Benefits and Risk of Fetal 3D

ABSTRACT The purpose of this literature review was to survey available information and research related to routine three- dimensional (3D) ultrasound technology in , with an emphasis on current medical uses, safety, and availability 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 than the more difficult issues of safety and commercial applications. Professional organizations associated with ul- trasound technology support limiting in 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 address these important questions. Key Words: Fetal ultrasonography; Ultrasonography, fetal; Ultrasonography, prenatal.

102 VOLUME 32 | NUMBER 2 March/April 2007 ince the early 2000s, opportunities for captur- images of the body, it replaces the need for ionizing (x- ing the lifelike image of a developing have ray) methods to obtain the same information. Fetal scan- emerged in shopping malls around the world ning with two-dimensional (2D) ultrasounds, which de- (Gordon, 2003). Parents can now purchase pict length and width, has been used routinely in obstet- Sthree-dimensional (3D) ultrasound images by rics since the 1960s, but these images are black and white, merely entering a mall and leaving with pic- flat and grainy, and need an expert to interpret the results. tures suitable for framing; no physician involvement is With the advent of 3D ultrasound in the early 2000s, the needed for this event (Capitulo, McClintock, & Armour, added dimension of depth resulted in a clearer photo- 2005). These commercial businesses, with names such as graphic image that is easily recognizable by the untrained Fetal Foto, 3D Baby View, American Baby, Baby Insight, eye (Woo, 2005). Four-dimensional (4D) ultrasound, and Baby’s First Image, perform 3D ultrasounds and pro- which captures movement, recently was added to the ul- vide a photo package similar to any commercial photo- trasound possibilities, resulting in a more complete repre- graphic enterprise currently available. sentation of the developing fetus. Some nonmedical mall The subject of private fetal ultrasound has been debated ultrasound businesses include this as an optional service in the nursing literature (Capitulo et al., 2005) and recently or part of the photo package. found its way into Hollywood when it was reported that Initially, ultrasounds were confined to hospital settings

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

celebrities were purchasing ultra- with centralized control and regulation. sound machines to monitor their In the early 1980s, because of a reduc- developing babies themselves. tion in cost and added mobility, ultra- This underscores the dilemma sound scanners decentralized from the with this available technology. hospitals into physicians’ clinics and of- According to the American Col- fices (Woo, 2005). As the technology lege of (2005), fetal ul- has evolved, regulation and control trasound should be performed have become problematic, and con- only by certified technologists for cerns are now emerging about the safe- medical purposes and with a pre- ty of this procedure in nonmedical/com- scription from an appropriately licensed provider. The Unit- mercial venues. There is no regulation of the commercial ap- ed States Food & Drug Administration (USFDA, 2005) plication of this; the USFDA is responsible for the verifica- stated on August 30, 2005 that casual exposure to ultra- tion of maintenance of the ultrasound machines, but not sound, especially during pregnancy, should be avoided. Ob- where the machines can be used (Volker, 2005). stetrical ultrasound is a common procedure, and yet the The purpose of this article, therefore, was to analyze machines can be purchased by any private citizen. What are available information and research related to fetal 3D ul- the implications of this? Can fetal 3D ultrasonography be trasound technology use, safety, and DTC marketing. The safely practiced by anyone, at any time, outside the confines following databases were used in this analysis: Cochrane, of a health visit with a provider? WHO, NIH, CINALH, Blackwell Synergy, ERIC, According to Woo (2005), ultrasound technology has PubMed, and Medline. Inclusion criteria for reviewed ar- been termed the most important diagnostic tool in the ticles included text in English, professional journal arti- field of obstetrics, because by using sound waves to form cles, professional organization standards, published re-

March/April 2007 MCN 103 Parents-to-be can now merely enter a shopping mall and obtain 3D ultrasound images of their fetus, with no healthcare provider involvement.

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 addressed with the use of ultrasound to measure the length of the cervix during pregnancy. Severi et al. (2003) studied this in 103 high-risk women and found that 3D ultrasound tech- nology was superior in identifying women who would de- search, and direct to consumer marketing of fetal 3D ul- liver early. trasounds. Nine recent studies (2000-2005) that addressed Pregnancy ultrasound information about the first current uses were reviewed, and two older (1993, 1998) trimester has been limited by standard 2D views, but 3D landmark studies identifying possible side effects from ul- ultrasound offers new opportunities in this area. Early 3D trasound exposure were also included. Consumer market- use in pregnancy has now been studied. Michailidis, Papa- ing and related professional organizational information georgiou, Morris, and Economiders (2003) compared the was accessed using the Internet search engines Google, ability to determine gender identification between 2D and Yahoo, and Ask Jeeves. 3D ultrasound, finding that 3D ultrasound technology was superior. Ohman, Saltvedt, Grunewald, and Waldenstrom Studies About Medical Uses (2004) examined the anxiety felt by women when early ul- trasounds were used to detect Down syndrome and found of Fetal Ultrasound that early use of 3D ultrasound did not increase anxiety No research studies were found directed at fetal 3D technolo- levels in women. gy use in commercial venues. Therefore, medical use of fetal Because of the clarity of 3D and 4D ultrasounds, innova- ultrasound research was used to examine current practice, tive uses are still being developed. Kurjak et al. (2004) used shown in Table 1. Recent medical studies demonstrate the de- 4D ultrasound to compare observed fetal behavior in utero sirability of fetal 3D ultrasounds when compared to the tradi- with subsequent behavior after birth, noting that move- tional 2D standard. Schild, Fimmers & Hansmann (2000) ments and facial expressions were the same for individual compared 2D and 3D ultrasound for EFW (estimated fetal infants before and after birth. This finding suggests that weight) in 190 scans completed at 7 days before birth with there could be a potential for identifying neurological prob- the actual , demonstrating that 3D ultrasounds lems before birth, thus adding to the literature on whether were superior in determining fetal weight. neurological problems are caused by birth trauma. Rotten and Levaillant (2004) studied more than 10,000 women who received standard 2D ultrasounds during preg- Studies About Safety nancy, examining the number of 2D views necessary to identify facial deformities when compared to 3D technolo- of Fetal Ultrasound gy. Their findings supported 3D technology, which required In the early 1980s, the National Institutes of Health (NIH, fewer views, was easier to use, was more efficient, and re- 1984) convened an expert panel to determine possible safe- sulted in a clearer image. Merz and Welter (2005) had simi- ty concerns related to exposure to ultrasound technology. lar results and demonstrated that in 70% of the cases with This panel recommended against the routine use of prenatal abnormalities, 3D ultrasounds provided more information scanning (embryonic and fetal), suggesting that although about the severity of the abnormality. there are no known hazards, caution should be exercised Several studies have focused on abnormalities during regarding developing organisms. In June 1988, a subse- pregnancy and birth, such as nuchal cord. Hanaoka, quent professional group was convened by the NIH to start Yanagihara, Tanaka, and Hata (2002) compared 2D and a 3-year process to develop standards for operation at high- 3D ultrasound in a convenience sample of 85 pregnant er levels of exposure to increase diagnostic capabilities. One women with evidence of a nuchal cord and demonstrated result was the “output display standard,” which gives the that 3D ultrasound was superior in nuchal cord identifica- operators information about possible temperature increases

104 VOLUME 32 | NUMBER 2 March/April 2007 TABLE 1. SUMMARY OF OBSTETRICAL ULTRASOUND RESEARCH

Study Sample Design Outcomes Chaoui et al. (2001) 133 pregnant women; n = 45 Visualization of fetal 64% of abnormalities could be normal; n = 87 abnormal; con- vasculature; abnormalities visualized. Lack of visualization venience sample from hospital with 3D U/S due to and clinic in Germany differentiation between other vascular structures. Superior to 2D U/S in visualization of vascular abnormalities in fetus.

Fatemi et al. (2001) N = 9; 3rd trimester fetus Fetal reactions to U/S; clinical Demonstrated reaction by the study, prospective fetus to U/S.

Garcia et al. (2002) Systematic review of literature Women’s views about U/S in Positive experience, minimal pregnancy information of safety issues and reasons for scans.

Hanaoka et al. (2002) 85 pregnant women in Japan; Identification of nuchal cord No overall differences convenience sample with 3D U/S in pregnancy between compared modali- compared to 2D and color ties, although subjective visu- Doppler alization was deemed better with 3D U/S by the operators.

Kurjak et al. (2004) n = 10, 3rd trimester; n = 10, Compare fetal behavior/ Demonstrated the same newborns; convenience sam- movements with newborns; movements, facial expres- ple from Croatia Real timeVideo/4D U/S used sions newborns and fetus. for fetal observation. 4D U/S as powerful tool for assessing fetal behavior. Possible use for assessing CP-type perinatal impairments.

Ji et al. (2005) n = 50, 2D; n = 50, 3D Compared bonding measures 3D may have greater bonding between 2D and 3D; random- potential. ized, control trial

Michailidis et al. (2003) N = 200 pregnant women, 1st trimester 3D U/S for sex Demonstrated effective identi- 1st trimester; convenience determination; prospective fication of gender at an earlier sample from England stage than 2D U/S.

Merz & Welter (2005) N = 3,472 high-risk Convenience sample in 3D U/S was advantageous in Germany. Compare identifica- 70% of the identified cases. tion of fetal anomalies Provides > information about a between 2D and 3D U/S; normal fetus and anomalies. prospective

Ohman et al. (2004) N = 2,026 pregnant women; Early U/S (12-14 weeks) for Did not cause more anxiety multicenter in Sweden Down syndrome identification during pregnancy. in pregnancy: Does this increase anxiety?

Rotten & Levaillant N = 10,500 2D U/S exams Determine the number of 3D superior to 2D in identify- (2004) 2nd trimester, France views to identify facial anom- ing fetal facial deformities. alies and compare 3D; retro- Need 2+ views in 2D to identi- spective fy abnormalities. 3D easier, rapid, and more precise.

Schild et al. (2000) N = 190 pregnant women, EFW comparisons between 3D U/S was more effective 7 days < EDC, Germany 2D and 3D U/S at term; at determining fetal weight prospective, cross-sectional at term.

Severi et al. (2003) N = 103 pregnant women; Comparison between 2D and Demonstrated superiority of 2nd and 3rd trimester; conven- 3D examination of cervical 3D U/S in determining cervical ience sample from Italy. length; prospective length and subsequent PTD.

March/April 2007 MCN 105 TABLE 2. SAFETY STATEMENTS FOR FETAL ULTRASOUNDS

Organization Year Statement

ISUOG Limit to medically indicated procedures rather than for (International Society for Ultrasound in 2002 purely entertainment purposes Obstetrics and Gynecology) www.isuog.org

BMUS Investigations are in early stages, advise “prudent” use 2000 (British Society) of this modality www.bmus.org

AIUM Limit to medically indicated reasons (American Institute of Ultrasound in 1999 www.aium.org Medicine)

No convincing evidence that diagnostic ultrasound caus- ASUM es adverse health effects but does not recommend non- (Australasian Society for Ultrasound in 2003 medical use Medicine) www.asum.com.au

FDA Discourage nonmedical use of ultrasounds 2005 (Food and Drug Administration) www.fda.org

ACOG Fears about the qualifications of providers, inaccuracy of (American College of Obstetrics and 2005 findings, and increased exposure ultrasound technology Gynecology) www.acog.org

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

(thermal index) and mechanical damage (mechanical index) Garcia et al. (2002) confirmed this work and noted that to use in clinical decision-making (AIUM, 1992). Findings in all of the studies they reviewed from industrialized coun- from these groups resulted in the principle of exposure to tries, women rarely expressed fears about the safety of the ultrasound called ALARA (As Low As Reasonably procedure. Because ultrasound is approached by the med- Achievable), which is the current industry standard. This ical community as part of normal , it seems standard implies a level of knowledge about upper (or that few women are aware of the safety concerns that are dangerous) levels of exposure and the effect on living tis- inherent in this procedure. sue that may or may not be present in clinics and com- The two major effects of ultrasound on living organ- mercial venues. isms are heat and cavitation. Because tissue heating relat- The lack of scientific knowledge about the safety of mul- ed to the time of exposure is a major concern in the prac- tiple ultrasounds in pregnancy stands in stark contrast to tice of obstetrics, all professional organizations have sup- the fact that women consistently express the desire to know ported limits for the maximum exposure time to 20 min their babies before they are born. Ultrasound has given for the developing fetus. Cavitation is the formation of them that opportunity. Clement, Wilson, and Sikorski gaseous “bubbles” when tissue is exposed to ultrasound (1998) described three main elements in a pregnant (Miller, 1999). Although no studies have demonstrated a women’s desire to have an ultrasound: direct relationship with complications related to heat or 1. Meeting the baby cavitation, the AIUM (1999) suggests that the possibility 2. Developing a visual confirmation of the pregnancy exists for biological effects to be identified in the future. 3. Reassurance of fetal well-being Many professional organizations and others support lim-

106 VOLUME 32 | NUMBER 2 March/April 2007 Many professional organizations support limiting pregnancy ultrasound to medically necessary events.

iting ultrasounds in pregnancy to medically necessary 1997, this policy was clarified by the USFDA to address events (see Table 2) broadcast advertising concerns about information to con- Although recent studies are difficult to identify, three sumers. This clarification stated that DTC marketers should studies that demonstrate possible health effects on the de- include a referral to a toll-free number, referrals back to veloping fetus were found related to neurological their clients’ physician providers, summaries of risks, and changes, increased incidence of growth-restricted infants, related Web sites to fulfill any obligations to consumers re- and hearing impacts on the developing fetus. Kieler et al. garding use and product safety. (1998) studied data collected from a cohort of children Consumer marketing has been used by pharmaceutical and whose mothers had participated in an earlier study medical companies for the past 35 years, but the growth in (1985-1987) in Norway, comparing women who received this “new market” of 3D ultrasound technology is unprece- ultrasound in pregnancy with women who did not. This dented (Gordon, 2003). DTC bypasses the normal physician study focused on the possible neurological impact of rou- interface between consumers and medical services and sup- tine ultrasounds as reported by the mothers involved in plies. Readily available in this and other countries, commercial the previous study. No evidence of neurological impair- providers of 3D ultrasounds offer photographic services for ment was reported, but an increase in left-handedness in unborn children of all interested parents. boys was demonstrated. Although this finding could not Public availability of fetal ultrasound empowers con- be connected to any impairment, the authors recom- sumers with the ability to access services that bypass their mended that further studies be directed at this finding, personal medical provider plus enjoy the convenience of because it may indicate a subtle influence on the develop- scheduling to include other family members. These appeal- ing neurological system of the fetus. ing aspects for 3D ultrasound services are driving the bur- The question of effects from repeated ultrasound was geoning market place. the subject of Australian research by Newnham, Evans, Unfortunately, there are problems inherent in DTC mar- Michael, Stanley, and Landau (1993), who randomized keting of these services. It is unknown whether consumers women into receiving only one ultrasound during preg- understand the results of a commercial 3D encounter, nancy or a total of five ultrasounds during the pregnancy. whether there is follow-up for treatment, and whether med- Birth outcomes were compared, and there was a higher ical providers even know that such encounters are taking incidence of IUGR (intrauterine growth restriction) in the place. By taking the medical provider out of the service dy- group that received five ultrasounds. This study would be namic, the consumer assumes the responsibility for any re- difficult to repeat because of ethical considerations but is sults that emanate from the service. In the case of fetal ul- worth noting. trasound, what if a problem is detected? How this is identi- Finally, two studies (Fatemi, Alizad, & Greenleaf, fied and what is the follow-up? Is the information obtained 2005; Fatemi, Ogburn, & Greenleaf, 2001) have report- from a commercial enterprise available to the patient’s med- ed that the developing fetus responds to pulsed ultra- ical provider to develop a plan, or will all of the informa- sound directed at the head during routine examinations. tion have to be reinvented with a new ultrasound, thus in- Although no untoward effects were noted, this finding curring additional exposure to the fetus? All of these ques- underscores our current lack of understanding about this tions are relevant to modern DTC marketing and 3D ultra- common practice in obstetrics. Fatemi et al. (2005) also sound commercial venues. stated that ultrasound can no longer be viewed as a pas- sive procedure. Clinical Implications Clinical implications of the ever-increasing use of fetal ultra- Availability of Fetal Ultrasound sound are broad and encompass medicine, nursing, consumers, In the early 1970s, direct-to-consumer (DTC) marketing safety, government/regulations, and marketing/business. exploded when the USFDA stated that consumer marketing was legal if companies disclosed the major risks and “made Education of Women and Healthcare Providers adequate provisions for information regarding side effects, Consumers and providers need more information regarding contraindications and effectiveness” available to the public this new technology. Professional and commercial providers (Rosenthal, Berndt, Donohue, Frank, & Epstein, 2002). In may have limited educational backgrounds for performing

March/April 2007 MCN 107 fun, so “why would we want to subject a fetus to testing at an unregulated site by an unregulated practitioner?” When the individual consumer has no information about safety or experience of the operator, how can she make a determina- tion about what to do?

Practice Standards In the United States, individual states may regulate the providers of ultrasound through licensing (Volker, 2005), but it is extremely difficult to even obtain information Clinical Implications for Providers about 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 or • Following the AIUM guidelines, ultrasonogra- no training related to individual state requirements. phy providers should be licensed medical 2. Possible side effects: Professional organizations sug- professionals. gest no more than 20 minutes of exposure during fe- • Patients should be educated to ask ultra- tal ultrasounds, although information about this cau- sonography providers about their expertise tion is not readily available to consumers (Garcia et and license before submitting to ultrasound. al., 2002). • Formal communication linkages should exist 3. Informed consent: Consumers typically sign a release between commercial and medical providers. form stating that they have been advised of the possi- ble risks and benefits of medical procedures, but have • Patients who receive any commercial ultra- they really been advised when so little is actually sound should be instructed to discuss this known? with their healthcare provider. 4. Standards: Few standards exist for ultrasound outside • Nurses can work with professional organiza- of medical diagnostics. tions to help develop standards for fetal ultra- 5. Linkages: Developing communication between the sound. commercial venues and the medical community is • Consideration should be given to a true critical. informed consent process for ultrasound pro- 6. Medical history: Should records be required that doc- cedures. 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”: ultrasounds. Because the operators of ultrasound machines are not regulated, consumers have no safeguards about “The AIUM advocates the responsible use of who performs ultrasounds on their . Minimally, con- diagnostic ultrasound for all fetal imaging. The sumers should be apprised of their right to know the pro- AIUM understands the growing pressures from fessional training and licensure of anyone attempting to patients for the performance of ultrasound exami- perform an ultrasound on them during pregnancy, especial- nations for bonding and reassurance purposes ly in commercial venues. largely driven by the improving image quality of Most consumers are woefully unaware of any possible 3D sonography and by more widely available in- side effects from this procedure (Garcia et al, 2002). Ob- formation about these advances. Although there stetrical ultrasounds in a healthcare setting are offered spar- is only preliminary scientific evidence that 3D ingly during pregnancy, and few women forego the oppor- sonography has a positive impact on parental--fe- tunity to “see” their baby before the actual birth. With the tal bonding, the AIUM recognizes that many par- emergence of DTC marketing, consumers need scientific in- ents may pursue scanning for this purpose. formation based on the best available medical evidence as The AIUM recommends that licensed medical they consider 3D ultrasound opportunities. Ji et al. (2005) professionals (either physicians or registered or have demonstrated increased maternal-fetal bonding when registry-eligible sonographers) who have received comparing 2D and 3D ultrasound experiences, but does specialized training in fetal imaging perform all fe- this bonding experience outweigh the potential risks related tal ultrasound scans. These individuals have been to ultrasound technology? According to Capitulo et al. trained to recognize medically important condi- (2005, p.9), we don’t consider having other procedures for tions, such as congenital anomalies, artifacts asso-

108 VOLUME 32 | NUMBER 2 March/April 2007 A lack of regulation about ultrasound technology exists, which means that no standards or licensure for operators are available in many states in the U.S.

ciated with ultrasound scanning that may mimic Fatemi, M., Alizad, A., & Greenleaf, J. F. (2005). Characteristics of the audio sound generated by ultrasound imaging systems. Journal of the pathology, and techniques to avoid ultrasound ex- Acoustical Society of America, 117, 1148-1155. posure beyond what is considered safe for the fe- Fatemi, M., Ogburn, P. L., & Greenleaf, J. F. (2001). Fetal stimulation by tus. Any other use of "limited medical ultra- pulsed diagnostic ultrasound. Journal of Ultrasound in Medicine, 20, 883-889. sound" may constitute practice of medicine with- Garcia, J., Bricker, L., Henderson, J., Martin, M-A., Mugford, M., Nielson, out a license. The AIUM reemphasizes that all im- J., et al. (2002). Women's views of pregnancy ultrasound: A systemat- aging requires proper documentation and a final ic review. Birth, 29, 225-250. Gordon, R. (2003). Medical Networks Workshop, TRLabs. Paper presented report for the patient medical record signed by a at A New Paradigm for Medical Care in Canada, Winnipeg, Canada. physician.” (AIUM, 2005) Hanaoka, U., Yanagihara, T., Tanaka, H., & Hata, T. (2002). Comparison of three-dimensional, two-dimensional and color Doppler ultrasound in predicting the presence of a nuchal cord at birth. Ultrasound in Ob- Implications for Further Research stetrics and Gynecology, 19, 471-474. Ji, E. K., Pretorius, D. H., Newton, R., Uyan, A. D., Hollenbach, K., & Nel- Fetal exposure to ultrasound is not easy to study because of son, T. R. (2005). Effects of ultrasound on maternal-fetal bonding: A ethical and legal considerations (Woo, 2005). Long-term bi- comparison of two- and three-dimensional imaging. Ultrasound in ological effects are difficult to connect to individual medical Obstetrics and Gynecology, 25, 473-477. Kieler, H., Axelsson, O., Haglund, B., Nilsson, S., & Salvesen, K. A. (1998). occurrences in fetal development. Currently, 3D ultrasound Routine ultrasound screening in pregnancy and the children's subse- is a relatively new, very promising technology being used in quent handedness. Early Human Development, 50, 233-245. some venues without consideration of future effects on de- Kurjak, A., Stanojevic, M., Andonotopo, W., Salihagic-Kadic, A. Carrera, J. M., & Azumendi, G. (2004). Behavioral pattern continuity from prena- veloping babies; women are told that there are no known tal to postnatal life-a study by four-dimensional (4D) ultrasonography. adverse effects, yet few research endeavors have been di- Journal of Perinatal Medicine, 32, 346-353. Merz, E., & Welter, C. (2005). 2D and 3D ultrasound in the evaluation of rected at exposure levels or long-term problems. Research is normal and abnormal fetal anatomy in the second and third needed not only concerning the beneficial effects of ultra- trimesters in a level III center. Ultrasound in Medicine, 1, 9-16. sound in pregnancy but also its possible negative conse- Michailidis, G. D., Papageorgiou, P., Morris, R. W., & Economiders, D. L. (2003). The use of three-dimensional ultrasound for fetal gender deter- quences before women should submit to unlimited ultra- mination in the first trimester. British Journal of Radiology, 76, 448-451. sound scans during pregnancy.  Miller, M. (1999). Non-thermal, ultrasound-induced cellular effects and in- ertial cavitation activity. Retrieved June 7, 2005, from www.ece.rochester.edu/users/rcbu/99RCBUAnnual.pdf Claudia S. Wiseman is a Doctoral Student, School of Nurs- National Institute of Health (NIH). (1984). Diagnostic ultrasound imaging in ing, College of Health and Public Affairs, University of pregnancy. Report of an NIH Consensus Development Conference. (NIH Publication No. 84-667). Washington, DC: U.S. Government Printing Office. Central Florida, Orlando. She can be reached via e-mail at Newnham, J. P., Evans, S. F., Michael, C. A., Stanley, F. J., & Landau, L. I. [email protected]. (1993). Effects of frequent ultrasound during pregnancy: a randomized Ermalynn M. Kiehl is an Associate Professor, School of controlled trial. Lancet, 342, 887-891. Ohman, S. G., Saltvedt, S., Grunewald, C., & Waldenstrom, U. (2004). Does Nursing, University of Louisville, KY. fetal screening affect women's worries about the health of their baby? Academy of Obstetrics and Gynecology of Scandinavia, 83, 634-640. Rosenthal, M. B., Berndt, E. R., Donohue, B. A., Frank, R. G., & Epstein, A. References M. (2002). Promotion of prescription drugs to consumers. New Eng- American College of Radiology. (2005).Testimony by James Borstgstede, land Journal of Medicine, 346, 498-505. MD, Chair, Board of Chancellors, American College of Radiology for Rotten, D., & Levaillant, J. M. (2004). Two- and three-dimensional sono- the Subcommittee on Ways and Means. Retrieved November 3, 2006, graphic assessment of the fetal face: A systematic analysis of the nor- from http://waysandmeans.house.gov/hearings. mal face. Ultrasound in Obstetrics and Gynecology, 3, 224-231. American Institute of Ultrasound in Medicine (AIUM). (1992). Standard for Schild, R. L., Fimmers, R., & Hansmann, M. (2000). Fetal weight estima- real-time display of thermal and mechanical indices on diagnostic ul- tion by three-dimensional ultrasound. Ultrasound in Obstetrics and trasound equipment. Laurel, MD: American Institute of Ultrasound in Gynecology, 16, 445. Medicine. Severi, F. M., Bocchi, C., Florio, P., Picciolini, E., D’Aniello, G., & Petragilia, F. American Institute of Ultrasound in Medicine (AIUM). (2005).The AIUM (2003). Comparison of two-dimensional and three-dimensional ultra- releases new statement regarding keepsake imaging. Retrieved No- sound in the assessment of the cervix to predict preterm delivery. Ul- vember 3, 2006, from www.eurekalert.org/pub_releases/2005-08/ trasound Medical Biology, 29, 1261-1265. aiou-tar081005.php United States Food & Drug Administration (USFDA). (2005).Center for De- Capitulo, K. L., McClintock, R., & Armour, K. (2005). Second opinion: vices and Radiological Health (CDRH). CDRH consumer information: Should 3D ultrasound be used for nondiagnostic portraits? MCN The Fetal keepsake videos. Retrieved February 19, 2006, from American Journal of Maternal Child Nursing, 30, 2-4. www.fda.gov/cdrh/consumer/fetalvideos.html Chaoui, R., Kalacheand K. D., & Hartung, J. (2001). Application of three-di- Volker, R. (2005). The business of baby pictures: Controversy brews over mensional power Doppler ultrasound in prenatal diagnosis. Ultra- "keepsake" fetal ultrasounds. Journal of the American Medical Associ- sound in Obstetrics and Gynecology, 17, 22-29. ation, 293, 25-27. Clement, S., Wilson, J., & Sikorski, J. (1998). Psychological perspectives on Woo, D. J. (2005). History of ultrasound in obstetrics and gynecology. Re- pregnancy and . Edinburgh, Scotland: Churchill Livingstone. trieved May 27, 2005, from www.ob-ultrasound.net

March/April 2007 MCN 109