The AED Pregnancy
Registry is affiliated with the Genetics
and Teratology Unit at Massachusetts
General Hospital in Boston, Massachusetts and is sponsored by Abbott,
Eisai, Novartis, Ortho-McNeil, Pfizer and Sunovion. The Registry is the
first North American Registry of its kind, encompassing the U.S.A. and
Canada. It began enrolling women in February 1997. Since that time over
8,500 women have enrolled (as of April 2012).
Please tell your patients to call the Registry TOLL FREE at 1-888-233-2334 to enroll in the AED Pregnancy Registry. We can only enroll women if they call themselves. Providers cannot enroll their patients, but they can tell their patients about the Registry and recommend that they call. The Registry truly depends on the enthusiasm of providers to tell their patients about the Registry and to strongly encourage them to participate.
Please feel free to download and print our brochure or flyer to distribute to your patients. If you would like us to send you copies of these items, please do not hesitate to contact us.
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 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.
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.
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).
Consistent with these guidelines, we have established several steps to protect any confidential information obtained. Information on potential enrollees is kept in a paper file (not entered into any computer) in a locked room to which only research staff have access. When women decide not to participate, the preliminary paper records are destroyed.
on participants is entered into the study computer, using a study number
as the only identifier. The names and other identifiers of each patient
are kept in a locked cabinet to which only the research staff have access.
Still have questions about the Registry? Please vist our Frequently Asked Questions page, or feel free to contact us.
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The AED Pregnancy Registry - The Massachusetts General Hospital
121 Innerbelt Road ~ Room 220 ~ Somerville, MA ~ 02143 ~ Toll Free: 888-233-2334
Sponsored by: Abbott, Eisai, Novartis, Ortho-McNeil, Pfizer, Sunovion, UCB
-How you can help