Third trimester and ready for your close-up

Angie and Barry Kruselearned the sex of their unborn daughter during a pair of ultrasound sessions with their obstetrician this summer. But the static-filled, two-dimensional, black-and-white photo of the 18-week-old fetus they named "Kennedy Joy" hardly satisfied their curiosity.

So, the Salem couple turned to Sneak Peek Video, a new business that offers three-dimensional ultrasound videos of fetuses. The live images are so detailed that at times the Kruses could clearly make out their daughter's face, nose, chin and eyes.

"This is better than ESPN," said Barry Kruse as he stared intently at his balled-up daughter slowly moving her arm on a 27-inch color screen, New Age music playing in the background. "It almost feels like we're cheating a bit."

Imaging centers such as Sneak Peek Video, which charge between $100 and $300 for what are known as fetal keepsake videos, have been around for about decade. But their growing popularity with expectant parents is drawing them into the cross hairs of a largely hostile medical profession.

Though there are no reports of any injuries caused by ultrasound exams in 50 years of use, the US Food and Drug Administration opposes exposing fetuses to the powerful ultrasound waves for no greater purpose than getting a neatly packaged DVD or video keepsake. Ultrasound waves increase the temperature in body tissue, the American Institute of Ultrasound in Medicine has noted, and should be used only when necessary and by physician-supervised personnel.

Technically, the FDA prohibits the promotion of keepsake videos, but the agency so far has done little more than issue stern warnings to the companies that offer them. Search the Internet, or read parenting magazines, and you'll find advertisements for dozens of businesses, including Fetal Fotos Inc., a national franchise with 14 stores, including outlets in shopping malls and West Hartford, Conn.

But there may be more regulations to come, at least at the state level. The state Board of Registration in Medicine plans to discuss placing limits on keepsake fetal videos at the September or October meeting.

"These machines are regulated and checked," said Dr. Beryl Benacerraf, professor of radiology, obstetrics and gynecology at Harvard Medical School. "If you start going outside the medical community, you don't know what you're getting.

"There just isn't any other test in medicine where someone is going to buy it and use it without supervision. Because it's so appealing to get a picture of that child's face, does all caution go to the wind?"

Dr. Laura Riley, a maternal fetal medicine specialist at Massachusetts General Hospital, also questioned how such businesses handle situations in which an ultrasound image reveals previously undetected problems.

"People go into these places expecting their baby is fine. Are they going to tell you there's a major malformation?"

But some doctors believe that their colleagues are getting worked up over the wrong issue. Family practitioner Audrey Tracy of Fitchburg routinely recommends patients to "That's My Baby" keepsake videos in Fitchburg, saying the parental bond magnifies when an expecting couple can see its growing child.

"It's such a routine exam. And who's to say that knowing what's going on with your baby and having some pictures isn't a good thing," Tracey said. "It's modern technology. We all use cellphones. Does that cause brain cancer? It doesn't seem to be, but we all thought that for a while."

Three-dimensional ultrasound does have some medical advantages, offering better images to diagnose a cleft palate, for example. But doctors can usually gather all the information they need about a fetus, such as the baby's size, sex, number of kidneys and heart condition, based on two-dimensional readings. Two-dimensional ultrasound machines are also more common because they are half or one-quarter the cost of three-dimensional ultrasounds, doctors say.

Some doctors say, however, that the 3-D images have another value -- reassuring nervous parents that their child is all right.

"It helps them feel good about the pregnancy, especially if they've had problems in the past," said Dr. Martin Crane, an obstetrician and chairman of the state Board of Registration in Medicine.

The Kruses say they were drawn to Sneak Peek in part by just such reassurance. An earlier ultrasound had shown Kennedy Joy had a bubble of fluid in her skull that can indicate other problems, such as a malformed jaw or hands.

Though Angie's second, two-dimensional ultrasound showed no problems, the Kruses said they weren't 100 percent sure things would be all right until they visited Sneak Peek.

"I could see she had a good chin and her hands were not clenched. It was for peace of mind," Barry Kruse said.

But the private services are selling more than just a better image of the fetus. Unlike with most hospital-provided ultrasounds, private businesses hold sessions in comfortable offices with dimmed lighting and smoothing music playing. Extended family members are invited to view exams. Angie Kruse's mother, Julie Erhart, was by her side. And while diagnostic exams usually last about 30 minutes, private sessions can be twice as long.

As of today, Massachusetts has no guidelines pertaining to such centers, leaving owners to operate and inspect ultrasound equipment on their own. Such ambiguity has left open the door for businesses such as Sneak Peak to enter the market with nothing more than a standard business license.

The lack of rules -- and the FDA warnings without further action -- leaves expecting parents to sift through mixed messages about the safety of ultrasounds.

"We had heard that there may be some risk with additional ultrasounds -- to use them as necessary," said Barry Kruse, a business consultant. "But we had a friend who had complications during her pregnancy who had 10 ultrasounds with her child, and the child is fine."

Tracey sai0 that doctors don't place limits on the number of ultrasounds they order for women, while in some countries, pregnant women are examined monthly.

Kelli Twiss, a homemaker and mother of four, and her husband, Dan, a union carpenter, purchased a used General Electric "4-D" ultrasound machine for about $50,000, rented an office, and opened in July, making them the closest 3-D center to Boston. While they have hired a trained ultrasound technician, or sonographer to run the equipment, they do not claim to be a medical practice or offer diagnostic exams.

Twiss said she would welcome state guidelines, but disagrees that her clients are at risk.

"If I were issuing any kind of medical diagnosis, I would agree with" the FDA's position, she said. "I think their concern is that people will use this instead of a doctor's care. I will not see anyone for their first ultrasound, and I screen everyone to make sure they are [seeing] a doctor."

Susan Maxim, who has worked as a sonographer for 13 years, opened "That's My Baby" in April 2002. Like Twiss, she said she runs an ethical and safe business, but would welcome better state or federal guidelines.

"I've called the FDA at least seven times and have never heard back from them," she said. "I just want to do this legally, the correct way. It's an excellent product." The FDA, through a spokesperson, said it could not comment on enforcement issues.

Maxim said she has voluntarily cut back the time she sees clients to 15 minutes, just to be on the safe side, and tries to follow the FDA's requirement that clients must have written prescriptions for ultrasounds. Twiss said that if the FDA told her to inform clients about the agency's view of keepsake video businesses, or require written prescriptions, or stop advertising, she would comply.

"If they say I can't advertise, I can't advertise," she said. "But word of mouth is where I get my business anyway. Moms want this."