benefitsandriskoffetal3d ultrasound -...

102 VOLUME 32 | NUMBER 2 March/April 2007

Benefits and Risk of Fetal 3D UltrasoundABSTRACT

The purpose of this literature review was to survey available information and research related to routine three-dimensional (3D) ultrasound technology in obstetrics, with an emphasis on current medical uses, safety, andavailability issues. Several data bases, including Cochrane, WHO, NIH, CINALH, Blackwell Synergy, ERIC,PubMed, and Medline, were used along with information from Internet search engines. Although fetal 3D ultra-sound is used in both medical and commercial settings, recent studies focus on its possible uses rather thanthe more difficult issues of safety and commercial applications. Professional organizations associated with ul-trasound technology support limiting ultrasounds in pregnancy to medically necessary events, whereas com-mercial venues use “direct to consumer” marketing to promote this technology as a way to “see” the baby be-fore it is born. How safe is routine or frequent use of 3D ultrasound? Further research is needed to addressthese important questions.

Key Words: Fetal ultrasonography; Ultrasonography, fetal; Ultrasonography, prenatal.

Since the early 2000s, opportunities for captur-ing the lifelike image of a developing fetus haveemerged in shopping malls around the world(Gordon, 2003). Parents can now purchasethree-dimensional (3D) ultrasound images bymerely entering a mall and leaving with pic-

tures suitable for framing; no physician involvement isneeded for this event (Capitulo, McClintock, & Armour,2005). These commercial businesses, with names such asFetal Foto, 3D Baby View, American Baby, Baby Insight,and Baby’s First Image, perform 3D ultrasounds and pro-vide a photo package similar to any commercial photo-graphic enterprise currently available.

The subject of private fetal ultrasound has been debatedin the nursing literature (Capitulo et al., 2005) and recentlyfound its way into Hollywood when it was reported that

March/April 2007 MCN 103

celebrities were purchasing ultra-sound machines to monitor theirdeveloping babies themselves.This underscores the dilemmawith this available technology.According to the American Col-lege of Radiology (2005), fetal ul-trasound should be performedonly by certified technologists formedical purposes and with a pre-scription from an appropriately licensed provider. The Unit-ed States Food & Drug Administration (USFDA, 2005)stated on August 30, 2005 that casual exposure to ultra-sound, especially during pregnancy, should be avoided. Ob-stetrical ultrasound is a common procedure, and yet themachines can be purchased by any private citizen. What arethe implications of this? Can fetal 3D ultrasonography besafely practiced by anyone, at any time, outside the confinesof a health visit with a provider?

According to Woo (2005), ultrasound technology hasbeen termed the most important diagnostic tool in thefield of obstetrics, because by using sound waves to form

CLAUDIA S. WISEMAN, MN, MPH, CNM, APRN, AND ERMALYNN M. KIEHL, PHD, ARNP, CNS

images of the body, it replaces the need for ionizing (x-ray) methods to obtain the same information. Fetal scan-ning with two-dimensional (2D) ultrasounds, which de-pict length and width, has been used routinely in obstet-rics since the 1960s, but these images are black and white,flat and grainy, and need an expert to interpret the results.With the advent of 3D ultrasound in the early 2000s, theadded dimension of depth resulted in a clearer photo-graphic image that is easily recognizable by the untrainedeye (Woo, 2005). Four-dimensional (4D) ultrasound,which captures movement, recently was added to the ul-trasound possibilities, resulting in a more complete repre-sentation of the developing fetus. Some nonmedical mallultrasound businesses include this as an optional serviceor part of the photo package.

Initially, ultrasounds were confined to hospital settings

with centralized control and regulation.In the early 1980s, because of a reduc-tion in cost and added mobility, ultra-sound scanners decentralized from thehospitals into physicians’ clinics and of-fices (Woo, 2005). As the technologyhas evolved, regulation and controlhave become problematic, and con-cerns are now emerging about the safe-ty of this procedure in nonmedical/com-

mercial venues. There is no regulation of the commercial ap-plication of this; the USFDA is responsible for the verifica-tion of maintenance of the ultrasound machines, but notwhere the machines can be used (Volker, 2005).

The purpose of this article, therefore, was to analyzeavailable information and research related to fetal 3D ul-trasound technology use, safety, and DTC marketing. Thefollowing databases were used in this analysis: Cochrane,WHO, NIH, CINALH, Blackwell Synergy, ERIC,PubMed, and Medline. Inclusion criteria for reviewed ar-ticles included text in English, professional journal arti-cles, professional organization standards, published re-

search, and direct to consumer marketing of fetal 3D ul-trasounds. Nine recent studies (2000-2005) that addressedcurrent uses were reviewed, and two older (1993, 1998)landmark studies identifying possible side effects from ul-trasound exposure were also included. Consumer market-ing and related professional organizational informationwas accessed using the Internet search engines Google,Yahoo, and Ask Jeeves.

Studies About Medical Uses of Fetal UltrasoundNo research studies were found directed at fetal 3D technolo-gy use in commercial venues. Therefore, medical use of fetalultrasound research was used to examine current practice,shown in Table 1. Recent medical studies demonstrate the de-sirability of fetal 3D ultrasounds when compared to the tradi-tional 2D standard. Schild, Fimmers & Hansmann (2000)compared 2D and 3D ultrasound for EFW (estimated fetalweight) in 190 scans completed at 7 days before birth withthe actual birth weight, demonstrating that 3D ultrasoundswere superior in determining fetal weight.

Rotten and Levaillant (2004) studied more than 10,000women who received standard 2D ultrasounds during preg-nancy, examining the number of 2D views necessary toidentify facial deformities when compared to 3D technolo-gy. Their findings supported 3D technology, which requiredfewer views, was easier to use, was more efficient, and re-sulted in a clearer image. Merz and Welter (2005) had simi-lar results and demonstrated that in 70% of the cases withabnormalities, 3D ultrasounds provided more informationabout the severity of the abnormality.

Several studies have focused on abnormalities duringpregnancy and birth, such as nuchal cord. Hanaoka,Yanagihara, Tanaka, and Hata (2002) compared 2D and3D ultrasound in a convenience sample of 85 pregnantwomen with evidence of a nuchal cord and demonstratedthat 3D ultrasound was superior in nuchal cord identifica-

tion at term. Chaoui, Kalacheand, and Hartung (2001)studied 3D ultrasound to identify abnormal fetal develop-ment, finding that it could verify the abnormality in the fe-tus in 64% of the abnormal cases.

In recent years, concerns over cervical length and the in-cidence of PTD (preterm delivery) have been addressedwith the use of ultrasound to measure the length of thecervix during pregnancy. Severi et al. (2003) studied this in103 high-risk women and found that 3D ultrasound tech-nology was superior in identifying women who would de-liver early.

Pregnancy ultrasound information about the firsttrimester has been limited by standard 2D views, but 3Dultrasound offers new opportunities in this area. Early 3Duse in pregnancy has now been studied. Michailidis, Papa-georgiou, Morris, and Economiders (2003) compared theability to determine gender identification between 2D and3D ultrasound, finding that 3D ultrasound technology wassuperior. Ohman, Saltvedt, Grunewald, and Waldenstrom(2004) examined the anxiety felt by women when early ul-trasounds were used to detect Down syndrome and foundthat early use of 3D ultrasound did not increase anxietylevels in women.

Because of the clarity of 3D and 4D ultrasounds, innova-tive uses are still being developed. Kurjak et al. (2004) used4D ultrasound to compare observed fetal behavior in uterowith subsequent behavior after birth, noting that move-ments and facial expressions were the same for individualinfants before and after birth. This finding suggests thatthere could be a potential for identifying neurological prob-lems before birth, thus adding to the literature on whetherneurological problems are caused by birth trauma.

Studies About Safety of Fetal UltrasoundIn the early 1980s, the National Institutes of Health (NIH,1984) convened an expert panel to determine possible safe-ty concerns related to exposure to ultrasound technology.This panel recommended against the routine use of prenatalscanning (embryonic and fetal), suggesting that althoughthere are no known hazards, caution should be exercisedregarding developing organisms. In June 1988, a subse-quent professional group was convened by the NIH to starta 3-year process to develop standards for operation at high-er levels of exposure to increase diagnostic capabilities. Oneresult was the “output display standard,” which gives theoperators information about possible temperature increases


Parents-to-be can now merely enter ashopping mall and obtain 3D ultrasound images of their fetus, withno healthcare provider involvement.


Study Sample Design Outcomes

Chaoui et al. (2001) 133 pregnant women; n = 45normal; n = 87 abnormal; con-venience sample from hospitalclinic in Germany

Visualization of fetal vasculature; abnormalitieswith 3D U/S

64% of abnormalities could bevisualized. Lack of visualizationdue to fetal movement anddifferentiation between othervascular structures. Superiorto 2D U/S in visualization ofvascular abnormalities in fetus.

Fatemi et al. (2001) N = 9; 3rd trimester fetus Fetal reactions to U/S; clinicalstudy, prospective

Demonstrated reaction by thefetus to U/S.

Garcia et al. (2002) Systematic review of literature Women’s views about U/S inpregnancy

Positive experience, minimalinformation of safety issuesand reasons for scans.

Hanaoka et al. (2002) 85 pregnant women in Japan;convenience sample

Identification of nuchal cordwith 3D U/S in pregnancycompared to 2D and colorDoppler

No overall differencesbetween compared modali-ties, although subjective visu-alization was deemed betterwith 3D U/S by the operators.

Kurjak et al. (2004) n = 10, 3rd trimester; n = 10,newborns; convenience sam-ple from Croatia

Compare fetal behavior/movements with newborns;Real timeVideo/4D U/S usedfor fetal observation.

Demonstrated the samemovements, facial expres-sions newborns and fetus. 4D U/S as powerful tool forassessing fetal behavior.Possible use for assessing CP-type perinatal impairments.

Ji et al. (2005) n = 50, 2D; n = 50, 3D Compared bonding measuresbetween 2D and 3D; random-ized, control trial

3D may have greater bondingpotential.

Michailidis et al. (2003) N = 200 pregnant women, 1st trimester; conveniencesample from England

1st trimester 3D U/S for sexdetermination; prospective

Demonstrated effective identi-fication of gender at an earlierstage than 2D U/S.

Merz & Welter (2005) N = 3,472 high-risk pregnancies

Convenience sample inGermany. Compare identifica-tion of fetal anomaliesbetween 2D and 3D U/S;prospective

3D U/S was advantageous in70% of the identified cases.Provides > information about anormal fetus and anomalies.

Ohman et al. (2004) N = 2,026 pregnant women;multicenter in Sweden

Early U/S (12-14 weeks) forDown syndrome identificationin pregnancy: Does thisincrease anxiety?

Did not cause more anxietyduring pregnancy.

Rotten & Levaillant(2004)

N = 10,500 2D U/S exams 2nd trimester, France

Determine the number ofviews to identify facial anom-alies and compare 3D; retro-spective

3D superior to 2D in identify-ing fetal facial deformities.Need 2+ views in 2D to identi-fy abnormalities. 3D easier,rapid, and more precise.

Schild et al. (2000) N = 190 pregnant women, 7 days < EDC, Germany

EFW comparisons between2D and 3D U/S at term;prospective, cross-sectional

3D U/S was more effective at determining fetal weight at term.

Severi et al. (2003) N = 103 pregnant women;2nd and 3rd trimester; conven-ience sample from Italy.

Comparison between 2D and3D examination of cervicallength; prospective

Demonstrated superiority of3D U/S in determining cervicallength and subsequent PTD.

TABLE 1. SUMMARY OF OBSTETRICAL ULTRASOUND RESEARCH

(thermal index) and mechanical damage (mechanical index)to use in clinical decision-making (AIUM, 1992). Findingsfrom these groups resulted in the principle of exposure toultrasound called ALARA (As Low As ReasonablyAchievable), which is the current industry standard. Thisstandard implies a level of knowledge about upper (ordangerous) levels of exposure and the effect on living tis-sue that may or may not be present in clinics and com-mercial venues.

The lack of scientific knowledge about the safety of mul-tiple ultrasounds in pregnancy stands in stark contrast tothe fact that women consistently express the desire to knowtheir babies before they are born. Ultrasound has giventhem that opportunity. Clement, Wilson, and Sikorski(1998) described three main elements in a pregnantwomen’s desire to have an ultrasound:

1. Meeting the baby2. Developing a visual confirmation of the pregnancy3. Reassurance of fetal well-being

Garcia et al. (2002) confirmed this work and noted thatin all of the studies they reviewed from industrialized coun-tries, women rarely expressed fears about the safety of theprocedure. Because ultrasound is approached by the med-ical community as part of normal prenatal care, it seemsthat few women are aware of the safety concerns that areinherent in this procedure.

The two major effects of ultrasound on living organ-isms are heat and cavitation. Because tissue heating relat-ed to the time of exposure is a major concern in the prac-tice of obstetrics, all professional organizations have sup-ported limits for the maximum exposure time to 20 minfor the developing fetus. Cavitation is the formation ofgaseous “bubbles” when tissue is exposed to ultrasound(Miller, 1999). Although no studies have demonstrated adirect relationship with complications related to heat orcavitation, the AIUM (1999) suggests that the possibilityexists for biological effects to be identified in the future.Many professional organizations and others support lim-


Organization Year Statement

ISUOG(International Society for Ultrasound inObstetrics and Gynecology)

2002Limit to medically indicated procedures rather than forpurely entertainment purposeswww.isuog.org

BMUS(British Medical Ultrasound Society)

2000 Investigations are in early stages, advise “prudent” useof this modality www.bmus.org

AIUM(American Institute of Ultrasound inMedicine)

1999Limit to medically indicated reasons www.aium.org

ASUM(Australasian Society for Ultrasound inMedicine)

2003

No convincing evidence that diagnostic ultrasound caus-es adverse health effects but does not recommend non-medical usewww.asum.com.au

FDA(Food and Drug Administration)

2005Discourage nonmedical use of ultrasoundswww.fda.org

ACOG(American College of Obstetrics andGynecology)

2005Fears about the qualifications of providers, inaccuracy offindings, and increased exposure ultrasound technologywww.acog.org

MOD (March of Dimes) 2005Casual use during pregnancy should be avoided www.marchofdimes.com

TABLE 2. SAFETY STATEMENTS FOR FETAL ULTRASOUNDS

iting ultrasounds in pregnancy to medically necessaryevents (see Table 2)

Although recent studies are difficult to identify, threestudies that demonstrate possible health effects on the de-veloping fetus were found related to neurologicalchanges, increased incidence of growth-restricted infants,and hearing impacts on the developing fetus. Kieler et al.(1998) studied data collected from a cohort of childrenwhose mothers had participated in an earlier study(1985-1987) in Norway, comparing women who receivedultrasound in pregnancy with women who did not. Thisstudy focused on the possible neurological impact of rou-tine ultrasounds as reported by the mothers involved inthe previous study. No evidence of neurological impair-ment was reported, but an increase in left-handedness inboys was demonstrated. Although this finding could notbe connected to any impairment, the authors recom-mended that further studies be directed at this finding,because it may indicate a subtle influence on the develop-ing neurological system of the fetus.

The question of effects from repeated ultrasound wasthe subject of Australian research by Newnham, Evans,Michael, Stanley, and Landau (1993), who randomizedwomen into receiving only one ultrasound during preg-nancy or a total of five ultrasounds during the pregnancy.Birth outcomes were compared, and there was a higherincidence of IUGR (intrauterine growth restriction) in thegroup that received five ultrasounds. This study would bedifficult to repeat because of ethical considerations but isworth noting.

Finally, two studies (Fatemi, Alizad, & Greenleaf,2005; Fatemi, Ogburn, & Greenleaf, 2001) have report-ed that the developing fetus responds to pulsed ultra-sound directed at the head during routine examinations.Although no untoward effects were noted, this findingunderscores our current lack of understanding about thiscommon practice in obstetrics. Fatemi et al. (2005) alsostated that ultrasound can no longer be viewed as a pas-sive procedure.

Availability of Fetal UltrasoundIn the early 1970s, direct-to-consumer (DTC) marketingexploded when the USFDA stated that consumer marketingwas legal if companies disclosed the major risks and “madeadequate provisions for information regarding side effects,contraindications and effectiveness” available to the public(Rosenthal, Berndt, Donohue, Frank, & Epstein, 2002). In

1997, this policy was clarified by the USFDA to addressbroadcast advertising concerns about information to con-sumers. This clarification stated that DTC marketers shouldinclude a referral to a toll-free number, referrals back totheir clients’ physician providers, summaries of risks, andrelated Web sites to fulfill any obligations to consumers re-garding use and product safety.

Consumer marketing has been used by pharmaceutical andmedical companies for the past 35 years, but the growth inthis “new market” of 3D ultrasound technology is unprece-dented (Gordon, 2003). DTC bypasses the normal physicianinterface between consumers and medical services and sup-plies. Readily available in this and other countries, commercialproviders of 3D ultrasounds offer photographic services forunborn children of all interested parents.

Public availability of fetal ultrasound empowers con-sumers with the ability to access services that bypass theirpersonal medical provider plus enjoy the convenience ofscheduling to include other family members. These appeal-ing aspects for 3D ultrasound services are driving the bur-geoning market place.

Unfortunately, there are problems inherent in DTC mar-keting of these services. It is unknown whether consumersunderstand the results of a commercial 3D encounter,whether there is follow-up for treatment, and whether med-ical providers even know that such encounters are takingplace. By taking the medical provider out of the service dy-namic, the consumer assumes the responsibility for any re-sults that emanate from the service. In the case of fetal ul-trasound, what if a problem is detected? How this is identi-fied and what is the follow-up? Is the information obtainedfrom a commercial enterprise available to the patient’s med-ical provider to develop a plan, or will all of the informa-tion have to be reinvented with a new ultrasound, thus in-curring additional exposure to the fetus? All of these ques-tions are relevant to modern DTC marketing and 3D ultra-sound commercial venues.

Clinical ImplicationsClinical implications of the ever-increasing use of fetal ultra-sound are broad and encompass medicine, nursing, consumers,safety, government/regulations, and marketing/business.

Education of Women and Healthcare ProvidersConsumers and providers need more information regardingthis new technology. Professional and commercial providersmay have limited educational backgrounds for performing


Many professional organizations support limiting pregnancy ultrasound to medically necessary events.

ultrasounds. Because the operators of ultrasound machinesare not regulated, consumers have no safeguards aboutwho performs ultrasounds on their fetuses. Minimally, con-sumers should be apprised of their right to know the pro-fessional training and licensure of anyone attempting toperform an ultrasound on them during pregnancy, especial-ly in commercial venues.

Most consumers are woefully unaware of any possibleside effects from this procedure (Garcia et al, 2002). Ob-stetrical ultrasounds in a healthcare setting are offered spar-ingly during pregnancy, and few women forego the oppor-tunity to “see” their baby before the actual birth. With theemergence of DTC marketing, consumers need scientific in-formation based on the best available medical evidence asthey consider 3D ultrasound opportunities. Ji et al. (2005)have demonstrated increased maternal-fetal bonding whencomparing 2D and 3D ultrasound experiences, but doesthis bonding experience outweigh the potential risks relatedto ultrasound technology? According to Capitulo et al.(2005, p.9), we don’t consider having other procedures for

fun, so “why would we want to subject a fetus to testing atan unregulated site by an unregulated practitioner?” Whenthe individual consumer has no information about safety orexperience of the operator, how can she make a determina-tion about what to do?

Practice StandardsIn the United States, individual states may regulate theproviders of ultrasound through licensing (Volker, 2005),but it is extremely difficult to even obtain informationabout which states have done so. Some of the issues sur-rounding this lack of regulation are as follows:

1. Licensing: Currently, providers may have limited orno training related to individual state requirements.

2. Possible side effects: Professional organizations sug-gest no more than 20 minutes of exposure during fe-tal ultrasounds, although information about this cau-tion is not readily available to consumers (Garcia etal., 2002).

3. Informed consent: Consumers typically sign a releaseform stating that they have been advised of the possi-ble risks and benefits of medical procedures, but havethey really been advised when so little is actuallyknown?

4. Standards: Few standards exist for ultrasound outsideof medical diagnostics.

5. Linkages: Developing communication between thecommercial venues and the medical community iscritical.

6. Medical history: Should records be required that doc-ument the number of ultrasounds and level of expo-sure during each pregnancy?

The American Institute of Ultrasound in Medicine(AIUM) has addressed practice standards in its 2005 state-ment on “keepsake imaging”:

“The AIUM advocates the responsible use ofdiagnostic ultrasound for all fetal imaging. TheAIUM understands the growing pressures frompatients for the performance of ultrasound exami-nations for bonding and reassurance purposeslargely driven by the improving image quality of3D sonography and by more widely available in-formation about these advances. Although thereis only preliminary scientific evidence that 3Dsonography has a positive impact on parental--fe-tal bonding, the AIUM recognizes that many par-ents may pursue scanning for this purpose.

The AIUM recommends that licensed medicalprofessionals (either physicians or registered orregistry-eligible sonographers) who have receivedspecialized training in fetal imaging perform all fe-tal ultrasound scans. These individuals have beentrained to recognize medically important condi-tions, such as congenital anomalies, artifacts asso-


• Following the AIUM guidelines, ultrasonogra-phy providers should be licensed medicalprofessionals.

• Patients should be educated to ask ultra-sonography providers about their expertiseand license before submitting to ultrasound.

• Formal communication linkages should existbetween commercial and medical providers.

• Patients who receive any commercial ultra-sound should be instructed to discuss thiswith their healthcare provider.

• Nurses can work with professional organiza-tions to help develop standards for fetal ultra-sound.

• Consideration should be given to a trueinformed consent process for ultrasound pro-cedures.

Clinical Implications for Providers

ciated with ultrasound scanning that may mimicpathology, and techniques to avoid ultrasound ex-posure beyond what is considered safe for the fe-tus. Any other use of "limited medical ultra-sound" may constitute practice of medicine with-out a license. The AIUM reemphasizes that all im-aging requires proper documentation and a finalreport for the patient medical record signed by aphysician.” (AIUM, 2005)

Implications for Further ResearchFetal exposure to ultrasound is not easy to study because ofethical and legal considerations (Woo, 2005). Long-term bi-ological effects are difficult to connect to individual medicaloccurrences in fetal development. Currently, 3D ultrasoundis a relatively new, very promising technology being used insome venues without consideration of future effects on de-veloping babies; women are told that there are no knownadverse effects, yet few research endeavors have been di-rected at exposure levels or long-term problems. Research isneeded not only concerning the beneficial effects of ultra-sound in pregnancy but also its possible negative conse-quences before women should submit to unlimited ultra-sound scans during pregnancy. <

Claudia S. Wiseman is a Doctoral Student, School of Nurs-ing, College of Health and Public Affairs, University ofCentral Florida, Orlando. She can be reached via e-mail [email protected].

Ermalynn M. Kiehl is an Associate Professor, School ofNursing, University of Louisville, KY.

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A lack of regulation about ultrasound technology exists, which means that nostandards or licensure for operators are available in many states in the U.S.

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