Benefits and Risk of Fetal 3D Ultrasound ABSTRACT 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, 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 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 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 fetus 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 Radiology (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 birth weight, 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