Obstetric Ultrasound Examination

Summary of Key Points

Recent years have seen dramatic advances in ultrasound technology, including improved spatial and contrast resolution, routine use of three-dimensional (3D) and four-dimensional (4D) imaging, volumetric scanning, expanded indications for color and spectral Doppler, new and improved ultrasound scanning probes, and improved digital review workstations.
With improved imaging comes the complicating corollary as to what minor findings should be reported to the patient and which merely lead to unnecessary anxiety.
Although there is high-quality evidence that ultrasound is safe for the fetus when used appropriately, consensus statements conclude that Doppler examination of fetal vessels in early pregnancy should not be performed without a clinical indication.
The nonmedical use of ultrasound for psychosocial or entertainment purposes is strongly discouraged by professional organizations such as the American Institute of Ultrasound in Medicine (AIUM).
Only those with adequate training in a conventional training program should be performing and interpreting ultrasound examinations.
Consensus guidelines and criteria for transvaginal sonographic diagnosis of pregnancy failure in a woman with an intrauterine pregnancy of uncertain viability have been established and should be followed.
Although early detection of a morphologic abnormality is useful, the confident unequivocal detection of an abnormality is even more important. Unless one is extremely confident of the existence of an abnormality in the first trimester, a follow-up examination should be performed.
Measurements made early in pregnancy, for the most part, are more accurate than those made near term.
Although a diagnosis of oligohydramnios and polyhydramnios can be made subjectively, the extremes of amniotic fluid volume should also be assessed objectively using either the deepest vertical pocket (DVP) or amniotic fluid index (AFI).
It is preferable to report the distance from the inferior edge of the placenta to the internal cervical os rather than relying on terms that may have differing meanings (e.g., marginal placenta).
If a single obstetric ultrasound or a targeted examination is performed, it should be done at a gestational age of 18 to 20 weeks.
Obstetric ultrasound examinations represented the majority of medical malpractice cases involving ultrasound.
Ultrasound examination is a noninvasive, safe procedure that has a high degree of patient acceptance and can yield a wealth of information.

It has now been over 4 decades since sonography was first used to evaluate the obstetric patient. At first, the questions this modality sought to answer were very basic: Is there a pregnancy? Is the fetus alive? Is there a singleton or a twin gestation? What is the location of the placenta? What is the gestational age? Probably, few envisioned the day when ultrasonography would be used to identify subtle anatomic defects such as cleft lip or palate, to predict obstetric complications such as placenta accreta, or to accurately detect the presence of fetal anemia. It is hard to believe that, at its inception, it was difficult to convince clinicians as to the usefulness of this new diagnostic modality in obstetric management. Now, it is routine for a patient to have at least one, and often several, ultrasound examinations during her pregnancy. The technologic advances in ultrasound imaging, including 3D/4D and volumetric measurements, the use of high-frequency transvaginal probes, and the utility for chromosomal screening in early pregnancy (e.g., nuchal translucency) have only expanded the indications for sonographic imaging in the obstetric patient.

Since the last edition of this textbook, there have been dramatic advances in ultrasound technology, including improved spatial and contrast resolution, routine use of 3D and 4D imaging, volumetric scanning, expanded indications for color and spectral Doppler, new and improved ultrasound scanning probes, and improved digital review workstations, to name a few. Likewise, our knowledge of normal fetal anatomy and pathology, and the pathophysiology of disease in general, has increased substantially. The Internet has made communication among and between researchers and clinicians easier. In addition, there have been many collaborative studies and refinements of the guidelines for the performance of the obstetric ultrasound examination. However, there are still differences in the approach to the obstetric ultrasound examination from one group to the next. Although guidelines have improved consistency in the conduct and reporting of obstetric examinations, several issues are often hotly debated: for example, what constitutes a basic ultrasound examination, what structures should be evaluated, what is the ideal timing of the examination, what is the appropriate role of the first trimester anatomic survey, who should perform and interpret the examination, how safe is ultrasound, how should it be recorded and documented, how should it be reported, and last, how should the patient be told the results of the examination? With improved images comes the complicating corollary as to what minor findings should be reported to the patient and which merely lead to unnecessary anxiety. These issues are addressed later in the text and some of them are discussed here.

Safety of Ultrasound Examination

It was not long after the inception of ultrasound imaging that questions were raised as to the safety of this new modality. Despite numerous claims for the safety of ultrasound to the mother and fetus, a number of studies have noted possible adverse effects of diagnostic ultrasound to the developing fetus. These studies have focused primarily on thermal and cavitation mechanisms leading to possible injuries to the developing fetus.

Absorption of the ultrasound wave's energy by soft tissue and bone, and its conversion to heat, are measured by the thermal index (TI). A TI of 1 means an increase of 1° C. Several studies have suggested a general threshold of temperature elevation of 1.5° to 2° C above maternal core temperature before any evidence of a developmental effect occurs. With modern ultrasound machines, there is only a negligible rise in temperature, usually less than 1° C. The World Federation for Ultrasound in Medicine and Biology has stated that “a diagnostic exposure that produces a maximum in situ temperature rise of not more than 1.5° C above normal physiological levels may be used without reservation on thermal grounds.” However, this organization further stated that “a diagnostic exposure that elevates embryonic and fetal in situ temperature above 41° C for 5 minutes should be considered potentially hazardous.” The conclusion overall is that it is unlikely that there is a deleterious effect of ultrasound in the first trimester during embryogenesis with routine gray-scale ultrasound.

However, when Doppler ultrasound is used during the first trimester, it is likely that temperature increases of over 1.5° C may occur. Studies of the effect of Doppler on soft tissues adjacent to bone and nerve conductance demonstrated a significant rise in temperature when the ultrasound Doppler beam was held for more than 30 seconds. The European Federation for Societies in Medicine and Biology in 1998 concluded that “until further scientific information is available, investigations using pulsed or color Doppler should be carried out with careful control for output levels.” It is recommended that when performing Doppler imaging in early pregnancy, the displayed TI should be 1.0 or less and exposure time should be kept as short as possible, usually no longer than 5 to 10 minutes and not exceeding 60 minutes. A thermal index for soft tissue (TIs) should be used at earlier than 10 weeks' gestation, and a thermal index for bone (TIb) should be used at 10 weeks' gestation or later when bone ossification is evident. In keeping with the ALARA (As Low As Reasonably Achievable) principle of prudent scanning, M-mode imaging should be used instead of spectral Doppler imaging to document embryonic/fetal heart rate. Transvaginal ultrasound is not more harmful than transabdominal scanning; again, the risk is dependent on the TI.

Although the potential for embryonic effects from Doppler imaging exists, there is little evidence that ultrasound is teratogenic. As stated in one editorial on the subject, “Many of the studies to date have shown the embryo to be remarkably resilient to ultrasound exposure. Logic would suggest that Doppler techniques should not affect the embryo if the pulses are applied at a low level.” In one study, Zhu and associates insonated pregnant rats with diagnostic levels of color Doppler ultrasound energy and studied the cell cycles of newborn rats by flow cytometry and factorial analysis. They found that the deoxyribonucleic acid content was not affected in any phase of the cell cycle in newborn rats by any of the different insonation times and frequencies. In another animal study, Pellicer and colleagues examined cellular damage in rats following exposure to low-intensity ultrasound for as long as 10 minutes. These investigators found that the longer the exposure time, the greater the liver cell damage that was observed. Other animal studies have likewise demonstrated a relationship between the length of exposure to Doppler ultrasound and potential effects on the developing brain. Although such studies support caution and minimizing unnecessary exposure, it is unclear whether such animal models can be extrapolated to humans and if such findings are important. However, at the present time, consensus statements conclude that Doppler examination of fetal vessels in early pregnancy should not be performed without a clinical indication.

Cavitation involves the occurrence of gaseous bubble formation in an air-water interface. One concern is that stress from the fluid adjacent to the gaseous body during the process of cavitation may disrupt cell membranes. Cavitation has been difficult to document in mammalian fetuses, because, for the most part, there is not an air-water interface, which is needed for the cavitation mechanism. The mechanical index (MI) is an onscreen indicator that provides a rough guide to the likelihood that ultrasound will induce an adverse biologic effect by a nonthermal mechanism, including cavitation. For all practical purposes, this index is probably not relevant for obstetric scanning owing to the relative absence of gas bubbles (air) in the fetus.

A number of studies have evaluated the effect of prenatal ultrasound on neonatal and infant outcome in animal models. Although some studies have documented lower birth weights, shorter heights, and lowered white blood cell counts in neonates who were scanned in utero compared with control subjects, the size differences disappeared when studied after 3 months. In addition, hematologic parameters normalized by this time. Neurodevelopmental studies revealed no significant differences in motor or cognitive tasks, or in learning skills. Studies evaluating the human fetus and neonate have reached similar conclusions. Studies have found either no difference in birth weights between exposed and nonexposed fetuses, or a difference that, although present at birth, was not present at 6 to 7 years of age.

The information on an association between ultrasound and congenital malformations is limited. Studies evaluating chromosomal aberration and ultrasound exposure have demonstrated little or no change.

The major difficulties with the studies investigating a possible deleterious effect of diagnostic ultrasound evaluation are threefold: (1) experimental ultrasound exposure levels or time of exposure often far exceeded those that are normally used diagnostically; (2) the systems used to show ultrasound effect (plants, cell culture, laboratory animals) may not be applicable to humans; and (3) many studies that have demonstrated adverse effects in vitro have not been reproducible.

One study evaluating the effect of diagnostic ultrasound on neuronal migration in mice raised much attention in the media. Although this is an interesting study in mice, for the reasons stated earlier, it has little to no applicability in humans. There are two major criticisms of this study. Although the study did use commercially available equipment in which only slightly greater ultrasound frequency than normal was used (6.7 MHz vs. 3.5-5.0 MHz), the fixed duration of exposure far exceeded what would normally be used in humans. The study did not demonstrate statistically significant abnormal results until 30 minutes of exposure. More than 10 years ago, when a sonologist wished to determine whether an embryo was nonviable, the recommended evaluation of the embryo was 3 minutes of observation, demonstrating no evidence of embryonic or cardiac activity. Two minutes of evaluation, let alone 3 minutes, seemed like an eternity, and most examiners, in our experience, stopped after 1 minute. In the slightly older embryo and early fetus, greater than 5 to 10 minutes of sustained evaluation of the fetal brain would be excessive. In most cases, the transducer would be moving around the brain rather than being in a fixed position during the examination.

The second criticism relates to the timing of embryology and the relative sizes of the mouse and human brains. As stated by the authors of this study: “The duration of neuronal production and the migratory phase of cortical neurons in the human fetus lasts approximately 18 times longer than in mice (between 6 and 24 weeks of gestation in humans, with the peak occurring between 11 and 15 weeks, compared with the duration of only approximately 1 week (between E11 and E18) in a mouse). Thus an exposure of 30 minutes represents a much smaller time dedicated to the development of the cerebral cortex in the human than in the mouse, and thus could have a lesser overall effect, making human corticogenesis less vulnerable to ultrasound waves.”

The AIUM statement on the clinical safety of diagnostic ultrasound reiterates previous findings that no confirmed bioeffects caused by exposure at intensities typical of present diagnostic instruments have ever been reported in patients or instrument operators. This statement acknowledges the possibility that bioeffects may be identified in the future but emphasizes the current data indicating that the benefits of the prudent use of diagnostic sonography outweigh the risks, if any. At a recent consensus conference on fetal imaging, it was concluded that there is high-quality evidence that ultrasound is safe for the fetus when used appropriately. However, as stated by Kremkau, “even if this risk is so minimal that it is difficult to identify, prudent practice dictates that routine measures be implemented to minimize the risk while obtaining the necessary information to achieve the diagnostic benefit. This is the ALARA (as low as reasonably achievable) principle of prudent scanning” ( Fig. 1-1 ).

FIG 1-1, Minimizing risk by minimizing exposure ( A ) is the cornerstone of the ALARA principle ( B ).

The sonographer's knowledge of ultrasound and its safety is crucial to the safe implementation of this modality. Merritt, in an editorial, summarized it best: “In view of the rapid growth of sonography and its proliferation into the hands of minimally trained clinicians, it is likely that more patients are harmed each day by misdiagnosis resulting from improper indications, poor examination technique, and errors in interpretation than from all bioeffects.”

Indications for Obstetric Ultrasound Examination

National guidelines from many organizations in the United States and elsewhere, including the American College of Obstetricians and Gynecologists (ACOG), the Royal College of Obstetricians and Gynaecologists, and the Society of Obstetricians and Gynaecologists of Canada, highlight the benefits of obstetric ultrasound examination, including accurate determination of gestational age, fetal number, cardiac activity, placental localization, and diagnosis of major fetal anomalies. Because of these benefits, and because most congenital anomalies occur in patients with no known risk factors, these organizations agree that second trimester ultrasonography should be offered routinely to all pregnant women and should follow specific guidelines. In addition, ACOG recommends that all pregnant women should be offered first trimester screening for aneuploidy, which may include nuchal translucency sonography.

The benefit of routine sonography in the detection of fetal anomalies has been debated. Large studies and systematic reviews report detection rates of 16% to 44% of anomalies prior to 24 weeks of gestation. Higher detection rates of major and lethal anomalies, as high as 84%, have been reported. The sensitivity of anomaly detection has been noted to vary with respect to the type of abnormality, patient factors, gestational age, and expertise of the imager. Possible explanations for the variance in the detection rate of anomalous fetuses may include (1) differences in neonatal assessment, (2) differences in the definition of a major anomaly, (3) a differing risk status of the population, (4) differences in what is considered a routine or standard sonogram, and (5) the expertise of the examiner.

Who Should Perform the Ultrasound Examination and How Should It Be Performed?

Theoretically, the answer to who should perform the ultrasound examination should be extremely easy. In fact, it is one of the most controversial issues relating to the ultrasound examination. The answer should be that only those persons who have had adequate training (including didactic as well as supervised “hands-on” experience) should perform and interpret an ultrasound examination.

More than 30 years ago, the Joint Task Group on Training for Diagnosis in Obstetrical and Gynecologic Ultrasound developed guidelines for the post-resident physician who had completed residency programs in either radiology or obstetrics and gynecology that did not provide formal training in obstetric and gynecologic ultrasound evaluation. These guidelines have been continuously updated, most recently in 2014, and include a recommendation of a minimum experience in obstetric and gynecologic ultrasound evaluation as well as training that includes basic physics, technique, performance, and interpretation. In addition, the physician should obtain practical and supervised experience (at least 300 examinations) before offering services as a physician competent in diagnostic ultrasound examination. Ongoing experience with at least 170 examinations per year is also recommended.

The “turf” battles between radiologists and obstetricians as to who should perform the examination are unfortunate. As long as the examining physician is adequately trained and performs the minimum standard obstetric ultrasound examination, as per the guidelines of the American College of Radiology (ACR), AIUM, and ACOG, the specialty of the examiner does not matter. However, we do not believe in the practice of self-referral. Self-referral examinations tend to be performed more and more frequently and are often less “complete” and of a lower quality than when they are performed by a dedicated ultrasound practitioner. Except in localities where there are no diagnostic ultrasound specialists, patients should be referred to practitioners whose major practice is ultrasonography.

Guidelines for the performance of obstetric ultrasound examinations have been published by ACR, ACOG, and AIUM, and components of the standard fetal examination at 18 to 20 weeks of gestation were published in a consensus report by National Institute of Child Health and Human Development (NICHD), Society for Maternal-Fetal Medicine (SMFM), ACOG, ACR, AIUM, Society of Pediatric Radiology (SPR), and Society of Radiologists in Ultrasound (SRU) in 2014. AIUM has likewise published guidelines for performance of a detailed fetal anatomic survey, referred to by the billing code 76811. Although there may be sonologists who exceed these guidelines, the guidelines serve as a minimum standard for practitioners of basic and detailed obstetric ultrasonography.

Nonmedical Use of Ultrasonography

The AIUM has published a ‘‘prudent use’' statement, which was also endorsed by ACOG. The AIUM advocates the responsible use of diagnostic ultrasonography and strongly discourages its nonmedical use for psychosocial or entertainment purposes. The use of either 2D or 3D ultrasound imaging only to view the fetus, obtain a picture of the fetus, or determine the fetal sex without a medical indication is inappropriate and contrary to responsible medical practice. Although there are no confirmed biologic effects on patients caused by exposures from present diagnostic ultrasound instruments, the possibility exists that such biologic effects may be identified in the future. Thus, ultrasound imaging should be used in a prudent manner to provide medical benefit to the patient. This position has been ethically defended.

Terminology

The latest classification of fetal sonographic examinations by the AIUM, ACR, and ACOG groups the examinations into four major categories: (A) the first trimester ultrasound examination, (B) the standard second or third trimester examination, (C) the limited examination, and (D) specialized examinations. The standard second and third trimester obstetric examination is often referred to as a routine examination, basic examination, Level 1 examination, or complete ultrasound examination. Specialized examinations might include a detailed anatomic examination, as well as fetal Doppler ultrasound, a biophysical profile, a fetal echocardiogram, and additional biometric measurements. A detailed anatomic examination is generally performed when a patient is at high risk for a fetal anomaly, or when an anomaly is suspected on the basis of the history, biochemical abnormalities or abnormal results on other screening tests, or the results of either the limited or standard scan.

It is important to note that although those individuals performing detailed anatomic examinations must be proficient in evaluating patients for congenital anomalies, it is not acceptable for the Level 1 examiner to be unskilled. In an excellent editorial on the subject, Filly notes that unfortunately some examiners have chosen to use the term “Level 1” as a shield for incompetency. As he states, the Level 1 sonogram is not defined by the technical capability of the examiner, nor by the cost of the sonographic instrumentation employed. In fact, the Level 1 examination “requires a high degree of competency” and should follow the standard second or third trimester obstetric sonographic examination as described in the AIUM/ACR/ACOG guidelines.

The specialized examination (CPT 76811) has been referred to as the Level 2 examination, survey examination, or targeted examination. As the AIUM/ACR/ACOG guidelines state, this is a detailed anatomic examination that is performed when an anomaly is suspected on the basis of history, abnormalities detected on prenatal screening tests, or the results of either a limited or standard examination previously performed.

The individuals performing the sonographic examination are referred to as either sonographers or sonologists. Traditionally, the technical component and initial production of images has been the responsibility of the sonographer (nonphysician), and the professional component and interpretation of images has been the responsibility of the sonologist (physician). The degree of collaboration between the two and their degree of involvement in the ultrasound examination vary from locality to locality. In many parts of the world, examinations are performed predominantly by physicians. Although the contribution of sonographers to the ultrasound examination is invaluable, it should be remembered, as stated by the AIUM, that “Ultrasound studies shall be supervised and interpreted by a physician with training and experience in the specific area of sonography. Findings must be recorded and results communicated in a timely fashion to the health care provider responsible for care. Although a sonographer may play a critical role in extracting the information essential to deriving a diagnosis, the rendering of the final diagnosis of ultrasound studies represents the practice of medicine, and, therefore, is the responsibility of the supervising physician.”

Perhaps the least controversial aspect of this discussion should be who should interpret the ultrasound examination. This, we believe, is straightforward. Only those with adequate training in a conventional training programs (e.g., residency) in which there are didactic lectures, hands-on scanning, and physician supervision in the performance and interpretation of cases should be performing and interpreting ultrasound findings. Training by manufacturer's training specialists or 1- to 2-week mini-courses do not constitute adequate training in ultrasound.

Ultrasound Lexicon

Undoubtedly, hundreds of terms are used in obstetrics and ultrasonography that are either incorrect or confusing. Many of these terms are addressed later in this chapter and in other chapters in this text. Two areas in which terminology is often either misused or misunderstood in obstetric ultrasonography are fetal life and age. The term viability is defined as the ability to survive in the extrauterine environment. Even in cases of very late third trimester examinations, this statement cannot be used with complete certainty. We prefer to state that the embryo or fetus is living, if that is the case, and use the term nonviable for those embryos or fetuses that either are dead or are not capable of living in the extrauterine environment. Early pregnancy failure is another, perhaps even better, way of communicating this information.

The second often-confused term is gestational age. Taken as it sounds, this term would seem to imply the actual age of the fetus from conception to the present. In fact, this term, which is widely used by obstetricians and sonologists, is most often meant to be synonymous with menstrual age. Menstrual age refers to the length of time calculated from the first day of the last normal menstrual period to the point at which the pregnancy is being assessed. The true age of the embryo or fetus, fetal age , is rarely known accurately unless the patient has had assisted fertilization or has extremely regular menstrual periods and the day of conception is known. In general, the fetal age is 2 weeks less than the menstrual age.

In this text, the terms gestational age and menstrual age are used interchangeably. The important point for any examiner to remember is not which term is necessarily preferable but rather that the person interpreting the examination and the physician who ordered the examination both use the same terminology.

Another often-misused term is fetal pole . This term should be abandoned. It is most often used to describe the presence of the embryo in the early first trimester sonogram. The embryonic period lasts until the end of the 10th menstrual week; during this time the developing conceptus should be referred to as the embryo. Thereafter, the conceptus should be referred to as a fetus.

The American Institute of Ultrasound in Medicine Guidelines

In 2013 the Practice Guideline for the Performance of an Antepartum Obstetric Ultrasound Examination was updated by the AIUM in collaboration with the ACR, the SRU, and ACOG. It is a modification of previously developed guidelines that were first published in 1986. The actual ACR/AIUM/ACOG guidelines are presented in Table 1-1 . What follows is our own bias as to what constitutes an appropriate ultrasound examination. In some respects, this discussion is an expansion of the guidelines previously mentioned. Because this multiauthor text is essentially a detailed review of the obstetric ultrasound examination, we recognize that our viewpoint in this chapter and those of the authors of the subsequent chapters may differ.

TABLE 1-1

Guidelines for Performance of the Antepartum Obstetric Ultrasound Examination

Modified from American Institute of Ultrasound in Medicine: AIUM practice guideline for the performance of obstetric ultrasound examinations. J Ultrasound Med 32(6):1083-1101, 2013.

I. Introduction

The clinical aspects contained in specific sections of this guideline (Introduction, Classification of Fetal Sonographic Examinations, Specifications of the Examination, Equipment Specifications, and Fetal Safety) were revised collaboratively by the American Institute of Ultrasound in Medicine (AIUM), the American College of Radiology (ACR), the American College of Obstetricians and Gynecologists (ACOG), and the Society of Radiologists in Ultrasound (SRU). Recommendations for personnel qualifications, written request for the examination, procedure documentation, and quality control vary among the organizations and are addressed by each separately.

This guideline has been developed for use by practitioners performing obstetric sonographic studies. Fetal ultrasound 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. A limited examination may be performed in clinical emergencies or for a limited purpose such as evaluation of fetal or embryonic cardiac activity, fetal position, or amniotic fluid volume. A limited follow-up examination may be appropriate for reevaluation of fetal size or interval growth or to reevaluate abnormalities previously noted if a complete prior examination is on record.

While this guideline describes the key elements of standard sonographic examinations in the first trimester and second and third trimesters, a more detailed anatomic examination of the fetus may be necessary in some cases, such as when an abnormality is found or suspected on the standard examination or in pregnancies at high risk for fetal anomalies. In some cases, other specialized examinations may be necessary as well.

While it is not possible to detect all structural congenital anomalies with diagnostic ultrasound, adherence to the following guidelines will maximize the possibility of detecting many fetal abnormalities.

II. Classification of Fetal Sonographic Examinations

A. First-Trimester Examination

A standard obstetric sonogram in the first trimester includes evaluation of the presence, size, location, and number of gestational sac(s). The gestational sac is examined for the presence of a yolk sac and embryo/fetus. When an embryo/fetus is detected, it should be measured and cardiac activity recorded by a 2-dimensional video clip or M-mode imaging. Use of spectral Doppler imaging is discouraged. The uterus, cervix, adnexa, and cul-de-sac region should be examined.

B. Standard Second- or Third-Trimester Examination

A standard obstetric sonogram in the second or third trimester includes an evaluation of fetal presentation, amniotic fluid volume, cardiac activity, placental position, fetal biometry, and fetal number, plus an anatomic survey. The maternal cervix and adnexa should be examined as clinically appropriate when technically feasible.

C. Limited Examination

A limited examination is performed when a specific question requires investigation. For example, in most routine nonemergency cases, a limited examination could be performed to confirm fetal heart activity in a bleeding patient or to verify fetal presentation in a laboring patient. In most cases, limited sonographic examinations are appropriate only when a prior complete examination is on record.

D. Specialized Examinations

A detailed anatomic examination is performed when an anomaly is suspected on the basis of the history, biochemical abnormalities, or the results of either the limited or standard scan. Other specialized examinations might include fetal Doppler ultrasound, a biophysical profile, a fetal echocardiogram, and additional biometric measurements.

III. Qualifications and Responsibilities of Personnel

See the AIUM Official Statement Training Guidelines for Physicians Who Evaluate and Interpret Diagnostic Abdominal, Obstetric, and/or Gynecologic Ultrasound Examinations and the AIUM Standards and Guidelines for the Accreditation of Ultrasound Practices .

IV. Written Request for the Examination

The written or electronic request for an ultrasound examination 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 provider 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

A. First-Trimester Ultrasound Examination

1.
Indications

Indications for first-trimester sonography include but are not limited to:
- a.
  Confirmation of the presence of an intrauterine pregnancy;
- b.
  Evaluation of a suspected ectopic pregnancy;
- c.
  Defining the cause of vaginal bleeding;
- d.
  Evaluation of pelvic pain;
- e.
  Estimation of gestational (menstrual) age;
- f.
  Diagnosis or evaluation of multiple gestations;
- g.
  Confirmation of cardiac activity;
- h.
  Imaging as an adjunct to chorionic villus sampling, embryo transfer, and localization and removal of an intrauterine device;
- i.
  Assessing for certain fetal anomalies, such as anencephaly, in high-risk patients;
- j.
  Evaluation of maternal pelvic masses and/or uterine abnormalities;
- k.
  Measuring the nuchal translucency (NT) when part of a screening program for fetal aneuploidy; and
- l.
  Evaluation of a suspected hydatidiform mole.
  
  Comment
  
  A limited examination may be performed to evaluate interval growth, estimate amniotic fluid volume, evaluate the cervix, and assess the presence of cardiac activity.

2.
Imaging Parameters

Comment

Scanning in the first trimester may be performed either transabdominally or transvaginally. If a transabdominal examination is not definitive, a transvaginal scan or transperineal scan should be performed whenever possible.
- a.
  The uterus (including the cervix) and adnexa should be evaluated for the presence of a gestational sac. If a gestational sac is seen, its location should be documented. The gestational sac should be evaluated for the presence or absence of a yolk sac or embryo, and the crown-rump length should be recorded when possible.
  
  Comment
  
  A definitive diagnosis of intrauterine pregnancy can be made when an intrauterine gestational sac containing a yolk sac or embryo/fetus with cardiac activity is visualized. A small, eccentric intrauterine fluid collection with an echogenic rim can be seen before the yolk sac and embryo are detectable in a very early intrauterine pregnancy. In the absence of sonographic signs of ectopic pregnancy, the fluid collection is highly likely to represent an intrauterine gestational sac. In this circumstance, the intradecidual sign may be helpful. Follow-up sonography and/or serial determination of maternal serum human chorionic gonadotropin levels are/is appropriate in pregnancies of undetermined location to avoid inappropriate intervention in a potentially viable early pregnancy.
  
  The crown-rump length is a more accurate indicator of gestational (menstrual) age than is the mean gestational sac diameter. However, the mean gestational sac diameter may be recorded when an embryo is not identified.
  
  Caution should be used in making the presumptive diagnosis of a gestational sac in the absence of a definitive embryo or yolk sac. Without these findings, an intrauterine fluid collection could represent a pseudo-gestational sac associated with an ectopic pregnancy.
- b.
  The presence or absence of cardiac activity should be documented with a 2-dimensional video clip or M-mode imaging.
  
  Comment
  
  With transvaginal scans, while cardiac motion is usually observed when the embryo is 2 mm or greater in length, if an embryo less than 7 mm in length is seen without cardiac activity, a subsequent scan in 1 week is recommended to ensure that the pregnancy is nonviable.
- c.
  Fetal number should be documented.
  
  Comment
  
  Amnionicity and chorionicity should be documented for all multiple gestations when possible.
- d.
  Embryonic/fetal anatomy appropriate for the first trimester should be assessed.
- e.
  The nuchal region should be imaged, and abnormalities such as cystic hygroma should be documented.
  
  Comment
  
  For those patients desiring to assess their individual risk of fetal aneuploidy, a very specific measurement of the NT during a specific age interval is necessary (as determined by the laboratory used). See the guidelines for this measurement below.
  
  NT measurements should be used (in conjunction with serum biochemistry) to determine the risk of having a fetus with aneuploidy or other anatomic abnormalities such as heart defects. In this setting, it is important that the practitioner measure the NT according to established guidelines for measurement. A quality assessment program is recommended to ensure that false-positive and false-negative results are kept to a minimum.
  
  Guidelines for NT Measurement:
  - i.
    The margins of the NT edges must be clear enough for proper placement of the calipers.
  - ii.
    The fetus must be in the midsagittal plane.
  - iii.
    The image must be magnified so that it is filled by the fetal head, neck, and upper thorax.
  - iv.
    The fetal neck must be in a neutral position, not flexed and not hyperextended.
  - v.
    The amnion must be seen as separate from the NT line.
  - vi.
    The + calipers on the ultrasound must be used to perform the NT measurement.
  - vii.
    Electronic calipers must be placed on the inner borders of the nuchal line space with none of the horizontal crossbar itself protruding into the space.
  - viii.
    The calipers must be placed perpendicular to the long axis of the fetus.
  - ix.
    The measurement must be obtained at the widest space of the NT.

- f.
  The uterus including the cervix, adnexal structures, and cul-de-sac should be evaluated. Abnormalities should be imaged and documented.
  
  Comment
  
  The presence, location, appearance, and size of adnexal masses should be documented. The presence and number of leiomyomata should be documented. The measurements of the largest or any potentially clinically significant leiomyomata should be documented. The cul-de-sac should be evaluated for the presence or absence of fluid. Uterine anomalies should be documented.

B. Second- and Third-Trimester Ultrasound Examination

1.
Indications

Indications for second- and third-trimester sonography include but are not limited to:
- a.
  Screening for fetal anomalies;
- b.
  Evaluation of fetal anatomy;
- c.
  Estimation of gestational (menstrual) age;
- d.
  Evaluation of fetal growth;
- e.
  Evaluation of vaginal bleeding;
- f.
  Evaluation of abdominal or pelvic pain;
- g.
  Evaluation of cervical insufficiency;
- h.
  Determination of fetal presentation;
- i.
  Evaluation of suspected multiple gestation;
- j.
  Adjunct to amniocentesis or other procedure;
- k.
  Evaluation of a significant discrepancy between uterine size and clinical dates;
- l.
  Evaluation of a pelvic mass;
- m.
  Evaluation of a suspected hydatidiform mole;
- n.
  Adjunct to cervical cerclage placement;
- o.
  Suspected ectopic pregnancy;
- p.
  Suspected fetal death;
- q.
  Suspected uterine abnormalities;
- r.
  Evaluation of fetal well-being;
- s.
  Suspected amniotic fluid abnormalities;
- t.
  Suspected placental abruption;
- u.
  Adjunct to external cephalic version;
- v.
  Evaluation of premature rupture of membranes and/or premature labor;
- w.
  Evaluation of abnormal biochemical markers;
- x.
  Follow-up evaluation of a fetal anomaly;
- y.
  Follow-up evaluation of placental location for suspected placenta previa;
- z.
  History of previous congenital anomaly;
  - aa.
    Evaluation of the fetal condition in late registrants for prenatal care; and
  - bb.
    Assessment for findings that may increase the risk for aneuploidy.
    
    Comment
    
    In certain clinical circumstances, a more detailed examination of fetal anatomy may be indicated.

2.
Imaging Parameters for a Standard Fetal Examination
- a.
  Fetal cardiac activity, fetal number, and presentation should be documented.
  
  Comment
  
  An abnormal heart rate and/or rhythm should be documented. Multiple gestations require the documentation of additional information: chorionicity, amnionicity, comparison of fetal sizes, estimation of amniotic fluid volume (increased, decreased, or normal) in each gestational sac, and fetal genitalia (when visualized).
- b.
  A qualitative or semiquantitative estimate of amniotic fluid volume should be documented.
  
  Comment
  
  Although it is acceptable for experienced examiners to qualitatively estimate amniotic fluid volume, semiquantitative methods have also been described for this purpose (eg, amniotic fluid index, single deepest pocket, and 2-diameter pocket).
- c.
  The placental location, appearance, and relationship to the internal cervical os should be documented. The umbilical cord should be imaged and the number of vessels in the cord documented. The placental cord insertion site should be documented when technically possible.
  
  Comment
  
  It is recognized that the apparent placental position early in pregnancy may not correlate well with its location at the time of delivery. Transabdominal, transperineal, or transvaginal views may be helpful in visualizing the internal cervical os and its relationship to the placenta. Transvaginal or transperineal ultrasound may be considered if the cervix appears shortened or cannot be adequately visualized during the transabdominal sonogram.
  
  A velamentous (also called membranous) placental cord insertion that crosses the internal os of the cervix is vasa previa, a condition that has a high risk of fetal mortality if not diagnosed before labor.

- d.
  Gestational (menstrual) age assessment.
  
  First-trimester crown-rump measurement is the most accurate means for sonographic dating of pregnancy. Beyond this period, a variety of sonographic parameters such as biparietal diameter, abdominal circumference, and femoral diaphysis length can be used to estimate gestational (menstrual) age. The variability of gestational (menstrual) age estimation, however, increases with advancing pregnancy. Significant discrepancies between gestational (menstrual) age and fetal measurements may suggest the possibility of a fetal growth abnormality, intrauterine growth restriction, or macrosomia.
  
  Comment
  
  The pregnancy should not be redated after an accurate earlier scan has been performed and is available for comparison.
  - i.
    The biparietal diameter is measured at the level of the thalami and cavum septi pellucidi or columns of the fornix. The cerebellar hemispheres should not be visible in this scanning plane. The measurement is taken from the outer edge of the proximal skull to the inner edge of the distal skull.
    
    Comment
    
    The head shape may be flattened (dolichocephaly) or rounded (brachycephaly) as a normal variant. Under these circumstances, certain variants of normal fetal head development may make measurement of the head circumference more reliable than biparietal diameter for estimating gestational (menstrual) age.
  - ii.
    The head circumference is measured at the same level as the biparietal diameter, around the outer perimeter of the calvarium. This measurement is not affected by head shape.
  - iii.
    The femoral diaphysis length can be reliably used after 14 weeks' gestational (menstrual) age. The long axis of the femoral shaft is most accurately measured with the beam of insonation being perpendicular to the shaft, excluding the distal femoral epiphysis.
  - iv.
    The abdominal circumference or average abdominal diameter should be determined at the skin line on a true transverse view at the level of the junction of the umbilical vein, portal sinus, and fetal stomach when visible.
    
    Comment
    
    The abdominal circumference or average abdominal diameter measurement is used with other biometric parameters to estimate fetal weight and may allow detection of intrauterine growth restriction or macrosomia.
- e.
  Fetal weight estimation.
  
  Fetal weight can be estimated by obtaining measurements such as the biparietal diameter, head circumference, abdominal circumference or average abdominal diameter, and femoral diaphysis length. Results from various prediction models can be compared to fetal weight percentiles from published nomograms.
  
  Comment
  
  If previous studies have been performed, appropriateness of growth should also be documented. Scans for growth evaluation can typically be performed at least 2 to 4 weeks apart. A shorter scan interval may result in confusion as to whether measurement changes are truly due to growth as opposed to variations in the technique itself.
  
  Currently, even the best fetal weight prediction methods can yield errors as high as ±15%. This variability can be influenced by factors such as the nature of the patient population, the number and types of anatomic parameters being measured, technical factors that affect the resolution of ultrasound images, and the weight range being studied.
- f.
  Maternal anatomy.
  
  Evaluation of the uterus, adnexal structures, and cervix should be performed when appropriate. If the cervix cannot be visualized, a transperineal or transvaginal scan may be considered when evaluation of the cervix is needed.
  
  Comment
  
  This will allow recognition of incidental findings of potential clinical significance. The presence, location, and size of adnexal masses and the presence of at least the largest and potentially clinically significant leiomyomata should be documented. It is not always possible to image the normal maternal ovaries during the second and third trimesters.
- g.
  Fetal anatomic survey.
  
  Fetal anatomy, as described in this document, may be adequately assessed by ultrasound after approximately 18 weeks' gestational (menstrual) age. It may be possible to document normal structures before this time, although some structures can be difficult to visualize due to fetal size, position, movement, abdominal scars, and increased maternal abdominal wall thickness. A second- or third-trimester scan may pose technical limitations for an anatomic evaluation due to imaging artifacts from acoustic shadowing. When this occurs, the report of the sonographic examination should document the nature of this technical limitation. A follow-up examination may be helpful. The following areas of assessment represent the minimal elements of a standard examination of fetal anatomy. A more detailed fetal anatomic examination may be necessary if an abnormality or suspected abnormality is found on the standard examination.
  - i.
    Head, face, and neck:
    - Lateral cerebral ventricles;
    - Choroid plexus;
    - Midline falx;
    - Cavum septi pellucidi;
    - Cerebellum;
    - Cistern magna; and
    - Upper lip.
      
      Comment
      
      A measurement of the nuchal fold may be helpful during a specific age interval to assess the risk of aneuploidy.

- - ii.
    Chest:
    - Heart:
    - Four-chamber view;
    - Left ventricular outflow tract; and
    - Right ventricular outflow tract.
  - iii.
    Abdomen:
    - Stomach (presence, size, and situs);
    - Kidneys;
    - Urinary bladder;
    - Umbilical cord insertion site into the fetal abdomen; and
    - Umbilical cord vessel number.
  - iv.
    Spine:
    - Cervical, thoracic, lumbar, and sacral spine.
  - v.
    Extremities:
    - Legs and arms.
  - vi.
    Sex:
    - In multiple gestations and when medically indicated.

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 accompanied by measurements. Images should be labeled with the patient identification, facility identification, examination date, and side (right or left) of the anatomic site imaged. An official interpretation (final report) of the ultrasound findings should be included in the patient's medical record. Retention of the ultrasound examination should be consistent both with clinical needs and with relevant legal and local health care facility requirements.

Reporting should be in accordance with the AIUM Practice Guideline for Documentation of an Ultrasound Examination .

VII. Equipment Specifications

These studies should be conducted with real-time scanners, using a transabdominal and/or transvaginal approach. A transducer of appropriate frequency should be used. Real-time sonography is necessary to confirm the presence of fetal life through observation of cardiac activity and active movement.

The choice of transducer frequency is a trade-off between beam penetration and resolution. With modern equipment, 3- to 5-MHz abdominal transducers allow sufficient penetration in most patients while providing adequate resolution. A lower-frequency transducer may be needed to provide adequate penetration for abdominal imaging in an obese patient. During early pregnancy, a 5-MHz abdominal transducer or a 5- to 10-MHz or greater vaginal transducer may provide superior resolution while still allowing adequate penetration.

VIII. Fetal Safety

Diagnostic ultrasound studies of the fetus are generally considered safe during pregnancy. This diagnostic procedure should be performed only when there is a valid medical indication, and the lowest possible ultrasonic exposure setting should be used to gain the necessary diagnostic information under the ALARA (as low as reasonably achievable) principle.

A thermal index for soft tissue (Tis) should be used at earlier than 10 weeks' gestation, and a thermal index for bone (Tib) should be used at 10 weeks' gestation or later when bone ossification is evident. In keeping with the ALARA principle, M-mode imaging should be used instead of spectral Doppler imaging to document embryonic/fetal heart rate.

The promotion, selling, or leasing of ultrasound equipment for making “keepsake fetal videos” is considered by the US Food and Drug Administration to be an unapproved use of a medical device. Use of a diagnostic ultrasound system for these purposes, without a physician's order, may be in violation of state laws or regulations.

IX. Quality Control and Improvement, Safety, Infection Control, and Patient Education

Policies and procedures related to quality control, patient education, infection control, and safety should be developed and implemented in accordance with the AIUM Standards and Guidelines for the Accreditation of Ultrasound Practices.

Equipment performance monitoring should be in accordance with the AIUM Standards and Guidelines for the Accreditation of Ultrasound Practices .

X. ALARA Principle

The potential benefits and risks of each examination should be considered. The ALARA 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 , Second Edition.

Ultrasound Equipment and Documentation

It seems that there will always be differences of opinion as to which ultrasound machines produce the best images. With the present state of ultrasound technology, these differences are often subjective, particularly when discussing state-of-the-art machines. Most ultrasound machines use phased-array real-time technology and include 3D/4D ultrasound technology and color and pulsed Doppler flow capabilities and cine recording.

An often-debated issue is which transducer should be used for the ultrasound examination. The answer is as many transducers as are necessary should be used to answer the question for which the patient is referred. There is a misconception that the newest transducer introduced by a manufacturer may be the only one that is needed. When sector and, ultimately, transvaginal probes were first introduced, many practitioners believed that these transducers alone could be used for the entire examination. Many learned that using only a single transducer restricts the field of view or visualization of detail, making diagnosis more difficult.

The most common transducers, which are the workhorses of the ultrasound laboratory, are a convex linear array, a sector transducer (3 to 5 MHz), and a transvaginal probe (5 to 10 MHz). The higher frequency transducers are most useful in achieving high-resolution scans, particularly in the near-field, and the lower frequency transducers are useful in those circumstances in which increased penetration of the sound beam is necessary. Variations of transducer technology include convex linear transducers and multifrequency probes as well as probes allowing harmonic and 3D imaging and Doppler flow imaging.

Whatever technology is used, images from the examination should be documented and stored. The purpose of documentation is twofold. First, the identification of normal structures is important so they can be viewed retrospectively and compared with later images if pathologic processes are ultimately demonstrated. Second, if a pathologic problem is identified, it can be shown to referring examiners, who will be doing further examinations.

Most imaging centers utilize picture archiving and communication systems (PACS). These systems allow for the storage of digital ultrasound images on computers and transmission of complete studies to computer workstations for viewing and interpretation. The quality of the images is excellent with these systems. Digital images can be also transmitted to remote locations (telemedicine) for review and consultation.

In addition to digitally stored images, a written report of the ultrasound examination should be included in the patient's medical record. When significant pathologic processes are present, the referring physician should be notified immediately. This immediate communication should occur not only in cases of fetal malformations but also in cases of serious obstetric complications, such as oligohydramnios, diminished fetal movement, macrosomia, and fetal growth restriction. Physician notification should be documented.

The First Trimester Ultrasound Examination

Identification of an Intrauterine Pregnancy

Patients referred for first trimester ultrasound evaluation often have vaginal bleeding, which raises the question of an ectopic pregnancy or a threatened abortion. The primary goal of ultrasound evaluation in the first trimester is to determine whether the pregnancy is intrauterine and whether the embryo is living. With present-day equipment, particularly transvaginal transducers, both of these tasks should be readily accomplished at very early stages of gestation. The same care taken in concluding that a pregnancy in the second or third trimester has a lethal malformation should be applied in deciding that an early pregnancy is nonviable. If there is reasonable doubt about embryonic life, a repeat examination in as few as 7 to 10 days will invariably make the conclusion unequivocal. In 2012 a consensus conference from the SRU established guidelines and criteria for transvaginal ultrasonographic diagnosis of pregnancy failure in a woman with an intrauterine pregnancy of uncertain viability (see Table 1-2 and Chapter 4 ).

TABLE 1-2

Guidelines for Transvaginal Ultrasonographic Diagnosis of Pregnancy Failure in a Woman With an Intrauterine Pregnancy of Uncertain Viability *

Findings Diagnostic of Pregnancy Failure	Findings Suspicious for, But Not Diagnostic of, Pregnancy Failure ^†
Crown-rump length of ≥7 mm and no heartbeat	Crown-rump length of <7 mm and no heartbeat
Mean sac diameter of ≥25 mm and no embryo	Mean sac diameter of 16-24 mm and no embryo
Absence of embryo with heartbeat ≥2 wk after a scan that showed a gestational sac without a yolk sac	Absence of embryo with heartbeat 7-13 days after a scan that showed a gestational sac without a yolk sac
Absence of embryo with heartbeat ≥11 days after a scan that showed a gestational sac with a yolk sac	Absence of embryo with heartbeat 7-10 days after a scan that showed a gestational sac with a yolk sac
	Absence of embryo ≥6 wk after last menstrual period
	Empty amnion (amnion seen adjacent to yolk sac, with no visible embryo)
	Enlarged yolk sac (>7 mm)
	Small gestational sac in relation to the size of the embryo (<5 mm difference between mean sac diameter and crown-rump length)

* Criteria are from the Society of Radiologists in Ultrasound Multispecialty Consensus Conference on Early First Trimester Diagnosis of Miscarriage and Exclusion of a Viable Intrauterine Pregnancy, October 2012.

† When there are findings suspicious for pregnancy failure, follow-up ultrasonography at 7 to 10 days to assess the pregnancy for viability is generally appropriate.

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