Trial Information

Summary: Lamotrigine Pregnancy Registry – examining pregnancy outcomes of women exposed to lamotrigine

The purpose of the Registry is to assess whether there is any large risk of major malformations following exposure to lamotrigine in pregnancy and to provide information on outcomes following pregnancy exposure to lamotrigine so that patients and physicians can best determine how to manage pregnancies. The combination of the large number of women with epilepsy who are of reproductive capacity and the lack of data concerning lamotrigine use during pregnancy makes such a Registry an essential component of the ongoing program of epidemiologic studies of the safety of lamotrigine. This study is an observational, exposure-registration, and follow-up study. Patient confidentiality is strictly upheld. Furthermore, the Registry has initiated a registration process which will protect patient anonymity at the Registry Office. The intent of the Registry is to prospectively collect data concerning exposure to lamotrigine during pregnancy, potential confounding factors (such as exposure to other antiepileptic medications, the number and severity of seizures occurring during pregnancy), and information related to the outcome of the pregnancy.

The Lamotrigine Pregnancy Registry is managed by GlaxoSmithKline considering the advice of the CDC, a U.S.-based institution, neurology, and teratology specialists. These individuals provide independent review of the data as members of the Advisory Committee for the Registry. The Registry began in September 1992.

The minimum criteria required to enroll a subject are:

• Country of origin of the report
• Documentation that lamotrigine was taken during pregnancy,
• Sufficient information to determine whether the pregnancy is being prospectively or retrospectively registered
• Date the pregnancy was registered
• Source of the report (health care professional, subject)
• Whether the outcome of pregnancy was known at the time of the report
• Timing of the prenatal exposure to lamotrigine (no broader than trimester during which the exposure took place),
• Full reporter contact information to allow for follow-up (name, address, etc.)

If you would like to learn more about participating in this study, please send an e-mail message using the form below.