Ascertainment of malformations in pregnancy registries: Lessons learned in the North American AED Pregnancy Registry.

Background: Pregnancy registries, designed to assess the safety of medications and vaccines for the exposed mother and fetus, have been developed since the 1990s. Malformations present in the exposed liveborn or stillborn infant or fetuses in elective terminations are the outcome of greatest concern. The experiences of the North American AED (antiepileptic drug) Pregnancy Registry (NAAPR) can be used to identify the challenges and limitations of a pregnancy registry in identifying congenital malformations.

Fetal growth and premature delivery in pregnant women on antiepileptic drugs.

Objective: To evaluate the effects of epilepsy and antiepileptic drugs (AEDs) used during pregnancy on fetal growth and preterm delivery.

Methods: This study included singleton liveborn infants born to women enrolled in the North American Antiepileptic Drug Pregnancy Registry between 1997 and 2016. Data were collected prospectively through telephone interviews.

Advantages and problems with pregnancy registries: observations and surprises throughout the life of the International Lamotrigine Pregnancy Registry.

Purpose: The International Lamotrigine Pregnancy Registry monitored for a signal of a substantial increase in the frequency of major congenital malformations associated with lamotrigine exposures in pregnancy over an 18-year period. Key methodological lessons are discussed.

Methods: The strengths and weaknesses of the Registry were assessed using quantifiable methodological and operational parameters including enrollment, completeness of exposure and outcome data reporting, and lost to follow-up.

Association between topiramate and zonisamide use during pregnancy and low birth weight.

Objective: To assess the possible effects of topiramate and zonisamide use during pregnancy on fetal growth.

Methods: The study population was the singleton liveborns born to women who enrolled in the North American Antiepileptic Drug Pregnancy Registry between 1997 and 2012. Data were collected through telephone interviews at enrollment, 7 months of gestation, and postpartum.

Teratogenicity and antiepileptic drugs: potential mechanisms.

Congenital malformations often the most concerning risk of taking antiepileptic drugs (AEDs) during pregnancy for both the patient and the physician. This chapter reviews aspects of the association between AEDs and congenital malformations, including a historical perspective, type and patterns of congenital malformations, possible confounding factors, and potential mechanisms of teratogenicity. The role of folic acid in preventing birth defects in the general population and in setting of taking AEDs is also presented.

Risks and management of pregnancy in women with epilepsy.

Most women with epilepsy today can conceive and bear normal, healthy children, but their pregnancies present an increased risk for complications. Pregnancy can exacerbate seizure frequency in some women with epilepsy, and both maternal epilepsy and in utero exposure to antiepileptic drugs can increase the risk of adverse outcomes in children born to women with epilepsy. These outcomes include fetal loss and perinatal death, congenital malformations and anomalies, neonatal hemorrhage, low birth weight, developmental delay, and childhood epilepsy.

Management issues for women with epilepsy: neural tube defects and folic acid supplementation.

For infants exposed to antiepileptic drugs (AEDs) in utero, the risk for congenital malformations is approximately 4 to 6%, twice the rate reported in the general population. A variety of malformations have been reported in association with prenatal exposure to AEDs. However, a particular association of valproate and carbamazepine with neural tube defects (NTDs)--specifically, with spina bifida aperta (SB)--has been identified.

Clinical care of pregnant women with epilepsy: neural tube defects and folic acid supplementation.

Women with epilepsy (WWE) have a risk of bearing children with congenital malformations that is approximately twice that of the general population. Most antiepileptic drugs (AEDs) have been associated with such risk. Valproate and carbamazepine have been associated specifically with the development of neural tube defects (NTDs), especially spina bifida.