Researchers from the Medical College of Georgia are soon to launch a study of whether the medicines the mothers-to-be must take to control seizures have a negative, lasting impact on their babies’ developing brains.
The study will follow 285 women taking one of the three most commonly prescribed anti-seizure medications from their first trimester until their children are several years old. Researchers want to determine what impact phenytoin, carbamazepine and valproate have on the children’s ability to think and learn.
"A really important aspect of this study is to find out if there is a difference between these drugs; are some of these drugs better for the child long-term than other drugs?" said Dr. Kimford J. Meador, chief of the MCG Section of Behavioral Neurology and principal investigator on the $6 million, five-year study funded by the National Institutes of Health. "If that’s true, then we will want women to try to use the drugs which have reduced adverse effects. It would dramatically alter how we prescribe drugs. But right now we don’t know if it’s true.
"We do know that the vast majority of women with epilepsy have healthy children," he said. "We are talking about a relatively small increased risk, but we want to reduce that risk as much as possible. We want them to have the same lack of risk other children have."
Dr. Meador emphasized that most women with epilepsy can have healthy children and that they should continue taking their medication while pregnant.
"In a woman who has significant seizures, the risk from the seizures themselves is worse than the risk of the drugs," Dr. Meador said. "The number-one reason for miscarriage late in pregnancy for women with epilepsy is trauma (resulting from a seizure)."
Researchers at 17 study sites in the U.S. will collect data on mothers, fathers and babies in an effort to determine the impact.
Much of the data is the type normally accumulated during pregnancy, but they will look at other parameters as well such as the mother’s seizure frequency and blood levels of the medication. They will perform IQ tests on mothers and fathers to get a predictive IQ for the baby and, beginning at about age 2, will do similar testing on children. They also will gather data on the children’s nutritional status and general health, noting milestones such as when children begin to walk and talk. Contributing risk factors, such as low socioeconomic status and poor diet, also will be considered. The NIH-funded study will focus on women taking one of the three oldest anti-seizure medications, but Dr. Meador hopes to expand the study to include some newer drugs as well.