TOPICS ON THIS PAGE: Introduction | How You Can Help | Study Details | HIPAA | Questions?

INFORMATION FOR PROVIDERS

INTRODUCTION TO THE REGISTRY

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).

For a more detailed description of the creation and history of the Registry, please visit our About The Registry page.

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HOW YOU CAN HELP

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.

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STUDY DETAILS

Study Description:

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 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.

Medications being studied:

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.

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).

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WHAT ABOUT HIPAA?

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.

Information 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.

Confidentiality is very important to our participants and we take every precaution to uphold the privacy of each individual.

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