The study is being conducted in the General Clinical Research Center at the Massachusetts General Hospital. The enrollment process includes: 1) verbally agreeing to the informed consent document read to the participant over the phone; 2) participants are sent release forms to sign and return by mail; these forms are mailed to the mother’s neurologist, a psychiatrist and her infant’s pediatrician to obtain copies of their findings this documentation is very helpful in confirming the heath status of the infant and helps to document the reason that the mother is taking the anticonvulsant drug.
A major goal of The Registry is to document how many infants exposed to each drug during pregnancy have a major malformation. These findings are used to determine whether or not the mother’s use of this drug in pregnancy is associated with an increased risk of malformations. The Registry also evaluates whether there is an increase in the occurrence of any specific abnormalities, such as spina bifida, heart defects or cleft lip and palate.
Inclusion | Exclusion
Any woman who is pregnant and taking anticonvulsant drugs for any reason is eligible to participant in The Registry. Women who have completed their pregnancy, or women who are planning to become pregnant are not eligible to enroll.
The medical records of the anticonvulsant drug-exposed infants are obtained to confirm that the infant does or does not have a major malformation.
A major malformation is defined as a structural abnormality with surgical, medical or cosmetic importance. Features excluded as not being major malformations are: minor anomalies, deformities, physiologic features (such as patent ductus arteriosus heart defect in a premature infant), biochemical disorders (PKU, cystic fibrosis) and neurologic findings (hearing loss).