UC studies epileptic moms-to-be

Better understanding the risks that some epileptic women and their children face is the goal of a major, decade-long national study now underway at 20 medical centers, including the University of Cincinnati.

Most children born to mothers with epilepsy are normal, although some are at increased risk for developmental delays or problems, including with their behavior and thinking. Babies of epileptic mothers suffer anatomical birth defects at roughly twice the rate as other babies. The mothers also face potential problems, ranging from seizures and depression to the challenge of switching medications to additional complications such as C-section births.

The problem that doctors and patients face is complex because the easy fix – taking women off their anti-epilepsy medications – is no solution. Pregnant women with uncontrolled epilepsy risk injury or death to both themselves and their unborn children.

"If we could take women off these medications (to have children), we would," explained Dr. Jennifer Cavitt, a UC associate professor of neurology who is an investigator on the study. Because some people with epilepsy respond to one drug and not to others, the challenge for doctors is to identify the proper drug and determine the minimally effective dose that will keep seizures from happening.

The goal of the 10-year study of 550 women is to understand if there are differences in how anti-epileptic drugs affect both mother and child. Researchers say 1 million American women of childbearing age have some type of seizure disorder and about 20,000 of them have children in a typical year.

The study is unusual because not only pregnant women with epilepsy are eligible to enroll in it, but so are healthy pregnant women without epilepsy and women with epilepsy who aren't pregnant. The idea is to compare the results from the different groups and see what role epilepsy and the different drugs used to control it play in such pregnancy issues as sleeping problems and postpartum depression. "We want it to be open to all women," Cavitt said.

In addition, the child's father and a first-degree relative of each mother will be invited to participate in the study to provide additional family information.

Finally, children born to epileptic mothers will undergo testing for intelligence, autism and other cognitive measures until they turn 6.

For an epileptic mother, testing of their children "is a real advantage," said study participant Megan Patel.

Patel, who is expecting her first child in September, was diagnosed with the disease in the fall of 2010, after her marriage that summer. The diagnosis was made after the former schoolteacher had a seizure that doctors "attributed to stress."

She and her husband, a post-doctoral fellow at the UC Medical Center, moved here in 2013. Although the couple wanted children, they were "a little nervous at first," Patel said. But knowing that epilepsy is not hereditary made the decision easier. "It wasn't a big concern" in the end, Patel said.

Patel's doctors moved her to a different anti-epilepsy drug once she and her husband decided to have a baby.

"No matter what medication they're receiving, women with epilepsy should work closely with their doctors in planning pregnancy and be closely monitored during pregnancy to minimize the risk of mother and child," said Dr. Michael Privitera, director of the UC Epilepsy Center, in a statement. Privitera and Cavitt are leading the study locally with Dr. Kellie Flood-Shaffer, associate professor of obstetrics and gynecology.

The UC Medical Center enrolled more people than any other site in a previous study, published in 2009, that included a recommendation that valproate (marketed under the brand name Depakote) not be used as the anti-epilepsy drug of first choice in women of child-bearing age.

Women in the current study will get an iPad Touch to answer daily questions from an interactive electronic diary about their moods, sleep, seizures, medications and other information. Participants can keep the iPad after the study.

Non-pregnant women with epilepsy will be followed for 18 months; pregnant women will be followed until their children turn 6.

The extra care for study participants and the knowledge expected to be gained from it "are such a gift to women with epilepsy," Patel said.

The $8.9 million study is being sponsored by the National Institute of Neurological Disorders and Stroke and the National Institute of Child Health and Human Development. ¦

To learn more about the national study, go to web.emmes.com/study/monead/index.htm.

To get more information about the local arm of the study or to enroll in it, contact study coordinator Lucy Mendoza at 513-558-3020 or via email at mendozlc@ucmail.uc.edu

FINDING SIX ANSWERS

Three key questions a study now underway at the University of Cincinnati and 19 other sites nationally will try to answer about epileptic mothers are:

• Which drug causes the lowest incidence of malformations or other problems in children born to mothers with epilepsy receiving anti-epileptic drugs?

• Does having epilepsy and/or taking anti-epileptic drugs increase the risk of pregnancy complications such as eclampsia (seizures in a pregnant woman not related to a pre-existing brain condition) or other problems?

• Does pregnancy cause worsening of the epilepsy in the mother?

Three key questions it will try to answer about their children are:

• Does long-term in utero anti-epileptic drug exposure affect verbal intellectual abilities and other neurobehavioral outcomes? Anti-epilepsy drugs are designed to work on targets in the brain to stop the neurotransmitters that trigger seizures. Once the drugs cross the blood/brain barrier in their mother, they are going to the fetus, through the mother's placenta.

• Are newborns more likely to be small for their gestational age or have other adverse neonatal outcomes?

• Does breastfeeding when taking these drugs impair the child's ultimate verbal and other cognitive outcomes?

This last question is especially crucial since breastfeeding is normally preferred by pediatricians as a way to boost a baby's health and is usually recommended for epileptic mothers. But anti-epilepsy drugs "will cross into breast milk," said Dr. Jennifer Cavitt, a UC associate professor of neurology.