HOW THE REGISTRY WORKS
An eligible woman can register here or call TOLL-FREE 888.233.334 to obtain information and enroll. She is read an informed-consent document over the phone, and gives her verbal consent. She will then be interviewed 3 times: at enrollment (15 mins), at 7 months’ gestation (5 mins), and 6-8 weeks after delivery (10 mins).
The findings by the doctor of each exposed infant are obtained with the mother’s written permission. The study dysmorphologist uses established inclusion/exclusion criteria to identify major malformations (defined as structural abnormality with surgical, medical, or cosmetic importance). The Scientific Advisory Committee meets separate from the representatives of the sponsoring companies to anonymously review the major findings. Findings in women who have enrolled before having any prenatal screening, a “pure” prospective group, are used to decide when findings should be released
The criterion for release of results for a positive association (relative risk, >1) is met when the lower of the 95% confidence interval (CI) is greater than or equal to 2.0. The release criterion for no associated increase in the frequency of all major malformations is met when the upper of the 95% confidence limits does not exceed 2.0. The external comparison group is the findings in the Active Malformations Surveillance Program at Brigham and Women’s Hospital. The findings in 69,277 newborns was a baseline rate of 2.24%, which was reduced to 1.62% after excluding infants with genetic disorders and chromosome abnormalities. The major malformations are identified between birth and age 5 days. The inclusion/exclusion criteria are the same as those used in the North American AED Pregnancy Registry. As the total number of women taking the same AED as treatment increases we assess whether or not the frequency of specific birth defect, such as cleft lip or spina bifida, has occurred.