Registry Alerts Women to Substances Dangerous in Pregnancy
“Did you snort it or take it intravenously? . . . Oh, OK, it was crystal. . . . When did you take it? . . . Do you remember how often?”
Susanna Valji, a volunteer at the California Teratogen Registry, asked the questions matter-of-factly and listened carefully. She cradled the phone on her shoulder as she took notes and then opened up one of her reference books.
“And what month are you in? . . . Well, when was your last period?”
The woman on the other end of the line was pregnant. And she had been taking amphetamines.
For the last six years, concerned pregnant women who have been exposed to anything from aspirin, bug spray and caffeine to the entire spectrum of street drugs have dialed 294-3584 or (800) 532-3749 with their concerns. The California Teratogen Registry, an extension of the pediatrics department at UC San Diego Medical Center and funded by the state Legislature and by the medical center, fields a wide variety of questions. Some callers wonder whether they can safely have their hair dyed or get a permanent. Others are concerned about medications their doctors have prescribed.
Registry volunteers say they try to keep their responses strictly factual and non-judgmental. When questions come up that have nothing to do with teratogens, they refer the caller to an appropriate clinic or back to her doctor.
“There’s a lot of misinformation and old wives’ tales out there,” says Lyn Dick, a former Registry volunteer who now is associate coordinator of the program. “Some women tell us unbelievable things that they’ve heard. We can do a lot of education there.”
The California Teratogen Registry was started in 1979 by Dr. Kenneth Lyons Jones, a pediatrician and dysmorphologist who terms himself a “human teratologist.” He launched the program with Gerald (Buzz) Chernoff, an experimental teratologist now working at Washington State University. The meaning of the word “teratology” stems from “the study of the biological production of monsters,” meaning babies with birth defects.
“It’s a terrible word,” Jones says.
Not a Matter of Genetics
Teratology is not to be confused with the study of genetic birth defects. A teratogen is any agent, such as a drug, chemical or virus, that causes a defect. Registry brochures use the phrase “preventable birth defect.”
“We were being called by a number of pregnant women in this community who were concerned about a drug or chemical they’d been exposed to in their early pregnancy,” Jones said. “We were giving them whatever information was available, which frequently was no information.”
Jones was not only concerned about the lack of available information, but about the fact that he would lose touch with most callers right after talking with them.
“We suddenly became aware, one night, that in fact there was an experiment in human teratology going on, right in front of our faces. By that I mean, it was out there. Clearly one could not, nor would one want, to take a group of 100 pregnant women and give them a drug and see what happened to their baby when their baby was born. On the other hand, there were not only 100, but hundreds of women out there who were giving themselves drugs, some because they had to, others because they wanted to. Our awareness was, if we could just capture those women and follow those women through their pregnancy and see what happened to their baby, then we would have that study that obviously no human studies committee would ever allow you to do.”
The registry therefore was designed with two goals: to provide an educational service and to gain information.
“Pregnant women really are viciously protective of their unborn baby, and the vast majority of them, given the information, respond to that information positively,” Jones said. “I see it as our responsibility to give them that information. I have a lot of faith in pregnant women, in that they will do everything they can to prevent harming their unborn baby.”
Different Exposures Tracked
Initially, the registry was used mainly as a call-in information service. But in recent months, Jones and his staff have stepped up their effort to gather information and conduct follow-up examinations. As of mid-1984 the registry had logged about 27,000 calls, Jones said; it now averages about 1,000 calls monthly. About 40% of the calls come from San Diego County, and Jones hopes to increase that number so he can conduct a larger number of follow-up exams on babies born to women who are registered, thereby maximizing the research and refining the information that can be shared. To date, about 800 follow-up exams have been done on newborns.
Jones and his group are tracking 11 specific exposures: accutane, alcohol, anti-convulsants, chicken pox, cocaine, flagyl, lithium, hyperthermia, marijuana, PCP and Valium. Pregnant women who call for information and who have been or are being exposed to these agents are asked to register. When their babies are born they are given a free pediatric exam. The exam is non-invasive, and the study is “blind” --Jones does not know in advance what exposure the woman has registered.
Valji said over 80% of the women she asks to register agree to do so.
“When they don’t, it’s usually because they are pressed for time,” she said, “or because some are taking street drugs and are reluctant to give their names to an agency . . . even though we reassure them about the confidentiality.”
The 11 exposures under study are known to be teratogens in humans in some instances. The effect of heavy alcohol use during pregnancy on a fetus was documented by Jones 12 years ago as the fetal alcohol syndrome, though he says the warning against drinking during pregnancy dates back to the Bible. Compared with the general 4% to 5% risk of birth defects, Jones said there is a 45% risk of mental retardation and other problems in children born to mothers who are chronic heavy drinkers.
Accutane, a vitamin A derivative touted as a “miracle drug” for cystic acne, is another that is “very definitely a human teratogen,” Jones said. “But we’re studying it because we have no idea what the actual risk is.”
Hyperthermia--which can result from an unusually high fever or even from sitting in a hot tub or a sauna--is, on the other hand, very clearly documented as a teratogen in animals. Jones wants to find out whether it has a teratogenic effect on humans.
When women call the registry for information, they are often surprised that there is no information given on animal studies, Valji and others say.
“The effect of a drug on an organism is completely species-specific,” Jones explained.
There are very few animals in which Thalidomide (a sedative) is a teratogen, for example, while it was found to cause severe physical deformities in humans. Conversely, Jones added, “Cortisone is exquisitely teratogenic in most animals, and yet cortisone is not a teratogen in humans. Therefore, to base anything that we tell a pregnant women on studies that are totally different than the one she’s concerned about is not relevant and it’s not helpful to her.”
Cautious With Information
Those at the registry are very cautious to share only information that is known. Sometimes the information given simply boils down to a statement that there is no clear information.
“We never say, ‘Don’t worry. It’s not a threat.’ What we say is there’s no evidence to date, or no evidence based upon available data that this agent is a teratogen in humans,” Jones said.
“We’re just telling them the facts as they are known,” Dick said. “Mostly, we get calls where we don’t know anything--we tell them with their help maybe we can have those answers--or we get calls where we can be reassuring. And we always have to tell them that there is a 4% risk, no matter what they do.”
“You often have to say just that there’s no known increased risk,” Valji agreed. “You might say that other people who have called have chosen to stop, or you might ask, ‘Why take any risk?’ But in the training, you learn that you’re not there to tell them what to do with their pregnancy. You’re not there to pass judgment on them.”
Valji, who has volunteered at the registry since April, said she enjoys the counseling and being able to give people accurate information that is often very reassuring.
“You come away feeling very gratified when someone calls up with a total misconception and they’re feeling very anxious about a drug, and there isn’t any evidence to show there’s a risk associated with that drug. You get off the phone and you know that that person can breathe easy for the next nine months in a way she couldn’t before.”
