The process was very quick and easy! The research team’s calls lasted only a few minutes and the researchers were very friendly over the phone. I’d highly recommend pregnant women participate in this study.
– Elizabeth
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, as are women who are currently pregnant and not taking anticonvulsant drugs (controls). Women who have completed their pregnancy, or women who are planning to become pregnant are not eligible to enroll.
Outcome Variables
The medical records of the anticonvulsant drug-exposed infants are obtained to confirm that the infant does or does not have a major malformation.
Outcomes Evaluated
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).