How the Registry Works
Women who are currently pregnant and taking AEDs for any reason can sign up as cases and women who are currently pregnant and not taking AEDs can sign up as controls. Current pregnancy is a key criterion for eligibility.
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A Registry representative will read you an informed-consent document over the phone and get your verbal consent, then enroll you, and conduct your first phone interview (15 mins).
Following your first interview, if you are taking AED medications, the Registry will e-mail you medical records release forms for the healthcare provider overseeing your AED, which we ask you to e-sign and e-mail back to us. If you are a control this step does not apply.
Around your seventh month of pregnancy, the Registry will call you for your second phone interview (5 mins).
When your infant is one or two months old, the Registry will call you for your third phone interview (10 mins).
Following your third interview, the Registry will e-mail you medical records release forms for your infant’s pediatrician, which we ask you to e-sign and e-mail back to us.
The findings by the doctor of each exposed infant are obtained with the mother’s written permission, which is obtained via steps three and six above. The study clinician uses established inclusion/exclusion criteria to identify major malformations (defined as structural abnormality with surgical, medical, or cosmetic importance). The Scientific Advisory Committee meets separately 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 289,365 births surveyed was a baseline rate of 2.1% which was reduced to 1.7% 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 increases we assess whether or not the frequency of a specific birth defect, such as cleft lip or spina bifida, has occurred.
When my neurologist gave me a brochure about the AED Registry, I didn’t hesitate to participate. I don’t want women to question if they can have a safe and healthy pregnancy. All of the other women out there who participated along with me have shown that it IS possible.