Bioeffects and Safety: What the Practitioner Should Know
Figure 1-4. First trimester (11 weeks) measurement of the crown-
rump length: the entire fetus is within the ultrasound beam (“whole body
scanning”).
proportion in the fetus). As mentioned previously, one must
then wonder why, from the time intensities were checked
and recommended in clinical practice, ISPTA was from the
beginning and has continued to be maintained at 17 mW/
cm2, while for fetal imaging it was allowed to reach 720
mW/cm2, up from 46 mW/cm2. At about weeks 4 to 5, the
gestational sac is about the size of the eye (2.5 cm in diam-
eter), and by week 8 it is around 8 cm in diameter. This may
allow whole-body fetal scanning (and possibly temperature
increase), a concept that is generally ignored in the literature
dealing with thermal effects of ultrasound (Figure 1-4).
The issue of transducer heating, which may be par-
ticularly relevant in the first trimester, specifically if per-
forming endovaginal scanning, is also often ignored.63,64
There are additional concerns in early gestation because
of minimal or lack of perfusion. Only at about weeks
10 to 11 does the embryonic circulation actually linkup
with the maternal circulation.65 There may thus be some
underestimation of the actual DUS-induced temperature
in early gestation, mainly because of the absence of perfu-
sion. The perfusion issue is in addition to modifications
of tissue temperature due to ambient maternal and fetal
temperatures. Furthermore, motions (even very small)
of the examiner’s hand as well as the patient’s breathing
and body movements (in the case of obstetric ultrasound,
both the mother and the fetus) tend to spread through
the region being heated. However, for spectral (pulsed)
Doppler studies, it is necessary to have the transducer as
steady as possible. This is because, in general, blood ves-
sels are small in comparison to the general organ or body
size being scanned with B-mode imaging, and hand move-
ments while performing Doppler studies will have more
undesired effects on the resulting image. As described
earlier, the intensity (ISPTA) and acoustic power associated
with Doppler ultrasound are the highest of all the general-
use categories. Ziskin66 reported that among 15,973 Dop-
pler ultrasound examinations, the average duration was 27
minutes (and the longest 4 hours!).
There is a mathematical/physical relation between tem-
perature elevation and several beam characteristics. The
Fleischer_CH01_p001-p024.indd 7
7
elevation is proportional to the product of the wave ampli-
tude, length of the pulse, and PRF. Hence, manipulating any
of these via instrument controls will alter the in situ condi-
tions. It is clear that temperature increases of 1°C are easily
reached in routine scanning.67 Elevation of up to 1.5°C were
obtained in the first trimester and up to 4°C in the second
and third trimesters, particularly with the use of pulsed Dop-
pler.68 There is a large body of literature on heat shock pro-
teins (HSPs), the production of which is triggered by a core
temperature increase and the function of which is to protect
against hazardous effects of elevated temperature as well as
to induce some thermotolerance, ie, the ability to withstand
higher elevations than in the past, with no harmful results.69
While their production is activated by whole-body tempera-
ture elevation, and may be speculated in ultrasound-induced
thermal effects, it has not been shown to actually occur dur-
ing experimental (or clinical) insonation.
MECHANICAL EFFECTS
Ultrasound bioeffects also occur through mechanical mech-
anisms.70,71 These are interactions between the ultrasound
wave and the tissue that do not cause a significant degree
of temperature increase (less than 1°C above physiologic
temperature). These include acoustic cavitation as well as
radiation torque and force, and acoustic streaming second-
ary to propagation of the ultrasound waves. While included
in this category, some effects are, in fact, the result of the
mechanical interaction but are actually physical (shock
wave) or chemical (release of free radicals) effects. Table 1-29
summarizes nonthermal effects described in the literature
in laboratory or animal experiments—and not in humans—
which may be pertinent to fetal ultrasound.
Investigations with laboratory animals clearly indicate
that nonthermal interactions of ultrasound fields with tis-
sues can produce biological effects in vivo.71 It is interesting
 MAJOR NONTHERMAL EFFECTS
OF ULTRASOUND OBSERVED
IN THE LABORATORY AND
Table 1-2
IN ANIMALS AND WITH THE
POTENTIAL TO AFFECT THE
FETUS
Free-radical generation
Increase in cell membrane permeability
Erythrocyte agglutination
Growth restriction (transient decrease)
DNA single-strand break
Increased sister chromatid exchange
Increased mutation frequency
Capillary petechiae
Vasoconstriction
Lung microvascular hemorrhage
Intestine microvascular hemorrhage
Neuronal migration delay
Auditory tract stimulation
Tactile radiation pressure perception effect
Cardiac, premature contractions
Modified with permission from Stratmeyer ME, Greenleaf JF, Dalecki D, et al.
Fetal ultrasound: mechanical effects. J Ultrasound Med. 2008 Apr;27(4):597-605.
08/09/17 10:50 am
 8 Part 1 GENERAL OBSTETRIC SONOGRAPHY
to note that chemical effects of ultrasound were described
more than 80 years ago!72 Cavitation seems to be the major
factor in mechanical effects73 as it has been demonstrated to
occur in living tissues under ultrasound insonation.74,75 Two
types of cavitation can be described—stable and inertial
(previously defined as transient)—both of which need the
presence of gas bubbles to occur. Stable cavitation indi-
cates vibrations or small backward and forward move-
ments with possible resulting microstreaming. Inertial
cavitation indicates expansion and reduction in volume,
secondary to alternating positive and negative pressures
generated by the ultrasound wave. Expansion in growth is
less with each cycle until collapse occurs with production
of very high pressure (hundreds of atmospheres) and very
elevated temperature (thousands of degrees), but on such a
small area (less than 100 nm) and for such a brief time (few
tens of nanoseconds) that it will not be felt and is very hard
to measure (adiabatic reaction—occurring without the gain
or loss of heat) but can produce microstreaming—a phe-
nomenon that has been described also with no clear involve-
ment of bubbles,76-78 or even release of free radicals.79,80
Acoustic streaming is easily demonstrated by watch-
ing ultrasound-induced movements of solid-matter-
containing fluids in insonated cavities (see Video 1).
Radiation torque refers to the induction, in objects
found in the acoustic field, of rotation or of the tendency
to rotate. Biological effects of ultrasound in animals such as
local intestinal,81 renal,82 and pulmonary83 hemorrhages have
been attributed to mechanical effects, although cavitation
could not always be implicated. Furthermore, since gas bub-
bles do not seem to be present in fetal lungs or bowels (where
effects have been described in neonates or adult animals), the
risk from mechanical effect secondary to cavitation appears
to be minimal.84 There are several other effects that do not
appear to involve cavitation such as tactile sensation of the
ultrasound wave, auditory response, cell aggregation, and cell
membrane alteration. Hemolysis has also been reported.85 It
seems, however, that the presence of some cavitation nuclei
is necessary for hemolysis to occur. At present, there is no
clear clinical indication for the use of ultrasound contrast
agents (a source of cavitation nuclei, when injected into the
body before ultrasound examination) in fetal ultrasound, and
to date, no studies have specifically investigated the interac-
tion of ultrasound and microbubble contrast agents in fetal
tissues in vivo. Nevertheless, it should be noted that in the
presence of such contrast agents, fetal red blood cells are
more susceptible to lysis from ultrasound exposure in vitro.86
Additionally, fetal stimulation caused by pulsed ultra-
sound insonation has been described, with no appar-
ent relation to cavitation.87 This effect may be secondary
to radiation forces associated with ultrasound exposures.
These forces were suspected at the earliest stages of ultra-
sound research88 and are known to possibly stimulate audi-
tory,89 sensory,90 and cardiac tissues.91 No harmful effects
of DUS, secondary to nonthermal mechanisms, have been
reported in human fetuses. A very intriguing nonthermal
effect of ultrasound is acceleration of bone fractures heal-
ing in animals and humans.92 Because of these known
effects of ultrasound in living tissues and the fact that pres-
sures involved with Doppler propagation are much higher
than B-mode, caution is further recommended, based on
Fleischer_CH01_p001-p024.indd 8
scientific evidence of potential effect, particularly in the first
trimester.93
THE OUTPUT DISPLAY STANDARD
In 1992, the FDA yielded to pressure from ultrasound
clinical users as well as manufacturers to increase the power
output of instruments. The rationale for this request was
that higher outputs would generate better images, and thus
improve diagnostic accuracy. To allow clinical users of
ultrasound to use their instruments at higher powers than
originally intended and to reflect the two major potential
biological consequences of ultrasound (mechanical and
thermal, see above), the American Institute of Ultrasound
in Medicine (AIUM), the National Electrical Manufacturers’
Association (NEMA), and the FDA (with representatives
from the Canadian Health Protection Branch, the National
Council on Radiation Protection and Measurements,94 and
14 other medical organizations30) developed a standard
related to the potential for ultrasound bioeffects. The full
name was the Standard for Real-Time Display of Thermal
and Mechanical Indices on Diagnostic Ultrasound Equip-
ment, generally known as the Output Display Standard
or ODS.15 The importance of this document and what it
describes is that it represents historically the first attempt
at providing the end user with quantitative safety-related
information. One important result is that the end users are
able to see how manipulation of the instrument controls
during an examination causes alterations in the output and,
thus, on the exposure. As a consequence, for fetal imaging
the output, as expressed by the ISPTA, went from a previous
value of 92 to 720 mW/cm2 (see Table 1-1).
To allow the output to reach such levels, the manufac-
turers were requested to display, on screen and in real-time,
two types of indices with the intent of making the user aware
of the potential for bioeffects, as described earlier. These
indices are the thermal index (TI), to provide some indica-
tion of potential temperature increase, and the mechanical
index (MI), to provide indication of potential for nonther-
mal (ie, mechanical) effects15,30,95 (Figure 1-5). The TI is the
ratio of total acoustic power to the acoustic power estimated
Figure 1-5. Onscreen TI (= 0.3, red arrow) and MI (= 1, yellow arrow).
08/09/17 10:50 am
 Chapter 1 Ultrasound Bioeffects and Safety: What the Practitioner Should Know
to be required to increase tissue temperature by a maximum
of 1°C. It is an estimate of the maximal temperature rise at
a given exposure. There are 3 variants: for soft tissue (TIS),
to be used mostly in early pregnancy when ossification is
low; for bones (TIB), to be used when the ultrasound beam
impinges on bone at or near the beam focus, such as late
second and third trimesters of pregnancy; and for transcra-
nial studies (TIC) when the transducer is essentially against
bone, mostly for examinations in adult patients, but also
in neonatal scanning, which is an area that is, generally,
ignored. These indices were required to be displayed if equal
to or over 0.4. It needs to be made very clear that TI does
not represent an actual or an assumed temperature increase.
It bears some correlation with temperature rise in degrees
Celsius but in no way allows an estimate or a guess as to
what that temperature change actually is in the tissue.95
The MI represents the potential for nonthermal damage in
tissues but is not based on actual in-situ measurements. It is
a theoretical formulation of the ratio of the pressure to the
square root of the ultrasound frequency (hence, the higher
the frequency, the lesser risk of mechanical effect).
Both the TI and MI can and should be followed as an
indication of change in output during the clinical examina-
tion with higher values indicating the potential for higher
thermal and nonthermal effects than lower values. A clear
mandate in the ODS original document was education
of the end user as a major part in the implementation of
the indices. Attempts have been made to educate the end
users,96 but, unfortunately, this aspect of the ODS does not
seem to have succeeded as end users’ knowledge of bioef-
fects, safety, and output indices is found lacking.97,98
In a questionnaire that was distributed to ultra-
sound end users (82% were obstetricians) attending review
courses and hospital grand rounds, only 17.7% gave the
correct answer of the definition of the TI, and only 3.8%
described MI properly. Almost 80% of end users did not
know where to find the acoustic indices when various
responses included the machine documentation, a text-
book, a complicated calculation or in real time on the
ultrasound monitor (the correct answer).97 Similar results
were recorded in surveys abroad, performed in Europe,
Asia, or the Middle East98,99,100,101 indicating that clini-
cal end users worldwide show poor knowledge regarding
safety issues of ultrasound during pregnancy.102,103 More
recently, knowledge of residents in obstetrics and gyne-
cology was also found to be grossly lacking 104 and, fur-
thermore, similar results were obtained when surveying
sonographers, with no difference in years of experience.105
Compliance with the ALARA (as low as reasonably
achievable) principle by practitioners seeking credential-
ing for nuchal translucency (NT) measurement between
11 and 14 weeks’ gestation was evaluated. Only 5% of the
providers used the correct TI type (TIb) at lower than 0.5
for all submitted images, 6% at lower than 0.7, and 12% at
1.0 or lower. A TI (TIb or TIs) higher than 1.0 was used
by 19.5% of the providers. Proficiency in NT measurement
and educational background (physician or sonographer)
did not influence compliance with ALARA. The authors
concluded that clinicians seeking credentialing in NT do
not demonstrate compliance with the recommended use
of the TIb in monitoring acoustic output.106
Fleischer_CH01_p001-p024.indd 9
9
Furthermore, several assumptions were made, which
prompts some questions on the clinical value of these
indices. Maybe the most significant (from a clinical aspect)
is the choice of the homogeneous attenuation path model
(defined as the H3 model), with an attenuation coefficient
of 0.3 dB/cm/MHz, as detailed previously in Tissue Char-
acteristics. The reason to employ models of that nature is
the impossibility, for obvious reasons, to perform certain
measurements in pregnant women. This coefficient may
be an overestimation of the attenuation in many clinical
scenarios, a situation that would underestimate the actual
exposure. In National Council on Radiation Protection
and Measurements (NCRP) report number 140,30 there is
an entire chapter (Chapter 9) indicating conditions where
both indices may be inaccurate, eg, long fluid path (full
bladder, amniotic fluid, ascites, or hydrocephalus) or path
through increased amounts of soft tissue such as obese
patients. Because of these uncertainties, the accuracy of
the TI and MI may be within a factor of 2 or even 6.107 For
example, an on-screen TI of 1 may correspond to an actual
value of 0.5°C or 2°C if the error factor is 2, but possibly
0.33°C or 6°C, if the error factor is 6 (as previously stated,
these are not actual temperature indications). A further
disturbing and confusing element is that outputs reported
by manufacturers are not necessarily equivalent to those
calculated in the laboratory.108
Risk Assessment
Risk means the chance or the possibility of loss or bad
consequence. It refers to the possibility, with a certain
degree of probability, of damage to health, environment,
and objects, in combination with the nature and magni-
tude of the damage.109 These are the 3 important charac-
teristics of risk: probability of occurrence, and nature and
magnitude of harm. It has been, specifically, applied to the
use of medical instruments.110 A complicating factor that
makes definition and classification difficult is that the con-
cept of risk means various things to different people. Age,
background, education, morals, religion, and many other
traits will direct this evaluation and not only the absolute
possible result of the activity, putting the participant at
risk. For instance, in bungee jumping, rupture of the elas-
tic cord and subsequent death may be, indisputably, the
worst possible outcome, but different people evaluate this
and make decisions that are not necessarily based on this
absolute result. Furthermore, the reason to take a possible
risk has to be taken in consideration.
Two approaches are possible in risk evaluation: how
much harm is acceptable to obtain the desired results
(risk-benefit ratio) or how much harm can be avoided by
withholding the action or modifying it (the precautionary
principle). The risk-benefit principle is what is almost
universally used in medicine to justify a medical diag-
nostic procedure (such as ultrasound) or a therapeutic
intervention. If the benefit to be obtained from the proce-
dure in terms of diagnosis (ultrasound) or intervention (a
newly discovered and not yet commercialized cancer or
AIDS drug, for instance) is deemed to be sufficient, then,
even if this diagnostic or interventional procedure car-
ries some risks (recognized or presumed to be possible),
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 10 Part 1 GENERAL OBSTETRIC SONOGRAPHY
the benefit overrides these risks, assuming the subject
understands those risks and is willing to take them. The
precautionary principle (PP) is a diametrically opposed
ethical, political, and economic approach stating that if
a certain action may cause severe damage to the public,
in the absence of a scientific consensus that harm would
not ensue, the burden of proof falls on those who would
advocate taking that action.111 This principle is much
less familiar to the medical field, although “first do no
harm” is its direct application, but it may be extremely
relevant when considering safety and risks of a proce-
dure, such as prenatal ultrasound. The concept origi-
nated in the 19th century when John Snow, a London,
UK, physician, determined that cholera was due to the
extensive, common use of an unclean water supply and
recommended closing of this source of water, although it
was the sole one in a large vicinity.112 This may have been
the first epidemiological analysis of a disease. Although
the beginning of the PP was medical, it became a social
idea in Germany in the 1930s as Vorsorge, “forecaring.”
This later became the Vorsorgeprinzip, the forecaring or
precautionary principle, in West German environmental
law in the 1970s.113 The idea was adopted by decision and
policy makers but, remarkably, much more extensively
in Europe than in the United States. Some key concepts
in the original formulation were environmental harm to
a population and responsibility: “When an activity raises
threats of harm to human health or the environment,
precautionary measures should be taken even if some
cause and effect relationships are not fully established
scientifically. In this context the proponent of an activity,
rather than the public, should bear the burden of proof”
(the Wingspread Statement on the Precautionary Prin-
ciple114). From environmental research it spread to toxi-
cology and was first applied only recently in the United
States to a clinical medical field.115 However, several med-
ical mishaps clearly belong to the history of the develop-
ment of the PP—from the diethylstilbestrol debacle116
to the thalidomide tragedy.117 While referring mostly to
environmental issues, such as global warming, the PP can
certainly be extended to other medical activities (such
as diagnostic ultrasound) and be applied to individuals
(such as fetuses). The simple enunciation of the prin-
ciple, particularly in reference to diagnostic ultrasound
in general, and entertainment ultrasound in particular, is
that even if a particular action or procedure has not been
proven to be harmful, it is better to avoid it so as not to
take the risk until safety is established through clear, sci-
entific evidence, popularly expressed as “better safe than
sorry.”118 This is also the basis of the Hippocratic Oath,
which includes the recommendation to first do no harm.
A major difference with the risk-benefit principle is that
proponents of the PP believe that public action is neces-
sary if there is any evidence of likely or substantial harm,
however limited but plausible, and the burden of proof
is shifted from showing the presence of risk to demon-
strating its absence.119 As such, epidemiologic research
on chronic diseases and the use of surrogates for human
studies (eg, animal research or tissue cultures) have been
shown to be uncertain.120 There are several variations of
the PP, but all have some common key elements:
Fleischer_CH01_p001-p024.indd 10
1. There must be scientific uncertainty about nature of
harm, probability, magnitude, and causality (fulfilled
by DUS).
2. Mere speculation is not enough to invoke the PP.
Scientific analysis must have triggered the process
(also fulfilled by DUS).
3. Per definition, the PP deals with procedures with
probability of unclear outcome, in that it is differ-
ent from prevention or from risk-benefit assessment
where some clear knowledge or precise suspicion
exists, and where decision may be made to go ahead
despite this risk by, for instance, taking additional
measures to attempt and limit the danger. Clearly,
the ALARA principle is the exact application of this
element121,122 (fulfilled by DUS).
4. In general, the PP applies to unacceptable (“serious,”
“irreversible,” “global”) high levels of risk to large
populations, present or future, local or distant123
(may not be the case for DUS).
5. One needs to intervene (not observe or procrasti-
nate) before damage has been demonstrated (eg, “do
not perform DUS”).
6. The intervention must be proportional to the pos-
sible risk: indicating DUS may be acceptable but not
nonclinical use of DUS. A level of “zero risk” is prob-
ably never attainable.
Those who support the PP make the following very
strong argument for precaution: serious damage may be
caused if one uses a risk-based approach. A well-known
example is what constitutes toxic levels of lead in paint.
As early as 1897, it was known that lead may be toxic, but
at first the upper limit of safety for children was assumed
to be 60 μg/dL of blood, and this had terrible results. The
“safe” level was reduced over the years to 40, then 20, then
10, which it is today, although some scientists feel that
even 2 μ/dL may pose some risk.124 The basic conclusion of
risk analysis with the PP is that measures against a possible
risk should be taken (such as exposure avoidance) even if
the available evidence is weak (or maybe absent) regard-
ing the existence of that risk as a scientifically established
fact.125 In many European countries this “stop first then
study” approach (a clear application of the PP) has been
adopted (particularly for chemicals). The exact opposite
is often true in the United States where something, once
introduced, has to be proven harmful by science before
being removed or forbidden. A major goal of the PP is to
help delineate (preferably quantitatively) the possibility
that some exposure is hazardous, even in cases where this
is not established beyond reasonable doubt.126 The classi-
cal statistical approach to hypothesis testing is unhelpful
because lack of significance can be due to either uninfor-
mative data or genuine lack of effect (type II error).127
There are many critics of the PP because of the risk
of exaggeration in caution and slowing down of scientific
progress.128,129 A major issue is that the PP relies very heav-
ily on a single conjecture: prevention is better than cure.
There is no scientific evidence for this. Furthermore, it
may be true that, often, it is better to be “safe than sorry”
and the primum non nocere (first do no harm) principle is
a direct application of this, but preventative measures can
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 Chapter 1 Ultrasound Bioeffects and Safety: What the Practitioner Should Know
be long lasting and possibly incapacitating, whereas cures
can be targeted and effective.128 What is more, no moral
opinion is formed of people when treating them, but if the
main focus is upon precaution, then it can be deemed mor-
ally wrong not to take preventative measures. The whole
precaution approach is imbued with what may appear to
many as an excessively moralistic tone and a “I am the
expert and therefore know what is best for you” attitude.130
Furthermore, the probability of a problem occurring that
one tries to avoid has to be high (which does not apply, as
far as we know, to ultrasound) and preventative measures
have to be effective. Hence this approach may be adopted
with some restrictions and this is, in fact, exactly what
ALARA recommends.122 Most scientists and professional
organizations have recommended such a practice in clini-
cal obstetrical ultrasound.131-133
HISTORICAL RESEARCH
The first descriptions of ultrasound as an imaging mode
date from the 19th century.134 The French engineer Paul
Langevin designed an ultrasound machine using Pierre
Curie’s principle of the piezoelectric effect. During World
War I, he attempted to use this instrument to detect sub-
marines through echo location (hence the later coined
term SONAR: Sound Navigation And Ranging). He also
demonstrated that the waves produced by his machine
could kill small animals in an insonated water bath, and
could cause pain to his assistants when they were required
to plunge their hands in the water bath in the path of the
beam. Other bioeffects observed included the searing of
skin when touching a resonant quartz bar, and explosive
atomization (!) of fluid drops from the end of the rod. Since
that time, the question of effects and safety has been on
the minds of researchers88 and has given rise to literature
too extensive to review in detail.2,3,6,49,131,135-147 Initially, cell
suspensions and cell and tissue cultures were employed,
and many reports described clear effects of the ultrasound
waves on these, mostly secondary to cavitational and
other nonthermal mechanisms, such as cell aggregation,148
membrane damage,149 and cell lysis.150 Plants were another
extensively studied organism for effects of ultrasound,151
particularly the Elodea leaf, since internal gas channels
are present.152 Insects have been exposed to ultrasound
with significant effects, such as death of eggs and larvae as
well as abnormal development, presumably secondary to
the presence of gas-filled channels.153 Additionally, altera-
tions at the chromosomal and even DNA levels have been
described.154 These effects have been reviewed extensively
elsewhere,5,30 and while they are of major scientific and
historical importance, they are not of major relevance to
clinical exposure of human fetuses.
Animal Research
Effects of ultrasound were demonstrated in animals more
than 80 years ago.88 Since then, multiple studies have
been performed with ultrasound on a wide variety of
species. Studies of gross effects on the brain and liver of
cats were first performed with well-defined lesions and
demyelination in the brain155 and tissue damage in the
Fleischer_CH01_p001-p024.indd 11
11
liver,156 resulting from ultrasound exposure of a few sec-
onds at 1 and 3 MHz, respectively. Other observed effects
include limb paralysis as a result of spinal cord injury in the
rat,157,158 as well as lesions in the liver, kidney, and testicles
of rabbits.159 While some effects are likely due to mechani-
cal influences, very high temperature elevations (much
higher than anything reachable with diagnostic ultra-
sound) have also been observed and may be more directly
involved with the tissue damage. Effects in muscles have
been obtained, but with outputs much higher than those
usually generated in clinical studies,160 and so have intes-
tinal81 and lung161 hemorrhages, also at acoustic pressures
well above those generated by ultrasound fields. These are
helpful in understanding the mechanisms involved with
possible bioeffects of DUS. It should also be noted that
some similar effects have also been demonstrated with
acoustic fields much closer to clinically pertinent ones, in
particular lung and intestinal hemorrhage.81 Several major
clinical end points for bioeffects that could have direct
relevance to human studies include fetal growth and birth
weight, effects on brain and CNS function, and change in
hematological function, and these will be considered in
more detail. Decreased birth weight after prenatal expo-
sure to ultrasound has been reported in the monkey162,163
and the mouse,164,165 but not convincingly in the rat.166
Therefore, clear species differences seem to exist,167 mak-
ing it difficult to generalize, and even more difficult to
extrapolate, to humans.
Tarantal and Hendrickx162 evaluated 30 pregnancies
in monkeys, half of which were exposed to ultrasound.
The scanned fetuses had lower birth weights and were
shorter than the control group. No significant differences
were noted between the groups with regard to the rate of
abortions, major malformations, or stillbirths. Moreover,
all showed catch-up growth when examined at 3 months
of age.162 It should be noted that in-situ intensities were
higher than what is considered routine in clinical obstet-
rical imaging in humans. Hande and Devi168 evaluated
the effect of prenatal exposure to diagnostic ultrasound
on the development of mice. Swiss albino mice were
exposed to diagnostic ultrasound for 10 minutes on day
3.5 (preimplantation period), 6.5 (early organogenesis
period), or 11.5 (late organogenesis period) of gestation.
Sham-exposed controls were maintained for comparison.
Fetuses were dissected out on the 18th day of gestation,
and changes in total mortality, body weight, body length,
head length, brain weight, sex ratio, and microphthalmia
were recorded. Exposure on day 3.5 of gestation resulted
in a small increase in the resorption rate and a significant
reduction in fetal body weight. Low fetal weight and an
increase in the incidence of intrauterine growth-restriction
were produced by exposure on day 6.5 postcoitus.168
Others have also demonstrated restricted growth
in newborns after in utero exposure to DUS.169 Subtler
findings have also been described. Pregnant Swiss albino
mice were exposed to diagnostic ultrasound (3.5 MHz, 65
mW, ISPTP = 1 W/cm2, ISATA = 240 W/cm2) for 10, 20, or
30 minutes on day 14.5 (fetal period) of gestation.170 Sham-
exposed controls were studied for comparison. There were
significant alterations in behavior in the exposed groups as
revealed by decreased locomotor and exploratory activity,
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 12 Part 1 GENERAL OBSTETRIC SONOGRAPHY
and an increase in the number of trials needed for learn-
ing. No changes were observed in physiological reflexes
and postnatal survival. The authors concluded that ultra-
sound exposure during the early fetal period can impair
brain function in the adult mouse.170 Likewise, Hande
et al171 found that anxiolytic activity and latency in learn-
ing were more noticeable in ultrasound-treated animals.
The authors exposed pregnant Swiss mice to diagnostic
levels of ultrasound (3.5 MHz, maximum acoustic out-
put: ISPTP = 1 W/cm2 and ISATA = 240 mW/cm2, acoustic
power = 65 mW) for 10 minutes on postcoital day 11.5
or 14.5. At 3 and 6 months postpartum, offspring were
subjected to behavioral tests. The effect was more pro-
nounced in the 14.5 days postcoital group than in the
11.5 days group. They concluded that exposure to diag-
nostic ultrasound during late organogenesis period or
early fetal period in mice may cause changes in postna-
tal behavior.171 Temperature elevations were induced by
ultrasound in guinea pig fetal brains.46 In fact, mean tem-
perature increases of 4.9°C close to parietal bone and 1.2°C
in the midbrain were recorded after 2-minute exposures,
albeit at exposure conditions higher than what is usually
employed in clinical examinations.46 This greatest temper-
ature rise recorded close to the skull correlated with both
gestational age and progression in bone development.43
The skull bone becomes progressively thicker and denser
between 30 and 60 days’ gestational age (normal gesta-
tion for guinea pigs is 66 to 68 days). After only 2 minutes
of insonation with an ISPTA of 2.9 W/cm2 (about 4 times
higher than currently permitted by the FDA for diagnostic
use), mean maximum temperature increases varied from
1.2°C at 30 days to 5.2°C at 60 days. It is important to note
that most of the heating (80% of the mean maximum tem-
perature increase) occurred within 40 seconds. The rate of
heating is relevant to the safety of clinical examinations in
which the dwell time may be an important factor. Because
maximal ultrasound-induced temperature increase occurs
in the fetal brain near bone, worst-case heating will occur
later in pregnancy, when the ultrasound beam impinges on
bone, and less will occur earlier in pregnancy, when bone is
less mineralized. However, milder insults early in gestation
may be as significant (or more) than more severe ones in
later stages.
Neurons of the cerebral neocortex in mammals, includ-
ing humans, are generated during fetal life in the brain pro-
liferative zones and then migrate to their final destinations
by following an inside-to-outside sequence. Ang et al172
evaluated the effect of ultrasound waves on neuronal
positioning within the embryonic cerebral cortex in mice.
Neurons generated at embryonic day 16 and destined
for the superficial cortical layers were chemically labeled
in over 335 animals. A small, but statistically significant,
number of neurons failed to acquire their proper position
and remained scattered within inappropriate cortical lay-
ers and/or in the subjacent white matter when exposed to
ultrasound for a total of 30 minutes or longer during the
period of their migration. The magnitude of dispersion of
labeled neurons was variable but systematically increased
with duration of exposure to ultrasound (although not
linearly, with some extended exposure yielding less effect
than lower ones). These investigators concluded that
Fleischer_CH01_p001-p024.indd 12
further research in larger and slower-developing brains of
nonhuman primates and continued scrutiny of unneces-
sarily long prenatal ultrasound exposure is warranted. It
is unclear whether a relatively small misplacement in a
relatively small number of cells that retain their origin cell
class is of any clinical significance. It is also important to
note that there are several major differences between the
experimental setup of Ang et al172 and the clinical use of
ultrasound in humans.6 The most noticeable difference
was the length of exposure of up to 7 hours in the setup of
Ang et al. No real mechanistic explanation was given for
the findings, and furthermore, there was no real dose effect
with high effects at the penultimate high dose, but less so
at the highest dose. Moreover, scans were performed over
a small period of several days. The experimental setup was
such that embryos received whole-brain exposure to the
beam, which is rare in humans, although quite possible in
the earliest stages of gestation. In addition, brains of mice
are much smaller than those in humans, and develop over
days. This should not completely deter from the study,
but encourages caution. It should be noted that some have
described a complete lack of effects of prenatal ultrasound
exposure on postnatal development and growth173 or
behavior.174 The influence of prenatal ultrasound exposure
on the blood–brain barrier (BBB) integrity as measured by
the permeation of Evans blue (EB) through the BBB during
the postnatal development of 139 rats was evaluated by
Yang et al.175 Diagnostic levels of ultrasound (2.89 MHz,
mechanical index = 1.1, acoustic output power = 70.5 mW)
for 1 and 2 hours per day, for 9 consecutive days were used
on Sprague-Dawley rats. Offspring were assessed postna-
tally on days 10, 17, 24, and 38. A statistically significant
amount of EB extravasation into the cerebrum and cer-
ebellum could be detected on postnatal day 10 (but not
later), following exposure to diagnostic levels of ultrasound
during embryonic development. The authors concluded
there is a need for further investigation of the effects of
ultrasound exposure during the potentially vulnerable
period of intense BBB development in the human fetus.
This study did not provide clear evidence that there is
cause for concern for clinical prenatal diagnostic imaging
in humans. The study had several methodological flaws,
and specifically, the acoustic exposure was intense and
untranslatable to clinical practice.176
In another study177 chick brains were exposed, in ovo,
on day 19 of a 21-day incubation period to B-mode (5 or
10 minutes), or to pulsed Doppler (1, 2, 3, 4, or 5 minutes)
ultrasound. After hatching, learning and memory function
were assessed at day 2 post hatch. B-mode exposure did
not affect memory function. However, significant memory
impairment occurred following 4 and 5 minutes of pulsed
Doppler exposure. Short-, intermediate-, and long-term
memory was equally impaired, suggesting an inability
to learn. Chicks were also unable to learn with a second
training session. In this study, exposure to pulsed Doppler
ultrasound adversely affected cognitive function in chicks.
Although some methodological issues exist and extrapo-
lation to humans is unwarranted, these findings justify
further investigations.
The hematological system is the second major system
to be investigated for ultrasound effects. The following have
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 Chapter 1 Ultrasound Bioeffects and Safety: What the Practitioner Should Know
been assessed: hemolysis, coagulation factors and platelets,
and leukocyte production and function.178 Increased hemo-
lysis has been demonstrated for ultrasound in (human)
fetal cells as compared to adult cells, but only in the pres-
ence of ultrasound contrast agents, with human cells being
less fragile than certain tested animals.86,179 Other altera-
tions have been described in the hemolytic system180 but
appear to be of minimal, if any, clinical significance.
Human Research and Epidemiology
In 2005, the American Institute of Ultrasound in Medicine
(AIUM) published the following statement: “Based on the
epidemiological data available and on current knowledge
of interactive mechanisms, there is insufficient justification
to warrant a conclusion of a causal relationship between
diagnostic ultrasound and recognized adverse effects in
humans. Some studies have reported effects of exposure to
diagnostic ultrasound during pregnancy, such as low birth
weight, delayed speech, dyslexia, and non–right-handed-
ness. Other studies have not demonstrated such effects.
The epidemiological evidence is based on exposure condi-
tions prior to 1992, the year in which acoustic limits of
ultrasound machines were substantially increased for fetal/
obstetrical applications.”181 Applied to ultrasound, epide-
miology is the study of effects on human populations as a
result of ultrasound scanning and, in the case of obstetri-
cal ultrasound, this should include the pregnant patient as
well as her infant. Laboratory animal experiments under
similar diagnostic exposure levels have shown some effects
from ultrasound, under certain conditions. Effects have
also been reported in humans, but a definitive statement
regarding risk should, ideally, include direct analysis of
the effects in human populations. Several epidemiologi-
cal studies have been published.4,49,182 For an extensive
discussion, including elements of statistics, see Chapter
12 in NCRP report number 140,30 an extensive review by
Newnham,143 and AIUM document, Conclusions Regard-
ing Epidemiology for Obstetric Ultrasound.183,184. Relevant
details will be summarized.
Several biological end points have been analyzed in the
human fetus/neonate in an attempt to determine whether
prenatal exposure to diagnostic ultrasound had observ-
able effects: intrauterine growth restriction (IUGR) and
low birth weight, delayed speech, dyslexia, neurological
and mental development or behavioral issues, and, more
recently, non–right-handedness. Occasional studies report
an association between diagnostic ultrasound and some
specific abnormalities such as lower birth weight,182 delayed
speech,185 dyslexia,186 and non–right-handedness.187,188
With the exception of low birth weight (also demonstrated
in monkeys,179) these findings have never been duplicated,
and the majority of studies have been negative for any asso-
ciation. Moore et al189 examined a large number of infants
(over 2000, half of them exposed to ultrasound) and found a
small but statistically significant lower mean birth weight of
exposed versus nonexposed infants. However, information
was collected several years after exposure, no indications for
the examination are known, and no exposure information is
available. This lack of detail about the exposure parameters
is, very often, the major problem in analyzing these reports.
Fleischer_CH01_p001-p024.indd 13
13
In a later study, the authors concluded that the relation-
ship of ultrasound exposure and reduced birth weight may
be due to shared common risk factors, which lead to both
exposure and a reduction in birth weight.190 Another ret-
rospective study, with Moore as a coauthor, reported a 2.0
greater risk of low birth weight after 4 or more exposures to
diagnostic ultrasound.144 These results were not reproduced
in other retrospective studies.189 In a large study (originally
10,000 pregnancies exposed to ultrasound matched with
500 controls) with a 6-year follow-up, Lyons et al191 did not
find differences in birth weight (nor increased congenital
malformations, chromosomal abnormalities, infant neo-
plasms, speech or hearing impairment, or developmental
problems).
Newnham et al192 performed a randomized control
trial including more than 2800 parturients. Of these,
about half received 5 ultrasound imaging and Doppler
flow studies at 18, 24, 28, 34, and 38 weeks’ gestation, and
half received a single ultrasound imaging at 18 weeks.
They found an increased risk of IUGR when exposed
to frequent Doppler examinations, possibly via some
effects on bone growth. However, when children from
the previously mentioned study were examined at 1 year
of age, there were no differences between the study and
control groups. In addition, after examining their original
subjects after 8 years, no evidence of long-term adverse
impact in neurological outcome was noted by the same
group.192 Similarly, no harmful effect of a single or 2 pre-
natal scans on growth were found in several randomized
studies.193,194 In fact, in some studies, birth weight was
slightly higher in the scanned group, but not significantly
so, except in one.195 In conclusion, decreased birth weight
has been extensively analyzed after DUS exposure in
utero, and it does not appear that such exposure is associ-
ated with reduced birth weight, although Doppler expo-
sure may have some risks.147 In a few studies that appear
to favor such an effect, a major problem is that there is
an important confounding factor: many studies include
pregnancies at risk for IUGR due to existing maternal or
fetal conditions.
A second major potential effect extensively evaluated
is delayed speech. In an attempt to determine if there is
an association between prenatal ultrasound exposure and
delayed speech in children, Campbell et al185 studied 72
children with delayed speech and found a higher rate of
ultrasound exposure in utero than the 144 control sub-
jects. Some issues render these results less valid: there
was neither a dose-response effect nor any relationship to
time of exposure, and many of the records were more than
5 years old. Another study of over 1100 children exposed
to ultrasound in utero and over 1000 controls found no
significant differences in delayed speech, limited vocabu-
lary, or stuttering.196
Dyslexia is another widely studied subject. In one study
over 4000 children, aged 7 to 12, exposed to ultrasound in
utero were used as a study group and compared to matched
controls to evaluate the appearance of adverse effects.186
Seventeen outcomes measures were examined, at birth
(APGAR scores, gestational age, head circumference, birth
weight, length, congenital abnormalities, neonatal infection,
and congenital infection) or in early infancy (hearing, visual
08/09/17 10:50 am
 14 Part 1 GENERAL OBSTETRIC SONOGRAPHY
acuity and color vision, cognitive function, and behavior).
No significant differences were found, except for a sig-
nificantly greater proportion of dyslexia in those children
exposed to ultrasound. The authors, however, indicated
that this could be an incidental finding, given the design
of the study and the presence of several confounding fac-
tors that could have contributed to the possible dyslexia
finding. On the other hand, it should be noted that expo-
sure conditions were probably much lower than modern
ultrasound systems, given that the fetal examinations were
performed from 1968 to 1972. Subsequently, a long-term
follow-up study was performed on over 2100 children.193,197
End points included evaluation for dyslexia along with
additional hypotheses, including an examination of non–
right-handedness said to be associated with dyslexia. These
studies198-200 included the specific examination of more than
600 children with various tests for dyslexia such as spelling
and reading. No statistically significant differences were
found between ultrasound-exposed children and controls
for reading, spelling, arithmetic, or overall performance as
reported by teachers. Specific dyslexia tests showed similar
rates of occurrence among scanned children and controls
in reading, spelling, and intelligence scores, and no discrep-
ancy between intelligence and reading or spelling. Since the
original finding of dyslexia was not confirmed in subsequent
randomized controlled trials, it is considered unlikely that
routine ultrasound screening exams can cause dyslexia.
However, these studies did raise the issue of laterality (in
terms of handedness).
The topic of non–right-handedness as a result of pre-
natal exposure has caused much ink to be used in extensive
discussions and reports. The first report of a possible link
between prenatal exposure to ultrasound and subsequent
non–right-handedness in insonated children was published
in 1993 by Salvesen et al,198 but according to the authors,
“only barely significant at the 5% level.” In a later analysis of
the data, they described that the association was restricted to
males.193 A second group of researchers (with Salvesen, the
main author of the first study, included but with a new popu-
lation, in Sweden as opposed to Norway) published similar
findings of a statistically significant association between
ultrasound exposure in utero and non–right-handedness in
males.187 Salvesen then published a meta-analysis of these 2
studies and of previously unreported results.188 No difference
was found in general, but a small increase in non–right-
handedness was present when analyzing boys separately.
No valid mechanistic explanation is given in the studies to
explain the findings. In conclusion, although there may be a
small increase in the incidence of non–right-handedness in
male infants, there is not enough evidence to infer a direct
effect on brain structure or function or even that non–right-
handedness is an adverse effect. An intriguing recent study
showed that fetuses self-touched their faces more often with
the left hand than the right, as observed by ultrasound, in
correlation to stress levels of the mother.189 Furthermore, lat-
erality is, mostly, genetically determined.190 Other end points
that have been considered but not found to be associated
with ultrasound exposure include congenital malformations,
hearing problems and malignancies.204,205
There has been no published epidemiological study
that found negative effects of obstetrics ultrasound in
Fleischer_CH01_p001-p024.indd 14
populations scanned after 1992, when regulations were
altered and acoustic output of diagnostic instruments
were permitted to reach levels many times higher than
previously allowed (from 94 to 720 mW/cm2 ISPTA for fetal
applications). There are no epidemiological studies related
to the output display standard (thermal and mechanical
indices) and clinical outcomes. The safety of new technolo-
gies such as harmonic imaging and three-dimensional (3D)
ultrasound, as well as that of probe self-heating, needs to
be investigated.
Clinical Exposimetry
There is, unfortunately, no way to perform actual sono-
graphic exposure measurements in the human fetus. Pres-
sure, intensity, and power are not measured in situ, but
are estimated from laboratory obtained measurements.
Several tissue models have been developed to help with
this estimation, depending mostly on approximate attenu-
ation coefficients for various tissues or beam paths.30,50 A
large range of variation is expected secondary to individual
patient characteristics, such as weight and thickness of tis-
sues.206 Because of these possible variations, the reasonable
worst-case scenario is usually considered. There are scarce
data on instruments’ acoustic output (nor patient acous-
tic exposure) for routine clinical ultrasound examina-
tions. Acoustic output was recorded in several prospective
observational studies investigating first-trimester ultra-
sound,207,208 Doppler studies,209 and 3D/four-dimensional
(4D) studies.210 Basically, first-trimester ultrasound was
associated with very low TI values (with a mean of 0.2 ±
0.1).207 The TI was significantly higher in the pulsed wave
Doppler (mean 1.5 ± 0.5, range 0.9-2.8) and color flow
imaging studies (mean 0.8 ± 0.1, range 0.6-1.2) as com-
pared to B-mode ultrasound (mean 0.3 ± 0.1, range 0.1-0.7;
P < .01).209 In the same study, TI was above 1.5 in 43% of
the Doppler studies.209 Mean TI during the 3D (0.27 ± 0.1)
and 4D examinations (0.24 ± 0.1) was comparable to the TI
during the B-mode scanning (0.28 ± 0.1; P = .343).210 There
is ever-increasing use of 3D/4D ultrasound in clinical
Figure 1-6. TI and MI during M-mode examination. Please note
TI = 0.8 (arrow).
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 Chapter 1 Ultrasound Bioeffects and Safety: What the Practitioner Should Know 15

Figure 1-7. TI and MI during color Doppler exam. Please note TI = 0.6 Figure 1-8. TI and MI during spectral Doppler examination. Please
(arrow). note TI = 2.4 (arrow).

medicine, thus knowledge about bioeffects and safety is
mandatory.211 Figures 1-6 through 1-9 are examples of
actual screen shots during clinical exams, for M-mode,
color Doppler, spectral Doppler, and 3D acquisition,
respectively. Figure 1-10 demonstrates that extremely
elevated TIs are easily reachable with spectral Doppler,
although in manufacturer’s fetal setting.
Adequate diagnostic information may be obtained
with low output levels (as documented by values of the
TI). This is seen in Figure 1-11 and Video 1. This has
been reported in the literature, specifically for Doppler,
the mode with the highest output, both in early and later
pregnancy.212,213 It should be noted that, under pressure
from Bioeffects and Safety Committees of various profes-
sional organizations (American Institute of Ultrasound
in Medicine-AIUM, European Federation of Ultrasound
in Medicine and Biology-EFSUMB, International Society
for Ultrasound in Obstetrics and Gynecology-ISUOG,
and World Federation for Ultrasound in Medicine and
Biology-WFUMB), several manufacturers have changed
their default settings, specifically for pulsed Doppler in
fetal mode, from very high (as it was originally, presumably
in an attempt to obtain better images) to very low, with
the end user capable or raising the output, if desired. Since
acoustic output is high in Doppler, special precaution is
recommended, particularly in early gestation.214

Figure 1-9. TI and MI during multiplanar acquisition in 3D scanning. Please note TI = 0.4 (arrow).

Fleischer_CH01_p001-p024.indd 15 08/09/17 10:50 am

 16 Part 1 GENERAL OBSTETRIC SONOGRAPHY
Figure 1-10. Second-trimester spectral Doppler. Please note TI = 3.3
(arrow). This is with the instrument on “fetal” setting.
A B
C D
Figure 1-11. Color and spectral Doppler of umbilical artery. A: Color Doppler with high output power (as reflected by TI = 0.7). B: Lower output
power (TI = 0.1). C: Spectral Doppler with high output power (as reflected by TI = 2.4). D: Lower output power (TI = 0.6). Image is equally diagnostic.
Fleischer_CH01_p001-p024.indd 16
Because of the possible errors inherent in the calcula-
tion of the TI and MI, various attempts have been made to
find a better quantification of the potential risk.215 These
have not been adopted by the clinical community.
The other side of the equation is, “What are we looking
for?” Ultrasound is neither radiation nor thalidomide, and
it is certain that ultrasound does not kill fetuses, does not
cause limb amputations, and does not cause gross structural
anomalies.216 But are we looking where we should, and have
we studied enough cases in a scientific fashion, looking at
subtle changes? The answer is clearly, “No.” We have been
looking for macroscopic, gross findings and have not found
any, but is it possible that harmful effects of ultrasound
have been missed because the wrong time frame refer-
ence was used? Two possible factors are described for such
errors.217 If one uses a term human pregnancy (280 days
[40 weeks]) to life expectancy of 70 years (25,550 days) ratio,
then 7 in utero days are comparable to about 631 ex-utero
days. Therefore, it is conceivable that a much shorter time
interval (1 day) should be used to group fetuses to evaluate
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 Chapter 1 Ultrasound Bioeffects and Safety: What the Practitioner Should Know
effects, not intervals of 1 or more weeks as is usually done.
Furthermore, there is also a potential “dilution error.”
Assuming an event has a background rate of 10% in the
general population but occurs in 100% of fetuses exposed
on day 35, if a large number (for instance, 1000) of fetuses
exposed on that particular day are examined, the incidence
will be 100%, ie, 90% increase over the control population
(background rate of 10%). But if we assume 1000 fetuses
are exposed per day for 12 weeks, this represents 84,000
scans, and only 11.1% will be affected (all 1000 scanned on
day 30 and 10% [the background rate] of all 83,000 others
[8300], or 9300 total), an increase of only 1.1% (1.07 to be
precise) over the background rate of 8400 (10% of 84,000),
which is very difficult to extract and observe, but still present
in 100% of the fetuses exposed at the critical time (day 35 in
the above example). The actual numbers are probably even
more complicated since more than 1000 fetuses are scanned
every day, the background rate of major anomalies is 3% to
4% in the general population and much lower for nongross
macroscopic findings, and furthermore, the hit rate of any
teratological agent is rarely 100%. This points to the need
for extensive, well-planned research—a goal very difficult to
accomplish, given that the majority of pregnant women who
receive prenatal care will have 1 or several DUS scans dur-
ing their pregnancy. It has been shown that subtle changes
can be observed in animals.218 As detailed previously, there
is a possible male preponderance of non–right-handedness
after in utero ultrasound exposure. In addition, an increased
prevalence of autism exists in males, and there are reports of
excess non–right-handedness in this population. Pregnant
mice were exposed to 30 minutes of diagnostic ultrasound at
embryonic day 14.5. Social behavior of their male pups was
analyzed 3 weeks after birth. Ultrasound-exposed pups were
significantly (P < 0.01) less interested in social interaction
than sham-exposed pups and demonstrated significantly
(P < 0.05) more activity relative to the sham-exposed pups,
but only in the presence of an unfamiliar mouse.218 These
results suggest that social behavior in young mice was
altered by in utero fetal exposure to diagnostic ultrasound.
The authors conclude that this may be relevant for autism
but that major differences between the exposure of DUS of
mice and humans preclude conclusions regarding human
exposure and require further studies.
Nonmedical Ultrasound
Nonmedical ultrasound refers to the performance of
obstetrical ultrasound with no medical indication but
to provide the mother/parents-to-be with images or video
clips of the fetus (on hard copy, tape, CD, DVD, tablet or
cell-phone), also called “scanning for pleasure.”219 There are
several reasons why most official organizations are opposed
to this practice, such as issues of training of the providers,
quality and nature of the scans, feedback to the “custom-
ers,” and risks that these customers will not have a regular,
clinical exam. But perhaps the most obvious reason for the
resistance to these scans is the safety issue. For instance,
the FDA is strongly opposed, stating, “… ultrasound energy
delivered to the fetus cannot be regarded as completely
innocuous. Laboratory studies have shown that diagnostic
levels of ultrasound can produce physical effects in tissue,
Fleischer_CH01_p001-p024.indd 17
17
such as mechanical vibrations and rise in temperature.
Although there is no evidence that these physical effects can
harm the fetus, public health experts, clinicians and industry
agree that casual exposure to ultrasound, especially during
pregnancy, should be avoided.”220 The FDA goes further
and indicates, “Persons who promote, sell or lease ultra-
sound equipment for making ‘keepsake’ fetal videos should
know that the FDA views this as an unapproved use of a
medical device. In addition, those who subject individuals
to ultrasound exposure using a diagnostic ultrasound device
(a prescription device) without a physician’s order may be
in violation of state or local laws or regulations regarding
use of a prescription medical device.”220 Equally opposed
to the nonclinical use of DUS are the American Institute of
Ultrasound in Medicine (AIUM), the American College of
Obstetrics and Gynecology (ACOG), the European Com-
mittee for Medical Ultrasound Safety (ECMUS), and the
World Federation for Ultrasound in Medicine and Biology
(WFUMB). The AIUM’s most recent statement is, “The
AIUM advocates the responsible use of diagnostic ultra-
sound . . . [and] strongly discourages the non-medical use of
ultrasound . . . . The use of either two-dimensional (2D) or
three-dimensional (3D) 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 con-
firmed biological effects on patients caused by exposures
from present diagnostic ultrasound instruments, the pos-
sibility 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.”221 Simi-
larly, the ECMUS’s statement includes the following: “The
embryonic period is known to be particularly sensitive to
any external influences. Until further scientific information
is available, investigations should be carried out with careful
control of output levels and exposure times. With increas-
ing mineralization of the fetal bone as the fetus develops the
possibility of heating fetal bone increases.”222 More recently
the WFUMB and the International Society of Ultrasound
in Obstetrics and Gynecology (ISUOG) issued a joint state-
ment with identical conclusions: “The WFUMB and ISUOG
disapprove of the use of ultrasound for the sole purpose of
providing souvenir images of the fetus . . . . Furthermore,
ultrasound should be employed only by health profession-
als who are well trained and updated in ultrasound clinical
usage and bioeffects.”223
Official Positions
Many national and international organizations or societies
have issued official statements regarding the epidemiology,
bioeffects, and safety of ultrasound, as well as the nonmed-
ical usage of ultrasound such as the AIUM, WFUMB, Brit-
ish Medical Ultrasound Society (BMUS), and European
Committee of Medical Ultrasound Safety (ECMUS). They
all state, in one way or another, that ultrasound appears
safe if performed for clinical indications by appropriately
trained personal, but that prudence is recommended
because of the possibility of yet unknown deleterious
effects. For instance, the AIUM has several statements
available on its Web site for epidemiology,180 prudent
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 18 Part 1 GENERAL OBSTETRIC SONOGRAPHY
 MAXIMAL ALLOWED EXPOSURE
Table 1-3
TIME AS A FUNCTION OF TI
TI Maximum Exposure Time (min)
0.7 60
1.0 30
1.5 15
2.0 4 (as is the case in fetal lungs and bowels and assuming no use
2.5 1
use,221 and keepsake fetal imaging.223 The Keepsake Fetal
Imaging statement contains a clear “safety clause” par-
ticularly addressing pulsed Doppler: “Although the general
use of ultrasound for medical diagnosis is considered safe,
ultrasound energy has the potential to produce biological
effects. Ultrasound bioeffects may result from scanning for
a prolonged period, inappropriate use of color or pulsed
Doppler ultrasound without a medical indication, or
excessive thermal or mechanical index settings.”223
RECOMMENDATIONS
The sonographer and sonologist are interested in knowing
how to keep the examination safe. One needs to provide
recommendations based on scientific evidence. This is a
difficult task. In terms of clinical exposure, what should
be recommended? A general recommendation is that DUS
should be used only when indicated and minimal exposure
should be used to obtain the diagnostic images. Further-
more, exposure time should be kept as short as possible.123
Precautions are, naturally, of particular importance in
early gestation224 and for Doppler exposure.225
Several organizations have actually published recom-
mendations, based more or less on scientific data.226 The
most rigorous is the BMUS, as can already be inferred by
its title: Statement on the Safe Use, and Potential Hazards
of Diagnostic Ultrasound.227 Their 1999 statement declares,
“For equipment for which the safety indices are displayed
over their full range of values, the TI should always be less
than 0.5 and the MI should always be less than 0.3*.”
When the safety indices are not displayed, Tmax should
be less than 1°C and MImax should be less than 0.3. Fre-
quent exposure of the same subject is to be avoided.”223
They have very strict recommendations for maximum
allowed exposure time, depending on the TI (Table 1-3). In
2012, they updated their recommendations, and these are,
at the moment, the most detailed guidelines for safe use of
DUS in medicine in general and obstetrics in particular.228
The 2015 AIUM Statement on Mammalian Biological
Effects of Heat229 is a must read for all ultrasound practi-
tioners and states: “Acoustic output from diagnostic ultra-
sound devices is sufficient to cause temperature elevations
in fetal tissue.” The WFUMB offers some scientific ratio-
nalization, stating that diagnostic exposure resulting in a
*Italics ours.
Fleischer_CH01_p001-p024.indd 18
temperature rise of no more than 1.5°C above normal physi-
ological levels (37°C) may be used clinically without reserva-
tion on thermal grounds. Furthermore, diagnostic exposure
that elevates embryonic and fetal in situ temperature above
41°C (4°C above normal temperature) for 5 minutes or more
should be considered potentially hazardous.48 In addition,
in febrile patients, extra precaution may be needed to avoid
unnecessary additional embryonic and fetal risk from ultra-
sound examinations. Precautions are much softer regarding
mechanical phenomena, which, in the absence of gas nuclei
of contrast agents) are probably negligible. Hence, BMUS,
despite its very cautionary statements also published a state-
ment directed at the public, stating: “the British Medical
Ultrasound Society considers ultrasound imaging to be safe
when it is performed prudently, for a clear medical purpose,
by properly trained professionals, using well maintained
equipment.”230
FUTURE DIRECTIONS
Scientists continue to be interested in biophysics of ultra-
sound and remain worried about potential harmful effects.
Hence, research in this area is continuing. Ideally, epidemio-
logical studies should be performed on large populations,
blindly randomizing 50% to ultrasound testing and 50% to
no testing. Given the extensive indications for DUS in preg-
nancy and the fact that most (and in certain countries, all)
pregnant patients are referred for one ultrasound examina-
tion (or many more), this would be extremely difficult to
realize in a human population. More accurate techniques
to measure in vivo real exposure may appear, allowing more
precise assessment of safety, possibly by generating actual
safety indices, correlated with actual length of exposure. In
the meantime, areas of uncertainty persist and caution is
justified, particularly in Doppler mode early in pregnancy,
but also when insonating the fetal skull for relatively long
periods. Education of the end users will continue to be vital
to maintaining the good safety record of ultrasound and
preventing possible harmful bioeffects.
KEY POINTS
1. Know the machine you use.
2. Perform a scan only when indicated.
3. Keep the examination as short as possible. The lon-
ger the exposure, the higher the risk.
4. Always start a scan at the lowest possible output
(default) and increase only if necessary.
5. Use receiver gain, PRF, and amplitude change out-
put. Output and receiver gain can affect the image
in the same way, and receiver gain changes are
without any effect on the intensity of the outgoing
beam (and hence are completely safe).
6. Follow the ALARA principle.
7. Keep track of the TI and MI values on the screen.
8. Keep TI below 1.
9. Keep MI below 1 (although some recommend 0.5).
10. Be extremely cautious when using Doppler in the
first trimester.
08/09/17 10:51 am
 Chapter 1 Ultrasound Bioeffects and Safety: What the Practitioner Should Know
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 22 Part 1 GENERAL OBSTETRIC SONOGRAPHY
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186. Stark CR, Orleans M, Haverkamp AD, Murphy J. Short- and long-
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187. Kieler H, Axelsson O, Haglund B, Nilsson S, Salvesen KA. Routine
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188. Salvesen KA, Eik-Nes SH. Ultrasound during pregnancy and subse-
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189. Reissland N, Aydin E, Francis B, Exley K. Laterality of foetal self-
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191. Moore RM Jr, Barrick MK, Hamilton TM. Effect of sonic radiation
on growth and development. Am J Epidemiol. 1982;116:571.
192. Moore RM Jr, Diamond EL, Cavalieri RL. The relationship of birth
weight and intrauterine diagnostic ultrasound exposure. Obstet
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193. Lyons EA, Dyke C, Toms M, Cheang M. In utero exposure to diag-
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194. Newnham JP, Doherty DA, Kendall GE, Zubrick SR, Landau LL,
Stanley FJ. Effects of repeated prenatal ultrasound examinations on
childhood outcome up to 8 years of age: follow-up of a randomised
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195. Bakketeig LS, Eik-Nes SH, Jacobsen G, et al. Randomised con-
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1984;2:207-211.
196. Saari-Kemppainen A, Karjalainen O, Ylostalo P, Heinonen OP.
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Trial. Lancet. 1990;336:387-391.
197. Waldenstrom U, Axelsson O, Nilsson S, et al. Effects of routine one-
stage ultrasound screening in pregnancy: a randomised controlled
trial. Lancet. 1988;2:585-588.
198. Salvesen KA, Vatten LJ, Bakketeig LS, Eik-Nes SH. Routine ultra-
sonography in utero and speech development. Ultrasound Obstet
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199. Eik-Nes SH, Okland O, Aure JC, Ulstein M. Ultrasound screening in
pregnancy: a randomised controlled trial. Lancet. 1984;1:1347.
200. Salvesen KA, Bakketeig LS, Eik-nes SH, Undheim JO, Okland O.
Routine ultrasonography in utero and school performance at age 8-9
years. Lancet. 1992;339:85-89.
201. Salvesen KA, Vatten LJ, Jacobsen G, et al. Routine ultrasonography
in utero and subsequent vision and hearing at primary school age.
Ultrasound Obstet Gynecol. 1992;2:243-4, 245-247.
202. Salvesen KA, Vatten LJ, Eik-Nes SH, Hugdahl K, Bakketeig LS.
Routine ultrasonography in utero and subsequent handedness and
neurological development. BMJ. 1993;307:159-64.
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203. Salvesen KA, Eik-Ness SH, Vatten LJ, Hugdahl K, Bakketeig LS.
Routine ultrasound scanning in pregnancy. Authors’ reply. BMJ.
1993;307:1562.
204. Newnham JP. Studies of ultrasound safety in human: clinical benefit
vs. risk. In: Barnett SB, Kossoff G, eds. Safety of Diagnostic Ultra-
sound. New York, London: The Parthenon Publishing Group, 1998.
205. Harbarger CF1, Weinberger PM, Borders JC, Hughes CA. Prenatal
ultrasound exposure and association with postnatal hearing out-
comes. J Otolaryngol Head Neck Surg. 2013 Jan 31;42:3.
206. Kossoff G, Griffiths KA, Garrett WJ, Warren PS, Roberts AB, Mitch-
ell JM. Thickness of tissue intervening between the transducer and
fetus and models for fetal exposure calculations in transvaginal
sonography. Ultrasound Med Biol. 1993;19:59-65.
207. Sheiner E, Shoham-Vardi I, Hussey MJ, et al. First-trimester sonog-
raphy: is the fetus exposed to high levels of acoustic energy? J Clin
Ultrasound. 2007;35:245-249.
208. Sheiner E, Abramowicz JS. Acoustic output as measured by thermal
and mechanical indices during fetal nuchal translucency ultrasound
examinations. Fetal Diagn Ther. 2009;25(1):8-10.
209. Sheiner E, Shoham-Vardi I, Pombar X, Hussey MJ, Strassner HT,
Abramowicz JS. An increased thermal index can be achieved when
performing Doppler studies in obstetric sonography. J Ultrasound
Med. 2007;26:71-76.
210. Sheiner E, Hackmon R, Shoham-Vardi I, et al. A comparison
between acoustic output indices in 2D and 3D/4D ultrasound in
obstetrics. Ultrasound Obstet Gynecol. 2007;29:326-328.
211. Pooh RK, Maeda K, Kurjak A, et al. 3D/4D sonography—any safety
problem. J Perinat Med. 2016 Mar;44(2):125-129.
212. Sande RK, Matre K, Eide GE, Kiserud T. Ultrasound safety in
early pregnancy: reduced energy setting does not compromise
obstetric Doppler measurements. Ultrasound Obstet Gynecol. 2012
Apr;39(4):438-443.
213. Sande RK, Matre K, Eide GE, Kiserud T. The effects of reducing the
thermal index for bone from 1.0 to 0.5 and 0.1 on common obstetric
pulsed wave Doppler measurements in the second half of pregnancy.
Acta Obstet Gynecol Scand. 2013 Jul;92(7):790-796.
214. ter Haar GR, Abramowicz JS, Akiyama I, Evans DH, Ziskin MC, Maršál
K. Do we need to restrict the use of Doppler ultrasound in the first
trimester of pregnancy? Ultrasound Med Biol. 2013 Mar;39(3):374-380.
215. Bigelow TA, Church CC, Sandstrom K, et al. The thermal index: its
strengths, weaknesses, and proposed improvements. J Ultrasound
Med. 2011 May;30(5):714-734.
216. Cardinale A, Lagalla R, Giambanco V, Aragona F. Bioeffects of
ultrasound: an experimental study on human embryos. Ultrasonics.
1991;29:261-263.
217. Bello SO. How we may be missing some harmful effects of ultra-
sound—a hypothesis. Med Hypotheses. 2006;67:765-767.
218. McClintic AM, King BH, Webb SJ, Mourad PD. Mice exposed to
diagnostic ultrasound in utero are less social and more active in social
situations relative to controls. Autism Res. 2014 Jun;7(3):295-304.
219. Chudleigh T. Scanning for pleasure. Ultrasound Obstet Gynecol.
1999;14:369-371.
220. Rados C. FDA cautions against ultrasound “keepsake” images. FDA
Consumer Magazine: U.S Food and Drug Administration, January-
February 2004.
221. AIUM. Prudent Use in Obstetrics: American Institute of Ultra-
sound in Medicine, Approved 4/1/2012. http://www.aium.org/
officialStatements/33. Accessed December 24, 2015.
222. Thermal teratology. European Committee for Medical Ultrasound
Safety (ECMUS). Eur J Ultrasound. 1999;9:281-283.
Fleischer_CH01_p001-p024.indd 23
23
223. AIUM. Keepsake Fetal Imaging, reapproved 2012. http://www.aium.
org/officialStatements/31. Accessed December 23, 2015.
224. Lees C, Abramowicz JS, Brezinka C, et al. Ultrasound from concep-
tion to 10+0 weeks of gestation. Scientific impact paper no. 49. Royal
College of Obstetricians and Gynaecologists, London, UK, 2015.
225. Abramowicz JS. Fetal Doppler: how to keep it safe? Clin Obstet
Gynecol. 2010 Dec;53(4):842-850.
226. Harris GR, Church CC, Dalecki D, Ziskin MC, Bagley JE. Compari-
son of thermal safety practice guidelines for diagnostic ultrasound
exposures. Ultrasound Med Biol. 2016 Feb;42(2):345-357.
227. BMUS. Statement on the safe use, and potential hazards of diagnostic
ultrasound. 2000, reapproved 2012. https://www.bmus.org/static/
uploads/resources/STATEMENT_ON_THE_SAFE_USE_AND_
POTENTIAL_HAZARDS_OF_DIAGNOSTIC_ULTRASOUND.
pdf. Accessed December 23, 2015.
228. ter Haar G. The Safe Use of Ultrasound in Medical Diagnosis. 3rd ed.
London, UK: The British Institute of Radiology; 2012: 173.
229. AIUM. Statement on Mammalian Biological Effects of Heat.
Approved 2015. http://www.aium.org/officialStatements/17.
Accessed December 23, 2015.
230. BMUS. Statement for the General Public on the Safety of Medical
Ultrasound Imaging. Approved 2012. https://www.bmus.org/static/
uploads/resources/Statement_for_the_General_Public_on_the_
Safety_of_Medical_Ultrasound_Imaging.pdf. Accessed December
23, 2015.
Highlighted References
1. Tarantal AF, O’Brien WD, Hendrickx AG. Evaluation of the
bioeffects of prenatal ultrasound exposure in the cynomolgus
macaque (Macaca fascicularis): III. Developmental and hemato-
logic studies. Teratology. 1993;47:159-170.
A classical animal study of the bioeffects of ultrasound. The authors
published several such reports detailing the possible effects of ultra-
sound in monkeys.
2. Miller MW, Ziskin MC. Biological consequences of hyperther-
mia. Ultrasound Med Biol. 1989;15:707-722.
One of the studies that formed the basis of modern analysis of ultra-
sound bioeffects. It solidified the notions of a correlation between
duration of exposure and temperature increase.
3. Sheiner E, Shoham-Vardi I, Abramowicz JS. What do clinical users
know regarding safety of ultrasound during pregnancy? J Ultra-
sound Med. 2007;26:319-325; quiz 326-327.
A very disturbing study demonstrating a general lack of knowledge
about bioeffects and safety of ultrasound among users of this technol-
ogy in obstetrics in the United States of America (#95 is a study with
similar results from Europe).
4. ter Haar GR, Abramowicz JS, Akiyama I, Evans DH, Ziskin MC,
Maršál K. Do we need to restrict the use of Doppler ultrasound
in the first trimester of pregnancy? Ultrasound Med Biol. 2013
Mar;39(3):374-380.
An important discussion on the use of Doppler in early gestation.
5. Lees C, Abramowicz JS, Brezinka C, et al. Ultrasound from con-
ception to 10+0 weeks of gestation. Scientific impact paper no.
49. Royal College of Obstetricians and Gynaecologists, London, UK,
2015.
A document published by the RCOG on the use of ultrasound in the
first trimester, with specific emphasis on bioeffects and safety.
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 Chapter 2 Normal Pelvic Anatomy as Depicted with Transvaginal Sonography
Chapter 2
NORMAL PELVIC ANATOMY AS DEPICTED
WITH TRANSVAGINAL SONOGRAPHY
Arthur C. Fleischer ● Lori Deitte
Key Terms
1. Coronal: images obtained in the “elevational” plane.
2. Curved (convex) array transducer: transducer ele-
ments arranged in curved fashion.
3. Linear array: transducer elements linearly arranged.
4. Phased array transducer: aims beam by selective
activation of transducer elements.
5. Sagittal: images obtained in the long axis of the
body.
6. Sector transducer: provides a pie-shaped field of
view.
7. Transverse: images obtained in the short axis of the
body.
INTRODUCTION
Transvaginal sonography (TVS) affords improved resolu-
tion of the uterus and ovaries over the conventional transab-
dominal sonography (TAS) approach. Although TVS allows
a closer proximity of the transducer to the pelvic organs
and more detailed depiction, it may be more difficult for the
sonographer to become oriented to the images when com-
pared with conventional TAS because of the limited field of
view and unusual scanning planes depicted with TVS. As
one develops a systematic approach to the examination of
the uterus and adnexal structures with TVS, however, the
examination becomes much easier to perform. Appendix
2-1 lists the American Institute of Ultrasound in Medicine
(AIUM) guidelines for a complete pelvic sonogram.
In this chapter, the sonographic appearances of the
uterus, ovary, and other pelvic structures will be described,
with particular emphasis on how they are best depicted in
a real-time TVS examination.
SCANNING TECHNIQUE AND
INSTRUMENTATION (Figures 2-1 to 2-3)
The 3 scanning maneuvers that are used in TVS include:
1. Vaginal insertion of the transducer with side-to-
side angulation within the upper vagina for sagittal
imaging.
Fleischer_CH02_p025-p044.indd 25
25
● Jill Trotter
2. Transverse orientation of the transducer for imag-
ing in various degrees of semiaxial to semicoronal
planes.
3. Variation in depth of transducer insertion for opti-
mal imaging of the fundus to the cervix by gradual
withdrawal of the transducer into the lower vagina
for imaging of the cervix.
In contrast to conventional TAS, bladder distention
is not necessary for TVS. In fact, overdistention can hin-
der TVS by placing the desired field of view outside the
optimal focal range of the transducer. Minimal distention
is useful in a patient with a severely anteflexed uterus to
straighten the uterus relative to the imaging plane.
As is true for conventional sonographic equipment,
the highest-frequency transducer possible should be used
that allows adequate penetration and depiction of a par-
ticular region of interest. Thus, transducers with a high-
central frequency are preferred (broadband 5.5-7.8 MHz).
Higher-frequency (>8 MHz) transducers may limit the
field of view to within only 6 cm of the transducer.
The major types of transducers that are used for TVS
include those that contain a single-element oscillating
transducer, multiple small transducer elements that are
arranged in a curved linear array, and those that consist
of multiple small elements steered by an electronic phased
array. All of these transducers depict the anatomy in a sec-
tor format that usually encompasses 100 to 120 degrees.
In our experience, the greatest resolution is achieved with
a curved linear array that contains multiple (up to 200)
separate transmit-receive elements. Mechanical transducers
may be subject to minor image distortions at the edges of the
field due to the hysteresis (lag in effect when stopping and
starting) that occurs with an oscillating element. Reverbera-
tion artifacts can be created by suboptimal coupling of the
condom/transducer/vagina surfaces. Although degradation
of image quality by side-lobe artifacts can occur in the far
field in a phased array transducer, they do not significantly
degrade the image in the near field. Therefore, phased array
transducers have similar resolution capabilities to sector
as curved linear array transducers for use in transvaginal
examinations.
Transvaginal equipment that utilizes a mechanical
transducer is relatively rarely used today when compared
to electronic transducers.
08/09/17 4:44 pm
 26 Part 1 GENERAL OBSTETRIC SONOGRAPHY

Long axis Short axis

Long axis Short axis
A
A

Figure 2-2. Major scanning planes for transabdominal sonography

(TAS) and transvaginal sonography (TVS). A: Normal adult, parous
uterus in long and short axis as depicted with transabdominal sonography
(TAS) through a fully distended urinary bladder. B: Transvaginal sonog-
raphy (TVS) of an anteflexed uterus in long axis. The hand not holding
the probe can be used to gently manipulate the uterus and ovaries to
an optimal position for scanning. C: TVS of a patient with a retroflexed
uterus. The probe is within the posterior fornix of the vagina and is in
C
direct line of the uterine corpus and fundus.
Figure 2-1. Scan planes (A) and representative transabdominal pelvic
sonograms (B and C). Transabdominal Sonograms (TAS) in long (B) and
short (C) axis with accompanying typical sonograms showing uterus and
right ovary in sagittal plane and right ovary and uterus in transverse plane
(between cursors). By convention, the left of the image depicts the cephalic
or superior of the patient whereas the right of the patient is depicted on
the left of the image of the transverse scans.

Fleischer_CH02_p025-p044.indd 26 08/09/17 4:44 pm

 Chapter 2 Normal Pelvic Anatomy as Depicted with Transvaginal Sonography 27

C D

Figure 2-3. Typical scan planes used for TVS of the uterus. A: First, the long axis of the uterus is imaged. B: The probe is angled toward the right, then
the left, cornu in the semisagittal plane. A sonohysterography catheter is shown in its long axis. C: Next, the probe is rotated to image the uterus in short
axis, sweeping from fundus to cervix. D: Additional views can be obtained by directing the probe in a semicoronal plane. In this plane, the transverse
endometrial width is obtained.

Practitioners should follow the AIUM guidelines for
the disinfection of transvaginal transducers. These guide-
lines are included as Appendix 2-2. The more recent
widespread use of the Trophon device has extended disin-
fection capabilities to include the human papilloma virus
(HPV) virus. There is evidence that some disinfectants
such as glutaraldehyde and ortho-phthalaldehyde are inef-
fective against HPV16, the leading cause of cervical can-
cer.1-3 The Trophon system has been shown to be effective
against HPV16 and HPV18.4 This is considered a major
advantage since HPV contamination was identified in up
to 7% of disinfected transducers used in TVS.2 HPV has
been shown to account for up to 5% of all cancers world-
wide and is responsible for almost all cases of cervical can-
cer. The HPV virus is a leading cause of oral, throat, anal,
and genital cancers. In addition, the design of the Trophon
unit affords disinfection of the handle of the transvaginal
transducer, which has been shown to be a reservoir for
pathogens.4-6
For infection control purposes, a disposable protec-
tive sheath is used to cover the transducer. After com-
pletely covering the transducer with a sheath such as a
condom and securing the sheath to the shaft of the trans-
ducer with a rubber band, the transducer is lubricated on
its tip and periphery and then inserted into the vagina
and manipulated around the cervical lips and into the
fornix to depict the structures of interest in best detail.
When the transducer is oriented in the longitudinal or
sagittal plane, the long axis of the uterus can usually be
depicted by slight angulation off midline. The uterus is
used as a landmark for depiction of other adnexal struc-
tures. Once the uterus is identified, the transducer can be

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 28 Part 1 GENERAL OBSTETRIC SONOGRAPHY

A Left A Right

B Left B Right

C Left C Right
Figure 2-4. TVS of normal uterus. A:Transducer/probe motion to enhance depiction of the uterus and endometrium in an anteflexed uterus. The
probe is placed in the anterior vaginal fornix and directed anteriorly. B: Midline sagittal view (left) depicting uterus is long axis with accompanying
transvaginal sonogram. The sagittal image (right) is oriented with anterior or superior aspect of the patient to left of image. C: Transducer probe show-
ing direction of probe used to enhance depiction of a retroflexed uterus. Corresponding TVS of drawing shown in C showing retroflexed uterus with
secretory phase endometrium (between cursors).

Fleischer_CH02_p025-p044.indd 28 08/09/17 4:44 pm

 Chapter 2 Normal Pelvic Anatomy as Depicted with Transvaginal Sonography 29

D Left D Right

E Left E Right
Figure 2-4. (Continued) D: Diagram showing short-axis image of endometrium. Corresponding TVS of image plane in D showing short-axis view of
the endometrium with surrounding hypoechoic inner myometrium. E: Diagram (left) and TVS (right) showing angled imaging of cervix. The TVS probe
is inserted into the anterior vornix of the vagina.

directed to the right or left of midline in the sagittal plane
to depict the ovaries. The internal iliac artery and vein
appear as tubular structures along the pelvic side wall.
Low-level blood echoes can occasionally be seen stream-
ing within these vessels. The ovaries typically lie medial
to those vessels. After appropriate images are obtained
in the sagittal plane, the transducer can be turned 90
degrees counterclockwise to depict these structures in
their axial or semicoronal planes.
Particularly in larger patients, it is helpful for the
sonographer to use one hand to scan while the other is
used for gentle abdominal palpation to move structures,
such as the ovaries, as close as possible to the transducer.
UTERUS (Figures 2-4 to 2-7)
Examination of the uterus begins with its depiction in
long axis. The endometrial interface, which is typically
echogenic, is a useful landmark to depict in long axis. The
actual sonographic texture of the endometrium varies
according to its consistency, which is elaborated upon in
other sections of this chapter. Once the endometrium is
identified in long axis, images of the uterus can be obtained
in the sagittal and semiaxial/coronal planes.7
It may be difficult to determine the flexion of the uterus
with static images obtained solely from transvaginal scan-
ning except in extreme cases of anteflexion or retroflexion;

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 30 Part 1 GENERAL OBSTETRIC SONOGRAPHY

A Right

A Left

B Right
Figure 2-5. A: Diagram (left) and TV-CDS (right) of the uterine arterial network. The arcuate arterioles branch into radial arteries that course across
the myometrium ending in the spiral arteries within the endometrium B: Diagram (left) and TV-CDS (right) of arterial vascularity of the uterus. The
main uterine artery branches from the hypogastric artery (internal iliac artery) and courses along the lateral edges of the uterus, branching off into the
arcuates. The radial arteries then course toward the endometrium, branching into the basal and spiral arteries within the endometrium.

however, one can obtain an impression of uterine flexion
during the examination by the relative orientation of the
transducer needed to obtain optimal images of the uterus.
For example, retroflexed uteri are best depicted when the
transducer is in the anterior fornix and angulated in a
posterior direction. The fundus of the retroflexed uterus
is directed to the inferior right corner of the image. Con-
versely, the anteflexed uterus will demonstrate the fundus
directed to the upper left corner of the image.
The endometrium has a variety of appearances
depending on its stage of development. The stages of
endometrial development can be described in relation
to oocyte maturation (follicular vs luteal) or endometrial
development (proliferative vs secretory). In the prolif-
erative phase, the endometrium measures 5 to 7 mm in
anterior-posterior (AP) dimension. This measurement
includes the 2 layers of endometrium. A hypoechoic
interface can be seen within the luminal aspects of echo-
genic layers of endometrium in the peri-ovulatory phase
and likely represents edema and increased glycogen and
mucus in the inner layers of endometrium. In the few
days after ovulation, a small amount of secretion into the
endometrial lumen can be seen.
During the secretory phase, the endometrium typi-
cally measures between 6 and 12 mm in bilayer thickness;
is homogeneously echogenic, most likely as a result of
multiple interfaces resulting from stromal edema; and is
surrounded by a hypoechoic band, representing the inner
layer of the myometrium. This inner layer of myometrium
appears hypoechoic on TVS and corresponds roughly to
the “junctional zone” seen on magnetic resonance imag-
ing (MRI). The junctional zone, however, may be thicker
than the hypoechoic band seen in TVS, perhaps because of
different physical interaction with the myometrium in this

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 Chapter 2 Normal Pelvic Anatomy as Depicted with Transvaginal Sonography 31

A B

C D
Figure 2-6. Transvaginal sonography (TVS) planes for depiction of the endometrium A: Long axis of an anteflexed uterine showing orientation of the
endometrium to the transducer. The transducer can be advanced into the anterior fornix for better delineation of the endometrium. The opposite is true
for retroflexed uteri. B: Short-axis image of the endometrium. With pressure on the probe and placement of the probe head in the anterior fornix for an
anteflexed uterus, the endometrium is imaged in its short axis. C: Coronal view depicting “endometrial width.” This plane is most readily obtained in a
“neutral” positioned (neither ante- nor retroflexed) uterus. D: Long axis of endometrium in the retroflexed uterus. With pressure on the posterior fornix,
the endometrium becomes more horizontal to the transducer, allowing better detection. (Used with permission from Paul Gross, MS.)

area.8 This layer is hypoechoic, probably due to the longi-
tudinal arrangement of the myometrial fibers.
Endometrial volume may be calculated by measur-
ing its long axis and multiplying by the AP and transverse
dimension.9 Alternatively, volumetric measurements can
be made using 3D (see Chapter 49). One can use the axial
plane landmark where the endometrium invaginates into
the area of ostia in the region of the uterine cornu. This is
also a useful landmark to denote the proximal portion of
the tube.
Because of the close proximity of the transducer to
the cervix, the cervix is not as readily visualized as the
remainder of the uterus. This may make exact measure-
ment of the long axis of the uterus difficult due to the
imprecision of its measurement. If one slightly withdraws
the transducer into the vaginal canal, however, images of
the cervix can easily be obtained. The mucus within the
endocervical canal usually appears as an echogenic inter-
face. This interface may become hypoechoic during the
peri-ovulatory period because the cervical mucus has a
higher fluid content.
OVARIES (Figure 2-8)
Ovaries are typically depicted as oblong-shaped structures
measuring approximately 3 cm in long axis and 2 cm in
AP and transverse dimensions. On angled long-axis scans,
they are immediately medial to the pelvic vessels. They are
particularly well depicted when they contain a mature fol-
licle that is typically in the 1.5- to 2.0-cm range. It is not
unusual to depict multiple immature or atretic follicles in
the 3- to 7-mm range.
The size of an ovary is related to the patient’s age and
phase of follicular development. When the ovary contains
a mature follicle, it can become twice as large in volume
as one that does not contain mature follicles. The great-
est dimension of a normal ovary, however, is typically less
than 3 cm.10,11 The ovaries of postmenopausal women may

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 32 Part 1 GENERAL OBSTETRIC SONOGRAPHY

Figure 2-7. Normal endometrium. A: Three-dimensional diagram of endometrium (in blue). Note the configuration of the endometrium in the
corpus is more linear than in the fundus, where it invaginates in the cornual regions and is more transversally oriented. B: Diagram showing layers of
endometrium. The endometrium consists of a basal layer (in blue), which is not shed, and a functional layer (in pink), which thickens and sloughs. The
functionalis layer consists of glands and stroma as well as spiral vessels. C: Diagrams and graph of normal range of endometrial thicknesses throughout
cycle. Diagram and graph showing normal bilayer thicknesses of endometrium in different phases (mean and range).

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 Chapter 2 Normal Pelvic Anatomy as Depicted with Transvaginal Sonography 33

D Left D Right

E Left E Right

F Left F Right
Figure 2-7. (Continued) D: Normal endometrium as depicted by TVS. Long (left) and short (right) axes of early proliferative endometrium. Trans-
vaginal sonogram (left) and accompanying diagram show microscopic anatomy of the endometrium (right). E: Long axis of endometrium in midcycle
(left). A multilayered appearance is seen with the outer echogenic interfact representing basalis, the inner layer funcationalis, and the median echo arises
from refluxed mucus. Diagram of corresponding microscopic anatomy (right). F: The luteal phase endometrium appearing as thick (8 mm), regular, and
echogenic (left). Diagram showing thickened stroma and distended glands (right). (Used with permission from Paul Gross, MS.)

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 34 Part 1 GENERAL OBSTETRIC SONOGRAPHY
Figure 2-8. Myometrial layers as depicted by TVS (left shows midline: right shows layers). The innermost layer of myometrium is hypoechoic and pro-
vides endometrial peristalsis (in light pink). The middle layer is the thickest and arranged in a spiral fashion (shown as muscle bundles). The outermost
layer extends from the arcuate vessels to the serosa and is contiguous with the musculature of the tube.
be difficult to recognize because they are relatively small
and usually do not contain follicles which enhance their
sonographic recognition.
Ovarian volumes can be estimated by measurement of
the greater transverse, longitudinal, and AP dimensions.
The average ovarian volumes measured in menstruating
women were 9.8 cm3, in postmenopausal women were 5.8
cm3, and in premenarchal females were 3.0 cm3.11 There
is a gradual decrease in ovarian volume after menopause
except in women receiving hormone replacement.12 Echo-
genic foci can be seen on TVS within the center and/or
periphery of the ovary. Most of the central echogenic foci
are due to tiny cysts or calcifications within atretic fol-
licles. Those that are peripherally located are probably of
no clinical significance and represent calcified foci within
superficial epithelial inclusion cysts.13,14
Recent studies have further elucidated the origin of
echogenic foci within the ovary. Those without an asso-
ciated shadow may represent specular reflections from
unresolved microscopic (<0.5 mm) cysts.9 Ones that have
shadowing may represent hemosiderin or calcified foci
associated with benign histologic changes. They do not
appear to be associated with endosalpingiosis, which is
a histology correlated of benign overgrowth of epithelial
cells derived from coelomic peritoneum, or endometrio-
sis.15 Further studies correlating the sonographic findings
with histologic findings is needed, particularly in light
of an unknown histologic precursor of ovarian epithelial
cancers.
Sonographic assessment of structures adjacent to
the ovary such as the ampullary portion of the tube has
become important in light of the recent finding of type 2
ovarian cancers originating from tubal epithelium adjacent
to the ovary.16,17 These microscopic origins of ovarian can-
cer cannot be resolved using standard TVS transducers,
however. For a more detailed description of this topic, the
reader is referred to Chapter 35.
Fleischer_CH02_p025-p044.indd 34
OTHER PELVIC STRUCTURES
(Figures 2-9 and 2-10)
Transvaginal sonography can depict several pelvic struc-
tures other than the uterus and ovaries. These include
bowel loops within the pelvis, iliac vessels, and occasionally
distended fallopian tubes.18,19 Even small amounts (1 to 3
cc) of intraperitoneal fluid can be detected in the cul-de-
sac or surrounding the uterus.
The pelvic vessels appear as straight tubular structures
on either pelvic side wall. The internal iliac arteries have a
typical width of between 5 to 7 mm and tend to pulsate with
expansion of both walls. The iliac vein is larger (~1 cm) but
does not demonstrate this pulsation. Occasionally, low-level
blood echoes will be seen streaming within the vein. The
transducer can be manipulated or pivoted to demonstrate
these vessels in their long axis. Occasionally, a distended
distal ureter may have this appearance but does not dem-
onstrate pulsations. The distal ureter and urethra converge
toward the apex of the urinary bladder. In most patients, the
larger branches of the uterine vessels will be demonstrable
by TVS as tubular structures coursing within the paracervi-
cal area.
Distended uterine veins can be traced back into the
myometrium, where the arcuate veins in the outer third
of the myometrium lie. Ovarian veins tend to be located
superior to the ovary. When normal, these vessels do not
measure more than 5 mm. When there is valvular incompe-
tency, however, the ovarian vein can be distended (>5 mm).
Whether or not this finding is associated with a distinct
clinical entity, such as “pelvic congestion syndrome,” is con-
troversial because many women with distended veins do not
experience pain.
The nondistended fallopian tube is typically difficult
to depict on TVS, which is related to its small intraluminal
size, serpiginous course, and location in the cul-de-sac.18
Occasionally, one can identify the proximal segment of the
08/09/17 4:45 pm
 Chapter 2 Normal Pelvic Anatomy as Depicted with Transvaginal Sonography 35

Right
adnexal
B1 B2
Figure 2-9. Normal ovaries. A: Diagram of adnexal view of ovary with accompanying transvaginal sonogram (B1) in semiaxial or transverse plane; the
patient’s right is displayed on the left. B1: Right ovary containing a mature follicle (arrow) in a spontaneous cycle and diagram (B2).

fallopian tube by finding the invagination of endometrium
into the cornua depicting the area of the tubal ostia and
following these structures laterally in the axial or coronal
plane. In some rare instances, in patients with markedly
anteflexed uteri, the tube can be identified even without
surrounding fluid. In most patients, the ovarian and infun-
dibulopelvic ligaments usually cannot be depicted unless
there is fluid surrounding these structures.
Sonographic delineation of the tubes is facilitated by the
presence of intraperitoneal fluid that may be present in the
cul-de-sac.18 Placing the patient in a reverse Trendelenburg
position (head higher than hips) may augment intraperi-
toneal fluid around the fallopian tubes. When surrounded
by fluid, the normal tube appears as a 0.5- to 1-cm-wide
tubular echogenic structure that usually arises from the
lateral aspect of the uterine cornu posterolaterally into the
adnexal regions and cul-de-sac. The flaring of the fimbriated
end of the tube can be appreciated in some patients because
it approximates its nearby ovary. Transvaginal sonographic
depiction of the tubes is also facilitated when they contain
intraluminal fluid. Rarely, small (<1 cm) rounded structures
can be seen projecting from the fimbriated end of the tube
representing cysts of Morgagni.19 Paraovarian cysts may
have a similar appearance but are adjacent to the ovary.
The transvaginal sonographic appearances of the round
ligaments are somewhat similar to that arising from a non-
distended tube, except that its course is straighter and more
parallel to the uterine cornu.
Large and small bowel loops typically can be rec-
ognized as fusiform structures that frequently contain

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 36 Part 1 GENERAL OBSTETRIC SONOGRAPHY

Left
adnexal
C1 C2

D1 D2
Figure 2-9. (Continued) C: TVS (C1) and diagram (C2). Left ovary containing a fresh corpus luteum (+’s). The wall is thick and irregular secondary to
luteinization. Some pericervical vessels (curved arrow) are also seen. D: TV-color Doppler (left) sonogram of a mature follicle showing blood flow within
the ovary. Diagram shows waveform differences in area of no follicular development versus within wall of corpus luteum.

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 Chapter 2 Normal Pelvic Anatomy as Depicted with Transvaginal Sonography 37

Left
adnexal

A1 A2

Left
adnexal
B1 B2

Posterior
(CUL-DE-SAC)

C1 C2
Figure 2-10. Other pelvic structures. Drawings depict plane of section. A: Normal left tube (curved arrow) arising from cornual area adjacent to the
uterine attachment of the round ligament (straight arrow). B: Normal left uterine tube (curved arrow) extending from left uterine corpus. C: Internal
iliac vein (arrow) and artery in long axis adjacent to a follicle-containing ovary.

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 38 Part 1 GENERAL OBSTETRIC SONOGRAPHY

Central
sagittal

D1 D2

E F

Figure 2-10. (Continued) D: Fluid-filled small bowel (curved arrow) surrounded by intraperitoneal fluid. E: To evaluate the tube, one begins by identi-
fying the area of the tubal ostia. The endometrium can be seen to invaginate into the uterine cornua, particularly when it is thick and echogenic in the
luteal phase. F: TVS showing area of tube. The actual lumen and tube cannot be routinely depicted on TVS without the use of saline or contrast. With
contrast injection, the tortuous course of the tube is depicted. (Used with permission from A. Parsons, MD.)

intraluminal fluid and change in configuration due to SUMMARY

active peristalsis during real-time exam. If there is fluid
within the lumen, periodic intraluminal projections—
resulting from the valvulae conniventes—can be recog-
nized from small bowel or the haustral indentations that
are characteristic of large bowel.20,21 Nondistended bowel
appears as a fusiform structure that consists of an echo-
genic center, representing mucus and enteric contents,
surrounded by a hypoechoic rim, representing the muscu-
laris of the bowel wall.
Transvaginal sonography affords detailed depiction of the
uterus and ovaries; however, it requires a systematic evalua-
tion of these pelvic structures for their complete delineation
because of the limited field of view of transvaginal transduc-
ers. This can be achieved by understanding the anatomic
relations of these structures from previous experience with
TAS combined with anticipated findings from prior palpa-
tion of these structures during pelvic examination.

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 Chapter 2 Normal Pelvic Anatomy as Depicted with Transvaginal Sonography
KEY POINTS
1. Transvaginal sonography (TVS) affords detailed
depictions of the uterus, endometrium, and ovaries.
2. There is a range of normal sizes of the uterus and
ovaries, depending on age, menopausal status.
3. The normal tube typically cannot be seen routinely;
however, if it is surrounded by fluid some of its
length can be seen.
4. The sonographer should be able to recognize
nongynecologic structures such as those related to
bowel abnormalities.
5. Use of gentle pressure applied to an organ for
interest may optimize its visualization and give
indication for presence of adhesion.
6. Three-dimensional ultrasound can be particularly
helpful in selected cases such as improved
assessment of adnexal structures. This is discussed in
detail in Chapter 49.
7. Meticulous attention to detail is needed for
transducer disinfection between its uses.
ACKNOWLEDGMENTS
The authors acknowledge the use of additional images
and information regarding disinfection provided by Keith
Koby, MBA, Vice President, North America Nanosonics,
Inc., Fishers, IA, 46038.
REFERENCES
1. M’Zali F, Bounizra C, Leroy S, Mekki Y, Quentin-Noury C, Kann
M. Persistence of microbial contamination on transvaginal ultra-
sound probes despite low-level disinfection procedure. PLoS One.
2014;9(4):e93368.
2. Meyers J, Ryndock E, Conway M, Meyers C, Robison, R. Sus-
ceptibility of high-risk human papillomavirus type 16 to clinical
disinfectants. J Antimicrob Chemother. 2014;69(6):1546-1550. First
published online February 4, 2014. doi:10.1093/jac/dku006
3. Casalegno J, Le Bail Carval K, Eibach D, et al. High risk HPV con-
tamination of endocavity vaginal ultrasound probes: an underesti-
mated route of nosocomial infection? PLoS One. 2012;7(10):e48137.
doi:10.1371/journal.pone.0048137.
Appendix 2-1
AIUM Practice Parameter for the Performance of Ultrasound of
the Female Pelvis
Parameter developed in collaboration with the Ameri-
can College of Radiology (ACR), the American College of
Obstetricians and Gynecologists (ACOG), the Society for
Pediatric Radiology (SPR), and the Society of Radiologists
in Ultrasound (SRU).
Fleischer_CH02_p025-p044.indd 39
39
4. Ma STC, Yeung A, Chan, P, Graham, C. Transvaginal ultrasound
probe contamination by the human papillomavirus in the emergency
department. Emerg Med J. 2013;30:6 472-475. Published online 3 July
2012 doi:10.1136/emermed-2012-201407
5. Ryndock E, Robison R, Meyers C. Susceptibility of HPV16 and 18
to high level disinfectants indicated for semi-critical ultrasound
probes. J Med Virol. 2016 Jun; 88(6):1076-1080.
6. Meyers C, et al. Efficacy of a high-level disinfectant system against
high-risk human papilloma virus. Presented at SHEA, 2015.
7. Fleischer AC, Mendleson E, Bohm-Velez M. Sonographic depiction
of the endometrium with transabdominal and transvaginal scan-
ning. Semin Ultrasound CT MRI. 1988;9:81.
8. Mitchell DG, Schonholz L, Hilpert PL, et al. Zones of the uterus. Dis-
crepancy between US and MR images. Radiology. 1990;174:827-831.
9. Fleischer AC, Herbert CM, Hill GA, et al. Transvaginal sonography
of the endometrium during induced cycles. J Ultrasound Med. 1991;
10:93-95.
10. Granberg S, Wikland M. Comparison between endovaginal and
transabdominal transducers for measuring ovarian volume. J Ultra-
sound Med. 1987;16:649-654.
11. Cohen HS, Tice HM, Mandel FS. Ovarian volumes measured by US:
bigger than we think. Radiology. 1990;177:189-192.
12. Andolf E, Jorgensen C, Svalenius E, et al. Ultrasound measurement
of the ovarian volume. Acta Obstet Gynecol Scand. 1987; 66:387-389.
13. Kupfer M, Ralls P, Fu Y. Transvaginal sonographic evaluation of
multiple peripherally distributed echogenic foci of the ovary: preva-
lence and histologic correlation. AJR. 1998;171:483-486.
14. Muradali D, Colgan T, Hayeems E, et al. Echogenic ovarian foci
without shadowing: are they caused by psammomatous calcifica-
tion? Radiology. 2002;224:429-435.
15. Brown DL, Prates MC, Muto MG, Welch WR. Small echogenic foci
within the ovaries: correlation with histologic findings. J Ultrasound
Med. 2004;23:307-313.
16. Seidman JD, Yemelyanova A, Zaino RJ, et al. The fallopian tube-
peritoneal junction: a potential site of carcinogenesis. Int J Gynecol
Pathol. 2011 Jan;30(1):4-11.
17. Kurman RJ, Shih leM. The origin and pathogenesis of epithelial
ovarian cancer: a proposed unifying theory. Am J Surg Pathol. 2010
Mar;34(3):433-443.
18. Timor-Tritsch IE, Rottem S. Transvaginal ultrasonographic study of
the fallopian tube. Obstet Gynecol. 1987;70:424-428.
19. Schiebler ML, Dotters D, Baudoin L, et al. Sonographic diagnosis
of hydatids of Morgagni of the fallopian tube. J Ultrasound Med.
1992;11:115-116.
20. Fleischer AC. Muhletaler CA, Kurtz AB, et al. Real-time sonography
of bowel. In: Winsberg F, Cooperberg PL, eds. Clinics in Diagnos-
tic Ultrasound 10: Real-Time Ultrasonography. New York, NY:
Churchill Livingstone; 1982:117.
21. Warwick W, ed. Gray’s Anatomy. New York, NY: Churchill Living-
stone; 1994.
I. INTRODUCTION
The clinical aspects contained in specific sections of this
parameter (Introduction, Indications, Specifications of the
Examination, and Equipment Specifications) were developed
08/09/17 4:45 pm
 40 Part 1 GENERAL OBSTETRIC SONOGRAPHY
collaboratively by the American Institute of Ultrasound in
Medicine (AIUM), the American College of Radiology (ACR),
the American College of Obstetricians and Gynecologists
(ACOG), the Society for Pediatric Radiology (SPR), and the
Society of Radiologists in Ultrasound (SRU). Recommenda-
tions for physician requirements, written request for the
examination, documentation, and quality control vary among
the organizations and are addressed by each separately.
This parameter has been developed to assist physi-
cians performing sonographic studies of the female pelvis.
Ultrasound examinations of the female pelvis should be
performed only when there is a valid medical reason, and
the lowest possible ultrasonic exposure settings should
be used to gain the necessary diagnostic information. In
some cases, additional or specialized examinations may
be necessary. Although it is not possible to detect every
abnormality, adherence to the following parameter will
maximize the probability of detecting most abnormali-
ties. For ultrasound examinations of the urinary bladder,
see the AIUM Practice Parameter for the Performance
of an Ultrasound Examination of the Abdomen and/or
Retroperitoneum.
II. INDICATIONS
Indications for pelvic sonography include but are not lim-
ited to:
1. Evaluation of pelvic pain;
2. Evaluation of pelvic masses;
3. Evaluation of endocrine abnormalities, including
polycystic ovaries;
4. Evaluation of dysmenorrhea (painful menses);
5. Evaluation of amenorrhea;
6. Evaluation of abnormal bleeding;
7. Evaluation of delayed menses;
8. Follow-up of a previously detected abnormality;
9. Evaluation, monitoring, and/or treatment of infertil-
ity patients;
10. Evaluation in the presence of a limited clinical exam-
ination of the pelvis;
11. Evaluation for signs or symptoms of pelvic infection;
12. Further characterization of a pelvic abnormality
noted on another imaging study;
13. Evaluation of congenital uterine and lower genital
tract anomalies;
14. Evaluation of excessive bleeding, pain, or signs of
infection after pelvic surgery, delivery, or abortion;
15. Localization of an intrauterine contraceptive device;
16. Screening for malignancy in high-risk patients;
17. Evaluation of incontinence or pelvic organ prolapse;
18. Guidance for interventional or surgical procedures;
and
19. Preoperative and postoperative evaluation of pelvic
structures.
III. QUALIFICATIONS OF PERSONNEL
See www.aium.org for AIUM Official Statements includ-
ing Standards and Guidelines for the Accreditation of
Fleischer_CH02_p025-p044.indd 40
Ultrasound Practices and relevant Physician Training
Guidelines.
IV. WRITTEN REQUEST FOR THE
EXAMINATION
The written or electronic request for an ultrasound exami-
nation should provide sufficient information to allow for
the appropriate performance and interpretation of the
examination.
The request for the examination must be originated by
a physician or other appropriately licensed health care pro-
vider or under the provider’s direction. The accompanying
clinical information should be provided by a physician or
other appropriate health care provider familiar with the
patient’s clinical situation and should be consistent with
relevant legal and local health care facility requirements.
V. SPECIFICATIONS OF THE EXAMINATION
The following sections detail the examination to be per-
formed for each organ and anatomic region in the female
pelvis. All relevant structures should be identified by the
transabdominal and/or transvaginal approach. A transrec-
tal or transperineal approach may be useful in patients who
are not candidates for introduction of a vaginal probe and
in assessing the patient with pelvic organ prolapse. More
than 1 approach may be necessary.1,2
A. General Pelvic Preparation
For a complete transabdominal pelvic sonogram, the
patient’s bladder can be distended if necessary to displace
the small bowel from the field of view. Occasionally, over-
distention of the bladder may compromise the evaluation.
When this occurs, imaging may be repeated after partial
bladder emptying. If an abnormality of the urinary bladder
is detected, it should be documented and reported.
For a transvaginal sonogram, the urinary bladder is
preferably empty. The patient, the sonographer, or the
physician may introduce the vaginal transducer, prefer-
ably under real-time monitoring. Consideration of having
a chaperone present should be in accordance with local
policy.3
B. Uterus
The vagina and uterus provide anatomic landmarks that
can be used as reference points for the other pelvic struc-
tures, whether normal or abnormal. In examining the
uterus, the following should be evaluated: (1) the uterine
size, shape, and orientation; (2) the endometrium; (3)
the myometrium; and (4) the cervix. The vagina may be
imaged as a landmark for the cervix. The overall uterine
length is evaluated in a sagittal view from the fundus to the
cervix (to the external os, if it can be identified). The depth
of the uterus (anteroposterior dimension) is measured
in the same sagittal view from its anterior to posterior
walls, perpendicular to the length. The maximum width
is measured in the transverse or coronal view. If volume
measurements of the uterine corpus are performed, the
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 Chapter 2 Normal Pelvic Anatomy as Depicted with Transvaginal Sonography
Figure A2-1. Measurement of endometrial thickness. The endometrial
thickness is measured in its thickest portion from echogenic to echogenic
border (calipers) perpendicular to the midline longitudinal plane of the
uterus.
cervical component should be excluded from the uterine
length measurement.
Abnormalities of the uterus should be documented.4
The myometrium and cervix should be evaluated for
contour changes, echogenicity, masses, and cysts. Masses
that may require follow-up or intervention should be mea-
sured in at least 2 dimensions, acknowledging that it is
not usually necessary to measure all uterine fibroids. The
size and location of clinically relevant fibroids should be
documented.
The endometrium should be analyzed for thickness,
focal abnormalities, echogenicity, and the presence of fluid
or masses in the cavity. The thickest part of the endome-
trium should be measured perpendicular to its longitudinal
plane in the anteroposterior diameter from echogenic to
echogenic border (Figure A2-1). The adjacent hypoechoic
myometrium and fluid in the cavity should be excluded
(Figure A2-2). Assessment of the endometrium should
allow for variations expected with phases of the menstrual
cycle and with hormonal supplementation.5-7 It should be
Figure A2-2. Measurement of endometrium with fluid in the cavity. In
the presence of endometrial fluid, measurements of the 2 separate layers
of the endometrium (calipers), excluding the fluid, are added to deter-
mine the endometrial thickness.
Fleischer_CH02_p025-p044.indd 41
41
reported if the endometrium is not adequately seen in its
entirety or is poorly defined. Sonohysterography may be a
useful adjunct to evaluate the patient with abnormal uter-
ine bleeding or to further clarify an abnormally thickened
endometrium. (See the AIUM Practice Parameter for the
Performance of Sonohysterography.) If the patient has an
intrauterine contraceptive device, its location should be
documented.
The addition of 3-dimensional to 2-dimensional ultra-
sound (transabdominal, transvaginal, transperineal, and/or
transrectal) can be helpful in many circumstances, includ-
ing but not limited to evaluating the relationship of masses
with the endometrial cavity, identifying uterine congenital
anomalies and a thickened and/or heterogeneous endome-
trium, and evaluating the location of an intrauterine device
and the integrity of the pelvic floor.8,9
C. Adnexa, Including Ovaries and Fallopian Tubes2
When evaluating the adnexa, an attempt should be made
to identify the ovaries first, since they can serve as a major
point of reference for assessing the presence of adnexal
pathology. The ovarian size may be determined by measur-
ing the ovary in 3 dimensions (width, length, and depth)
on views obtained in 2 orthogonal planes.10 Any ovarian
abnormalities should be documented.11-15
The ovaries may not be identifiable in some patients.
This occurs most frequently before puberty, after meno-
pause, or in the presence of a large leiomyomatous uterus.
The adnexal region should be surveyed for abnormalities,
particularly masses and dilated tubular structures.
If an adnexal abnormality is noted, its relationship
with the ovaries and uterus should be assessed. The size
and sonographic characteristics of adnexal masses should
be documented.
Spectral, color, and/or power Doppler ultrasound may
be useful to evaluate the vascular characteristics of pelvic
lesions.15-19
D. Cul-de-Sac
The cul-de-sac and bowel posterior to the uterus may not
be clearly defined. This area should be evaluated for the
presence of free fluid or a mass. If a mass is detected, its
size, position, shape, sonographic characteristics, and rela-
tionship to the ovaries and uterus should be documented.
Differentiation of normal loops of bowel from a mass
may be difficult if only a transabdominal examination is
performed. A transvaginal examination may be helpful to
distinguish a suspected mass from fluid and feces within
the normal rectosigmoid colon.
VI. DOCUMENTATION
Adequate documentation is essential for high-quality
patient care. There should be a permanent record of the
ultrasound examination and its interpretation. Images of
all appropriate areas, both normal and abnormal, should be
recorded. Variations from normal size should be accompa-
nied by measurements. Images should be labeled with the
08/09/17 4:45 pm
 42 Part 1 GENERAL OBSTETRIC SONOGRAPHY

patient identification, facility identification, examination AIUM

date, and side (right or left) of the anatomic site imaged.
Beryl R. Benacerraf, MD
An official interpretation (final report) of the ultrasound
Steven R. Goldstein, MD
findings should be included in the patient’s medical record.
Elizabeth Puscheck, MD
Retention of the ultrasound examination should be consis-
Laurel Stadtmauer, MD
tent both with clinical needs and with relevant legal and
local health care facility requirements.
Reporting should be in accordance with the AIUM SRU
Practice Parameter for Documentation of an Ultrasound Rochelle F. Andreotti, MD
Examination. Oksana H. Baltarowich, MD
Anna S. Lev-Toaff, MD
VII. EQUIPMENT SPECIFICATIONS
AIUM Clinical Standards Committee
A sonographic examination of the female pelvis should
be conducted with a real-time scanner, preferably using Joseph Wax, MD, Chair
sector, curved linear, and/or endovaginal transducers. John Pellerito, MD, Vice Chair
The transducer or scanner should be adjusted to operate Bryann Bromley, MD
at the highest clinically appropriate frequency, realizing Pat Fulgham, MD
that there is a trade-off between resolution and beam Charlotte Henningsen, MS, RT, RDMS, RVT
penetration.3 Alexander Levitov, MD
Vicki Noble, MD, RDMS
VIII. QUALITY CONTROL AND Anthony Odibo, MD, MSCE
David Paushter, MD
IMPROVEMENT, SAFETY, INFECTION Dolores Pretorius, MD
CONTROL, AND PATIENT EDUCATION Khaled Sakhel, MD
Shia Salem, MD
Policies and procedures related to quality control, patient
Jay Smith, MD
education, infection control, and safety should be devel-
Paula Woodward, MD
oped and implemented in accordance with the AIUM
Standards and Guidelines for the Accreditation of Ultra-
sound Practices. ACOG
Equipment performance monitoring should be in Daniel M. Breitkopf, MD
accordance with the AIUM Standards and Guidelines for Wendy R. Brewster, MD, PhD
the Accreditation of Ultrasound Practices. John W. Seeds, MD

IX. ALARA PRINCIPLE SPR

The potential benefits and risks of each examination
should be considered. The ALARA (as low as reasonably
achievable) principle should be observed when adjusting
controls that affect the acoustic output and by considering
transducer dwell times. Further details on ALARA may
be found in the AIUM publication Medical Ultrasound
Safety, Third Edition.
ACKNOWLEDGMENTS
This parameter was revised by the AIUM in collaboration
with the American College of Radiology (ACR), the Ameri-
can College of Obstetricians and Gynecologists (ACOG),
the Society for Pediatric Radiology (SPR), and the Society
of Radiologists in Ultrasound (SRU) according to the pro-
cess described in the AIUM Clinical Standards Committee
Manual.
ACR
Marcela Bohm-Velez, MD, Chair
M. Stephen Ledbetter, MD, MPH
Henrietta Kotlus Rosenberg, MD
Jason M. Wagner, MD
Amy N. Dahl, MD
Kassa Darge, MD, PhD
Lynn A. Fordham, MD
REFERENCES
1. Garel L, Dubois J, Grignon A, Filiatrault D, Van Vliet G. US of the
pediatric female pelvis: a clinical perspective. Radiographics. 2001;
21:1393-1407.
2. Rosenberg, HK, Chaudhry H. Pediatric pelvic sonography. In:
Rumack CM, Wilson SR, Charboneau JW, Levine D, eds. Diag-
nostic Ultrasound. 4th ed. Philadelphia, PA: Elsevier Mosby;
2011:1923-1981.
3. Stagno SJ, Forster H, Belinson J. Medical and osteopathic boards’
positions on chaperones during gynecologic examinations. Obstet
Gynecol. 1999;94:352-354.
4. Ascher SM, Imaoka I, Lage JM. Tamoxifen-induced uterine abnor-
malities: the role of imaging. Radiology. 2000;214:29-38.
5. Bree RL, Bowerman RA, Bohm-Velez M, et al. US evaluation of the
uterus in patients with postmenopausal bleeding: a positive effect on
diagnostic decision making. Radiology. 2000;216:260-264.
6. Bree RL, Carlos RC. US for postmenopausal bleeding: consensus
development and patient-centered outcomes. Radiology. 2002;
222:595-598.
7. Nalaboff KM, Pellerito JS, Ben-Levi E. Imaging the endometrium:
disease and normal variants. Radiographics. 2001;21:1409-1424.
8. Fong K, Kung R, Lytwyn A, et al. Endometrial evaluation with trans-
vaginal US and hysterosonography in asymptomatic postmenopausal

Fleischer_CH02_p025-p044.indd 42 08/09/17 4:45 pm

Another random document with
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transversely, the vessels of the lumbar region are compelled to describe a
somewhat prolonged vertical course before reaching their point of
distribution. From these circumstances, even transitory congestions in the
circulation of the cord are easily followed by irreparable injury of its
delicate elements.
133 Loc. cit., Path. Trans., 1884.

Finally, in all discussions on pathogeny must not be forgotten the doctrine

of Leyden134 that infantile paralysis, also progressive muscular atrophy, is
a disease which may begin at the periphery and extend to the centres, as
well as the reverse. It must also be remembered that, as yet, only very
scanty evidence exists to support this, in itself, plausible theory.
134 See loc. cit., ut supra.

COURSE OF INFANTILE PARALYSIS.—The most ordinary course of infantile

paralysis is that already described as typical—namely, extremely rapid
development to a maximum degree of intensity, then apparent
convalescence, retrocession of paralysis, atrophy, and ultimate
deformities in limbs in which paralysis persists.

Several variations from this typical course are observed. Complete

recovery may take place, as in the so-called temporary paralysis of
Kennedy135 and of Frey.136 These cases are very rare. But their possibility
seriously complicates the estimate we may make of the efficacy of
therapeutic measures.137
135 Dublin Quarterly Journal, 1840.

136 Berlin. Klin. Wochensch., 1874. I have described one such temporary case in the article
already quoted. These cases seem about as frequent in adults. (See Frey, loc. cit.; also case
of Miles, etc. etc.)

137 As of the case of complete recovery, the only one the author had seen, related by Dally,
Journal de Thérap., 1880, 1, vii.

On the other hand, there may be a complete absence of regression; and

this is observed sometimes in cases where the paralysis is originally
limited; sometimes where it is extremely extensive, involving nearly all the
muscles of the trunk or limbs;138 or muscles or limbs originally spared may
become involved in a fresh attack. Laborde relates cases of this kind. In
Roger's first case paraplegia occurred under the influence of scarlatina
two months after paralysis of one arm.
138 Thus in Eulenburg's case, quoted ut supra.

The form of anterior poliomyelitis most frequent in adults is the subacute,

and after that the chronic. Both are extremely rare in children, the latter
excessively so. Seeligmüller and Seguin139 both admit the possibility of a
chronic form in children, and the latter has kindly communicated to me
one case from his private practice:

Miss N. D——, æt. 15, paresis in both legs, first at age of nine, increased
at age of twelve, when weakness of vision first noted. At fourteen both
feet in rigid pes equinus, and both tendons achilleis cut, without benefit.
Hands became tremulous, without paresis. On examination at age of
fifteen found moderate atrophy of muscles of both legs. Tendo Achillis
united on both sides, and equinus persists. Voluntary movement exists,
both in anterior tibial and in gastrocnemius muscles, but diminished in
anterior tibial. Faradic contractility diminished in both sets of muscles;
examination difficult from extreme sensibility of patient. In both hands
interossei, muscles of thumb, and little finger show tremors and fibrillary
contractions. Thenar eminences small, abductor pollicis nearly absent,
not reacting to faradic current. Optic nerves slightly atrophied. Mind
enfeebled, memory poor; articulation not affected. Five years later the
motor paralysis and mental enfeeblement had still further progressed, but
no exact notes exist of this period.
139 Loc. cit. (ed. 1877).

Erb140 relates a case that he considers unique at the time in a girl of six.
The paralysis began insidiously in the right foot in July; a fortnight later
had extended to the left foot; complete motor paralysis existed in August,
without any lesion of sensibility: after electrical treatment, then instituted,
first return to motility to peroneal muscles in November; by January child
able to walk again and electrical reactions nearly normal.141
140 Brain, 1883.

141 In the same number of Brain, A. Hughes Bennett quotes cases of so-called chronic
paralysis in very young children which are evidently cases of general paresis from congenital
 cerebral atrophy. The children were defective in intelligence, could not sit up nor hold up the
head; the electrical reactions were preserved. I have seen a great many such cases: they
are indeed not at all uncommon. Much more so is Bennett's diagnosis.

COMPLICATION WITH PROGRESSIVE MUSCULAR ATROPHY.—Raymond142 and

Seeligmüller describe some rare cases where progressive muscular
atrophy declared itself in persons previously affected with infantile
paralysis in other limbs. Both observers infer a gradual and chronic
extension along the cord of the originally acute anterior poliomyelitis.143
Similar cases have much more recently (1884) been quoted by Ballet as
tending to modify the prognosis which has usually been pronounced
favorable quoad life and further spinal accidents. (See infra.)
142 Gaz. méd., 1875. No. 17.

143 It seems to me that Seguin's case, above quoted, might be an example of such
complication(?). But I have not seen the patient myself, and describe the case according to
the views of the author.

PROGNOSIS.—The prognosis of atrophic paralysis, quoad vitam, is, as is

well known, extremely good. The prospect of recovery from the paralysis
is variable. It cannot be estimated either by the extent of the initial
paralysis or by the severity of the fever or attendant nervous symptoms.
The electrical reactions alone are of value in the prognosis, and their
value is very great. Duchenne first formulated their law: “All the cases of
infantile paralysis which I have seen where the faradic contractility was
diminished but not lost, and which could be treated by faradic electricity
within two years after the onset of the paralysis, have completely
recovered.”144 This encouraging statement must be read as applying
rather to individual muscles than to cases as a whole. Few complete
recoveries of patients are claimed even by so enthusiastic an electrician
as Duchenne; who nevertheless affirms his not unfrequent success in re-
creating entire muscles out of a few fibres saved from degeneration.
144 Loc. cit.

The persistence of galvanic irritability in muscles which fail to contract to

the faradic current has been shown by Erb to belong to the degenerative
reactions. Hammond, however, without alluding to the qualitative changes
in the galvanic contractions, sees in them the elements of a relatively
favorable prognosis, even when faradic contractility is lost. Thus, out of
87 cases, in 39 of which the paralyzed muscles contracted to the galvanic
but not the faradic current, 14 were entirely cured, 28 greatly improved,
30 slightly improved, 15 discontinued treatment very early.145
145 Loc. cit., p. 482.

Examination of fragments of living muscle obtained by Duchenne's

harpoon, though useful, should not be allowed to exaggerate an
unfavorable prognosis. Much fat may be found in such fragments when
the muscle is as yet by no means completely degenerated and can be
made to contract to one or the other current. Erb, however, admits that
the results of treatment have not, in his hands, been brilliant; but adds
that he has had no opportunity to treat any cases which were not of long
standing.146
146 Loc. cit.

Volkmann147 considers the paralysis entirely hopeless, and advises the

concentration of all effort upon the prevention or palliation of deformities.
147 Loc. cit.

It seems probable that at the present moment sufficient data do not exist
for formulating a fair prognosis; nor will they until a much larger number of
cases than hitherto have been submitted to all the resources of a complex
and persevering system of therapeutics from the earliest period of the
disease.

SPECIAL PARALYSES.—Among the paralyses, some exercise a more

unfavorable influence on locomotion than others. Thus, paralysis of the
muscles of the trunk is more difficult to palliate, either by apparatus or by
the efforts of the patient, than any paralysis of the limbs. Similarly,
paralysis of the upper segments of a limb is more crippling than when
confined to the lower. Partial paralysis of the muscles surrounding a joint
is often (but not always) more liable to lead to deformity than total
paralysis.

Influence of Neglect.—Apart from the influence of treatment in curing the

paralysis, must be estimated in the prognosis the effect of care and
watchfulness in limiting the disease and in averting many consequences,
even of those which are incurable. The rescue of muscles only partially
degenerated may often serve to compensate the inaction of those which
are irretrievably ruined.

Ballet148 has recently called attention to the fact that in certain cases
persons who had been attacked with an anterior poliomyelitis in childhood
became predisposed to different forms of spinal disease. Four have been
observed: (1) transitory congestion of the cord, causing paralysis of a day
or two's duration; (2) an acute spinal paralysis of the form usually seen in
adults; (3) subacute spinal paralysis; (4) progressive muscular atrophy.
The author relates cases under each of these heads, and further quotes
one related by Dejerine in 1882.149 The patient, a carpenter aged fifty-five
and with an atrophic deformity of the foot, became suddenly paralyzed in
the four limbs, trunk, and abdomen. The paralysis was complete in a
month, was stationary for three months, then began to improve, and at
the end of six months from the onset of the disease recovery was
complete.
148 Revue de Médecine, 1884.

149 Revue de Médecine, 1882.

The observations of progressive muscular atrophy in persons bearing the

stigmata of an infantile paralysis are quite numerous.150
150 Charcot, Soc. Biol., 1875, and Gaz. méd.; Seeligmüller (4 cases), in Gerhardt's
Handbuch, 1880; Hayem, Bull. Soc. de Biol., 1879; Vulpian, Clinique méd. de la Charité,
1879; Pitres, new observation, quoted by Ballet in 1884.

The prognosis cannot be the same for cases where everything is done to
avert malpositions and for those where all precautions are neglected.
Thus, prolonged rest in bed favors pes equinus; the use of crutches
necessitates flexion of the thigh and forced extension of the foot;
locomotion without support tends to displace articulations by
superincumbent weight, causing pes calcaneus, genu-recurvatum. Finally,
compensatory deformities must be averted from sound parts, as scoliosis
from shortening of the atrophied leg, equinus from passive shortening of
the gastrocnemii through flexion of the leg, etc.

ETIOLOGY.—Concerning the etiology proper of infantile paralysis little

definite is known. It is probable, as has been already noticed, that
traumatisms have a much more decided influence than is generally
assigned to them. Leyden particularly insists on this influence, and on the
facility with which a traumatism relatively severe for a young child may be
overlooked, because it would not be recognized as such for an adult. It
must be noticed, however, that children are much more liable to have the
arms wrenched and pulled violently than the lower extremities; yet in a
great majority of cases the lesion is situated in the lumbar cord.

It has been shown that the myelitis, though so limited transversely, is

often far more diffused in the longitudinal axis of the cord than might be
supposed from the permanent paralyses. This fact corresponds to the
initial generalization of the motor disturbance. It seems possible that the
traumatic irritation, starting from the central extremity of the insulted
nerve, diffuses itself through the cord until it meets with its point of least
resistance, and here excites a focal myelitis. That this point should most
frequently be found in the lumbar cord would be explained by its relatively
less elaborate development, corresponding to the imperfect growth and
function of the lower extremities.

A second cause of anterior poliomyelitis is, almost certainly, the presence

of some poison circulating in the blood. The frequent occurrence of the
accident in the course of one of the exanthemata is one indication of this;
other indications are found in such cases as that related by Simon, where
three children in one family were suddenly attacked—two on one day,
one, twenty-four hours later.151 The same author relates a case of motor
paralysis in an adult, followed by atrophy of left lower extremity, and which
occurred during a fit of indigestion caused by eating mussels.152 The
acute ascending paralysis of Landry, with its absence of visible lesion,
has been said to strikingly resemble the effects of poison. Hydrophobia
and tetanus are again examples of the predilection exhibited by certain
poisons for the motor regions of the cord.
151 Journal de Thérap., 7, vii., 1880, p. 16. These children belonged to an American family,
but were seen by several distinguished French physicians.

152 P. 357.

The evidence that infectious diseases may constitute the immediate

(apparent) causal antecedent of acute poliomyelitis has led, not
unnaturally, to the theory that all cases of acute infantile paralysis are due
to a specific infecting agent, some as yet unknown member of the great
class of pathogenic bacteria. It may be noticed, however, that the
occurrence of the spinal accidents after the ordinary infectious diseases,
as scarlatina and measles, should as well indicate that a specific agent
proper to itself was at least not essential to its development.153
153 Perhaps the occurrence of diphtheria in the course of scarlatina and typhoid should
indicate a similar lack of real specificity in the morbid agent of the former disease.

The influence of exposure to cold, which seems to have been sometimes

demonstrated, must probably be interpreted, as in the case of
rheumatism and pneumonia, as effective by means of some poison
generated in the organism when cutaneous secretion, exhalation, or
circulation has been suddenly checked.

DIAGNOSIS.—The diagnosis of the acute anterior poliomyelitis of childhood

is usually easy, but unexpected difficulties occasionally arise.

Typical cases are markedly different from typical cases of cerebral

paralysis, but in exceptional cases these differences disappear. This is
shown in the following table:

SPINAL PARALYSIS. CEREBRAL PARALYSIS.

Hemiplegic, (rule). Monoplegic as residuum of
Paraplegic or monoplegic (rule). hemiplegia or as consequence of solitary tubercle
(exception).
Hemiplegic as residuum from paraplegia, or
original and involving facial nerve (very
exceptional).
Intelligence free (rule). Intelligence depressed (rule).
Intelligence depressed (when spinal paralysis Intelligence free (exception, especially with solitary
has affected imbecile children). tubercle).
Disposition lively. Disposition apathetic or cross.
Initial convulsion unique; general symptoms Convulsions repeated; pyrexia prolonged several
of a few hours' duration (rule). days or weeks (rule).
Convulsion repeated during two to three
weeks before paralysis; fever a month (rare
exceptions).
Sensibility intact (rule). Sensibility intact after initial period.
Occasional hyperæsthesia (exception).
Reflexes cutaneous, and tenderness lowered
Reflexes intact.
or lost (rule).
Reflexes preserved when only single
muscles in groups paralyzed.
Associated movements of hand absent Associated movements frequently observed in
(Seeligmüller). hand.
Extensive and rigid contractions of upper extremity
No rigid contractions of upper extremity.
very frequent.
Atrophy of paralyzed muscles and arrested
Atrophy very slight.
development of limb, very marked.
Faradic contractility diminished or lost;
Electrical reactions normal.
degenerative galvanic reaction.

Rather singularly, the diagnosis from transverse myelitis is less liable to

error than that from cerebral paralysis:

ANTERIOR
TRANSVERSE MYELITIS.
POLIOMYELITIS.
Fever brief or absent. Persistent fever.
Sensibility intact. Hyperæsthesia, then anæsthesia.
Decubitus absent. Presence decubitus.
Reflexes lost. Reflexes increased.
Atrophy of muscles. Atrophy of muscles sometimes as intense.
Electrical muscular Loss of electrical contractility, but not proportioned to sensory and motor
contractility lost. disturbance; less rapidly completed.

The diagnosis from hæmatomyelitis is almost impossible, and practically

useless. For if the hemorrhage be severe, the child dies at once, as in
Clifford Albutt's case. If less severe, it excites a myelitis, and the history
becomes identical with that of the disease we are considering; or if the
clot beyond the anterior cornua, it is identified with a vulgar myelitis of
traumatic origin.

Progressive muscular atrophy is extremely rare in childhood, but is

occasionally seen under hereditary influence (Friedreich's disease). In
adult cases confusion is not only easy to make, but often difficult to avoid,
especially with the rare, chronic form of poliomyelitis. The basis of
distinction is as follows:
 ANTERIOR POLIOMYELITIS. PROGRESSIVE MUSCULAR ATROPHY.
Onset sudden; maximum of paralysis at the March very gradual; maximum of disease
beginning. not attained for years.
Faradic contractility not lost until atrophy
Faradic contractility lost almost at once.
complete.
Shortening of limbs and atrophy of limbs (in
No arrest of development of limbs.
infantile cases).
Functionally associated muscles frequently Capricious selection of muscles, but frequent
associated in paralysis: hand rarely affected. wasting of these at eminences.

Paralysis from lesion of a peripheric nerve closely imitates anterior spinal

paralysis.154 It is distinguished by closely following the distribution of the
injured nerve, and, usually, by concomitant lesions of the sensibility and of
cutaneous nutrition.
154 The importance of this fact has been shown in the section on Pathogeny. (See also
quotations from Leyden and remarks on lesions of peripheric nerves.)

The pseudo-paralysis sometimes observed in syphilitic children as a

consequence of a gummatous infiltration of the bones at the junction of
the epiphysis and diaphysis155 might easily be mistaken for a spinal
paralysis. But it is an affection peculiar to the new-born; the electrical
reactions of the paralyzed muscles are intact; careful examination will
show that the movements of the muscles are not impossible, but
restrained by pain; often other syphilitic affections are present.
155 Parrot, Wagner.

The diagnosis from diphtheritic paralysis is embarrassed, from the fact

that true anterior poliomyelitis may develop in the course of diphtheria as
of other infectious diseases. The paralysis of the soft palate, preservation
of faradic reaction, absence of atrophy, and the usually rapid recovery
must establish the differentiation.

In spinal paralysis there is loss of the reflexes,156 and also of faradic

contractility, both of which are preserved in hysteria. In hysterical
paralysis, also, there is no wasting of the affected muscles.
156 See Gowers's monograph on “Spinal-Cord Diseases” for an excellent summary of the
spinal reflexes.
Various diseases of the bony skeleton or articulations may simulate spinal
paralysis. Congenital club-foot, caused by unequal development of the
bones and cuticular surfaces, is to be distinguished from the paralytic
variety by the date of its appearance,157 by the deformity of the tarsal
bones, and by the extreme difficulty of reduction.
157 Though in some cases paralysis of the muscles of the foot seems to take place during
fœtal life, and a club-foot result which is both congenital and paralytic.

Caries of the calcaneum, leading the child to walk on the anterior part of
the foot to avoid pressure on the heel, may leave after recovery such a
retraction of the plantar fascia as to cause a degree of equinus and varus,
with apparent paralysis of the peroneal muscles. I have seen one such
case.

Congenital luxation of the hip may simulate paralysis; indeed, by Verneuil,

it has been attributed to an intra-uterine spinal paralysis. There is,
however, no change in the electrical reactions of the muscles surrounding
the joint.

In coxitis, however, Newton Shaffer158 has demonstrated a moderate

diminution of faradic contractility in such muscles, and a corresponding
degree of atrophy; and this fact might complicate the diagnosis of
paralysis from arthritis of the hip-joint. Gibney159 has called attention to
the facility with which this confusion may arise, and Sayre160 relates cases
of infantile paralysis mistaken for coxitis.
158 Archives of Medicine.

159 Am. Journ. Med. Sci., Oct., 1878.

160 Orthopædic Surgery.

In a case observed by myself, which had been previously diagnosed as

coxitis, the mistake was all the more interesting as the paralysis which
really existed seemed to have been caused by a meningitis rather than
primary myelitis of the cornua.161 It thus corresponded to the meningo-
myelitic case related by Leyden.
161 The details of this case are as follows: C. P——, aged 11, ten months previous to
consultation suffered from febrile attack, accompanied by retraction of head, severe pains
 diffused through body and intense at nape of neck; unconsciousness for thirty-six hours;
vomiting; no convulsions. Case diagnosed as cerebro-spinal meningitis by attendant
physician. Convalescence in a week, but with pain in lumbar region of back, predominating
on right side, so aggravated by standing or walking that both acts impossible. Coincidently,
pain in right calf; exquisite tenderness to pressure even from stocking. No complaint in
recumbent position. Child could not get from floor to bed, nor raise right leg from ground. As
pain subsided walking became possible, but right leg dragged. Chronic twitchings on left
side, face, arm, leg. These symptoms lasted ten or twelve weeks, but at end of nine weeks
patient could walk up stairs. In ten months power of walking almost recovered, but there
remained a certain amount of lordosis and oscillation of pelvis, which is jarred on the left
side while the right leg is swung forward. Recumbent, all movements executed equally well
on both sides and passive motion of the hip-joint perfectly free. Circumference of right thigh
and leg diminished from one-half to one inch as compared with the left. Faradic contractility
diminished on the right side in the gluteal muscles, vastus externus, and rectus, and in the
gastrocnemii. The sacro-lumbalis muscle was, unfortunately, not examined, but from the
lordosis was probably affected. The remaining muscles were intact. Pain on pressure
persisted over right side of second, third, and fourth lumbar vertebræ. Diagnosis was made
of a limited meningeal exudation, with compression of anterior part of cord or of a portion of
the lumbar and of the sacral plexus.

Scoliosis, which may be caused by the relatively rare unilateral paralysis

of some of the muscles of the trunk, may also be simulated by paralysis
with shortening of one lower extremity. To compensate the shortening, the
trunk is bent over on the paralyzed side; hence a lateral curvature, easily
reducible, but easily leading into error.

It would seem easy to distinguish traumatic cases of subluxation of the

humerus from those due to paralysis of the deltoid. Yet sometimes only
the history will serve to establish, and that somewhat doubtfully, the
diagnosis.162
162 A child of four was brought to me with a stiffness and rigidity of the shoulder-joint which
could only very partially be overcome by passive motion, and not at all by voluntary effort.
The mother stated that several months previously the child had, without apparent cause,
become suddenly unable to move the arm. After two months' delay it was taken to a
dispensary, and told that the arm was out of joint, and had it reset under ether. From this
date the stiffness had gradually developed. The deltoid was atrophied, with marked
diminution of the faradic contractility. Question: Were these signs merely symptomatic of an
arthritis consequent on a dislocation, or was the latter the result of a spinal paralysis of the
deltoid?
THERAPEUTICS.—The treatment of anterior poliomyelitis embraces two
stages. In the first it is directed against inflammation of the spinal cord
and the paralysis of the muscles; in the second period the spinal lesion
has run its course and the paralysis is considered incurable. Treatment is
then directed to the prevention or palliation of deformities or toward
facilitating the functions of the limb in spite of them.

These two periods are not, however, rigidly separated from each other in
chronological order. From the very outset it is important to take certain
precautions to prevent deformities, and while palliating these with
orthopædic apparatus it is important for years to continue treatment of the
paralyzed muscles in the hope that at least a remnant of them may be
saved. To abandon the case to the orthopædic instrument-maker, or to
neglect the problem of dynamic mechanics while applying electricity and
studying the progress of fatty degeneration, are errors greatly to be
condemned.

The treatment of the initial stage is necessarily purely symptomatic for the
fever and convulsions, since the diagnosis cannot be made out until these
have subsided.

As soon as the diagnosis is clear, however, certain measures should be

adopted to diminish the hyperæmia of the spinal cord. Dally163
recommends the ventral decubitus; almost all modern authorities advise
ice to the spine and ergot internally or subcutaneously. Thus, Althaus164
makes hypodermic injections of ergotin in doses of one-fourth of a grain
for a child between one and two years old; one-third of a grain between
three and five; and one half grain from five to ten; and these doses
repeated once or twice daily. The only objection to this treatment is the
degree of local irritation it can hardly fail to occasion. Hammond, who
“affirms ergot to be of great service, the only medicine capable of cutting
short the disease or of limiting its lesions,” recommends the internal
administration of the fluid extract—ten drops three times a day for infants
of six months, half a drachm for children between one and two years.165
163 Journ. Thérap., t. viii., 1880.

164 On Infantile Paralysis.

 165 I have elsewhere quoted one case of early recovery under the use of ice and ergot; or
was this a case of temporary paralysis?

The belladonna treatment, at one time so warmly praised by Brown-

Séquard, retains to-day few adherents.

Simon advises cutaneous revulsives to divert the circulation to the

surface; thus, hot-air baths, mustard powder sprinkled on cotton
enveloping the limbs. Ross advises mercurial inunction along the spine,
followed by iodine and blisters. At the same time, iodide of potassium
should be given internally in large doses. The action of this drug upon
inflammations of the nerve-centres seems, within certain limits, to be
indisputable, but its mode of action is certainly very obscure. Where the
lesion can be attributed to a meningo-myelitis,166 the iodide may be
expected to facilitate the absorption of the exudation. In these cases it
should be continued for a long time.167
166 As in Leyden's first case, and my own.

167 Binz explains the local action of iodine by an exudation of leucocytes which follows the
dilatation of blood-vessels. These elements break down the exudation into which they are
poured, and thus facilitate its absorption.

Electrical treatment may be begun by the end of the first week after the
paralysis. At this stage Erb recommends central galvanization as an
antiphlogistic remedy for the myelitis. For this purpose a large anode
must be placed over the spine at the presumed seat of the lesion, while
the cathode is applied over the abdomen. By a slight modification of the
method the cathode is placed over the paralyzed muscles. The
application is stabile, and, according to Erb, should last from three to ten
minutes; according to Bouchut, several hours daily. Erb's method is
intended exclusively as a sedative to the local inflammation. When the
cathode is placed on the muscles it is hoped that the descending current,
replacing the lost nervous impulses, may avert the threatening
degeneration of the muscle and nerve.

Faradization cannot modify the inflammatory lesions of the cord. As a

means of averting degeneration in completely paralyzed muscles it is
inferior to galvanism, and should not therefore be used in those muscles
which refuse to contract under its stimulus. Its immense utility, however, is
as a stimulus to muscles imperfectly paralyzed, but liable to degenerate
from inaction and to be overborne by their antagonists. The excitation of
contractions in such muscles is a powerful local gymnastic, helping to
maintain nutrition by artificially-excited function.

For the same purpose, muscles inexcitable to the faradic current should
be, when this is possible, made to contract by the interrupted galvanic
current. After this treatment has been prolonged during several months,
the faradic contractility often returns, and the current then should be
changed (Seguin).

The value of electrical treatment has been very differently estimated. Erb
remarks that “its results are not precisely brilliant.” Roth, whose testimony
perhaps is not above suspicion, since evidently prejudiced, insists that
numerous cases fall into his hands which have submitted for months to
electrical treatment without the slightest benefit. On the other hand,
Duchenne, as is well known, has expressed almost unbounded
confidence in the therapeutic efficacy of faradization, declaring that it was
capable of “creating entire muscles out of a few fibres.”

The sensitiveness of children to the electrical current, and their terror at

its application, seriously interfere with its persistent use; as, if the
patience of the physician is maintained, that of the parents is very likely to
fail in the presence of the cries and resistance of the child.

It is very probable that some of the failures of electrical treatment are due
to the attempt to rely upon it exclusively, instead of suitably combining
both electrical methods with each other and with other remedial
measures. With our present knowledge it is safe to assert the desirability
of persistent electrical treatment during at least the first two years
following the paralysis. The currents must never be too strong—the
faradic, at least, never applied for longer than ten minutes at a time. The
muscles should be relaxed by the position of the limbs (Sayre). If the
muscles continue to waste, and especially if they become fatty, the
electrical response will grow less and less, and finally cease altogether.168
In the contrary case the galvanic contraction will become normal in
quality, and the faradic contractility will return and increase, while the
atrophy is arrested and the muscle regains its bulk and voluntary powers.
Sometimes, as already stated, the latter is regained, while faradic
contractility remains greatly diminished.169
 168 Passing through three stages: faradic contractility diminished, galvanic contraction
increased; faradic response lost, galvanic degenerative; absence of contraction to either
current.

169 Sayre (loc. cit.) has noticed cases in which the muscle would contract several times
under faradism, then refuse to do so for a day or two. This observation, if valid and not due
to unequal working of the battery, is a most curious one.

A succedaneum to electricity that is highly prized by some authorities is

strychnia, especially when subcutaneously administered. Pelione170
relates the cure of two cases in children of four and five years, after three
and four years' duration of the paralysis, by strychnia—one-half
milligramme daily. None should be given to children under six months, but
over that age one-ninety-sixth of a grain may be given (Hammond). It
should not be given subcutaneously more than two or three times a week
(Seeligmüller).171
170 L'Union médicale, 1883.

171 Duchenne relates a case of a paralysis general at the outset and remaining so for six
months. It was then treated by strychnine for five or six months, and at the end of that time
had become limited to the lower extremities (Elect. local., ed. 1861, p. 278).

The incidental action of electricity in attracting blood to the paralyzed

muscles may be sustained by several other methods.

Among these the external application of heat, either dry or in the form of
hot douches, alternating with cold, is an adjuvant remedy of real
importance. Beard has suggested tubing, malleable to the limbs, for the
conduction of hot water. It is desirable to employ massage immediately
after cessation of the hot applications.

On the value of massage and passive gymnastics opinion is even more

variable than in regard to electricity. Roth, a specialist in orthopædics,
places it at the head of all remedial measures, and denounces electricity
in comparison. Many professional manipulators, ignorant of medical
science, continually claim wonderful triumphs over regular physicians
obtained by means of systematized massage. Volkmann, on the other
hand, dismisses the pretensions of the Heilgymnastik with considerable
contempt, declaring that faradization is the only method which can really
secure exercise to paralyzed muscles.
The Swedish movement cure consists in passive movements imparted to
a limb by the manipulator, at the same time that they are strenuously
resisted by the patient. From the nature of this method, and its aim in
stimulating the voluntary innervation of the muscles, it is admirably
adapted to hysterical paralysis. Theoretically, it is difficult to perceive the
applicability of this method in organic atrophic paralysis, especially in
young children, whose voluntary efforts cannot be commanded. There
are, however, several real indications for passive gymnastics in the
treatment of infantile paralysis. Surface friction and deep massage have
some influence in dilating the blood-vessels and causing an afflux of
blood to the cold and wasting muscles. A probably more important effect
may be produced upon the contraction caused by malposition and
adapted atrophy of certain groups of muscles. It is these contractions
which formerly constituted the special objection of the orthopædist, and
were treated almost universally by tenotomy. They are in any case the
proximate cause of deformities; and, generally existing on the side of the
joint opposite to the most severely paralyzed muscles, they keep these
over-stretched and prevent them from receiving the benefit of the
electrical treatment. Muscles which will not contract to the faradic current
while thus stretched will often begin at once to do so when the rigidity of
their antagonists has been overcome.

Persevering stretching by the hands will often overcome this rigidity as

completely, and even more permanently, than will the tenotomy-knife. It is
in this part of the treatment that entirely ignorant and even charlatan
manipulations do, not unfrequently, achieve remarkable results.172
172 Of course many of those on record, and to some of which I have been a witness, relate
to hysterical contractions, hysterical scoliosis, etc.

It is the retracted tendo Achillis and plantar fascia which most frequently
require this manipulation. In the paralytic club-foot of young children all
authorities agree in the value of repeated manipulations and restorations
of the foot as nearly as possible to a position where it may be retained by
simple bandaging. While turning the foot out it becomes perfectly white,
but on releasing hold of it the circulation is restored, after which the
manœuvre may be repeated (Sayre).

This principle of intermittent stretching by seizure of the segments of the

limb above and below the joint applies to all forms of paralytic contraction.
In the trunk the pelvis should be held by the mother, while the
manipulator, seizing the thorax of the child between both hands, moves it
gently but forcibly to and fro in the required direction. Great care is
required in these manipulations—not merely to avoid exhausting the
muscles, but even to avoid fracturing atrophied bones.

It may be laid down as a positive rule that tenotomy should never be

performed in the contractions of spinal paralysis until the resources of
manipulation have been exhausted. It is to be remembered that the
rigidity depends on no active contraction of the muscle, but on its elastic
retraction. The manœuvre of stretching does not appeal to the force of
contractility, which may have been lost, but to the force of elasticity, which
remains and can be made to act in a reverse direction. Finally, in the
cases where the retracted muscles have not been originally paralyzed,
but have lost the power of contracting during the process of shortening,
this power may be restored if the muscle regain its normal length.

The operation of tenotomy, apparently a far more heroic measure, is often

a less efficacious means of arriving at the results. Unless followed by the
application of apparatus which permits motion in the joint, section of
contracted tendons is only of brief utility.

Though the edges of the cut tendon have been kept apart until the
intervening space is filled by new tissue, union is finally effected by the
latter, and retraction through elasticity is again imminent. Often, therefore,
the deformity is repeated in spite of repeated operations; when it is not,
the happy issue is due to the fact that, with increased freedom of
locomotion immediately after the tenotomy, the patient has been enabled
to bring the influence of weight to bear in such a manner as to fix the limb
in a new and more convenient position. Thus, after section of the tendo
Achillis for pes equinus, if the patient begins at once to walk on the
paralyzed foot, the weight of the body, pressing down the heel, may keep
the tendon stretched. So walking immediately after section of the
hamstring muscles will have a tendency to produce genu-recurvation by
the same mechanism which produces it in total paralysis, and the original
deformity will not recur.

Besides the tendo Achillis, the parts which may be occasionally submitted
to tenotomy are the plantar fascia, the peroneal muscles, very rarely the
anterior tibial and extensors, the hamstrings, the thigh adductors. Section
of the external rotators of the thigh or of the tensors of the fascia lata
could hardly ever be required, and among these operations Hueter173
rejects that on the plantar aponeurosis as inadequate. The excavation in
the foot it is designed to remedy depends upon alteration in the form of
the tarsal bones, and can only be cured by means of forcible pressure
exerted on their dorsal surface. Section of the peroneal muscles, often
recommended by Sayre, is considered by Hueter to be superfluous after
section of the tendon achilleis. Paralytic contraction of the hamstrings or
of the hip flexors is rarely sufficiently severe to demand tenotomy.
173 Loc. cit., p. 416.

From what has preceded it is evident that maintenance of locomotion is of

great importance, in order to avoid the deformities which are threatened
by prolonged repose. Locomotion, however, can only be safely permitted
with the assistance of apparatus capable of restraining the movements
liable to be produced by the weight of the body. The supporting
instrument which restrains movement in certain directions must, however,
facilitate it in others: immovable apparatus, such as is not infrequently
applied after tenotomy, is always injurious.

In young children unable to walk, the development of pes equinus may

often be prevented by drawing down the foot to a sole splint made of thin
wood, gutta-percha, or felt, and fastening it with a flannel bandage. The
point of the foot may be drawn up toward the tibia by a strip of diachylon
plaster. If the equinus has already developed, a splint of gutta-percha or
of felt (Sayre) may be modelled to the leg and foot while the latter is held
forcibly in dorsal flexion. The splint is attached by means of strips of
adhesive plaster. It should extend as far as the knee, and be suitably
padded (Seeligmüller).

In children able to walk a sole splint of thin metal, to which the foot had
been previously attached by a flannel band, should be inserted in a stout
leather boot. On the outer side of this boot should run a metallic splint,
jointed at the ankle and extending to a leather band surrounding the leg
just below the knee. A broad leather band, attached to the outer edge of
the sole anterior to the talo-tarsal articulation, also passes up on the
outside of the foot, gradually narrowing until, opposite the ankle, it passes
through a slit in the side of the shoe, to be attached to the leg-splint. This
band tends to draw the point of the foot outward, and thus correct the
varus (Volkmann). Sayre174 has improved on this shoe by dividing the sole
at the medio-tarsal articulation, in which lateral deviation takes place, and
uniting the anterior and posterior parts by a ball-and-socket joint,
permitting movement in every direction.
174 Loc. cit., p. 88.

The orthopædic boot for the treatment of calcaneo-valgus is constructed

on the same principle. But the splint runs up the inner side of the leg, and
the leather strap passing to it from the edge of the sole draws the point of
the foot inward and raises its depressed inner border (Volkmann).
Essential to the treatment of this deformity, however, is the elevation of
the heel. This is effected by means of a gutta-percha strap which is
attached below to a spur projecting from the heel of the shoe, and above
to a band encircling the leg. If, by rare exception, a paralytic calcaneus
exists in a child unable to walk, a simple substitute may be found for the
shoe in a board sole-splint projecting behind the heel, attached to the foot
by a strip of adhesive plaster, which finally passes from the posterior
extremity of the board up the back of the leg, and is there secured by a
roller bandage.

The device of the gutta-percha elastic band to replace the gastrocnemius

muscle illustrates a principle of wide application in orthopædic apparatus.
The suggestion to replace paralyzed muscles by artificial ones was first
made by Delacroix175 in an apparatus designed for the hand. The
suggestion was repeated by Gerdy;176 and in 1840, Rigal de Gaillac
proposed to exchange the metallic springs hitherto used for India-rubber
straps. Duchenne elaborated the suggestion in a remarkable manner,177
using delicate spiral springs as a substitute for the lost muscles, and
taking the greatest pains to make the insertion-points of these to exactly
correspond with the insertions of the natural muscles. This was effected
by means of sheaths, imitating natural tendinous sheaths, sewed to a
glove or gaiter in which the hand or foot was encased.
175 Article “Orthopédie,” Dict. des Sciences médicales, quoted by Duchenne.

176 Traité des Bandages, 2d ed., Paris, 1837, quoted by Duchenne.

177 See chapter on “Prothetic Apparatus” in his treatise De l'Électrisation localisée.

At the present day the prothetic apparatus the most employed is that
contrived by Barwell.178 The principle is the same as Duchenne's, but the
artificial muscles are made of India-rubber, to which a small metallic chain
is adjusted, and they are attached to the limb by means of specially-
devised bands of adhesive plaster and pieces of tin bearing loops for the
insertion of the muscle. In this apparatus the artificial muscles do not
attempt to imitate the situation of the natural muscles with the precision
which Duchenne claimed for his. Barwell's own dressing for talipes valgus
consists of two rubber muscles which pass from the inner border of the
foot, one to the inner, the other to the anterior, part of a band which
encircles the leg just below the knee. For talipes calcaneus another band
is required behind the leg, passing to the heel, as in Volkmann's
apparatus, already mentioned. For talipes varus a rubber band should
pass on the outside of the foot; for equinus, one or more from the anterior
part of the leg to the sides of the anterior part of the foot.
178 A tolerably minute account of the Barwell dressing is given by Sayre, loc. cit., p. 84.

Sayre endorses Barwell's dressing as entirely adequate for the treatment

of any form of club-foot, but modifies it by substituting a ball-and-socket
shoe for the adhesive plaster which should encircle the foot. The artificial
muscles are then passed from the sides of the shoe to a padded leather
girdle encircling the leg. A straight splint, jointed opposite the ankle, runs
up from each side of the foot to this girdle, and from it two lateral upright
bars, jointed at the ankle, pass to the heel of the shoe; and from below
the joint passes forward on each side a horizontal bar reaching the point
of origin of the artificial muscles and giving attachment to them.

In equinus it is necessary to bind the heel of the foot down firmly in the
heel of the shoe; and this is accomplished by means of two chamois-
leather flaps which are attached to the inside walls of the shoe and lace
firmly across the foot.179
179 “The aim of the dressing or instrument is simply to imitate the action of the surgeon's
hand; accordingly, any apparatus combining elastic force is far superior to any fixed
appliance; and, moreover, that is to be preferred which is the most readily removable.
Shoes, therefore, are better than bandages or splints. A proper shoe must have joints
opposite the ankle and the medio-tarsal articulation; it must permit the ready application of
elastic power; and it must not so girdle the limb as to interfere with the circulation” (Sayre,
loc. cit., p. 91).