PBPK

STUDY BASICS

Are you a woman with epilepsy who is planning pregnancy? You may be eligible to participate in a research study that focuses on women with epilepsy during pregnancy. The purpose of this study is to learn more about anti-seizure medication blood level changes during pregnancy and the amount of exposure to the unborn child and nursing infant.

STUDY PURPOSE

Most women with epilepsy have normal pregnancies without complications. However, the blood concentrations of the antiseizure medications can be unstable during pregnancy and right after delivery. This could lead to seizure worsening if the dosages are not adjusted to compensate for this. This study will help to determine the timing and extent of these changes, to provide information that can lead to better treatment protocols for women on these medications in the future during pregnancy and childbirth. 

COULD THIS STUDY BE RIGHT FOR YOU?

• A woman between 18-45 years old
• Have a diagnosis of epilepsy
• Not currently pregnant but are planning pregnancy

WHAT PARTICIPANTS CAN EXPECT

This clinical research study involves approximately 6 visits.

• Preconception
• 1st Trimester
• 2nd Trimester
• 3rd Trimester
• Birth
• 6-12 weeks postpartum

If you decide to participate, you will be asked to have physical examinations, blood draws and collection of urine. You will also be shown how to use a paper diary to record your anti-seizure medication use, including the dose and time, missed doses, as well as seizure frequency and type.